(86 days)
Master & Frank Surgical Drapes (Sterile) is a single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision for microbial and other contamination..
Master & Frank Surgical Drapes (Sterile), is manufactured from nonwoven fabric , PE & Reinforce layer. The Surgical Drapes includes (3) basic configurations of SPLIT DRAPE , THYROID SHEET and PEDIATRIC LAPAROTOMY DRAPE. The Surgical Drapes is supplied sterile and for single use only.
The provided document is a 510(k) summary for the Master & Frank Surgical Drapes (Sterile). It describes the device, its intended use, and a performance summary. However, it does not contain a detailed study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or specific types of studies (MRMC or standalone) as requested in your prompt.
The document focuses on demonstrating substantial equivalence to a predicate device (Medline Disposable Surgical Drapes & Gowns K964142) by stating that the device meets applicable standards.
Here's a breakdown of what the document does provide in relation to your request, and what it does not provide:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit via Standards Met): The document states: "In terms of Physical specification -- ASTM D1424 , ASTM D5034 & NFPA Flammability standards --- etc, Biological specification ISO 10993 series & Sterilization Specification ISO 11137 & ISO 11607-1 , the device are designed to meet applicable standards .."
- This implies that the acceptance criteria are adherence to these specific standards for physical properties, biological safety, and sterilization.
- Reported Device Performance: The document only generically states that the device is "designed to meet applicable standards." It does not provide specific numerical or qualitative results for each standard (e.g., actual tensile strength measurements, specific flammability ratings, or detailed biocompatibility test reports).
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (as stated) |
|---|---|
| ASTM D1424 (Physical specification) | Designed to meet applicable standards |
| ASTM D5034 (Physical specification) | Designed to meet applicable standards |
| NFPA Flammability standards | Designed to meet applicable standards |
| ISO 10993 series (Biological specification) | Designed to meet applicable standards |
| ISO 11137 (Sterilization Specification) | Designed to meet applicable standards |
| ISO 11607-1 (Sterilization Specification) | Designed to meet applicable standards |
The following information is NOT available in the provided text:
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "bench testing contained in this submission" but provides no details on sample sizes or data provenance.
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 type of information is not relevant or included for a physical device like a surgical drape. Ground truth is established by adherence to documented standards and test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no human adjudication is described for the physical and biological testing of a surgical drape.
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 a physical medical device (surgical drape), not an AI/software product requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" would be established by the specifications defined in the referenced ASTM, NFPA, and ISO standards, and the results of laboratory tests performed according to those standards. The document only confirms the device "is designed to meet applicable standards."
8. The sample size for the training set:
- Not applicable as this is not a machine learning/AI model that requires a training set. The "design" for a physical device is not "trained" in this context.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as point 8.
§ 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.