(183 days)
The Dynarex Towel Drape is a device consisting of natural or synthetic materials intended to be used as a patient covering during General Surgical Procedures.
The Dynarex Towel Drape is composed of nonwoven fabric or polyethylene film and are of various configurations appropriate for General Surgical procedures. These devices use nonwoven and film materials as a protective patient covering during surgical procedures. These barrier materials are essentially impervious to fluids and microorganisms, thus function to isolate the operative site from the surrounding area. Dynarex Towel Drapes may feature tape adhesive to temporarily bind the drape to the periphery of the operative site. Fluid collection pouches are attached to the drape for collection of operative wound solid and liquid effluents. The Dynarex Towel Drape will be subjected to a sterilizing dose of gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10-6. This towel drape is a single use, disposable provided in a sterile package.
The provided text is a pre-market notification for a medical device called the "Dynarex Towel Drape." This document is a 510(k) submission to the FDA, which aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.
Based on the information provided, this submission is not for an AI/ML-driven device that would have the typical acceptance criteria and study designs you've listed. Instead, it's for a physical medical product (a surgical towel drape). Therefore, many of the requested fields are not applicable in this context.
Here's an analysis of the available information in relation to your questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence: The Dynarex Towel Drape is substantially equivalent in function, intended use, and functional design to predicate devices. | The Dynarex Towel Drape is "exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices" (referring to DEKA Medical Surgical Drape - K90210 and Invotec International Drape K911039). |
| Material Composition: Composed of nonwoven fabric or polyethylene film. | Composed of nonwoven fabric or polyethylene film. |
| Protective Barrier: Essentially impervious to microorganisms to isolate the operative site. | "These barrier materials are essentially impervious to microorganisms thus function to isolate the operative site from the surrounding area." |
| Sterility Assurance Level (SAL): Sterile product with an SAL of 10^-6. | The device "will be subjected to a sterilizing dose of gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10^-6." Compliance with ANSI/AAMI ST39-1991 for validation and routine monitoring of sterilization. |
| Packaging: Packaging methods and materials are the same as predicate devices. | "The packaging methods and packaging materials are exactly the same, respectively." |
| Intended Use: Patient covering during General Surgical Procedures. | Intended for "General Surgical Procedures." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission relies on demonstrating similarity to predicate devices rather than clinical trial data for performance. For a physical product like a drape, testing would typically involve material integrity, barrier effectiveness, and sterility validation, which usually don't involve "test sets" in the AI/ML sense.
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)
This is not applicable as the submission is not for an AI/ML device that requires expert-established ground truth for a diagnostic task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as above.
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
This is not applicable as the device is not an AI-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" would relate to its physical properties and performance characteristics, such as:
* Material specifications: Conformance to intended material (nonwoven fabric or polyethylene film).
* Sterility: Conformance to SAL 10^-6, verified by microbiological testing and sterilization validation.
* Imperviousness: Performance as a barrier to microorganisms, likely tested according to established standards for barrier materials.
* Functional design: Direct comparison and manufacturing to mimic the design of predicate devices.
The document states compliance with ANSI/AAMI ST39-1991 for sterilization validation, which would constitute a form of "ground truth" based on recognized standards.
8. The sample size for the training set
This is not applicable as there is no "training set" for a physical product like this.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set." The "ground truth" for demonstrating substantial equivalence for this device is primarily established by adherence to existing material standards, sterilization protocols, and direct comparison to legally marketed predicate devices.
§ 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.