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The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

The ACL TOP Family 50 Series are fully automated coagulation analyzers that utilize the same intuitive software, the same consumables, reagents, calibrators and controls, and provide the same analytical methodology for routine and specialty assay result reporting as the predicate ACL TOP Family.

The ACL TOP Family 50 Series instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family:

• Coagulometric (Turbidimetric) Measurements
• . Chromogenic (Absorbance) Measurements
• . Immunological Measurements

The ACL TOP Family 50 Series also offers new pre-analytical features not available on the current ACL TOP Family as described below. These features are not intended to replace laboratory quality policies. The features simply alert the instrument operator to a potential HIL (Hemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog. The user will determine how to handle these situations (for example, by not reporting the results, or reporting the results with, or without, additional comments).

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical or performance study for a diagnostic device.

This document is a 510(k) summary for a Special 510(k) submission, focusing on software changes (new remote features and enhanced cybersecurity measurements) to an existing device, the ACL TOP Family 50 Series. The key statement regarding acceptance criteria and proof of performance is:

"The software verification and validation study results demonstrate that the ACL TOP Family 50 Series with updated nonanalytical features is safe and effective for its intended purpose and equivalent in performance to the predicate device (K150877)."

This indicates that the "acceptance criteria" were related to the software's functionality, security, and the assertion that these non-analytical changes do not impact the analytical performance of the instrument. The "study" mentioned is a "software verification and validation study."

Given this, I will extract and infer the information based on the context of a software-focused 510(k) for a device where analytical performance is already established by a predicate.

Here's the breakdown based on your requested format:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document refers to a "software verification and validation study results." For software changes, the "test set" would typically involve functional and security testing scenarios rather than patient data. The document does not specify a sample size in terms of patient data or the provenance (country of origin, retrospective/prospective) because the changes are non-analytical software updates to an existing, already cleared device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable based directly on the provided text, as the "ground truth" for these software functionalities would be their correct operation and security posture, established by software engineers, cybersecurity experts, and regulatory experts. The document does not detail specific experts or their qualifications for the V&V study.

4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation of medical images or tests. For software verification and validation of non-analytical features, testing protocols and bug reporting/resolution processes would be used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is a coagulation analyzer, not an AI-powered diagnostic imaging device involving "human readers." The changes specifically "do not impact the analytical performance of the instrument."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a device that runs algorithms for coagulation measurements, and the "standalone" performance of these measurement algorithms was established by the predicate device (K150877). The new features are remote control and cybersecurity updates, not new analytical algorithms. The software verification and validation focused on these new non-analytical features operating correctly without human intervention (e.g., remote update deployment), but this is not an "algorithm only" performance study in the typical sense for clinical impact.

7. The type of ground truth used
For the software verification and validation related to the new remote and cybersecurity features, the "ground truth" would be:

• Functional Specification Adherence: The software correctly performs the defined remote control and update delivery functions according to its design specifications.
• Security Standard Compliance: The cybersecurity features meet established security standards and mitigate identified risks.
• Non-Interference: The new features do not interfere with the validated analytical performance of the device.

8. The sample size for the training set
Not applicable. This is a software update for an existing medical device, not a machine learning or AI algorithm development that requires a "training set" of data.

9. How the ground truth for the training set was established
Not applicable, as there is no training set for the software changes described.

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The ACL TOP Family 70 Series (ACL TOP 370, ACL TOP 570 and ACL TOP 770 / 770s / 770 LAS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use by health care professionals in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

The ACL TOP Family 70 Series are fully automated coagulation analyzers that utilize the same intuitive software, the same consumables, reagents, calibrators and controls, and provide the same analytical methodology for routine and specialty assay result reporting as the predicate ACL TOP Family 50 Series.

The ACL TOP Family 70 Series instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family 50 Series:

• . Coagulometric (Turbidimetric) Measurements
• Chromogenic (Absorbance) Measurements .
• . Immunological Measurements

The ACL TOP Family 70 Series also offers the same pre-analytical features available on the ACL TOP Family 50 Series. These features alert the instrument operator to a potential HIL (Hemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog.

Here's a breakdown of the acceptance criteria and study details for the ACL TOP Family 70 Series device, based on the provided document:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the ACL TOP Family 70 Series appears to be demonstrating equivalent analytical performance to its predicate device, the ACL TOP Family 50 Series, across various representative assays. This equivalency is assessed through precision and method comparison studies.

Table of Acceptance Criteria and Reported Device Performance:

• HemosIL D-Dimer HS 500: Low Control Total %CV 4.8, High Control Total %CV 2.1
• HemosIL Factor VIII: Normal Control Total %CV 3.4, Abnormal Control Total %CV 4.8
• HemosIL RecombiPlasTin 2G (PT): Normal Control Total %CV 1.8, High Abn Control %CV 4.0
• HemosIL RecombiPlasTin 2G (Fibrinogen): Normal Control Total %CV 3.9, Low Fibrinogen Control %CV 8.1
• HemosIL Liquid Anti-Xa: UF Low Control Total %CV 1.8, LMW High Control Total %CV 2.2 |
  | Method Comparison | Linear regression analysis (slope, intercept, correlation coefficient 'r') between the subject device and predicate device should demonstrate equivalent performance across the analytical measuring range (AMR), according to established guidelines (CLSI EP09c. 3rd Ed). | Successfully met criteria. All studies showed strong correlation (r ≥ 0.998) and slopes close to 1 with intercepts close to 0, indicating equivalence. Examples:
• HemosIL D-Dimer HS 500: Slope 1.022, Intercept 0.5575, r 0.998
• HemosIL Factor VIII: Slope 1.006, Intercept -0.0587, r 0.998
• HemosIL RecombiPlasTin 2G (PT): Slope 1.012, Intercept -0.0940, r 1.000
• HemosIL RecombiPlasTin 2G (Fibrinogen): Slope 0.9756, Intercept -1.1220, r 0.999
• HemosIL Liquid Anti-Xa: Slope 0.9804, Intercept -0.0145, r 0.999 |
  | Overall Conclusion | Updates introduced do not impact the labeled performance data of the current menu of FDA-cleared assays. Device is safe and effective for its intended purpose and equivalent in performance to the predicate device. | Analytical study results demonstrate that the ACL TOP Family 70 Series, with updated non-analytical features, is safe and effective for its intended purpose and equivalent in performance to the predicate device (K150877). |

Study Details:

1. Sample size used for the test set and the data provenance:

   • Precision Studies:
     • For each material/control for the selected representative assays, samples were run for 20 days at two runs per day, 2 replicates per run, resulting in a total of n=80 data points per material.
     • Provenance: Not explicitly stated, but based on the context of an FDA submission for an in vitro diagnostic device, these would typically be laboratory-generated samples or commercial control materials. The studies were performed internally by the manufacturer ("Instrumentation Laboratory Company").
   • Method Comparison Studies:
     • Sample sizes varied per assay:
       • HemosIL D-Dimer HS 500: N = 116 clinical samples
       • HemosIL Factor VIII: N = 104 clinical samples
       • HemosIL RecombiPlasTin 2G (PT): N = 116 clinical samples
       • HemosIL RecombiPlasTin 2G (Fibrinogen): N = 114 clinical samples
       • HemosIL Liquid Anti-Xa: N = 207 clinical samples
     • Provenance: The studies included "clinical samples spanning each assay's analytical measuring range (AMR)." The country of origin of these clinical samples is not specified, but they are prospectively collected or selected for the study based on their span across the AMR.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This being an in vitro diagnostic (IVD) device for laboratory analysis, the "ground truth" for the test set is established by the measurement itself on a recognized, cleared, and well-characterized comparator device (the predicate ACL TOP Family 50 Series), or by the known concentrations/activity of control materials. It's not a subjective interpretation task that requires human adjudication or expert consensus in the same way as, for example, image-based diagnostic AI. Therefore, no human experts are explicitly mentioned as establishing a subjective ground truth for these analytical performance studies. The "ground truth" for method comparison is the performance of the predicate device.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • None. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., radiology reads) where discrepancies need to be resolved. For analytical performance studies of a medical device measuring quantitative analytes, the ground truth is objective (the measured value from the predicate device or a known concentration in a control).

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. An MRMC study is not applicable here as this is an in vitro diagnostic instrument, not an AI-assisted diagnostic tool that involves human readers interpreting cases. The device automatically performs coagulation and/or fibrinolysis testing.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, effectively. The entire study evaluates the analytical performance of the device itself (the ACL TOP Family 70 Series) in a standalone manner. While trained lab personnel operate the instrument, the performance metrics (precision, method comparison) are about the instrument's ability to produce accurate and precise results, independent of human interpretive intervention for the results themselves. The device's "algorithm" (its internal measurement and calculation processes) is being evaluated.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For precision studies, the ground truth is the known concentration/activity of control and plasma pool materials.
   • For method comparison studies, the ground truth is the measured values obtained from the predicate device (ACL TOP Family 50 Series) for the same clinical samples. The principle is to see if the new device produces equivalent results when compared to an already accepted diagnostic method.

7. The sample size for the training set:

   • The document does not mention a training set in the context of machine learning or AI model development. This device is an IVD instrument that utilizes established analytical methodologies (coagulometric, chromogenic, immunological measurements) and software, rather than a machine learning model that requires a discrete training phase with labeled data. The studies performed are verification and validation studies to demonstrate performance and equivalency to a predicate.

8. How the ground truth for the training set was established:

   • As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The device's operation is based on pre-defined analytical principles, not on learning from a training dataset to establish a ground truth.

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The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters.

The ACL TOP Family are fully automated coagulation analyzers that utilize the same intuitive software, the same consumables, reagents, calibrators and controls, and provide the same analytical methodology for routine and specialty assay result reporting as the predicate ACL TOP Family. The ACL TOP Family instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family: Coagulometric (Turbidimetric) Measurements Chromogenic (Absorbance) Measurements Immunological Measurements

This document is a 510(k) premarket notification for a medical device called ACL TOP. The purpose of this submission is to demonstrate that the updated ACL TOP device, which has switched its operating system from Windows XP to Windows 7, is substantially equivalent to its legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here is "Substantial Equivalence" to the predicate device. For a Special 510(k) submission, this means there are no changes to the indications for use or operating principle, and no changes to labeled performance claims, hardware, data reduction software, test parameters, calibration, quality controls, or consumables/reagents.

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This is a Special 510(k) submission primarily focused on an operating system change, where the core assumption is that due to no changes in critical operational aspects (hardware, reagents, methodology, etc.), the performance remains substantially equivalent to the predicate. Such submissions typically rely on verification and validation activities demonstrating that the new software does not negatively impact existing performance, rather than a full clinical study with a patient test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This type of submission relies on technical verification and validation of the software change, ensuring that it operates as intended and does not alter the established clinical performance of the device previously demonstrated for the predicate. There is no mention of expert-established ground truth for a clinical test set in this document.

4. Adjudication Method for the Test Set

Not applicable. As noted above, there is no clinical test set described that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This document does not mention a MRMC comparative effectiveness study. This device is a coagulation instrument, not an AI-assisted diagnostic imaging device that would typically undergo such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an automated coagulation analyzer. Its "standalone" performance is its fundamental operation (i.e., producing test results). The change to the operating system is intended to maintain this standalone performance. No separate "algorithm-only" study distinct from the device's inherent function is described in the context of this submission.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the established and cleared performance of the predicate ACL TOP Family devices. The updated device is considered substantially equivalent if it performs identically or comparably to the predicate for all stated measurement parameters and clinical indications. The document describes the device's functionality as "results for both direct hemostasis measurements and calculated parameters," implying that the accuracy of these measurements against established principles and validated methods would be the "ground truth" for the device's function.

8. The Sample Size for the Training Set

Not applicable. This device is an in-vitro diagnostic instrument for coagulation testing, not a machine learning or AI algorithm in the context of a "training set" as commonly referred to in AI development. The software change is an operating system update, which would involve software development and testing, but not typically a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the AI sense for this device. The ground truth for the device's performance would have been established during the development and clearance of the predicate devices, likely through extensive analytical and clinical validation studies against reference methods and clinical outcomes.

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The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

The ACL TOP Family 50 Series are fully automated coagulation analyzers that utilize the same intuitive software, the same consumables, reagents, calibrators and provide the same analytical methodology for routine and specialty assay result reporting as the predicate ACL TOP Family. The ACL TOP Family 50 Series instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family: Coagulometric (Turbidimetric) Measurements, Chromogenic (Absorbance) Measurements, Immunological Measurements. The ACL TOP Family 50 Series also offers new pre-analytical features not available on the current ACL TOP Family: Pre-Analytical HIL Check, Pre-Analytical Tube Fill Height (THF) Check, and Pre-Analytical Clog Detection.

Acceptance Criteria and Device Performance for ACL TOP Family 50 Series

This document outlines the acceptance criteria and the results of the studies demonstrating that the ACL TOP Family 50 Series coagulation analyzers meet these criteria. The device is intended for in vitro diagnostic clinical use for hemostasis and fibrinolysis testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established through internal and external precision, linearity, and method comparison studies, specifically aiming for performance comparable to the predicate device (ACL TOP Family) and within CLSI guidelines. While explicit numeric acceptance criteria are not presented as a single consolidated table, the pass/fail status indicated in the reproducibility study and the strong correlation coefficients/slopes in the method comparison studies serve as de-facto acceptance criteria. The device consistently passed these criteria across various assays and models.

2. Sample Sizes Used for the Test Set and the Data Provenance

• Precision Study (Internal):

  • Sample Size: 80 replicates per level for each of 12 assays on each instrument model (ACL TOP 350 CTS, ACL TOP 550 CTS, ACL TOP 750 CTS, ACL TOP 750). This involved commercially available assays and their assayed control materials, as well as a prepared patient plasma pool.
  • Data Provenance: Internal, not specified country of origin, retrospective or prospective not explicitly stated but implies prospective as part of a 20-day study.

• Precision Study (External):

  • Sample Size: 80 replicates per level for each of 11 assays (two levels of control materials) on one ACL TOP 550 CTS model at three external US sites.
  • Data Provenance: Three US external sites, implies prospective as part of a 20-day study.

• Reproducibility Study (External):

  • Sample Size: 30 replicates per level for each of 12 assays (two levels of control materials) on one ACL TOP 550 CTS model at three external US sites.
  • Data Provenance: Three US external sites, implies prospective as part of a 5-day study.

• Linearity Study (Internal):

  • Sample Size: Minimum of 9 levels tested in quadruplicate for each of 10 assays on each instrument model (ACL TOP 350 CTS, ACL TOP 550 CTS, ACL TOP 750 CTS, ACL TOP 750). This involved prepared plasma pool panels.
  • Data Provenance: Internal, not specified country of origin, implies prospective.

• Method Comparison Study (External):

  • Sample Size (Assays): Ranged from 61 to 146 patient samples per assay at each of the three US external sites.
  • Sample Size (HIL Check): Hemoglobin (244-269 samples), Bilirubin (249-267 samples), Lipemia (257-272 samples) at each of the three US external sites.
  • Data Provenance: Three US external sites, patient samples, implies prospective.

• Pre-Analytical Clog Detection Testing:

  • Sample Size: Not explicitly stated beyond "All instrument models" (2 ACL TOP 350 CTS; 2 ACL TOP 550 CTS; 2 ACL TOP 750; 2 ACL TOP 750 CTS; 1 ACL TOP 750 LAS).
  • Data Provenance: Internal, likely simulated occluded samples.

• Pre-Analytical Tube Fill Height Check Testing:

  • Sample Size: Not explicitly stated beyond "All instrument models" (2 ACL TOP 350 CTS; 2 ACL TOP 550 CTS; 2 ACL TOP 750; 2 ACL TOP 750 CTS).
  • Data Provenance: Internal, likely simulated underfilled tubes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• For clinical assays (Precision, Linearity, Method Comparison): The ground truth is established by the calibrated reference methods and control materials themselves, which are well-established in clinical laboratory standards. No human "experts" are explicitly mentioned whose adjudication was required to establish ground truth for these quantitative measurements, as the values are determined by the analytical process and certified controls.
• For Pre-Analytical HIL Check (Lipemia): "Visual Matching" was used as a reference for Lipemia. While not explicitly stated, this would typically involve trained laboratory personnel or experts in visual assessment of lipemia. The number and qualifications of these individuals are not specified in the provided text.
• For Pre-Analytical Clog Detection and Tube Fill Height Check: The ground truth for these functional tests was whether the instrument correctly detected the intentionally created conditions (occluded probe, underfilled tube). This doesn't rely on expert human judgment for each instance, but rather on the designed functionality of the system.

4. Adjudication Method for the Test Set

• For the quantitative clinical assays, there is no indication of an adjudication method involving multiple human readers as the output is a numerical measurement. The CLSI guidelines followed (EP05-A2, EP09-A3) dictate statistical analysis of quantitative results.
• For the Lipemia "Visual Matching" reference method, no specific adjudication method (e.g., 2+1, 3+1) is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done, as this device (ACL TOP Family 50 Series) is a fully automated laboratory instrument for coagulation testing, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers. The new pre-analytical features (HIL Check, Tube Fill Height Check, Clog Detection) are described as alerts to the instrument operator, but there is no mention of an AI component or a study on human reader performance with or without such assistance. The device's primary function is quantitative measurement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are all standalone validations of the instrument's performance. The "ACL TOP Family 50 Series" is a fully automated analyzer. The precision, linearity, and method comparison studies directly evaluate the algorithm's (instrument's) ability to accurately and precisely measure coagulation parameters and detect pre-analytical issues without human intervention in the measurement process itself. The "Pre-Analytical HIL Check," "Pre-Analytical Clog Detection," and "Pre-Analytical Tube Fill Height Check" are new algorithmic features designed to flag samples automatically. The performance of these flags is evaluated in a standalone manner against a reference method (for HIL) or by simply checking if the instrument's detection mechanism worked correctly (for clog and tube fill).

7. The type of ground truth used

• For clinical assays (Precision, Linearity, Method Comparison): The ground truth is primarily based on reference methods and assayed control materials with known concentrations/values, as per established clinical laboratory standards (e.g., CLSI guidelines). For method comparison, the predicate device (ACL TOP 500) served as the reference for patient samples.
• For Pre-Analytical HIL Check:
  • Hemoglobin: HemoCue (K000043) was used as the reference device.
  • Bilirubin: Envoy 500 (K945271) was used as the reference device.
  • Lipemia: "Visual Matching" was used as the reference.
• For Pre-Analytical Clog Detection and Tube Fill Height Check: The ground truth was known induced conditions (occluded probe, underfilled tubes) that the instrument was designed to detect.

8. The sample size for the training set

The provided document describes validation studies (precision, linearity, method comparison) for the ACL TOP Family 50 Series. It does not explicitly mention a "training set" or "test set" in the context of machine learning, implying that the device's algorithms for analytical measurements are based on established physicochemical principles and validated through these performance studies rather than being developed through a machine learning training paradigm. The studies described are for validation of the device's performance, not for training a model.

9. How the ground truth for the training set was established

As there is no explicit mention of a "training set" in the context of machine learning for generating the core analytical measurements or the pre-analytical flagging algorithms, the question of how ground truth was established for a training set is not applicable based on the provided information. The device's foundational analytical capabilities would have been developed using known chemical/biological principles and standard calibration processes. The new pre-analytical features are described as programmed detections (e.g., measuring at 535 nm for HIL, pressure transducer for clogs, optical detection for tube fill) and their performance validated against reference methods or known conditions.

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The ACL TOP 700 LAS is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.

The system provides results for both direct hemostasis measurements and calculated parameters.

The ACL TOP 700 LAS is being introduced as a new family member to the ACL TOP (K073377), with the added feature of an extra arm and hardware to interface with laboratory automation systems (LAS). A Point-in-Space design solution is utilized where the patient sample remains under the control of the laboratory automation system (i.e., the automation track) and the ACL TOP 700 LAS analyzer aspirates an aliquot for sample analysis without removing the primary container from the automation track. The instrument's system software was also modified to interface with an IM (interface module) computer, which controls the communications to the LAS system.

The provided text describes the regulatory clearance for the ACL TOP 700 LAS coagulation instrument, asserting its substantial equivalence to a predicate device (ACL TOP K073377). However, the document (a 510(k) summary) focuses on the reason for submission and comparison to predicate device, stating that testing demonstrated substantial equivalence rather than providing specific acceptance criteria and detailed study results for the new device.

Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text, as this type of detailed study report is typically found in the full 510(k) submission, not the publicly available summary.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the given 510(k) summary. The summary states: "Testing demonstrated that the performance of the ACL TOP 700 LAS is substantially equivalent to the performance of the current legally marketed ACL TOP family (K073377)." This implies that the acceptance criteria for the new device were implicitly met by demonstrating performance equivalent to the predicate, but the specific criteria (e.g., precision, accuracy ranges) and the numerical results are not detailed.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the 510(k) summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the 510(k) summary. For a coagulation instrument, "ground truth" would typically relate to the accuracy and precision of its measurements compared to reference methods or established standards, rather than expert consensus on a diagnostic image.

4. Adjudication Method for the Test Set:

This information is not provided in the 510(k) summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

This information is not provided in the 510(k) summary. MRMC studies are typical for diagnostic imaging devices where human interpretation is involved. This device is a fully automated laboratory instrument; therefore, an MRMC study is unlikely to be relevant or performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The device is described as "fully automated," suggesting its performance would inherently be standalone (algorithm/instrument only). However, specific performance metrics of a standalone study are not detailed beyond the statement of substantial equivalence.

7. The Type of Ground Truth Used:

For a coagulation instrument, the "ground truth" would likely be established through reference methods, calibrated standards, and known-concentration samples. The 510(k) summary does not specify the exact type of ground truth used, but it implicitly relies on established laboratory practices for validating instrument performance.

8. The Sample Size for the Training Set:

This information is not provided in the 510(k) summary. For a coagulation instrument, "training set" might refer to data used for internal calibration or algorithm development, but it's not discussed in the context of clinical validation data in this summary.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided in the 510(k) summary.

Summary of Available Information from the Provided Text:

• Device Name: ACL TOP 700 LAS
• Predicate Device: ACL TOP (K073377)
• Nature of Study: A substantial equivalence demonstration (Special 510(k)) based on testing that confirmed the new device's performance is equivalent to the predicate.
• Key Change: Addition of an extra arm and hardware for interface with Laboratory Automation Systems (LAS), allowing aspiration without removing the primary container from the automation track. System software was also modified for LAS interface.
• Claim: The ACL TOP 700 LAS shares the same intended use/indications for use, analytical technology/operating principle, analytical specifications, labeled performance characteristics, analytical data reduction, software, test parameters, and uses the same consumables and racks as the predicate.

To obtain the detailed acceptance criteria and study results, one would typically need to review the full 510(k) submission available through FDA, as the summary often omits these specifics.

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The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.

The system provides results for both direct hemostasis measurements and calculated parameters.

The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.

The system provides results for both direct hemostasis measurements and calculated parameters.

System Software V3.0.0 is being introduced on the ACL TOP family (instrument available with and without the feature of closed tube sampling) to support the conversion from the Windows 2000 Operating System to the Windows XP Operating System. This software also includes additional features and ease-of-use enhancements.

This 510(k) summary is for a software update (System Software V3.0.0) for an existing device, the ACL TOP coagulation analyzer. The purpose of the submission is to support the conversion from Windows 2000 to Windows XP operating system and to introduce additional features and ease-of-use enhancements.

Therefore, the study described here is focused on demonstrating that the updated software does not negatively impact the performance of the device and that it remains substantially equivalent to the predicate device. It is not a study to establish new performance metrics or efficacy.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a table of specific acceptance criteria or reported device performance metrics in the way you might expect for a new device's clinical study. The submission focuses on demonstrating substantial equivalence, meaning the updated software does not alter the existing performance and indications for use.

Instead of quantitative performance metrics, the "acceptance criteria" here are implicitly met by showing that:

• There are no changes in ACL TOP test parameters.
• There are no changes to the labeled indications for use/intended use.
• There are no changes to the performance claims of the instrument or its reagents.

The "reported device performance" is the statement: "The performance of the ACL TOP family with System Software V3.0.0 is substantially equivalent to the performance of the current legally marketed ACL TOP (K063679)."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). This is because the submission is for a software update to an existing, cleared device. The focus is on demonstrating that the software change itself doesn't affect the established performance, rather than re-evaluating the device's original performance with a new clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This submission is not evaluating a diagnostic algorithm where expert ground truth is established for images or clinical cases. It's a software update for a clinical laboratory instrument.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of diagnostic interpretation that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study assesses how AI impacts human reader performance, which is not relevant for a software update to a laboratory instrument that performs automated assays.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study in the context of an algorithm interpreting data (like imaging or patient characteristics) was not explicitly described or performed. The device itself (ACL TOP) is a standalone automated analyzer, but the submission is about its operating software update, not a new diagnostic algorithm.

7. Type of Ground Truth Used

Not applicable/Implicit. For an automated coagulation instrument, the "ground truth" for its measurements would typically come from reference methods or established gold standards for coagulation testing. However, the software update submission focuses on ensuring the new software maintains the accuracy and reliability already established for the device. Therefore, no new "ground truth" was established for this specific submission; it relies on the predicate device's established performance.

8. Sample Size for the Training Set

Not applicable. This submission is not about an AI/machine learning algorithm that requires a training set of data. It's about an operating system and feature update for an existing instrument.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters.

The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters.

Major software/test parameter modifications to the factor assays include:

1. The calibration levels are now prepared by aspirating the calibrator directly from the calibrator vial (direct dilution instead of serial dilution).
2. The number of calibration points is being increased from 5 to either 7 or 8, dependent on the individual factor.
3. New mathematical tools are being implemented for generating the calibration curve, e.g. polynomial curve fitting capability as well as the capability for using segmented calibration curve (two different calibration curves for the lower and upper ends).
4. The robustness of the assays is increased by optimizing incubation time, transport air gap and probe rinse parameter modifications.

The provided 510(k) summary (K063679) describes modifications to the ACL TOP device, focusing on optimizing the performance of intrinsic and extrinsic factor assay applications. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested. The document primarily focuses on explaining what changes were made to the software and test parameters and noting that the performance of the optimized factor assay is substantially equivalent to the predicate device.

Specifically, the document lacks the following information required to fully answer the request:

• A table of acceptance criteria and reported device performance: The document states that the performance is "substantially equivalent" to the predicate, but it doesn't provide specific numerical acceptance criteria (e.g., precision limits, accuracy targets) or the measured performance values for the optimized assays.
• Sample sizes used for the test set and data provenance: No information is given regarding the number of samples used in any validation or verification testing, nor their origin (country, retrospective/prospective).
• Number of experts used to establish ground truth and their qualifications: This information is not provided as there is no mention of an expert panel or adjudication process for establishing ground truth for a test set. This type of device (coagulation analyzer) typically uses reference methods or calibrated controls for ground truth rather than expert interpretation of results in the way image-based diagnostics might.
• Adjudication method: Not applicable/not provided.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a benchtop analyzer, not an AI-assisted diagnostic tool for Human-in-the-Loop performance with human readers.
• Standalone performance study: The document doesn't provide a detailed standalone performance study report with specific metrics. It states the performance is equivalent but doesn't quantify it.
• Type of ground truth used: While implicitly using calibrated controls or reference methods for coagulation factor assays, the document does not explicitly state how ground truth was established for performance validation.
• Sample size for the training set: Not applicable and not provided, as this is not an AI/machine learning device that typically involves a separate training set. The "optimization" refers to mathematical tools for curve fitting, not a machine learning model trained on a dataset.
• How ground truth for the training set was established: Not applicable and not provided.

Based on the provided text, the most relevant information regarding "acceptance criteria" and "proving the device meets the acceptance criteria" is in the context of demonstrating substantial equivalence to a predicate device, rather than a detailed performance study against specific, quantified acceptance targets.

Here's a summary of what can be extracted or inferred, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing from the document: Specific numerical acceptance thresholds for performance metrics (e.g., %CV for precision, % bias for accuracy), or specific numerical results for these metrics before and after optimization.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable/Not specified. This type of device relies on analytical performance against controls and reference methods, not expert consensus for ground truth.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No, this is not applicable for this device type. The ACL TOP is an automated analyzer, not an imaging device or AI-assisted diagnostic requiring human reader input or comparison.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: The submission implies that the device itself (the "algorithm"/software modifications) was tested to confirm its performance is substantially equivalent. However, a detailed report of this standalone performance, with specific metrics and data, is not included in the provided 510(k) summary. The summary simply states that the performance is "substantially equivalent."

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated but inferred to be based on calibrated controls, reference materials, or recognized standard methods for coagulation factor assays, which are standard for laboratory instruments of this type.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The "new mathematical tools" for calibration curve generation are described as established methods (polynomial curve fitting, segmented calibration) rather than a machine learning algorithm requiring a separate training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable.

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The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters.

The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters.

This document describes the ACL TOP, an automated coagulation analyzer, and presents data to support its substantial equivalence to a predicate device, the ACL Advance.

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the ACL TOP are based on demonstrating substantial equivalence to the predicate device, the ACL Advance, through method comparison. This is achieved by showing statistical similarity between the measurements obtained by both devices for various coagulation parameters.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • Antithrombin: n=123 (method comparison), n=80 (precision)
  • APTT: n=205 (method comparison), n=80 (precision)
  • D-Dimer: n=120 (method comparison), n=80 (precision)
  • Factor II: n=101 (method comparison), n=80 (precision)
  • Factor V: n=93 (method comparison), n=80 (precision)
  • Factor VII: n=96 (method comparison), n=80 (precision)
  • Factor X: n=110 (method comparison), n=80 (precision)
  • Fibrinogen-C: n=98 (method comparison), n=80 (precision)
  • Protein C: n=123 (method comparison), n=80 (precision)
  • Prothrombin Time (PT): n=150 (method comparison), n=80 (precision)
  • PT-Based Fibrinogen: n=93 (method comparison), n=80 (precision)
• Data Provenance: The document states "in-house performance data" and "method comparison studies evaluating citrated plasma samples." It does not specify the country of origin of the data or whether the study was retrospective or prospective. However, given the context of a 510(k) summary for an in vitro diagnostic device, it is highly likely that these were prospective studies conducted in a laboratory setting. The samples were "citrated plasma samples," which are common for coagulation testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The concept of "ground truth" as typically used for AI/ML devices (e.g., expert consensus, pathology, outcomes data) does not directly apply here. For an in vitro diagnostic device like the ACL TOP, the "ground truth" for the method comparison study is implicitly established by the measurements obtained from the predicate device (ACL Advance). The predicate device itself has been cleared by the FDA and its performance characteristics are accepted as a standard against which the new device is compared. Similarly, for precision studies, the "ground truth" is the true analytical variability inherent to the control materials or samples used.

There is no mention of external human experts establishing ground truth for these types of analytical performance studies; the focus is on the analytical agreement between the new device and the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically employed in studies where human interpretation of medical images or data is being evaluated, often to resolve discrepancies between readers or between human readers and an AI algorithm. For an in vitro diagnostic instrument like the ACL TOP, the performance is assessed through quantitative measurements and statistical comparison against a predicate device, rather than subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. An MRMC study is relevant for diagnostic imaging AI/CAD systems that assist human readers in tasks like lesion detection or diagnosis. The ACL TOP is an automated laboratory instrument measuring coagulation parameters; it does not involve human readers interpreting AI output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are effectively standalone performance evaluations. The ACL TOP is a "fully automated, random access analyzer" and its performance data (precision and method comparison) reflects the device operating independently to produce results. There is no human-in-the-loop component described for its basic operation or for these performance studies, other than potentially loading samples and controls. The method comparison directly compares the ACL TOP's measurements to those of the predicate device (ACL Advance), with both devices acting in a standalone capacity.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the method comparison study is the analytical results generated by the predicate device, ACL Advance. For precision data, the ground truth is the inherent variability of the controls and samples, which is quantified by statistical measures like %CV. This is an analytical rather than a clinical ground truth.

8. The sample size for the training set

Not applicable. The ACL TOP is an automated analyzer, not an AI/ML device that requires a "training set" in the conventional sense of machine learning. Its operation is based on established analytical principles for coagulation testing, calibrated using standard laboratory calibration materials, not trained on a dataset.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for an AI/ML algorithm. Calibration and quality control for such instruments typically involve using reference materials with known concentrations or activities, established by manufacturers or regulatory bodies, to ensure accurate measurement.

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The intended use of the Sysmex® CA-500 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument uses citrated human plasma to perform coagulation tests.

The Sysmex® CA-500 series is a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The manufacturer has modified the series to include two new models with immunological testing capability. The proposed Sysmex CA-500 series can now provide accurate and precise test results for up to five parameters simultaneously and in random access. The CA-500 uses clot, chromogenic and immunological detection technologies for determination of the various parameters.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document presents two types of performance data: method comparison studies (comparing the CA-500 to predicate devices) and precision studies (evaluating the CA-500's internal consistency). The "acceptance criteria" are implied by the results needing to demonstrate substantial equivalence and acceptable precision for in vitro diagnostic use. Specific quantitative criteria are provided for the precision study.

All R-values are very close to 1, and regression equations show slopes generally close to 1 and intercepts close to 0, indicating strong correlation and agreement with the predicate devices. |
| Precision Studies (Total %CV) | Max. Error Criteria (%CV) specified for each assay/control level. | PT, Seconds (Thromborel® S): 0.9% and 1.5% (Max. 5% CV)
PT, INR (Thromborel® S): 0.8% and 1.3% (Max. 5% CV)
Derived Fibrinogen (Thromborel® S): 1.6% and 2.5% (Max. 10% CV)
PT, Seconds (Innovin®): 0.4% and 1.8% (Max. 5% CV)
PT, INR (Innovin®): 0.4% and 1.8% (Max. 5% CV)
Derived Fibrinogen (Innovin®): 2.8% and 3.4% (Max. 10% CV)
PT, Seconds (Thromboplastin C Plus): 0.4% and 1.8% (Max. 5% CV)
PT, INR (Thromboplastin C Plus): 0.7% and 3.5% (Max. 5% CV)
Derived Fibrinogen (Thromboplastin C Plus): 1.9% and 1.6% (Max. 10% CV)
APTT (Dade® Actin): 3.5% and 1.4% (Max. 5% CV)
APTT (Dade® Actin FS): 0.5% and 1.5% (Max. 5% CV)
APTT (Dade® Actin® FSL): 0.4% and 1.5% (Max. 5% CV)
D-Dimer (Advanced D-Dimer): 2.9% and 2.0% (Max. 15% CV)

All reported Total %CV values are well within the specified maximum error criteria, indicating excellent precision. |

2. Sample size used for the test set and the data provenance:

• Test Set Sample Sizes:
  • Method Comparison Studies:
    • D-Dimer Assay: 390 samples
    • PT (Thromborel® S): 248 samples
    • Derived Fibrinogen (Thromborel® S): 248 samples
    • PT (Innovin®): 243 samples
    • Derived Fibrinogen (Innovin®): 247 samples
    • PT (Thromboplastin C Plus): 245 samples
    • Derived Fibrinogen (Thromboplastin C Plus): 245 samples
    • APTT (Actin®): 864 samples
    • APTT (Actin® FS): 857 samples
    • APTT (Actin® FSL): 864 samples
  • Precision Studies:
    • For each assay and control level, 40 measurements (e.g., PT (Thromborel® S) at Control Plasma N: 40 measurements; PT (Thromborel® S) at Ci-Trol® Level 3: 40 measurements, etc.).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It describes the samples as "citrated human plasma" and refers to "Control Plasma N" and "Path. Plasmapool" for validation, suggesting laboratory-obtained samples rather than patient-specific demographic data from a specific geographical location.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For in vitro diagnostic devices like this coagulation analyzer, the "ground truth" is typically established by the reference methods performed on the predicate device or by established control materials with known values, not by independent expert interpretation in the same way it would be for imaging diagnostics. The study compares the new device's results to those of the predicate devices.

4. Adjudication method for the test set:

This information is not applicable for this type of device study. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved to establish ground truth. For an automated coagulation analyzer, the "ground truth" for method comparison is the measurement obtained from the predicate device, and for precision, it's the instrument's own internal consistency against known controls.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to this device. The Sysmex® Automated Coagulation Analyzer CA-500 is an automated instrument, not an AI-assisted diagnostic tool that human readers use. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The performance presented for the Sysmex® Automated Coagulation Analyzer CA-500 is inherently standalone (algorithm/instrument only performance). As an automated analyzer, its primary function is to process samples and provide results without direct human interpretive intervention at the point of measurement. The studies quantify the agreement of its measurements with predicate devices and its internal precision.

7. The type of ground truth used:

The ground truth used for these studies is based on:

• Reference measurements from legally marketed predicate devices: For the method comparison studies, the results obtained from the Sysmex® Automated Coagulation Analyzer CA-7000 and CA-6000 (which are themselves established and cleared devices) served as the reference standard against which the CA-500's measurements were compared.
• Known values of control materials: For the precision studies, "Control Plasma N," "Ci-Trol® Level 3," "Path. Plasmapool," "Adv. D-D Control 1," and "Adv. D-D Control 2" were used. These are standard laboratory control materials with established reference ranges or target values that enable the assessment of an instrument's accuracy and precision.

8. The sample size for the training set:

This information is not provided and is generally not applicable in the context of traditional automated laboratory instruments. These instruments are typically developed and validated using engineering principles, analytical chemistry, and statistical methods rather than machine learning models that require distinct "training sets." The studies described are validation and performance testing, not model training.

9. How the ground truth for the training set was established:

As noted in point 8, the concept of a "training set" and "ground truth for the training set" as used in machine learning is not applicable to this device and its validation. The device's operational parameters and algorithms are designed and verified against established principles of coagulation testing and validated using control materials and comparison with predicate devices.

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The Fisher Diagnostics ThromboScreen® 1000 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma specimens in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and Fibrinogen.

The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is intended to be used on the Fisher Diagnostics ThromboScreen® 1000 Coagulation Instrument for the quantitative determination of fibrinogen in plasma.

The ThromboScreen® 1000 (TS1000) is a photo-optical instrument used for the performance of in-vitro diagnostic clotting procedures in the clinical laboratory. The instrument utilizes photo-optical principles to measure and record the time required for subject plasma specimens to clot. The TS1000 light source is provided by a 660 nm LED. The incubator block is temperature regulated to 36.5 - 37.5°C and contains six measuring positions and six reagent positions.

The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is identical to the Pacific Hemostasis® Thrombin for Fibrinogen Kit, except that the thrombin is reconstituted with water containing kaolin rather than water. Kaolin is added to increase the visibility of the clot in the stirred reaction cell.

Here's a breakdown of the acceptance criteria and the study details for the Fisher Diagnostics ThromboScreen® 1000 and Pacific Hemostasis® Fibrinogen Reagent plus Kaolin, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner (e.g., "The correlation coefficient must be >0.95"). Instead, it presents comparative performance data against predicate devices to demonstrate substantial equivalence. The implication is that the performance must be comparable to the legally marketed predicate devices.

Important Note: The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate devices. The correlation coefficients are all very high (close to 1.0), and the precision data (CV%) also appears comparable between the ThromboScreen 1000 and the predicate MLA instruments.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Sizes:

  • Method Comparison (Correlation Studies):
    • Prothrombin Time (General Clinical Samples): 60 samples per site (across 3 sites = 180 total)
    • Prothrombin Time (Coumadin Samples): 100 samples per site (Site 1 & 2), 92 samples (Site 3) = 292 total
    • Activated Partial Thromboplastin Time (General Clinical Samples): 58 (Site 1), 60 (Site 2), 60 (Site 3) = 178 total
    • Activated Partial Thromboplastin Time (Heparin Samples): 60 samples per site (across 3 sites = 180 total)
    • Fibrinogen Concentration (General Clinical Samples): 28 (Site 1), 30 (Site 2), 30 (Site 3) = 88 total
  • Precision Studies: The specific number of samples for precision studies is not explicitly stated, but it involves "Coag 1, Coag 2, Coag 3" which likely represent different control levels or concentrations, and were performed "within-run," "run-to-run," and "day-to-day" at three sites.

• Data Provenance: The studies were conducted "in-house and at two external testing laboratories." While specific countries are not mentioned, the context of the FDA submission (U.S. Department of Health & Human Services) strongly suggests the data was generated within the United States or from sites compliant with U.S. regulatory standards. The data is prospective as it involves comparison testing and precision measurements on collected specimens. The document indicates specimens were collected from "apparently healthy individuals and from subjects with different pathological conditions which are expected to affect the results for a particular assay."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The description does not mention the use of "experts" in the sense of human readers adjudicating results or establishing ground truth for the test results. This is an in-vitro diagnostic device (IVD) where the "ground truth" is typically established by comparing the device's quantitative measurements against a legally marketed predicate device (MLA 900C/1600C) using the same patient samples and/or established reference methods for precision. The performance is assessed by correlation coefficients and precision metrics against these established methods, not by expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable. As described above, this is an IVD device measuring quantitative coagulation parameters. The "ground truth" is based on the results from predicate devices and internal validation, not human adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for imaging or diagnostic interpretation devices where multiple human readers interpret cases. The ThromboScreen® 1000 is an automated instrument for quantitative laboratory tests (Prothrombin Time, APTT, Fibrinogen), not an interpretation aid for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance evaluation was done. The entire study focuses on the performance of the ThromboScreen® 1000 instrument and the Pacific Hemostasis® Fibrinogen Reagent plus Kaolin. Its measurements are compared directly to those of established predicate instruments (MLA 900C/1600C). There is no "human-in-the-loop" aspect to its measurement process; it's an automated photo-optical instrument.

7. The Type of Ground Truth Used:

The ground truth for the device's performance was established by:

• Predicate Device Comparison: The results obtained from the ThromboScreen® 1000 were compared against results from legally marketed predicate devices, the MLA 900C and MLA 1600C, using the same "citrated plasma specimens."
• Internal Validation/Reference Methods: For precision studies, it implies that control materials or repeated measurements on samples were used to establish the variability (CV%) of the device itself and in comparison to the predicate devices.

Therefore, the ground truth is based on comparative measurements to predicate devices and established laboratory standards for precision and accuracy, rather than pathology, expert consensus, or outcomes data in the typical sense for imaging or pathology devices.

8. The Sample Size for the Training Set:

The document does not contain information about a "training set" or "training data." This type of terminology is usually associated with machine learning or artificial intelligence models. The ThromboScreen® 1000 is a photo-optical instrument. Its design and operational parameters would be developed through engineering and calibration processes, not a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a "training set" in the context of this device's development or evaluation.

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