(26 days)
The Convertors®Surgical Drapes are devices 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 drapes are comprised of a base layer of nonwoven material to which the absorbent reinforcement structure is laminated.
The acceptance criteria and the study proving the device meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. | "The Convertors®Surgical Drapes are devices 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." (Page 0) |
| Biocompatibility: Meet cytotoxicity and primary skin irritation standards. | "The biocompatibility test performed were cytotoxicity and primary skin irritation. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." (Page 1) |
| General Performance Attributes: Similar to currently marketed Allegiance drapes. | "The performance attributes are similar." (Page 1) |
2. Sample Size Used for the Test Set and Data Provenance
The provided documents do not contain information on specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) for Convertors® Surgical Drapes. The testing described is general and refers to adherence to "industry recognized test methods."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to "industry recognized test methods" for biocompatibility and general performance, implying standardized protocols rather than expert consensus on specific cases.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the device (surgical drapes) and the type of testing described (biocompatibility, general performance), a traditional adjudication method for a "test set" as understood in AI/diagnostic device studies is unlikely to be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This type of study focuses on human reader performance with and without AI assistance, which is not relevant to the evaluation of surgical drapes.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical product (surgical drapes), not a software algorithm.
7. Type of Ground Truth Used
The ground truth for the device's performance appears to be established through adherence to industry recognized test methods for biocompatibility (cytotoxicity and primary skin irritation) and general performance attributes. This likely involves laboratory measurements and assessments against established chemical and physical standards.
8. Sample Size for the Training Set
No information regarding a "training set" or its sample size is provided. This concept is typically relevant for machine learning algorithms, not for physical medical devices like surgical drapes.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for this device.
§ 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.