Search Results

The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.

The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.

Here's a breakdown of the acceptance criteria and study information for the Vital Scientific APTT device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The Fibrin-1, which uses clot formation as an endpoint, may be used for the performance of the Prothrombin Time Test (PT) and the Activated Partial Thromboplastin Test (APTT).

The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The instrument utilizes photo-optical principles for clot detection. The light source is a high intensity photodiode. The incubator block is temperature regulated to 36.5 - 37.5℃ and contains four measuring positions, 4 reagent and 4 cuvette pre-warming positions.

Here's a summary of the acceptance criteria and study findings for the Fibron-1 Coagulation Analyzer, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Instrument Correlation Studies (PT & APTT):

     • The exact sample size for the correlation studies (Fibron-1 vs. ACL 100 and Fibron-1 vs. Electra 900C) is not explicitly stated as a total number of patients, but rather states "Specimens were evaluated from healthy individuals and from patients with different pathological conditions." The clotting time range observed was 10 to 39 seconds.
     • Data Provenance: "in-house and at a community hospital." This suggests a mix of controlled laboratory environments and a real-world clinical setting. The country of origin is not specified but given the submitter's address (Newton, MA) and the FDA submission, it's likely US-based, at least for the community hospital. The study appears to be prospective, as specimens were evaluated as part of this specific testing.

   • Precision Studies:

     • Within-run Precision:
       • PT Control Level 1: n = 20
       • PT Control Level 2: n = 19
     • Day-to-Day Precision:
       • PT Normal Control: Day 1 (n=20), Day 2 (n=4), Day 3 (n=4), Day 4 (n=4), Day 5 (n=4)
       • PT Low Abnormal: Day 1 (n=19), Day 2 (n=4), Day 3 (n=4), Day 4 (n=4), Day 5 (n=4)
     • Precision (Duplicates):
       • PT Normal Control: 18 duplicates
       • PT Low Abnormal: 17 duplicates
       • PT High Abnormal: 18 duplicates
       • APTT Normal Control: 18 duplicates
       • APTT Low Abnormal: 16 duplicates
       • APTT High Abnormal: 18 duplicates
     • Data Provenance: "in-house" based on the context of the document.

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

   • This device is a laboratory instrument that provides quantitative measurements of clotting times. The "ground truth" for the test set is established by the measurements from the predicate devices (ACL 100, MLA-900C, Electra 900C) and established laboratory control materials. There is no mention of human experts establishing ground truth for the test set in the way one would for diagnostic imaging.

3. Adjudication method for the test set:

   • Not applicable. This is a comparison of instrument performance against predicate devices and known control values, not a subjective interpretation task requiring adjudication.

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 MRMC study was performed. This device is a standalone laboratory instrument, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, the entire study focuses on the standalone performance of the Fibron-1 instrument. Its accuracy and precision are evaluated against predicate devices and control materials without any human interpretive component beyond operating the machines.

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

   • The "ground truth" for evaluating the Fibron-1's performance is derived from:
     • Measurements from legally marketed predicate devices (ACL 100, MLA-900C, Electra 900C).
     • Known values of laboratory control materials (Normal, Low Abnormal, High Abnormal levels).
     • Actual clotting times from patient and healthy individual samples.

7. The sample size for the training set:

   • This is a traditional medical device (a photo-optical instrument), not an AI/ML-based device that would typically have a separate "training set" for an algorithm. Therefore, no training set is mentioned or applicable in the context of this 510(k) summary.

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

   • Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Coagulation Controls Levels 1, 2, and 3 are in-vitro diagnostic reagents intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT). Level 1 yields result in the normal range. Level 2 yields results in the moderately abnormal range. Level 3 is intended to yield results in the extremely abnormal range.

The Coagulation Control Levels 1, 2 and 3 are lyophilized preparations of citrated plasma obtained from healthy donors, which are adjusted to yield prolonged PT and APTT values. Prior to lyophilization buffer and a stabilizer are added. The bulk plasma is tested using an FDA approved method for HBsAG, HIV antibodies and HCV antibodies and is certified for negativity for each batch.

The provided document describes a 510(k) summary for "Coagulation Control Level 1, 2, 3" by Vital Scientific NV. The document focuses on demonstrating substantial equivalence to predicate devices through precision studies rather than establishing acceptance criteria against a predefined performance target for a novel device. The study design is a comparison to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a predefined target that the device must meet for approval. Instead, it demonstrates performance by comparing its precision data to that of existing, legally marketed predicate devices. The implicit acceptance criterion is that the new device's precision (measured by Average and %CV) should be "substantially equivalent" to that of the predicate devices.

Note: The document states "substantially equivalent data" were yielded, implying the reported performance met this implicit criterion.

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

• Test Set Sample Size: For within-run precision studies, n = 20 for both Vital Controls and Reference Controls for each level (1, 2, 3) and for both PT and APTT. ("Average ± %CV, n = 20"). For between-run precision, the sample size is not explicitly stated as 'n' but implies multiple measurements over several days ("Day to Day Precision Results").
• Data Provenance: Not explicitly stated. The study was conducted for a US 510(k) submission, but the location of the actual testing is not specified. It is a prospective study as it involves specific experiments for the submission. The plasma itself is obtained from healthy donors, but the origin of these donors (country) is not mentioned.

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

Not applicable. This study is a precision study comparing a control device to predicate control devices, not a diagnostic device where "ground truth" on patient samples would be established by experts. The "truth" here is the performance of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as it's a quantitative measurement of precision rather than a qualitative diagnostic outcome requiring expert consensus.

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 is not a study involving human readers or AI assistance. It's a laboratory precision and substantial equivalence study for a diagnostic control.

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

Not applicable. This is not an algorithm; it is a physical control plasma. The comparison is between the new control plasma and existing control plasmas run on a coagulometer (MLA-900C Coagulometer). The performance described is "standalone" in the sense that the control itself is being evaluated for its inherent precision characteristics.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established performance characteristics (precision, i.e., average and %CV) of the legally marketed predicate devices. The goal is to show the new device's performance is substantially equivalent to these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device. This is not a machine learning model.

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

Not applicable, as there is no training set mentioned.

Ask a specific question about this device

The Vital Scientific PT with Calcium is an in vitro diagnostic test intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X). The test is used for the quantitative determination of blood clotting factors in the extrinsic pathway, (VII), and common pathway (II, V and X) of coagulation. The capacity of blood to form a fibrin clot by way of the extrinsic haemostatic pathway requires thromboplastin, calcium, factors VII, V, X, II and I. The Vital Scientific PT with Calcium consists of a lyophilized extract of rabbit brain thromboplastin calcium salt, buffers and stabilizers.

The Vital Scientific PT with Calcium is an in-vitro diagnostic reagent intended for use for the performance of one-stage Prothrombin Time (PT) Testing and assays which are based on a modified prothrombin time.

The Vital Scientific PT with Calcium is an in vitro diagnostic test intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X). The test is used for the quantitative determination of blood clotting factors in the extrinsic pathway, (VII), and common pathway (II, V and X) of coagulation. The capacity of blood to form a fibrin clot by way of the extrinsic haemostatic pathway requires thromboplastin, calcium, factors VII, V, X, II and I. The Vital Scientific PT with Calcium consists of a lyophilized extract of rabbit brain thromboplastin calcium salt, buffers and stabilizers.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Vital Scientific PT with Calcium (Prothrombin Time Test)
Predicate Device: Instrumentation Laboratory Inc. IL Test PT-Fibrinogen HS (K981479)

The provided text describes a substantial equivalence comparison study, not a study specifically designed to meet pre-defined acceptance criteria with absolute thresholds for performance metrics. Instead, the "acceptance criteria" are implicitly defined by the need to demonstrate performance comparable to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a single number. The text mentions "PT testing of specimens from normal and abnormal patients, as well as samples from patients receiving anti-coagulant therapy." The specific number of patients or samples within each category is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was conducted "at a community hospital," implying a clinical setting within the country where the submission was made (presumably the USA, given the FDA context).
  • Retrospective or Prospective: Not explicitly stated. The phrasing "were tested using both reagent devices" could imply either. However, in substantial equivalence studies, retrospective analysis of banked samples or a prospective collection for comparison is common. It's more likely a prospective collection for the study or a retrospective analysis of samples that fit the criteria.

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

• Number of Experts: Not applicable. This study does not involve expert interpretation or ground truth establishment in the way a diagnostic imaging study might. The "ground truth" or reference values are derived from the predicate device's performance on the same patient samples.
• Qualifications of Experts: Not applicable. The comparison is against an established, legally marketed diagnostic device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No expert adjudication process is described for this type of in-vitro diagnostic device comparison study. The comparison is quantitative based on assay results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study Done: No. This is not an AI/imaging device. It's an in-vitro diagnostic reagent.

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

• Standalone Performance: Yes, in a sense. The device itself (the reagent system) is a standalone diagnostic tool. Its performance is measured directly by comparing its output (PT results, INR) to the predicate device's output on the same samples. There isn't a human-in-the-loop for interpreting the core result of the PT test itself; it's a quantitative measurement.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this study is the results obtained from the legally marketed predicate device (IL Test PT-Fibrinogen HS (K981479)) when run on the same patient samples. This is a common approach for demonstrating substantial equivalence for in-vitro diagnostics. In essence, the predicate device serves as the reference standard.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not a machine learning/AI device, so there is no "training set." The device is a chemical reagent.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

This notification is for an in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

A random access, automated Clinical Micro-Chemistry Analyzer with a throughput of up to 180 test per hour which is intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry. monitoring drugs of abuse and in therapeutic drug monitoring.

The provided text describes a 510(k) premarket notification for the Vitalab Flexor Clinical Laboratory Analysis and Reagent System, asserting its substantial equivalence to the Roche Cobas Mira. The document focuses on demonstrating comparable performance through various analytical modes for a range of analytes.

Here's an analysis of the acceptance criteria and the study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative "acceptance criteria" in the format of specific thresholds (e.g., "accuracy > 95%"). Instead, it states that the device's performance "demonstrates general agreement with levels that are comparable to other systems presently being marketed commercially in the United States" and shows "positive correlation and substantial equivalence" to the predicate device.

The reported device performance is qualitative in nature, emphasizing comparability rather than meeting pre-defined numerical targets.

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

• Sample Size for Test Set: The document mentions "data on twenty-nine (29) representative Clinical Chemistry analytes," "seven (7) representative analytes for Drugs of Abuse," and "two (2) representative analytes for therapeutic drug monitoring." Additionally, it states "Thirty-eight (38) representative methods were selected for evaluation." The exact number of individual samples (patients or controls) analyzed for each analyte or method is not specified. It refers to analytes/methods as the units of evaluation, not individual patient samples.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that the manufacturer is based in the Netherlands and has a USA branch, the studies could have been conducted in either location or a combination. The submission is for marketing in the United States.

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

This information is not provided in the document. The study appears to be a technical validation of an in-vitro diagnostic device assessing its analytical performance against a predicate device, rather than a clinical study requiring expert interpretation of diagnostic outcomes. Ground truth for chemical analytes would typically be established by established reference methods, not expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. As noted above, the evaluation is a technical comparison of an in-vitro diagnostic device's analytical performance against a predicate, not a clinical study involving human interpretation that would require 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an automated in-vitro diagnostic chemistry analyzer, meaning it performs chemical analysis of biological samples without direct human-in-the-loop interpretation of visual or complex data that would involve "readers" in the context of an MRMC study. The concept of "human readers improve with AI" is not relevant to this type of device.

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

The device itself is an automated system (algorithm only). The performance data presented (precision, accuracy, linearity, drift) specifically represents the standalone performance of the Vitalab Flexor system in processing samples and measuring analytes. Without a human in the loop, this is a standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth used for this type of device is implicitly based on:

• Reference Methods/Predicate Device: The performance is compared to "levels that are comparable to other systems presently being marketed commercially in the United States," specifically stating that the Vitalab Flexor is "substantially equivalent to the Roche Cobas Mira." Therefore, the predicate device (Roche Cobas Mira) itself, validated through its own established analytical performance, serves as a de facto "ground truth" or standard for comparison.
• Established Analytical Principles: The evaluation of precision, accuracy, linearity, and drift relies on established analytical principles and statistical methods commonly applied in clinical chemistry. These are fundamental measures of analytical performance, where "ground truth" would be the true value of an analyte as determined by highly accurate reference methods, or the expected range given a control material.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. The Vitalab Flexor is a traditional clinical chemistry analyzer, not a machine learning or AI-driven system that requires a "training set" in the conventional sense of supervised learning. Its operational parameters and calibration are established through manufacturers' protocols and reference materials, not through a large dataset of labeled training examples.

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

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device