(105 days)
SurgiPlus Surgical Drapes are single use, disposable patient coverings intended to be used by operating room personnel during surgical and other medical procedures as protective covers to isolate surgical incision sites from microbial and other contaminations.
The SurgiPlus Surgical Drapes are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
The drapes are classified as Level 3 or Level 4 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.
SurgiPlus Surgical Drapes are single use, disposable patient coverings. They are made of SMS base sheet with SPP with PE reinforcement or SMS base sheet. They are available in sterile and non-sterile forms.
The provided document is a 510(k) premarket notification for surgical drapes. It primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition and adherence to specific AAMI (Association for the Advancement of Medical Instrumentation) standards for liquid barrier performance.
This document does not contain information about studies involving AI/ML devices, human readers, or the establishment of ground truth by experts in a clinical context. It pertains to the physical performance characteristics of a surgical drape.
Therefore, many of the requested categories are not applicable to the provided document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device claims to be classified as Level 3 or Level 4 per AAMI Standard PB70 for liquid barrier performance. The document doesn't explicitly list a table of acceptance criteria and reported performance for the device against those criteria in a comparative format. Instead, it states the classification. To fully answer this, one would need to refer to AAMI Standard PB70. However, the FDA's acceptance of the 510(k) implies that the device meets the stated AAMI levels.
| Acceptance Criteria (AAMI PB70) | Reported Device Performance |
|---|---|
| Liquid Barrier Performance | |
| Level 3 or 4 | Meets Level 3 or Level 4 |
| (Specific performance metrics within AAMI PB70 - e.g., Hydrostatic Pressure, Impact Penetration Resistance) | (Implicitly meets these if classified Level 3 or 4) |
| Material Composition | SMS base sheet with SPP with PE reinforcement (for most products); SMS base sheet (for some products) |
| Intended Use | Single-use, disposable patient coverings to isolate surgical incision sites from microbial and other contaminations |
| Sterilization Status | Sterile (for product codes ending in -S) or Bulk Non-Sterile (for product codes ending in -B, for repackagers/relabelers) |
The remaining questions are largely not applicable (N/A) to this 510(k) submission because it describes the physical properties and intended use of surgical drapes, not an AI/ML diagnostic or therapeutic device that would involve clinical image analysis or human-in-the-loop performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This is a physical product (surgical drape) and the assessment relates to its material properties and barrier performance according to AAMI standards. There is no "test set" of clinical data to analyze. Testing would involve material samples for physical property assessment.
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)
- N/A. Ground truth from clinical experts is not relevant for the classification of a surgical drape based on AAMI liquid barrier performance standards. The "ground truth" would be the results of standardized physical tests performed by qualified lab personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical "test set" requiring adjudication.
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
- N/A. This device is a surgical drape, not an AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a surgical drape, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the AAMI liquid barrier performance, the "ground truth" would be established by standardized laboratory testing protocols as defined by AAMI PB70. This involves objective physical measurements (e.g., hydrostatic pressure, impact penetration) rather than expert consensus on clinical data.
8. The sample size for the training set
- N/A. This is a physical product (surgical drape) and does not involve AI/ML training sets.
9. How the ground truth for the training set was established
- N/A. No training set exists for this type of device.
§ 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.