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Kenad Protective Mitts are indicated for medical purposes where hand and finger movement must be limited to prevent grasping tubes or picking or scratching dressings and wounds.

The Kenad Protective Mitts subject to this Premarket Notification are devices that comprise the following modules, cited in this document: Mitt- Two sided flexible material. The inside, which faces the hand, is polyurethane, and the outside is polyester foam. Mesh Port Covering- Nylon mesh. Wrist Strap and Buckle- Flexible polypropylene and polished nickle plated buckle. Stay-Inflexible aluminum strip.

This submission describes a medical device, the Kenad Protective Mitt, and compares it to a legally marketed device. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in the prompt. The document primarily focuses on establishing substantial equivalence to a predicate device and relies on a historical safety record rather than a formal performance study with defined acceptance criteria.

The information requested in the prompt is not available in the provided text.
Here's a breakdown of why this information is missing:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states a lack of complaints, which is a retrospective safety observation, not a prospective performance metric with acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable. There was no formal "test set" or prospective study. The "sample" is the historical usage of "more than 5000 pairs over 5 years," which is observational rather than a controlled test. Data provenance is implied to be real-world usage in various medical settings.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication process is described.
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 device is a physical restraint, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a software/algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of device performance. The closest thing to "ground truth" here is the absence of reported patient injury or product failure complaints as an indicator of safety and effectiveness.
8. The sample size for the training set: Not applicable. This device does not involve a training set as it's not an AI or learning-based system.
9. How the ground truth for the training set was established: Not applicable.

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