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Here's a breakdown of the acceptance criteria and study details based on the provided text for the ProTime™ Microcoagulation System:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative thresholds in the provided text, but rather implied by the reported performance metrics demonstrating "high correlation," "small mean differences," and "equivalence." I will interpret the reported performance to infer the likely underlying acceptance goals.
| Acceptance Criteria Category | Specific Metric (Inferred) | Acceptance Criteria (Inferred from Report) | Reported Device Performance |
|---|---|---|---|
| Correlation | Patient Self-Test INR vs. Healthcare Professional ProTime™ INR | High correlation (e.g., r > 0.90) | r = 0.92 |
| Reference Lab INR vs. Hospital Lab INR | Significant and equivalent correlation | r = 0.90 | |
| Reference Lab INR vs. Home Use ProTime™ INR | Significant and equivalent correlation | r = 0.89 | |
| Reference Lab INR vs. Clinic ProTime™ INR | Significant and equivalent correlation | r = 0.91 | |
| Mean Difference | Patient Self-Test INR vs. Healthcare Professional ProTime™ INR | Small mean difference (e.g., 90% agreement) | Agreed with reference laboratory |
| User Experience | Ease of Use | Easy to use | Patients rated ProTime™ System easy to use. |
| Ability to Obtain Accurate Results | Successful repetition after error | Ability to repeat and obtain accurate results | Patients successfully repeated the test to obtain accurate results after errors. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: 45 patients
- Data Provenance:
- Country of Origin: Not explicitly stated, but the study was conducted with patients selected from "four anticoagulation clinics," implying a specific geographic region, likely domestic to the manufacturer given the lack of international mention.
- Retrospective or Prospective: Prospective. Patients were "selected," "received a 30 to 60 minute training session," "demonstrated the ability to perform the assay prior to enrollment," and then participated in the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not explicitly stated how many individual experts were used. The ground truth appears to be based on "healthcare professional using the ProTime™ System" and "hospital lab" and "reference lab" results. These would be considered expert-generated data.
- Qualifications of Experts: Assumed to be healthcare professionals trained in coagulation testing and laboratory technicians/professionals in hospital and reference laboratories, implying relevant clinical and laboratory certifications/experience. Specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
The text does not mention an adjudication method for disagreements. The ground truth seems to be established through a hierarchical or accepted standard: the "reference laboratory" is consistently used as the gold standard for comparison. Comparisons are made between the device, clinic, hospital, and patient self-tests against this reference.
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 was not an MRMC comparative effectiveness study in the context of AI assistance. The study compares a device (ProTime™ System) against established laboratory and healthcare professional methods, and patient self-testing. There is no mention of AI or human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in a way. The ProTime™ Microcoagulation System performs the coagulation test and generates an INR. The "patient self-test" results are effectively a standalone performance of the device by an untrained (but trained for the device) individual, and these results are compared to the "healthcare professional using the ProTime™ System" and "reference lab." The device itself produces the initial numerical output without human interpretation in the way one might consider image annotation or diagnosis.
7. The Type of Ground Truth Used
The primary ground truth used was reference laboratory results, specifically "reference lab INR." This is a highly controlled, expert-generated, and often external standard for clinical laboratory testing. "Hospital lab" results also served as a comparative standard.
8. The Sample Size for the Training Set
The text does not explicitly mention a separate "training set" for the device itself. The 45 patients described are part of the study assessing performance. If the device's internal algorithms required calibration or training, that information is not provided here. The context suggests that the study is a performance validation of a pre-existing device.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set for the device's algorithms is described in this excerpt, the method for establishing its ground truth is not provided. If we interpret "training" as patient training, then the patients were trained by clinic staff, and their ability to perform the test was verified before enrollment. The ground truth for this patient training assessment would be the observation and verification by the clinic staff.
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).