(164 days)
A surgical drape and drape accessories used as a protective covering between an instrument and the patient to isolate a site of surgical incision from microbial and other contaminants
A sterile bag to contain a non-sterile ultrasound transducer probe during a sterile procedure. A disposable, single use, sterile instrument cover/drape to protect the patients from cross contamination from bacteria's of a non-sterile ultrasound transducer probe. A sterile barrier between patient and ultrasound transducer probe.
This document is a 510(k) premarket notification for a Latex Ultrasound Transducer Surgical Drape, which is a medical device. Therefore, the questions related to device performance, study details, and AI/human reader performance are not directly applicable to this type of regulatory submission. This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the effectiveness or performance of a new treatment or diagnostic algorithm.
Here's an analysis based on the provided text, addressing the applicable questions:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in the typical sense of a diagnostic or therapeutic device with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" is primarily related to material properties and sterility, aligning with the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (PROTEK Medical Products Inc.) |
|---|---|
| Material: Natural Latex Rubber, Thickness .001-.007 | LATEX .001-.007 |
| Performance Standard: ASTM - ES - 22 | ASTM - ES - 22 |
| Sterility: ETO Sterilization | ETO |
| Biocompatibility: ISO-10993 Compliance | ISO-10993 |
| Mechanical Safety (Tensile Strength): 2400 - 3500 PSI | Tensile Strength 2400 - 3500 PSI |
| Chemical Safety: No Hazardous Components, 29CFR 1910.1200 | No Hazardous Components, 29CFR 1910.1200 |
| Resistance to Penetration: Global Test Methods | Global Test Methods for Resistance to Penetration |
| Packaging: TYVEK "Chevron Peel Pouch" | TYVEK "Chevron Peel Pouch" |
| Human Factor: Labels identify product as Latex | Labels identify this product as Latex |
2. Sample size used for the test set and the data provenance
The document does not detail specific "test sets" for performance studies in the way one would for a diagnostic algorithm. The testing appears to be centered on material properties and adherence to manufacturing standards. The provenance of the data is implicit through adherence to established standards (ASTM, ISO, CFR). Specific sample sizes for each test mentioned (e.g., tensile strength, penetration resistance) are not provided in this summary document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a surgical drape, and its "ground truth" is typically established through adherence to material standards and manufacturing processes, rather than through expert interpretation of a test set, as would be the case for an imaging or diagnostic device.
4. Adjudication method for the test set
This information is not applicable for the reasons stated 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 information is not applicable. The device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is not an algorithm.
7. The type of ground truth used
The "ground truth" for this device is based on:
- Material Specifications: Conformance to natural latex rubber properties and thickness.
- Established Standards: Adherence to ASTM-ES-22, ISO-10993, and 29CFR 1910.1200.
- Manufacturing Processes: "Dipped Latex" method and ETO sterilization.
- Predicate Device Characteristics: The existing qualities and performance of legally marketed surgical drapes from Civco Medical, Amedic of Sweden, and Microtek.
8. The sample size for the training set
This information is not applicable. The device is a physical product, not a machine learning algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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.