(105 days)
The various sizes of Polyethylene Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and do not have patient contact.
ValuMed's Cover Alls, the Sterile Equipment Covers by Custom Medical Products(K931417), Equipment Covers by United States Surgical(K964699) and the Equipment Snap Covers by Advance Medical Designs(K850959) consist of various sizes and shapes of polvethvlene covers that are positioned on surgical equipment. The covers are used to maintain a sterile field and as an aid in the clean up of equipment after surgery.
The provided documents describe a 510(k) premarket notification for "Cover All Equipment Covers" by ValuMed. This notification does not pertain to an AI/ML device, but rather to a simple medical device (protective covers). Therefore, many of the requested categories related to AI/ML device studies, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, and data provenance, are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain a sterile field | Implied by "intended to cover equipment" and "aid in the clean up of equipment after surgery" and comparison to predicate devices, but no specific performance metric related to sterility maintenance is provided. |
| Aid in the clean-up of equipment after surgery | Implied by the intended use and comparison to predicate devices, but no specific performance metric is provided. |
| Physical properties similar to predicate devices | Verified through "Seal Peel Test, Tear Resistance Test, and Flammability Test." No specific quantitative results are provided, only that testing was conducted. |
| Made of polyethylene | Stated as a characteristic of the device. |
| Intended use is the same as predicate devices | Stated as a characteristic and confirmed by FDA's substantial equivalence determination. |
| Size, configuration, color are similar to predicate devices | Stated as a characteristic. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a non-clinical evaluation of physical properties of a protective cover, not a study involving a "test set" of data in the context of an AI/ML device. The testing conducted (Seal Peel Test, Tear Resistance Test, Flammability Test) would have involved samples of the product, but the specific sample sizes are not reported. The data provenance is internal testing by ValuMed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of expert review, is not relevant for this type of device and testing.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the AI/ML sense requiring adjudication.
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 passive equipment cover, not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" here is based on engineering specifications and comparison to predicate devices. For physical properties, standard material testing methods (Seal Peel, Tear Resistance, Flammability) were used to confirm similarity with existing, legally marketed devices. The "truth" is that the material's properties meet certain standards or are comparable to those of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no AI/ML training set.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.