(21 days)
The Convertors® 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 gowns are comprised of a single layer of spunlaced nonwoven fabric with a polyethylene reinforcement in the chest area and a breathable monolithic film in the sleeves.
The information provided describes the acceptance criteria and the study conducted for the Convertors® Surgical Gowns.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: No cytotoxicity | Acceptable (evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1) |
| Biocompatibility: No sensitization | Acceptable (evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1) |
| Biocompatibility: No irritation/intracutaneous reactivity | Acceptable (evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1) |
| Performance attributes (implied: protection from transfer of microorganisms, body fluids, and particulate material) | Acceptable (tested in accordance with industry recognized test methods and found to be acceptable for the intended use) |
| Substantially equivalent to predicate device (Convertors® Optima Gowns) | Determined to be substantially equivalent (intended use is the same, performance attributes are similar) |
2. Sample size used for the test set and data provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of number of gowns. Instead, it states that "All materials used in the fabrication of this Convertors® Gowns were evaluated." This implies that material samples, rather than a fixed number of complete gowns, were subjected to the tests.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by or on behalf of Allegiance Healthcare Corporation. The study appears to be prospective in the sense that the new gown design was tested for safety and performance.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
- This information is not provided in the document. The tests performed are laboratory-based biological and performance assessments, not subjective evaluations requiring expert consensus on a "ground truth" for individual cases.
4. Adjudication method for the test set
- This information is not applicable as the tests performed are objective laboratory assessments (e.g., cytotoxicity, sensitization, irritation, physical performance attributes). There is no mention of human adjudication for these types of tests.
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
- No, an MRMC comparative effectiveness study was not done. This device (surgical gowns) is not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical product (surgical gown) and does not involve an algorithm.
7. The type of ground truth used
- The "ground truth" for the performance and safety of the surgical gowns was established based on adherence to recognized industry standards (e.g., ISO 10993 Part-1 for biological evaluation) and approved test methods for material properties. The results of these objective laboratory tests served as the basis for determining acceptability.
8. The sample size for the training set
- This information is not applicable. The context is the testing of a physical medical device (surgical gown), not a machine learning model. Therefore, there is no "training set" in the sense of data used to train an algorithm.
9. How the ground truth for the training set was established
- This information is not applicable for the reasons stated in 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.