(140 days)
3M Steri-Drape™ Surgical Fabric Drapes are used to create a sterile field for a surgical procedure. They are provided sterile using ethylene oxide or gamma irradiation, and intended for external use only.
3M Steri-Drape™ non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.
The Steri-Drape™ Fabric Drapes described in this submission are onepiece, single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of an absorbent nonwoven fabric backed with a protective film that stops fluid strike-through.
Steri-Drape™ Fabric Drapes are provided in various sizes and shapes to meet the surgeon's needs. In general, the surgeon delineates the proposed field of surgery and charges the nursing team with the responsibility of draping the patient using different types of drapes.
The provided text describes a medical device, "Steri-Drape™ Fabric Drape," and its summary of safety and effectiveness, leading to FDA clearance (K031287). However, the document does NOT contain the specific details required to answer many of the questions about acceptance criteria and the study that proves the device meets those criteria, especially in the context of AI/ML performance evaluation.
This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results with specific acceptance criteria that would be typical for an AI/ML device.
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly stated in the document) | Reported Device Performance (Explicitly stated in the document) |
|---|---|
| Biocompatibility (Cytotoxicity, Primary Skin Irritation, Sensitization) | "All testing indicated that the drapes described above were biocompatible and acceptable for the intended use." |
| (Performance testing in accordance with industry recognized test methods) | (Results not specified beyond general statement of testing performed) |
| Substantial Equivalence to predicate device | Stated as substantially equivalent to currently marketed Steri-Drape™ fabric drapes. |
| Intended Use: Create a sterile field for surgical procedure | Device has the same intended use as predicate device. |
Missing Information: Specific quantitative acceptance criteria (e.g., specific thresholds for irritation indices, specific performance metrics for barrier function, etc.) and their corresponding quantitative performance results are not detailed. The document states "performance testing in accordance with industry recognized test methods" but does not elaborate on the specific tests, their criteria, or the outcomes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document does not specify the sample size for any test set (e.g., number of drapes tested for biocompatibility or performance). It also does not mention the data provenance (country of origin, retrospective/prospective). This type of detail is usually found in detailed test reports, not a 510(k) summary.
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)
Missing Information: This question is not applicable to the type of device and testing described. The "ground truth" concept, especially involving expert consensus, is typically associated with diagnostic or image-analysis AI/ML devices where human expert interpretation is the standard. For a surgical drape, "ground truth" would be established through laboratory testing (e.g., chemical analysis, physical property measurements) and clinical observation of material safety and performance, not expert review of interpretative data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: This question is not applicable for the reasons stated in point 3. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not the nature of testing for 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
Missing Information: This question is not applicable. An MRMC study is relevant for evaluating the clinical utility and impact of AI assistance on human reader performance, typically for diagnostic tasks (e.g., radiologists interpreting images). This device is a surgical drape, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: This question is not applicable. The device is a physical surgical drape, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As discussed in point 3, the concept of "ground truth" in the AI/ML context doesn't directly apply here. For this device, the "truth" or validation relies on:
- Biocompatibility testing results: (cytotoxicity, primary skin irritation, sensitization testing) indicating safety for human contact.
- Performance testing: "in accordance with industry recognized test methods" to ensure the drape functions as intended (e.g., barrier properties, absorbency – though specific details are withheld).
- Predicate device comparison: Demonstrating substantial equivalence to an already legally marketed device with a known safety and effectiveness profile.
8. The sample size for the training set
Missing Information: Not applicable. This device is a physical product, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Missing Information: Not applicable, as there is no training set for this type of device.
Summary of Document Limitations:
The provided document is a 510(k) summary for a physical medical device (surgical drape). Its purpose is to demonstrate substantial equivalence to a predicate device, focusing on intended use, technology, safety, and effectiveness. It is not a detailed scientific study report for an AI/ML device. Therefore, the specific criteria and study details requested, particularly those related to AI/ML performance evaluation (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies), are not present in this document. The information available pertains to the biocompatibility and general performance claims of a physical product.
§ 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.