(104 days)
The Mentor Absorbent Drape is used to absorb fluids during surgical procedures.
The Mentor Absorbent Drape measures 29 X 35 inches and is comprised of layered absorbent material between a permeable spunbond layer and a non-permeable layer. The device is packaged sterile for single use only.
Acceptance Criteria and Device Performance Study for Mentor Absorbent Drape
This summary details the acceptance criteria and the study proving the Mentor Absorbent Drape meets these criteria, based on the provided 510(k) summary (K973146).
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Absorbency: Absorb at least 100 cc per ft² of saline solution without leaking. | Absorbency: "The Mentor Absorbent Drape was tested for absorbency and found to absorb at least 100 cc per ft² of saline solution without leaking." |
| Material Integrity (Absorbent material): Absorbent material does not leak out of the pad. | Material Integrity (Absorbent material): "The absorbent material did not leak out of the pad." |
| Strength: Does not rip, tear, or separate under simulated clinical use conditions. | Strength: "The Mentor Absorbent Drape was tested for strength under simulated clinical use conditions and was found to not rip, tear or separate during the testing." |
2. Sample Size and Data Provenance
The provided document does not specify the exact sample sizes used for the absorbency and strength tests. It simply states that the "Mentor Absorbent Drape was tested."
The data provenance is internal to the manufacturer (Mentor Corporation), and the tests were likely conducted prospectively as part of the device development and regulatory submission process. There is no information regarding the country of origin of the data beyond the manufacturer's location in the USA.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a "ground truth" for the absorbency or strength tests. These tests appear to be objective, quantitative measurements against predefined physical criteria rather than expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a surgical drape, and its performance is evaluated based on physical properties rather than diagnostic accuracy or human interpretation.
6. Standalone Performance Study
Yes, a standalone study was presented. The "Summary of Testing" describes the performance of the Mentor Absorbent Drape itself against the specified criteria for absorbency and strength. These tests were conducted on the device without human interaction being a variable in the performance measurement.
7. Type of Ground Truth Used
The ground truth used for these tests was objective, quantitative criteria for physical performance.
- For absorbency: A specific volume (100 cc) and area (per ft²) of saline solution, and the absence of liquid leakage.
- For strength: The absence of ripping, tearing, or separation under simulated clinical use conditions.
8. Sample Size for the Training Set
Not applicable. This device is a physical product (surgical drape), not an algorithm or AI model that requires a "training set" in the computational sense. The testing described focuses on the physical properties of the manufactured product.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The specifications for performance (e.g., 100 cc/ft² absorbency) would have been established through engineering design requirements, industry standards for surgical drapes, and potentially comparison to predicate devices, but not through a "ground truth" establishment process for a training set.
§ 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.