(96 days)
Exact Medical Manufacturing Equipment Cover - Polyethylene are sterile single use devices made of natural or synthetic materials intended to be used as a protective equipment covering, such as to isolate equipment from microbial and other contamination.
The Exact Medical Manufacturing Equipment Covers-Polyethylene are also sold as bulk nonsterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.
Exact Medical Manufacturing Equipment Cover- Polyethylene are single use, disposable equipment cover used in the OR as a protective covering, for the operating equipment, from the transfer of microorganisms, body fluids and particulates. Exact Medical Manufacturing Equipment Covers - Polyethylene are comprised Polyethylene with absorbent polypropylene. The Exact Medical Manufacturing Equipment Covers-Polyethylene are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.
The provided document is a 510(k) summary for a medical device called the "EMM Equipment Cover - Polyethylene." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the device's diagnostic or therapeutic performance. As such, many of the typical elements requested for an AI/diagnostic device study (like sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training data) are not applicable or present in this context.
However, I can extract the acceptance criteria and reported device performance from the provided "Non-Clinical Testing Summary."
1. Table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Water Resistance: Impact Penetration Test, Level 3 | 50 cm hydrostatic resistance | Pass |
| Flammability of Clothing Textiles - Class 1 | Class 1 =/> 3.5 sec. average flame spread | Pass |
| Tearing Strength of Fabrics by Trapezoid Procedure | Acceptance criteria not established in recognized standard. Tear Strength for Md and Cd within general industry tolerance of +/- 20% | Pass |
| Breaking Strength and Elongation of Textile Fabrics (Grab Test) | Acceptance criteria not established in recognized standard. Tensile Strength for Md and Cd within general industry tolerance of +/- 20% | Pass |
| Sterilization of health care products - Ethylene oxide - Part 1 | SAL of > 10-6 | Pass |
| Lint and other particles generation in the dry state | Acceptance criteria not established in the recognized standard | Pass |
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify the sample size for each test. It refers to a "Finished Good Lot Number: 0980APA3" for multiple tests, implying that samples were drawn from this lot.
- Data Provenance: The tests were conducted at "Nelson Labs, Utah, USA" and "SCDC, Shanghai, CN, LexaMed, Ohio, USA." This indicates the tests were conducted in the USA and China, presumably using newly manufactured equipment covers. These are non-clinical (laboratory/performance) tests, not clinical data sets.
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 an equipment cover, and the "ground truth" is established by laboratory performance standards and measurements, not by expert interpretation of clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. The tests are based on objective physical and chemical properties measured according to established standards, not on expert adjudication of ambiguous cases.
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 an equipment cover and not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is an equipment cover and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is defined by adherence to recognized international and national standards for material properties, barrier performance, flammability, and sterility. These are objective, measurable criteria, not subjective interpretations.
8. The sample size for the training set:
This information is not applicable. This is a manufactured product undergoing non-clinical performance testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable. As there is no training set, there is no ground truth establishment process for it.
§ 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.