(193 days)
JOYKEY Surgical Drapes (Sterile) are single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
JOYKEY Surgical Drapes (Sterile), are manufactured from non-woven fabric, PE & Reinforce layer. The Surgical Drapes include (3) basic configurations of SPLIT DRAPE, THYROID SHEET and PEDIATRIC LAPAROTOMY DRAPE. The Surgical Drapes are supplied sterile and for single use only.
The provided text is for a 510(k) summary for a medical device called "JOYKEY Surgical Drapes (Sterile)". This document primarily focuses on establishing substantial equivalence to a predicate device based on performance standards for surgical drapes, rather than a clinical study evaluating an AI algorithm.
Therefore, many of the requested points, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this type of submission. The device described is a physical sterile surgical drape, not an AI-powered diagnostic or therapeutic tool.
However, I can extract the relevant performance criteria and the study type conducted.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ASTM F1670-03 (Barrier properties against blood and body fluids) | Conforms |
| ASTM D1424 (Tearing Strength) (*) | Conforms |
| ASTM D5034 (Tensile Strength and Elongation) (*) | Conforms |
| NFPA Flammability standards (*) | Conforms |
| ISO 10993 series (Biological standards) | Conforms |
| ISO 11137 (Gamma Sterilization standard) | Conforms |
(*) Note: While the summary lists ASTM D1424, ASTM D5034, and NFPA Flammability standards, it doesn't explicitly state what specific aspect of these standards (e.g., minimum tensile strength, specific flammability class) was the acceptance criterion. The general statement "conforms to" is used.
2. Sample sized used for the test set and the data provenance:
- Not applicable. This submission involves bench testing of physical properties and biological compatibility standards for a surgical drape, not a test set of data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth establishment by experts is not relevant for testing physical and biological properties of a surgical drape.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods are for discrepancies in expert assessments or algorithm outputs, which are not relevant here.
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:
- No. An MRMC study was not done as this is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an algorithm.
7. The type of ground truth used:
- Objective performance standards. The "ground truth" here is compliance with established international and national performance standards (e.g., ASTM, ISO, NFPA) for material properties and sterilization.
8. The sample size for the training set:
- Not applicable. This device does not use a training set as it's not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
Summary of the Study:
The study proving the device meets its acceptance criteria was bench testing and compliance assessment against recognized international and national standards.
The key aspects of the study are:
- Type of Study: Bench testing for physical properties (e.g., barrier properties against blood and body fluids, tearing strength, tensile strength, flammability) and biological testing (biocompatibility and sterilization efficacy).
- Purpose: To demonstrate that the JOYKEY Surgical Drapes (Sterile) meet the performance characteristics required for their intended use and are substantially equivalent to the predicate device (MASTER & FRANK SURGICAL DRAPES, K020393).
- Standards Referenced:
- ASTM F1670-03 (Barrier properties against blood and body fluids)
- ASTM D1424 (Tearing strength)
- ASTM D5034 (Tensile strength and elongation)
- NFPA Flammability standards
- ISO 10993 series (Biological standards)
- ISO 11137 (Gamma Sterilization standard)
The report concludes that the device conforms to these standards, implying that the tested samples met the specified requirements within each standard. The details of the specific pass/fail criteria within each standard (e.g., minimum tensile strength, maximum fluid penetration) and the exact number of samples tested for each criterion are not provided in this summary but would have been part of the full 510(k) submission.
§ 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.