(18 days)
The Convertors® Fabric-Reinforced Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The gowns are comprised of a single layer of Optima® as the base fabric. The gowns are fabric-reinforced with a layer of nonwoven in the body area.
The provided text describes a 510(k) summary for "Convertors® Fabric-Reinforced Gowns" and focuses on their substantial equivalence to a predicate device, as well as biocompatibility testing of the materials. It does not contain information about acceptance criteria or a study demonstrating the device meets those criteria in the context of device performance as would typically be presented for efficacy or diagnostic accuracy.
Therefore, many of the requested sections regarding device performance, sample sizes, expert ground truth, adjudication, MRMC studies, and standalone algorithm performance cannot be extracted from this document as they are not present.
However, I can provide what is available regarding testing and equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance (e.g., barrier effectiveness, strength) or report specific device performance metrics against such criteria in a measurable way. Instead, it states that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility as per ISO 10993 Part-1 | Materials found to be "acceptable for the intended use" based on cytotoxicity, sensitization, and irritation/intracutaneous reactivity tests. |
| Compliance with "industry recognized test methods" | Materials found to be "acceptable for the intended use." |
| Intended Use as surgical apparel | "the intended use is the same" as the predicate device. |
| Performance attributes similar to predicate device | "the performance attributes are similar" to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document only mentions "All materials used...were evaluated through biological qualification safety tests" and "materials also were tested in accordance with industry recognized test methods." No details on sample sizes or data provenance are given for these tests.
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)
This information is not provided in the document. The tests mentioned (biocompatibility, industry-recognized methods) would typically involve laboratory analysis and standardized protocols rather than expert clinical assessment of "ground truth" in the way it's usually defined for AI/diagnostic devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable as the device is a surgical gown, not an AI-assisted diagnostic or decision-making tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a surgical gown, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the "ground truth" would be the results of standardized biological assays (e.g., cell viability in cytotoxicity, skin reaction in sensitization/irritation). For the "industry recognized test methods," the ground truth would be the results of those specific physical/barrier property tests, compared against established standards. The document does not provide details on these specific standards or assay results.
8. The sample size for the training set
This is not applicable as the device is a surgical gown and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable as the device is a surgical gown and does not involve a "training set" or ground truth establishment in the context of machine learning or AI.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.