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Skin Temp. H. Dressing is a sterile, disposable, single use wound dressing. It is a hydrocolloid and hydrophillic dressing composed of fibrous type I bovine collagen. The device is to be provided in hydrated as well as dry form. The device is to be used for the management of burns, blisters, sores, scrapes, ulcers and other wounds. The Skin.Temp. II. Dressing will be available in 2"X2", 3"X4" and 8"X12" sizes and additional sizes may introduced at a later time.

AI/ML Overview

This submission details the SkinTemp II Dressing, a collagen-based wound dressing, as substantially equivalent to the predicate device, BioCore SkinTemp sheet. The core of the submission revolves around demonstrating this substantial equivalence through a comparison of technological characteristics and non-clinical testing.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal table of "acceptance criteria" with quantitative performance metrics for the SkinTemp II Dressing. Instead, it relies on demonstrating substantial equivalence to a predicate device. The acceptance is implied by meeting or being analogous to the predicate device's characteristics and performance.

However, based on the non-clinical testing and comparison to the predicate, we can infer some "performance criteria" that the SkinTemp II Dressing met:

Accepted Performance Criteria Category	Target (Analogous to Predicate)	SkinTemp II Dressing Performance
Intended Use/Indications	Management of burns, sores, blisters, scrapes, ulcers, and other wounds.	Identical: "The HBS SkinTemp II Dressing is indicated for the management of burns, sores, blisters, scrapes, ulcers, and other wounds." (Page 2, Table 7.1)
Principles of Use	Cleanse wound, apply medication if needed, apply dressing, cover with non-adherent dressing, change as required.	Identical: "Cleanse the wound. Apply medication if needed. Apply dressing and cover with non-adherent dressing. Change as required." (Page 2, Table 7.1)
Scientific Technology	100% type I bovine collagen as primary constituent.	Identical: "The SkinTemp II Dressing uses 100% type I bovine collagen as its primary constituent." (Page 2, Table 7.1)
Configuration / System Components	Sterile, disposable, single use, collagen-based wound dressing with non-adherent backing. Hydrocolloid, absorbent, gel formation.	Identical: "Sterile, disposable, single use, collagen based wound dressing with non adherent backing. Further properties include: a) Hydrocolloid b) Absorbent Dressing c) Gel formation" (Page 2, Table 7.1)
Sterility Method	Electron Beam Sterilization.	Identical: "Each dressing is sterilized using Electron Beam Sterilization." (Page 2, Table 7.1) Validated per AAMI TIR-27 and ISO 11137-1:2006. (Page 4-5)
Materials	Type I Bovine Collagen, Distilled Water, Buffering Agent (Chemical Z).	Identical: "Type I Bovine Collagen, Distilled Water, Buffering agent / Chemical Z (proprietary name)" (Page 2, Table 7.1). The inclusion of Chemical Z was the specific reason for this new 510(k) submission to formally document an ingredient that was previously used but not formally documented in the predicate's 510(k). (Page 5)
Biocompatibility	Meet all biocompatibility testing requirements.	Confirmed: "Testing has confirmed that SkinTemp II Dressing meets all biocompatibility testing requirements stated by FDA regulations and ISO 10993." (Page 4) Performed by North American Science Association, Inc. (NAmSA).
Sterilization Assurance	Validated sterilization process.	Confirmed: Sterilized per AAMI TIR-27, validated, and routine control created in accordance with ISO 11137-1:2006. (Page 4-5)
Physical Requirements	General Physical Requirements, Dimensional Analysis, Visual Inspections, Moisture Content testing, Package and Labeling requirements, Operational Environment Requirements.	Confirmed: Design verification testing via functional testing detailed in Section 20.2 (not provided in the excerpt). This included General Physical Requirements, Dimensional Analysis (e.g., 2" ± 0.25" x 2" ± 0.25", < 17% Moisture Content, < 10 ppm Heavy Metals, Page 1), Visual Inspections, Moisture Content testing, Package and Labeling requirements and Operational Environment Requirements. (Page 5)
Manufacturing Process	Manufactured in a controlled environment with validated processes.	Confirmed: Manufactured in an ISO 13485:2003 certified cleanroom environment with complete process validation testing. (Page 5)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical or performance data from human subjects. The study presented here is a non-clinical substantial equivalence comparison.

Sample Size: Not applicable in the traditional sense of a clinical trial. The testing involves samples of the SkinTemp II Dressing undergoing physical, chemical, and biological evaluations. Specific sample sizes for each non-clinical test (e.g., biocompatibility samples, sterilization validation samples, dimensional analysis samples) are not provided in this summary.
Data Provenance: The testing was performed internally by Human BioSciences, Inc. and by a third-party laboratory, North American Science Association, Inc. (NAmSA), for biocompatibility. The summary does not provide country of origin or whether it's retrospective or prospective, but given it's non-clinical testing for a 510(k) submission, it would be prospective testing on the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a non-clinical submission demonstrating substantial equivalence to a predicate device, not a study requiring expert readers or interpretation of clinical data. The "ground truth" for the non-clinical tests would be the established scientific and regulatory standards (e.g., FDA regulations, ISO standards, AAMI guidelines) and the documented characteristics of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication or clinical assessment involved in this type of substantial equivalence submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of an MRMC study. This submission focuses on the device itself and its equivalence to a predicate, not on the improvement of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (wound dressing), not an algorithm or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is primarily:

Predicate Device Characteristics: The detailed specifications and approved 510(k) information of the BioCore SkinTemp sheet (K913023 & K925545). The new device's characteristics were compared point-by-point to this established device.
Regulatory Standards: ISO 10993 (Biocompatibility), AAMI TIR-27 (Sterilization), ISO 11137-1:2006 (Sterilization), and FDA regulations (e.g., 21 CFR Part 807.92). Performance parameters such as sterility, biocompatibility, and manufacturing quality are measured against these established standards.
Internal Specifications: For physical characteristics like size, moisture content, and heavy metals, the "ground truth" is the internal design specifications of the SkinTemp II Dressing, which are designed to be consistent with or superior to the predicate.

8. The Sample Size for the Training Set

Not applicable. There is no machine learning "training set" involved as this is not an AI/algorithm-driven device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/algorithm.

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