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Seal-On™ is a hemostatic powder spray containing Microdispersed Oxidized Cellulose in an aerosol form and is indicated for OTC use in the topical control of bleeding from minor cuts and abrasions of the skin surface.

AI/ML Overview

The provided text is related to an FDA 510(k) clearance for a device called Seal-On™ Topical Hemostatic Powder Spray. It confirms the device's substantial equivalence to predicate devices for its intended use. However, the document does not contain specific details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The letter primarily covers:

An administrative change in product code (from FRO to QSY).
Confirmation of substantial equivalence based on a submission from 2002.
The intended use of the device: "topical control of bleeding from minor cuts and abrasions of the skin surface."
A brief description comparing the device to predicate devices, stating it uses microdispersed oxidized cellulose, which is derived from a plant source like the predicate devices' active components (alginate). It also mentions the low toxicity and antigenicity of oxidized cellulose and its history of safe use.
A note that biocompatibility test results were included in the premarket notification.

Since the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text, I cannot complete the table or answer most of the questions.

Here's a breakdown of what can be inferred or what is explicitly missing:

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

Acceptance Criteria	Reported Device Performance
Not provided in the document. The document refers to "substantial equivalence" to predicate devices for its intended use, implying performance was deemed comparable in terms of achieving hemostasis for minor cuts and abrasions.	Not explicitly quantified in the document. The document states "Oxidized cellulose has very low systemic toxicity and virtually no antigenicity or immunogenicity and has a long history of safe and effective use as an absorbable hemostatic agent during surgical procedures where it is partially or fully absorbed." It also notes that "Appropriate biocompatibility test results were included in the premarket notification."

Acceptance Criteria

Reported Device Performance

Not provided in the document. The document refers to "substantial equivalence" to predicate devices for its intended use, implying performance was deemed comparable in terms of achieving hemostasis for minor cuts and abrasions.

Not explicitly quantified in the document. The document states "Oxidized cellulose has very low systemic toxicity and virtually no antigenicity or immunogenicity and has a long history of safe and effective use as an absorbable hemostatic agent during surgical procedures where it is partially or fully absorbed." It also notes that "Appropriate biocompatibility test results were included in the premarket notification."

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

Sample size for test set: Not provided.
Data provenance: Not provided.

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)

Number of experts: Not provided.
Qualifications of experts: Not provided.

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

Adjudication method: Not provided. Evidence of a test set or clinical study is not detailed in the provided text.

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 topical hemostatic powder spray, not an AI-assisted diagnostic tool for human readers.

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

Standalone performance: Not applicable. This is a physical medical device, not an algorithm.

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

Type of ground truth: Not explicitly stated. For a hemostatic device, this would typically involve direct observation of clotting time or cessation of bleeding in an appropriate model or trial, potentially with outcomes data confirming efficacy for minor cuts and abrasions. The document mentions "biocompatibility test results were included," but doesn't detail performance studies.

8. The sample size for the training set

Sample size for training set: Not applicable as this is not an AI/ML device requiring a training set in the conventional sense. The "training" for such a device would be based on historical data, literature, and general scientific understanding of its components.

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

Ground truth for training set establishment: Not applicable. This is a physical medical device. The "ground truth" for its development would be established through established scientific principles of hemostasis, material science, and prior regulatory approvals of similar components (like oxidized cellulose).

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