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HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

This document describes the performance data for the HemosIL SynthASil device after optimization of its APTT parameter settings on the ACL Futura and ACL Advance systems. The stated purpose of this submission is to demonstrate substantial equivalence to the predicate device (K953981 HemosIL SynthASil) and to the HemosIL SynthASil reagent run on the ACL TOP system (K033414).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly uses the performance of the predicate device (K953981 HemosIL SynthASil) and the HemosIL SynthASil on the ACL TOP (K033414) as the acceptance criteria for achieving "improved correlation" and "substantial equivalence." While explicit numerical acceptance criteria are not presented in a table format, the performance data provided aims to demonstrate this correlation.

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

• Precision Test Set: The sample size for the precision study is not explicitly stated as a number of individual samples. It mentions "three levels of control plasma" and "assessed over multiple runs." This implies multiple measurements were taken for each of these three control levels.
• Method Comparison Test Set: For each of the four SynthASil lots, n=93 or n=92 citrated plasma samples were used.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective in nature, performed to optimize and validate the device settings for regulatory submission. The samples are referred to as "human citrated plasma."

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

This type of in-vitro diagnostic device (reagent for APTT determination) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The "ground truth" for the method comparison is the measurement obtained from the predicate device or the ACL TOP system, which are themselves validated instruments. Therefore, there were no human experts establishing ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is an objective measurement study comparing an optimized device's performance to established methods, not subjective human interpretation requiring adjudication.

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

• No MRMC study was done. This study concerns the performance of an in-vitro diagnostic reagent and instrument settings, not a device that involves human interpretation of results requiring a comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, this is effectively a standalone performance study. The document describes the performance of the HemosIL SynthASil reagent and its optimized settings on the ACL Futura and ACL Advance instruments. The results reported (precision, slope, intercept, r) are direct measurements from the device system without requiring human-in-the-loop analysis. The "algorithm" here refers to the optimized parameter settings and the reagent's performance characteristics.

7. Type of Ground Truth Used

• The ground truth used for the method comparison study was the measurements obtained from a legally marketed predicate device (K953981 HemosIL SynthASil) or an equivalent, legally marketed device (HemosIL SynthASil on the ACL TOP system - K033414). This is a form of "reference standard" or "comparative standard" established by existing, validated medical devices.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. Instead, it refers to the "optimization" of APTT parameter settings. While this optimization process would have involved testing and refining these settings on various samples, the specific sample size, type, and method used for this optimization are not detailed in this summary. It's implied that the "optimization" process served a similar purpose to training, but no specific dataset is identified as a training set.

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

Since there is no explicitly defined "training set" in the context of an AI/ML model, the concept of establishing ground truth for it is not directly applicable here. The "optimization" likely involved iterative adjustments of the parameter settings and testing them against known reference values or comparative measurements (similar to the method comparison's ground truth, but likely a larger or different set of samples used during development) to achieve the desired performance, particularly for correlation with the ACL TOP and predicate devices.

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HemosIL ProS is a functional assay for the quantitative determination of free Protein S in human citrated plasma on IL coagulation systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency.

This in vitro diagnostic test determines the functional activity of free Protein S by measuring the degree of prolongation of a prothrombin time in the presence of the tissue factor, phospholipids, calcium ions and activated Protein C. The Protein S activity is proportional to the prolongation of the clotting time of a Protein S deficient plasma to which the diluted sample was added.

HemosIL ProS is a functional assay for the quantitative determination of free Protein S in human citrated plasma on IL coagulation systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency.

The reconstituted and onboard stability claims for HemosIL ProS on the ACL Futura (K951891) and ACL Advance (K002400) are being revised as a precautionary measure based on indications from internal QC release data on multiple product lots.

Here's an analysis of the provided text regarding the HemosIL ProS device, focusing on the requested information for acceptance criteria and the supporting study:

Disclaimer: The provided document is a 510(k) summary for a modification to a previously cleared device. It primarily focuses on changes to stability claims. Therefore, the depth of information on all requested points might be limited compared to an initial 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for the stability testing. The summary refers to "internal QC release data on multiple product lots."
• Data Provenance: "Internal QC release data," implying it's from the manufacturer (Instrumentation Laboratory Company) and likely refers to testing conducted in their facilities. The country of origin is implicitly the US (Lexington, MA).
• Retrospective/Prospective: Not specified, but generally, QC release data would be a form of prospective testing during manufacturing. The "additional stability testing" for the revised claims would also be prospective.

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

• Not Applicable. This document pertains to an in-vitro diagnostic (IVD) assay for measuring Protein S. The "ground truth" for such assays typically relies on established analytical methods and reference materials, not expert interpretation of images or patient data. The "ground truth" for stability would be the actual measured stability performance over time.

4. Adjudication Method for the Test Set:

• Not Applicable. As mentioned above, this is an IVD assay, not a diagnostic imaging or clinical interpretation device that would require adjudication of expert opinions. The assessment of stability would be based on predefined analytical specifications and statistical analysis of quantitative measurements.

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. This device is a standalone in-vitro diagnostic assay and does not involve human "readers" in the context of interpreting results in combination with AI. It measures a specific biochemical marker.

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

• Yes, effectively. The HemosIL ProS is a standalone in-vitro diagnostic assay. Its performance is evaluated intrinsically through laboratory testing (e.g., stability, accuracy, precision) without human interpretation in the loop of the primary measurement. The "algorithm" here refers to the chemical reactions and optical detection methods of the assay itself, rather than a separate AI algorithm processing data.

7. The Type of Ground Truth Used:

• For the core functionality of the device (quantitative determination of free Protein S), the ground truth would be established through a combination of:
  • Reference materials/calibrators: Samples with known concentrations of Protein S.
  • Reference methods: Established, often more laborious, analytical methods for Protein S measurement.
  • Clinical correlation: (Though not extensively detailed in this summary, an initial 510(k) for such a device would likely correlate results with patient diagnostic status, potentially against a "gold standard" clinical diagnosis or another validated Protein S assay.)
• For the stability claims (the focus of this K053499 submission), the ground truth is the actual measured concentration of Protein S in control samples over time, compared to initial measurements, to determine if the device's accuracy remains within acceptable limits.

8. The Sample Size for the Training Set:

• Not Applicable/Not Provided. This is not an AI/machine learning device that typically has "training sets." The "training" for such an assay involves method development and optimization, which utilizes various reagent lots and samples, but not in the sense of a dedicated training set for an algorithm. The stability testing itself relies on a number of control samples and product lots (as mentioned, "multiple product lots").

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

• Not Applicable/Not Provided. As it's not an AI/ML device with a training set in the conventional sense, this question does not apply. The "ground truth" in the context of stability testing is the direct analytical measurement against a specified initial value or an established range.

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HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in virro diagnostic determination in human citrated plasma of:

• Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems .
• Fibrinogen on IL Coagulation Systems only .
  The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

HemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of:

• Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems .
• . Fibrinogen on IL Coagulation Systems only
  The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
  The PT and fibrinogen parameter settings for HemosIL RecombiPlasTin on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert.

Here's an analysis of the provided text regarding the HemosIL RecombiPlasTin device, focusing on acceptance criteria, study details, and ground truth establishment:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be primarily focused on its analytical performance metrics, specifically method comparison (correlation coefficient and slope) and precision (CV%). The document compares the new parameter settings on the ACL Futura/Advance to a legally marketed predicate device on the ACL TOP.

Note: The exact numerical acceptance criteria are not explicitly stated as "must be greater than X" or "less than Y." Instead, the performance values of the legally marketed predicate device (HemosIL RecombiPlasTin on ACL TOP and HemosIL Fibrinogen-C on ACL TOP) serve as the benchmark for substantial equivalence. The reported values demonstrate very strong correlation and close agreement with the predicate for both PT and Fibrinogen, indicating the device meets the implied acceptance criteria for equivalence.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: 98 citrated plasma samples used for the method comparison study.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "citrated plasma samples," which are human biological specimens. It's not specified if they were prospective or retrospective samples. As this is an in vitro diagnostic test for coagulation, the samples would likely be from a clinical setting, but further details are not provided.

3. Number of Experts and Qualifications for Ground Truth of the Test Set

This type of device (Prothrombin Time and Fibrinogen determination) relies on quantitative measurements, not subjective interpretation. Therefore, there are no "experts" in the traditional sense establishing a ground truth based on visual or interpretive assessment. The "ground truth" or reference method is the measurement obtained from the legally marketed predicate device (HemosIL RecombiPlasTin on ACL TOP for PT and HemosIL Fibrinogen-C on ACL TOP for fibrinogen).

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established by a reference measurement from a predicate device, not through expert consensus or adjudication.

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

Not applicable.

• This is an in vitro diagnostic (IVD) device, specifically a reagent for automated coagulation analyzers.
• It does not involve human readers interpreting images or data in a way that would necessitate an MRMC study.
• The comparison is between two automated systems (the new device on ACL Futura/Advance vs. the predicate on ACL TOP), not between human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, this is essentially a standalone performance study. The HemosIL RecombiPlasTin reagent, when run on the ACL Futura/Advance, performs the measurements automatically. The reported performance metrics (precision, slope, correlation) represent the analytical performance of the optimized reagent-instrument combination without human intervention in the measurement process itself. The "comparison" is the standalone performance of the new configuration against the standalone performance of the predicate configuration.

7. Type of Ground Truth Used

The ground truth used is a reference measurement from a legally marketed predicate device. Specifically:

• For Prothrombin Time (PT), the reference was the HemosIL RecombiPlasTin on the ACL TOP.
• For Fibrinogen, the reference was the HemosIL Fibrinogen-C on the ACL TOP.
  This is a common approach for demonstrating substantial equivalence for IVD devices, comparing the new device's measurements to those of an established, cleared device.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" in the context of machine learning or AI models. This device is a reagent with optimized parameters for existing instruments. The text states:
"The PT and fibrinogen parameter settings for HemosIL RecombiPlasTin on the ACL Futura and ACL Advance are being optimized for improved correlation with the ACL TOP, impacting the instrument-specific performance claims in the product insert."

This "optimization" process would involve internal development and testing to fine-tune the parameters. However, the specific size of the dataset used during this optimization phase is not provided in this 510(k) summary. The 98 plasma samples are explicitly described as being part of the method comparison study (which acts as the test set for regulatory submission).

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

As there isn't a "training set" in the common AI/machine learning sense, the ground truth for any internal optimization would likely have been established in a similar manner to the test set: by running control plasmas and potentially patient samples on the predicate device (ACL TOP) to define the target reference values that the optimized parameters on the new instruments (ACL Futura/Advance) aimed to match. The goal was to achieve "improved correlation with the ACL TOP."

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HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy. For in vitro diagnostic use.

HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.

The HemosIL Liquid Antithrombin XL device is a modified version of the HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes. The modification does not alter the fundamental scientific technology or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma. It is intended as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.

1. Table of acceptance criteria and the reported device performance:

The provided document describes performance metrics related to precision and method comparison but does not explicitly state pre-defined acceptance criteria (e.g., "CV must be Y%"). Instead, it presents the results of these studies. For the method comparison, the results are presented in a highly obfuscated and unreadable table due to OCR errors.

However, based on standard laboratory practice for diagnostic assays, the reported precision (CV%) values demonstrate acceptable performance for an Antithrombin assay, especially given the range of AT levels tested. The predicate device (HemosIL Antithrombin K980499) serves as the benchmark for substantial equivalence.

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

• Precision Studies:
  • For Normal, Low Abnormal, and High Abnormal control levels, the sample size (n) for each level was 60.
  • Data provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based performance evaluations, likely retrospective as they involve control plasmas rather than patient samples for the precision part.
• Method Comparison Study:
  • The sample size for the method comparison study is not explicitly stated in the readable portion of the provided text. The table intended to present this data is corrupted.
  • Data provenance: Not explicitly stated.

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 an in vitro diagnostic device like this, "ground truth" often refers to reference methods or clinically established values for the analytes in the control or patient samples. The document focuses on comparing the new device to a predicate device and evaluating its precision, not on new clinical diagnoses established by experts.

4. Adjudication method for the test set:

This information is not applicable to this type of study for an in vitro diagnostic device where the "truth" is typically laboratory-derived values or predicate device results, not expert consensus on interpretations.

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. The HemosIL Liquid Antithrombin XL is an automated chromogenic assay, not an imaging device or AI-driven diagnostic tool that relies on human readers or interpretations. Therefore, an MRMC study and AI assistance are not relevant to its evaluation.

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

The device itself is an automated laboratory assay, which by its nature operates in a "standalone" fashion (algorithm/reagent/instrument only) to produce a quantitative result. The performance data provided, specifically precision and method comparison, represent this standalone performance. There isn't a "human-in-the-loop" component in the sense of a human interpreting the primary output of the assay.

7. The type of ground truth used:

• Precision Studies: The "ground truth" for precision is the mean Antithrombin (% AT) value established for each control level (Normal, Low Abnormal, High Abnormal). This is typically determined through repeated measurements and confirmation with established methods.
• Method Comparison Study: The "ground truth" for the modified device (HemosIL Liquid Antithrombin XL) was the results obtained from the legally marketed predicate device (HemosIL Antithrombin K980499). The study aimed to show substantial equivalence to this predicate.

8. The sample size for the training set:

For an in vitro diagnostic assay like this, there isn't typically a "training set" in the machine learning sense. The assay is based on chemical reactions and photometric detection. The development and optimization of the reagent volumes and assay parameters would involve extensive experimentation and optimization, but not a distinct "training set" of data in the way an AI algorithm is trained. The reported values for precision are from performance studies, not "training."

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

As indicated above, the concept of a "training set" and associated "ground truth" in the machine learning context does not directly apply to the development and validation of this chemical assay. The "ground truth" for optimizing the assay parameters would be the known concentrations of Antithrombin in reference materials and controls, used to ensure accuracy and precision.

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IL Test™ LAC Screen and IL Test™ LAC Confirm are in vitro diagnostic products for the detection of lupus anticoagulants (a type of phospholipid interfering antibody) in human citrated plasma on IL Coagulation Systems. These tests are indicated for use with patients who have prolonged APTT test of undetermined origin.

This 510(k) is intended to extend the use of these reagents onto another member in the IL family of coagulation analyzers, the ACL Futura (K951891).

IL Test™ LAC Screen and IL Test™ LAC Confirm are in vitro diagnostic products for the detection of lupus anticoagulants (a type of phospholipid interfering antibody) in human citrated plasma on IL Coagulation Systems. This 510(k) is intended to extend the use of these reagents onto another member in the IL family of coagulation analyzers, the ACL Futura (K951891).

Here's a breakdown of the acceptance criteria and study information for the IL Test™ LAC Screen and IL Test™ LAC Confirm (Extension onto the ACL Futura), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria. Instead, it demonstrates performance by comparing the device on the ACL Futura with its performance on an existing ACL 300 reference instrument and assessing precision. The reported performance suggests that the device operates comparably to the predicate device and within acceptable precision limits for diagnostic assays.

• CV of 6.32% (at mean ratio of 2.03)
• CV of 2.36% (at mean normalized ratio of 1.51) |

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

• Sample Size: n = 53 for the correlation study. "3 levels of plasma" were used for the precision study, but the exact number of runs or individual samples within each run is not specified beyond "multiple runs."
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective, using plasma samples, but this is not definitively stated. There's no mention of a prospective study design.

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

• The document describes performance studies for an in-vitro diagnostic product, not an imaging or interpretive device that would typically rely on expert human assessment for ground truth. Therefore, no experts were used to establish ground truth in the traditional sense for this type of device. The "ground truth" for this assay lies in the chemical and biological reactivity of the reagents and the accuracy of the instrument's measurement capabilities.

4. Adjudication Method for the Test Set

• None specified. As this is a performance study for an in-vitro diagnostic assay rather than an interpretive clinical assessment, an adjudication method for a test set is not applicable. The measurements are objective numerical results from the instrument.

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

• No. This is an in-vitro diagnostic product validation, not a study involving human readers interpreting results. Therefore, an MRMC study was not performed, and there's no data on the effect size of human readers improving with AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, implicitly. The entire study describes the performance of the device (IL Test™ LAC Screen and IL Test™ LAC Confirm on the ACL Futura analyzer) as a standalone system. The measurements of correlation and precision are direct evaluations of the algorithm/instrument system without human intervention in the measurement process itself.

7. Type of Ground Truth Used

• Reference Instrument Comparison and Known Samples:
  • For the correlation study, the "ground truth" was established by comparing results from the new device/instrument combination (ACL Futura) to a predicate/reference instrument (ACL 300) which is presumably already validated and considered accurate.
  • For the precision study, "3 levels of plasma" were used. These would likely be characterized plasma samples with known or expected ranges of the analyte to assess the reproducibility of the measurements.

8. Sample Size for the Training Set

• Not applicable / Not specified. This document describes the validation of an existing diagnostic reagent on a new instrument platform, not the development or training of a new algorithm (like an AI model). Therefore, there is no "training set" in the context of machine learning. The reagents and assay methodology would have been developed and validated previously.

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

• Not applicable. As there is no training set for an AI/machine learning algorithm, this question is not relevant to the provided document. The development of the reagents and assay would have involved standard chemical and biological validation methods, which are not detailed here.

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