(9 days)
The Convertors®Breathable Surgical 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 Breathable Surgical Gown consists of an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing a an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt nonwoven (SMS) with a polyolefin-based film reinforcement.
The submission for the Convertors® Breathable Surgical Gowns and Breathable Sleeve Surgical Gowns is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data to meet specific quantitative performance acceptance criteria. Therefore, much of the requested information regarding detailed study methodology, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance is not applicable to this type of submission for this particular device.
However, based on the provided text, I can extract the following relevant information regarding the device's assessment:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What was tested) | Reported Device Performance (Outcome) |
|---|---|
| Biocompatibility Tests: | |
| - Cytotoxicity | Materials were evaluated and found acceptable. |
| - Sensitization | Materials were evaluated and found acceptable. |
| - Irritation/Intracutaneous Reactivity | Materials were evaluated and found acceptable. |
| Functional/Performance Attributes (Implied) | Similar to the predicate device, found acceptable for intended use. |
| Intended Use (Same as predicate) | Protect both surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material. (Device aligns with this intended use). |
| Substantial Equivalence (Overall claim) | Determined to be substantially equivalent to the Convertors® Breathable Surgical Gowns. |
2. Sample size used for the test set and the data provenance:
- The document mentions "All materials used in the fabrication of this Convertors® Breathable Gowns were evaluated". This indicates material-level testing rather than a patient- or case-based "test set" in the context of AI/diagnostic devices. The sample size for material testing (e.g., number of material samples) is not specified.
- Data provenance is not specified (e.g., country of origin). The testing is described as in accordance with "industry recognized test methods."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a surgical gown, and its evaluation focuses on material properties and biocompatibility, not on diagnostic accuracy requiring expert interpretation of medical images or data. Ground truth for biocompatibility is typically established through standardized laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations of data, such as in diagnostic imaging. Biocompatibility tests have objective endpoints.
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:
- Not applicable. This is a surgical gown, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (surgical gown), not an algorithm or AI system.
7. The type of ground truth used:
- For biocompatibility tests, the ground truth is established by the results of standardized biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices." This includes objective measurements for cytotoxicity, sensitization reactions, and irritation/intracutaneous reactivity.
- For performance attributes, the "ground truth" is adherence to industry-recognized test methods for material properties, which are then compared to the predicate device.
8. The sample size for the training set:
- Not applicable. This submission is for a physical medical device (surgical gown) and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.