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The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape that is intended to provide and maintain a barrier against contamination between the OR Specific dual adjustable shelf operating room equipment tables and a variety of surgical and non surgical equipment during various procedures in the clinical and hospital operating room environment. In normal use as directed this product will not make direct contact with a patient. The drape is available 4 models to meet user requirements.

The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape manufactured using poly film and non woven material, separately and in combination designed to protect a variety of Surgical and non Surgical equipment from Contamination during various procedures throughput the clinical and operating room setting. These equipment drapes are specifically designed to fit, attach to and cover the OR Specific Big Case Back Table and function in an identical manner to other equipment drapes currently being marketed for the same intended use.
2 sizes of these covers are available designed to function with 2 different sizes of OR Specific Big Case Back Tables. In addition, the product is offered in either a standard or heavy duty version as follows.

This submission is for a Class II medical device, specifically an operating room equipment drape. As such, the FDA 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices rather than providing detailed acceptance criteria and study results typical of higher-risk devices or AI/software as a medical device submissions.

Based on the provided text, here's a breakdown:

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

The document does not explicitly state quantitative acceptance criteria or performance metrics for the OR Specific Big Case Back Table Cover. Instead, the demonstration of substantial equivalence relies on similarities in:

• Intended Use: "to provide and maintain a barrier against contamination" (identical to predicate devices).
• Materials: "manufactured from similar materials to the predicate devices."
• Packaging, Sterilization, and Labeling: "packaged, sterilized and labeled in a similar manner."
• Function: "function in an identical manner to other equipment drapes currently being marketed for the same intended use."

Therefore, the "reported device performance" is implicitly that it performs equivalently to the listed predicate devices in its barrier function, sterility, and ease of use, as suggested by its substantial equivalence determination.

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

The document makes no mention of a test set, sample size, or specific performance studies with data provenance. The substantial equivalence determination is based on a comparison to existing predicate devices, implying that the established performance of those predicates serves as the benchmark. This type of submission typically relies on existing knowledge of similar devices, material properties, and manufacturing processes rather than new clinical or performance studies for this device class.

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)

Not applicable. No "ground truth" establishment using experts for a test set is described or required for this type of 510(k) submission for an equipment drape.

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

Not applicable. No test set or adjudication method 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 sterile drape, not an AI or software device, and no MRMC study was conducted.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. The concept of "ground truth" in the context of diagnostic accuracy, as it applies to AI/software, is not relevant to a sterile equipment drape. The "ground truth" for this device's efficacy is the established performance and safety record of its predicate devices, which are also simple barrier drapes.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/software device.

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

Not applicable. There is no mention of a training set or ground truth establishment for a training set.

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