(49 days)
The Convertors® Trilaminate Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
These drapes will be composed of nonwoven fabrics adhesively laminated to a synthetic polymer film. The film is a finely embossed blended polyethylene construction. The drapes also have clear polyethylene side panels on either end of the drapes.
The provided text describes a 510(k) summary for "Convertors® Trilaminate Drapes," a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the way a novel diagnostic AI product might.
Therefore, many of the requested categories for AI-based device evaluation are not applicable or cannot be extracted from this document, as it concerns a physical medical drape.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (based on text) | Reported Device Performance (based on text) |
|---|---|---|
| Biocompatibility | ISO 10993 Part-1 "Biological Evaluation of Medical Devices" evaluation for cytotoxicity, sensitization, and intracutaneous reactivity. | All materials used "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Hydrostatic Head | Industry recognized test methods (specific values not provided in this summary). | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Impact Penetration | Industry recognized test methods (specific values not provided in this summary). | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Synthetic Blood Penetration | ASTM 1670-1995 standards for resistance to penetration by synthetic blood. | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Viral Penetration | ASTM 1671-1995 standards (specifically mentioning Phi X174, a bacteriophage, often used as a substitute for viruses in penetration testing). | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Grab Tensile | Industry recognized test methods (specific values not provided in this summary). | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Basis Weight | Industry recognized test methods (specific values not provided in this summary). | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
| Flammability | Class 1 flammability standard. | Materials "met the requirements of the identified tests and were found to be acceptable for the intended use." |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for each test mentioned (e.g., how many drapes were tested for synthetic blood penetration). The data provenance is not described as it would be for clinical data (e.g., country of origin, retrospective/prospective). The testing appears to be laboratory-based material testing rather than clinical study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for material properties is established by the results of standardized laboratory tests, not by expert consensus on clinical cases.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations.
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 device or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance claims cited in the document is the adherence to and successful completion of standardized industry test methods and biological qualification safety tests, as outlined by ISO 10993 Part-1 and various ASTM standards.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI model.
§ 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.