(150 days)
OsmoCyte™ Wound Manager Sheet Dressing is indicated for the management of partial and full thickness wounds, both chronic and acute, with low to moderate exudate, including the following: Pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 18 and 200 degree burns, donor sites, postoperative incisions, minor chemical and thermal burns, superficial lacerations, cuts and abrasions, severe sunburn, dermal lesions (e.g. poison ivy), trauma injuries or incisions.
A sterile, hydropolymer dressing which protects the wound and provides a moist wound environment for low to moderate exudating wounds.
The provided 510(k) K965143 for the OsmoCyte™ Wound Manager Sheet Dressing does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way modern device submissions typically do for AI/ML devices or diagnostic tools.
This document is from 1997 and relates to a wound dressing, which falls under a different regulatory pathway and testing paradigm than, for example, a diagnostic AI system. For a wound dressing, the "performance" is more related to its physical characteristics, biocompatibility, and ability to fulfill its intended function (e.g., maintaining a moist wound environment, absorption).
Here's a breakdown based on the information provided and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified as quantifiable metrics) | - Provides a moist wound environment. |
| (Not specified as quantifiable metrics) | - Protects the wound from the external environment. |
| (Not specified as quantifiable metrics) | - Absorbs excess wound exudate. |
| Biocompatibility (as per ISO 10993-1) | - "Biocompatibility testing has been performed as recommended in the 'International Standard for the Biological Evaluation of Medical Devices, ISO 10993-1.' These tests support the safe use of OsmoCyte™ Wound Manager Sheet Dressing as a wound dressing temporary in contact with breached or compromised skin." |
Explanation:
The document establishes equivalence to predicate devices based on "function and intended use" and "technological characteristics." The performance is described in terms of its intended actions (moist environment, protection, absorption) and successful biocompatibility testing. There are no specific quantifiable clinical performance metrics (e.g., sensitivity, specificity, accuracy, wound healing rates) stated as acceptance criteria with corresponding performance values, which would be typical for a diagnostic or AI-enabled device.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable / Not mentioned. (The biocompatibility testing described would typically involve animal or in vitro models as per ISO 10993, but specific subject numbers are not provided in this summary.)
- Data Provenance: Not applicable for clinical performance data. Biocompatibility testing follows international standards (ISO 10993-1).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a wound dressing, not a diagnostic tool requiring expert ground truth for a test set.
4. Adjudication method for the test set
- Not applicable.
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
- Not applicable. This is not an AI-enabled device or a diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used
- For biocompatibility: Adherence to ISO 10993-1 standards and endpoints (e.g., cytotoxicity, sensitization, irritation).
- For functional claims: The ground truth would be the known physical properties and performance characteristics of similar predicate wound dressings.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of what is present:
- The device is a sterile, hydropolymer dressing.
- Its function is to protect wounds, provide a moist healing environment, and absorb exudate.
- It is indicated for various partial and full-thickness wounds with low to moderate exudate.
- Biocompatibility testing was performed according to ISO 10993-1, supporting its safe use.
- The claim for substantial equivalence is based on similar function, intended use, and technological characteristics to several predicate wound and burn dressings already on the market.
Conclusion:
The K965143 document focuses on establishing substantial equivalence to existing predicate devices for a wound dressing. It demonstrates that the device functions similarly and is biocompatible. It does not present acceptance criteria or performance studies in the quantifiable, clinical outcome-based manner that would be expected for a diagnostic or AI-powered medical device. The "proof" consists of demonstrating equivalence to legally marketed devices and successful biocompatibility testing.
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