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EpiScreen is intended to collect oral fluid specimens, contain those specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.

The EpiScreen device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common (Specifical vial). The Generativertonic environment which produces an osmotic sails and gelain, ereating a my perival mucosae. The pad is placed in contact with the gingival mucosa (between the lower gum and cheek) which enhances the flow the gingival macoba (between was sorptive cotton fibers of the pad. Following the of Indecourt the Collection Pad is removed from the mouth and placed into a conection period, the Concession a preservative solution which serves to inhibit the Specifical The The Tim connect on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.

The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.

The document is a 510(k) summary for the EpiScreen™ Oral Specimen Collection Device. It describes the device, its intended use, classification, and states that a modification was made to the package insert of an already cleared device (K970357). The core claim is that the modified device is identical to the currently cleared device and therefore does not raise new questions of safety and efficacy.

Consequently, none of the requested information (acceptance criteria table, sample size, data provenance, expert details, adjudication method, MRMC study, standalone performance, ground truth types, training set size, or ground truth establishment for training set) can be extracted from the provided text. The document focuses on regulatory equivalence rather than performance studies against defined acceptance criteria.

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EpiScreen is intended to collect oral fluid specimens, contain those specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.
EpiScreen is intended for use in the collection, preservation, and transport of oral fluid specimens.

The EpiScreen device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common salts and gelatin, creating a hypertonic environment which produces an osmotic gradient across the buccal and gingival mucosa. The pad is placed in contact with the gingival mucosa (between the lower gum and cheek) which enhances the flow of mucosal transudate onto the absorptive cotton fibers of the pad. Following the collection period, the Collection Pad is removed from the mouth and placed into a Specimen Vial. The vial contains a preservative solution which serves to inhibit the growth of oral microorganisms recovered on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.

The provided text doesn't contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the EpiScreen Oral Specimen Collection Device, which primarily focuses on establishing substantial equivalence to existing predicate devices.

Here's what the document does include, which is related to the request but doesn't directly answer it:

1. A table of acceptance criteria and the reported device performance

• The document provides a "Comparison Table: EpiScreen, Saliva Sampler, Saliva Sac, and Salivette" which compares the indications and components of the EpiScreen device to three predicate devices. This table doesn't list acceptance criteria or performance metrics, but rather technological characteristics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided. The document focuses on regulatory classification and substantial equivalence, not a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided.

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 device is a specimen collection device, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant and not mentioned.

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

• This is not applicable to a specimen collection device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• This information is not provided.

8. The sample size for the training set

• This information is not provided. There is no mention of a training set as this is not an AI-driven device.

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

• This information is not provided.

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