(130 days)
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
| Acceptance Criterion | Metric | Fibron-1 Performance | Notes |
|---|---|---|---|
| Instrument Correlation (PT) | Correlation (vs ACL 100) | 0.972 | Strong positive correlation |
| Instrument Correlation (PT) | Slope (vs ACL 100) | 1.24 | |
| Instrument Correlation (PT) | Intercept (vs ACL 100) | -2.46 | |
| Instrument Correlation (APT) | Correlation (vs ACL 100) | 0.976 | Strong positive correlation |
| Instrument Correlation (APT) | Intercept (vs ACL 100) | 6.68 | |
| Instrument Correlation (APT) | Slope (vs ACL 100) | 0.763 | |
| Instrument Correlation (APT) | Correlation (vs Electra 900C) | 0.981 | Strong positive correlation |
| Instrument Correlation (APT) | Intercept (vs Electra 900C) | 2.05 | |
| Instrument Correlation (APT) | Slope (vs Electra 900C) | 0.892 | |
| Within-run Precision (PT, Control Level 1) | Average ± %CV | 12.0 ± 2.0 % (n=20) | Compared favorably to MLA 900C (11.5 ± 2.0%) |
| Within-run Precision (PT, Control Level 2) | Average ± %CV | 20.0 ± 1.9 % (n=19) | Compared favorably to MLA 900C (18.7 ± 1.2%) |
| Day-to-Day Precision (PT, Normal) | Average ± %CV | 11.6 ± 3.2 % | Compared favorably to MLA 900C (11.5 ± 1.2%) |
| Day-to-Day Precision (PT, Low Abnormal) | Average ± %CV | 19.6 ± 2.1 % | Compared favorably to MLA 900C (18.3 ± 2.0%) |
| Within-run Precision (PT, Normal Control) | Average %CV of Duplicates | 1.28% (n=18 duplicates) | |
| Within-run Precision (PT, Low Abnormal) | Average %CV of Duplicates | 1.12% (n=17 duplicates) | |
| Within-run Precision (PT, High Abnormal) | Average %CV of Duplicates | 1.01% (n=18 duplicates) | |
| Within-run Precision (APTT, Normal Control) | Average %CV of Duplicates | 1.90% (n=18 duplicates) | |
| Within-run Precision (APTT, Low Abnormal) | Average %CV of Duplicates | 0.86% (n=16 duplicates) | |
| Within-run Precision (APTT, High Abnormal) | Average %CV of Duplicates | 2.45% (n=18 duplicates) |
Study Details
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Sample size used for the test set and the data provenance:
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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.
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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.
- Within-run Precision:
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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.
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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.
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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.
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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.
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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.
- The "ground truth" for evaluating the Fibron-1's performance is derived from:
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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.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.