(55 days)
These equipment covers are equipment drapes or drape accessories 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 International Medsurg Connections equipment covers are made of polyethylene. The covers are offered sterile and non-sterile.
The provided text describes a 510(k) premarket notification for "International Medsurg Connections Equipment Covers." This document is for a medical device that falls under the category of protective covers, and not an AI/ML-driven diagnostic or analytical device. Therefore, many of the requested elements of the prompt related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable to the submitted document.
However, I can still extract the acceptance criteria related information about the device and the study as much as possible from the provided context.
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, implying these methods establish the acceptance criteria for the device based on established standards. The document states that the tests were performed, indicating compliance, but it does not explicitly provide numerical "reported device performance" values or specific "acceptance criteria" values for comparison in most cases.
| Test Method | Standard Used | Implicit Acceptance Criteria / Reported Performance |
|---|---|---|
| Flammability Testing, Class 1 | 16 CFR 1610 | Met "Class 1" (implies compliance with the standard) |
| Hydrostatic Pressure Test - Fluid Penetration Test | AATCC Test Method 127-1989 | Testing performed (implies compliance with the standard) |
| Grab Tensile | ASTM D882-91 | Testing performed (implies compliance with the standard) |
| Tear Resistance - Strip Tensile | ASTM D1424-96 | Testing performed (implies compliance with the standard) |
| Other characteristics listed under "Substantial Equivalence" | N/A | - Intended use is the same |
- Size, configuration, color are similar
- Made of polyethylene
- Physical properties are similar |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the stated tests (Flammability, Hydrostatic Pressure, Grab Tensile, Tear Resistance). It also does not provide information on data provenance (country of origin, retrospective/prospective). This is typical for submissions for physical barrier devices where the testing refers to material properties rather than clinical data.
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)
Not applicable. This device is an equipment cover, a physical product, not one requiring expert interpretation or ground truth establishment in a clinical or diagnostic context. The "ground truth" for these tests would be the material's physical properties meeting the specified standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective assessments or discrepancy resolution in diagnostic studies, not for objective material property testing.
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-assisted diagnostic or analytical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with established engineering and material standards (e.g., 16 CFR 1610 for flammability, AATCC Test Method 127-1989 for fluid penetration, ASTM D882-91 for grab tensile, ASTM D1424-96 for tear resistance). These are objective measurements against defined criteria.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning/AI 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.