(88 days)
REMEL's Par-One™ is a medium recommended for use in qualitative procedures for the transportation, preservation, and examination of stool specimens for intestinal parasites. Concentration, permanent stained smear, and immunoassay procedures can be performed from this single vial transport system.
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This document is a marketing clearance letter from the FDA for the Remel Inc. Par-One™ device, which is a medium for the transportation, preservation, and examination of stool specimens for intestinal parasites. As a 510(k) clearance letter, it primarily focuses on establishing "substantial equivalence" to a predicate device rather than providing a detailed study report with acceptance criteria and comprehensive performance data in the format requested.
Therefore, many of the specific details regarding acceptance criteria, study design, expert qualifications, sample sizes, and ground truth establishment are not present in this type of regulatory document. The FDA clearance is based on the submission demonstrating the device is as safe and effective as a legally marketed predicate device.
However, I can extract what information is available or infer from the context:
Here's an attempt to answer your questions based on the provided document, with an acknowledgment of what information is missing:
1. Table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or specific reported device performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. The FDA clearance is based on "substantial equivalence" to a predicate device. This implies that the device's performance was deemed to be at least as good as the predicate's for its intended use, but the specific numerical performance data and acceptance criteria from the company's internal studies are not detailed here.
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified in this document.
- Data Provenance: Not specified in this document. Typically, for a device like this, studies would involve human stool samples. Whether they were retrospective or prospective, or the country of origin, is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For parasite identification in stool, ground truth would typically be established by experienced clinical microbiologists or parasitologists.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: Not applicable. This device is a transport medium for specimens, not an AI or imaging diagnostic tool that would typically involve human readers interpreting images. Therefore, improvement of human readers with AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a specimen collection and transport medium, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: While not explicitly stated, for a device used to detect intestinal parasites from stool specimens, the ground truth would most likely be established by a combination of:
- Expert microscopic examination: Highly trained laboratory personnel identifying parasites directly.
- Molecular methods: PCR or other genetic tests for specific parasites (if available and used as a gold standard).
- Culture: For specific parasites that can be cultured.
This document does not specify which methods were used.
8. The sample size for the training set
- Sample Size for Training Set: Not specified. For a physical medical device like a transport medium, the concept of a "training set" as understood in machine learning is not directly applicable. If studies were performed to optimize the medium's composition or shelf-life, those would involve separate experimental designs, not a "training set" in the AI sense.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable in the AI sense. For the development and validation of the transport medium itself, "ground truth" would relate to its ability to preserve parasite morphology, viability, or antigenicity over time, which would be established through controlled laboratory experiments. These experiments would involve known positive and negative specimens and subsequent evaluation by appropriate diagnostic methods. However, the specific methodologies are not detailed in this clearance letter.
Summary of what can be gleaned from the document:
- Device Name: Par-One™
- Manufacturer: Remel Inc.
- Intended Use: "Recommended for use in qualitative procedures for the transportation, preservation, and examination of stool specimens for intestinal parasites. Concentration, permanent stained smear, and immunoassay procedures can be performed from this single vial transport system."
- Regulatory Status: 510(k) clearance, indicating "substantial equivalence" to a predicate device.
- Regulatory Class: Class I
- Product Code: LIO
- Prescription Use: Yes
The document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed study design and performance metrics typically found in a peer-reviewed publication or a comprehensive technical report for a device.
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.