(90 days)
The Sewing Source Custom Reusable Surgical Drapes, based on the both the Maxima ESD-AT and Mertex-Plus E5533-R materials, are reusable protective patient covering for isolating sites of surgical incisions from microbial or other contamination. For manufacturing, processing, or repackaging, these drapes must be reprocessed and packaged.
reusable protective patient covering for isolating sites of surgical incisions from microbial or other contamination.
The provided text is related to a 510(k) premarket notification for a non-sterile reusable surgical drape, Mertex-Plus Nonsterile Reuseable Surgical Drape (K012237). The acceptance criteria and the study that proves the device meets them are not explicitly detailed in the provided document.
This document is a marketing clearance letter from the FDA stating that the device is "substantially equivalent" to legally marketed predicate devices, which means it doesn't need to demonstrate novel performance characteristics or undergo new clinical trials for effectiveness in the same way a new drug or novel device might. The substantial equivalence is based on the device's technical characteristics and intended use being similar to existing cleared devices.
Therefore, the specific quantitative details requested in your questions (e.g., performance metrics, sample sizes, expert qualifications, effect sizes, etc.) are not present in this type of FDA clearance letter. Such information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in this excerpt.
However, I can infer what might have been considered based on the nature of a reusable surgical drape and the regulatory context of a 510(k) submission:
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Acceptance Criteria and Reported Device Performance: Instead of performance metrics like sensitivity/specificity for diagnostic AI, for a reusable surgical drape, acceptance criteria would likely relate to:
- Material properties: Tensile strength, tear resistance, fluid repellency, linting, microbial barrier effectiveness (after multiple reprocessing cycles).
- Biocompatibility: Confirmation that the material is not irritating or sensitizing.
- Reprocessing efficacy: Demonstration that the drape can be effectively cleaned, disinfected/sterilized, and maintained for a specified number of cycles without degradation of its protective properties.
- Substantial Equivalence to Predicate: The primary "performance" metric here is demonstrating that the Mertex-Plus drape performs similarly to existing legally marketed reusable surgical drapes.
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Sample Size and Data Provenance: Not applicable in the context of a 510(k) for substantial equivalence based on material properties and reprocessing. The "test set" would be the Mertex-Plus material and reprocessed drapes. The provenance would be the manufacturer's lab tests.
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Number of Experts and Qualifications: Not applicable. Material testing and reprocessing validation are usually done by engineers and microbiologists, not clinical experts for "ground truth" in the diagnostic sense.
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Adjudication Method: Not applicable.
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Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating diagnostic performance of AI with human readers.
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Standalone Algorithm Performance: Not applicable. This is not an AI device.
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Type of Ground Truth: For this type of device, "ground truth" would be established through:
- Standardized material testing: e.g., ASTM or ISO standards for textile properties, fluid resistance, breathability.
- Microbiological barrier testing: To demonstrate efficacy against microbial penetration.
- Reprocessing validation studies: Showing that the cleaning and sterilization protocols achieve the desired level of cleanliness and sterility while maintaining material integrity over multiple cycles.
- Biocompatibility testing: Following ISO 10993 standards.
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Sample Size for Training Set: Not applicable. This product does not involve machine learning.
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How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document is an FDA clearance letter for a device that received a 510(k) substantial equivalence determination. It does not contain the detailed performance study information typically associated with AI/diagnostic devices and the "acceptance criteria" here would be tied to material and reprocessing standards rather than clinical performance metrics.
§ 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.