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510(k) Data Aggregation
(223 days)
Disposable sterile drapes are used in the operating room as a protective covering, for both patient and operating room staff, from the transfer of body fluids, micro-organisms and particulates.
Drapes provided as sterile and non-sterile.
Non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 11135.
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Welmed Surgical Drapes are disposable sterile or non-sterile drapes used in the operating room to protect patients and staff from the transfer of bodily fluids, microorganisms, and particulates. The device's performance was evaluated through a series of tests against established standards.
1. Table of Acceptance Criteria & Reported Device Performance
| Parameter | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Hydrostatic Pressure | AATCC Test Method 127-1998 (Water Resistance: Hydrostatic Pressure Test) | Data Generated: Hydrostatic Pressure - Water Resistance |
| Impact Penetration | AATCC Test Method 42-2000 (Water Resistance: Impact Penetration Test) | Data Generated: Impact Penetration - Water Resistance |
| Tensile Strength | ASTM - D5034-95(2001) (Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)) | Data Generated: Tensile Strength |
| Tearing Strength | ASTM - D5734-95(2001) (Standard Test Method for Tearing Strength of Nonwoven Fabrics by Falling-Pendulum (Elmendorf) Apparatus) | Data Generated: Elmendorf Tear |
| Lint and Particle Generation | ISO 9073-10:2003 (Textiles -- Test methods for nonwovens -- Part 10: Lint and other particles generation in the dry state) | Data Generated: Gelbo Flex - Lint |
| Flammability | CPSC CS-191-53 Flammability Test Method (16 CFR 1610) (Standard for Flammability of Clothing Textiles) | Data Generated: Flammability |
| Biocompatibility | AAMI / ANSI / ISO 10993-1:2003(E) (Biological evaluation of medical devices -- Part 1: Evaluation and testing) | Data Generated: Biocompatibility Testing Evaluation |
| Cytotoxicity | AAMI / ANSI / ISO 10993-5:1999 (Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity) | Data Generated: Cytotoxicity |
| Skin Irritation/Sensitization | AAMI / ANSI / ISO 10993-10:2002(E) (Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization) | Data Generated: Skin Irritation, intra-cutaneous reactivity & sensitization |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for each test mentioned above. It simply states "Data Generated" for each test. The document does not provide information regarding the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The device's performance was assessed against established international and national standards for material properties and biocompatibility, not against expert-established ground truth in a clinical setting.
4. Adjudication Method for the Test Set
This information is not applicable. The testing involved measurements against predefined physical and biological standards, not subjective expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for this device. The device is a surgical drape, and its effectiveness is determined by its physical and biological properties as tested against industry standards, not by human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the device's material properties and biocompatibility were evaluated independently against specified standards, without the involvement of human interpretation or AI. The tests listed in the table (Hydrostatic Pressure, Tensile Strength, Biocompatibility, etc.) represent the standalone performance evaluation of the product.
7. Type of Ground Truth Used
The "ground truth" for evaluating the Welmed Surgical Drapes was based on established industry and regulatory standards and test methods. These standards define the acceptable performance characteristics for surgical drapes (e.g., water resistance, tensile strength, flammability, biocompatibility). The device was deemed substantially equivalent to a predicate device based on its compliance with these objective standards.
8. Sample Size for the Training Set
This information is not applicable. The product is a physical medical device (surgical drape), not an algorithm or an AI-powered system that requires 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 for this device.
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