(91 days)
Advance Medical Designs equipment drapes are used to cover a variety of surgical and non-surgical equipment in various clinical settings. It is to be used in general and Endoscopic surgery for use with saline.
The Advance Medical Designs, Inc Equipment Drapes consist of polyurethane film that is cut and configured to specification. Packaged in a pouch to act as a sterile barrier. These equipment drapes are equivalent to other equipment drapes currently being marketed for the same intended use
The provided text describes a medical device called "Advance Medical Designs, Inc Equipment Slush Drape" and its 510(k) submission (K053495). The document focuses on establishing substantial equivalence to a predicate device, rather than reporting on a study validating an AI-powered device. Therefore, many of the requested elements pertaining to AI studies (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable or cannot be extracted from this document.
However, I can provide information about the acceptance criteria and the studies mentioned for the slush drape device's material performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Viral Penetration (ASTM Method F 1671) | The material used in this product has been tested to ASTM Method F 1671. |
| Flammability (16 CFR Part 1610) | The material used in this product has been tested to 16 CFR Part 1610. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the document.
- Data Provenance: Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The tests performed are laboratory material tests, not expert-based clinical evaluations.
4. Adjudication method
- 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-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-powered device.
7. The type of ground truth used
For the material performance tests:
- Viral Penetration (ASTM Method F 1671): The "ground truth" would be the standard established by the ASTM F 1671 method for viral penetration, indicating whether the material resists viral passage according to the test protocol's criteria.
- Flammability (16 CFR Part 1610): The "ground truth" would be the standard established by 16 CFR Part 1610, indicating whether the material meets the flammability requirements outlined in the regulation.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" as this is not an AI-powered device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.