(64 days)
The Convertors® Surgical Drapes are devices 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 drapes are comprised of a sing e layer of degradable spunlaced nonwoven fabric with various reinforcements. The fiber is water soluble in temperatures above approximate v 190 degrees F.
The provided document is a 510(k) summary for a medical device (Convertors® Surgical Drapes) and does not contain information about the acceptance criteria and study proving device performance as typically understood for AI/ML-based medical devices or diagnostic tools.
Instead, this document describes a traditional medical device (surgical drapes) and focuses on demonstrating substantial equivalence to a predicate device based on:
- Same Intended Use: The drapes are for isolating surgical sites from contamination.
- Similar Performance Attributes: This is assessed through biological qualification safety tests and industry-recognized test methods.
- Materials: The drapes are made of a single layer of degradable spunlaced nonwoven fabric.
The "Summary of testing" section details the following:
- Biocompatibility tests:
- Cytotoxicity
- Sensitization
- Irritation/Intracutaneous reactivity
- These tests were performed "as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'."
- Materials were also tested "in accordance with industry recognized test methods" and found acceptable.
Therefore, an attempt to fill out the requested table and answer the questions based on the provided text will show many fields as "Not Applicable" or "Not Provided" because the context is for a physical medical device, not a software algorithm or diagnostic tool.
Table of Acceptance Criteria and Reported Device Performance (based on provided text):
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Intended Use | The intended use is the same as the predicate device (Isolyser Enviroguard Drapes): "devices 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." |
| Performance Attributes | Similar to the predicate device. |
| Biocompatibility | Materials evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1. |
| - Cytotoxicity | Found acceptable. |
| - Sensitization | Found acceptable. |
| - Irritation/Intracutaneous Reactivity | Found acceptable. |
| Material Testing | Materials tested in accordance with industry recognized test methods. |
| - General Acceptability | Found acceptable for the intended use. |
Detailed Answers to Questions (based on provided text):
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A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" are implied by the tests performed to demonstrate substantial equivalence and safety. The "reported device performance" is that it met the requirements of these tests.
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Sample size used for the test set and the data provenance:
- Not Provided. The document mentions "All materials used... were evaluated" but does not specify the sample size of materials or subjects for the biological tests.
- Data Provenance: Not specified, but generally, ISO 10993 tests are conducted in a controlled laboratory setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for biocompatibility tests is typically determined by laboratory measurements and established biological safety parameters, not expert consensus on diagnostic images or results.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As explained above, this isn't a diagnostic device with human adjudicators.
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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:
- Not Applicable. This is a physical surgical drape, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance, in terms of safety and biocompatibility, is established through standardized ISO 10993-1 biological evaluation methods and industry-recognized test methods. This involves laboratory assays and physical/chemical characterization against established safety thresholds.
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The sample size for the training set:
- Not Applicable. There is no "training set" in the context of a physical medical device demonstrating substantial equivalence through material testing.
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How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.