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The Centurion® Protective Restraint is a device, including a wristlet, anklet, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

This device is intended for use on neonatal/newborn patients by or on the order of a physician in a hospital or clinic setting.

The device is contraindicated for use on patients with dislocations, fractures, open wounds on the affected limb, or if I.V. site can be compromised.

The Centurion® Protective Restraint is a device comprised of hook and loop material, 100% nylon fabric with polyester foam core, and nylon tricot backing.

The provided text describes a 510(k) premarket notification for the Centurion® Protective Restraint. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety or effectiveness through extensive clinical trials. Therefore, the study described is a comparative bench performance test.

Here’s an analysis of the provided information, framed by your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text only mentions "Comparative bench performance testing was performed."
• Data Provenance: The study was a "bench performance testing," implying it was conducted in a laboratory setting, likely by the manufacturer (Tri-State Hospital Supply Corporation). There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies.

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

• This information is not provided as this was a bench performance test, not a clinical study involving human judgment on clinical outcomes. Ground truth for a bench test would be based on engineering specifications and direct measurements against those specifications.

4. Adjudication Method for the Test Set

• This is not applicable/not provided as no human expert adjudication of clinical performance was involved in this bench test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

• No, an MRMC comparative effectiveness study was not done. The submission describes a 510(k) for a Class I device, which relies on demonstrating substantial equivalence through bench testing, not clinical studies like MRMC.

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

• This question is not applicable as the device is a physical protective restraint, not an AI algorithm or software.

7. The Type of Ground Truth Used

• The ground truth for this bench testing would have been based on pre-defined engineering specifications, material properties, and functional requirements for protective restraints, derived from regulatory standards, internal product design specifications, and the characteristics of the predicate device. It's not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This section describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, this device does not utilize AI/ML and therefore does not have a "training set" or ground truth established for one.

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Centurion® SorbaView® OTC dressings are intended for medical purposes to cover and protect wounds, hold together the skin edges of a wound, support an injured part of the body, or to secure objects to the skin.

This device is intended for lay or prescription use by pediatric or adult patients.

Sorba View® dressings are highly permeable, self-adhesive, transparent film dressings that are of multi-layer construction. The multi-layer construction consists of:

• Polyurethane film, .
• . Solvent-spun cellulose,
• . Medical grade adhesive,
• ◆ Non-woven fabric, and
• Kraft liner with silicone release coating. .

This is a 510(k) premarket notification for a medical device (dressing), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and human/AI performance is not applicable.

The provided document describes the Centurion® SorbaView® OTC dressing and its substantial equivalence to predicate devices (Centurion® SiteGuard® Transparent Dressing K945977 and 3M Tegaderm™ + Pad K811291).

Here's a summary of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance: This section is designed for AI/ML performance metrics. For this device, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various tests.

   Acceptance Criteria (Implied)	Reported Device Performance
   Biocompatibility: Non-cytotoxic, non-sensitizing, negligible irritant	Results of testing validate SorbaView® is non-cytotoxic, non-sensitizing, and a negligible irritant.
   Barrier effectiveness against viral contaminants	Effective against penetration of viral contaminants (ASTM F 1671-97b).
   Barrier effectiveness against blood contaminants	Effective against penetration of blood contaminants (ASTM F 1671-97b and 107098).

2. Sample Size and Data Provenance: Not applicable for a non-AI/ML device. The testing conducted was for biocompatibility and barrier effectiveness, likely using standardized laboratory samples.

3. Number of Experts and Qualifications: Not applicable. Human experts are not involved in establishing ground truth for biocompatibility or barrier effectiveness tests in the same way they would be for an AI diagnostic.

4. Adjudication Method: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant for a medical dressing.

6. Standalone Performance Study: Not applicable in the context of an "algorithm only" performance. The device itself (the dressing) was tested for its properties (biocompatibility, barrier effectiveness).

7. Type of Ground Truth Used: For biocompatibility, the ground truth is established by standardized biological assays. For barrier effectiveness, the ground truth is established by physical testing against viral and blood contaminants according to ASTM standards.

8. Sample Size for Training Set: Not applicable. There is no training set for a medical dressing.

9. How Ground Truth for Training Set was Established: Not applicable.

In conclusion, the provided document details the safety and effectiveness testing of a transparent film dressing, demonstrating its substantial equivalence to existing products through standardized biological and physical tests, rather than through AI/ML performance evaluation.

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