(20 days)
Surgical gowns are devices that are intended to be worn by health care personnel during surgical or other Ourgiour gowns are a vice that and the wearer from transfer of microorganisms, body fluids, and particulate material.
reusable surgical ' gown manufactured with the W.L. Gore ASSIST™ medical fabric in the Critical Zones.
The provided document describes the acceptance criteria and performance data for the SRI/Surgical Express, Inc. SP™ Reusable Surgical Gown, but it does not contain information related to AI or algorithm-driven device performance. The document is a 510(k) premarket notification for a traditional medical device (a surgical gown) and details its physical, biological, and material properties.
Therefore, many of the requested fields (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone algorithm performance, training set sample size, how training set ground truth was established) are not applicable to this document as it does not describe an AI medical device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (as per document) |
|---|---|---|
| Biocompatibility | ISO 10993-1 1997 | Complies with requirements; acceptable test results for washed/dried/sterilized material. |
| Flammability | 16 CFR 1610 Standard (CPSC 1954), Class 1 | Complies with requirements. |
| NFPA 99-1999 regulations | Meets requirements for non-flammable anesthetizing locations. | |
| Barrier Performance | AATCC 42-Impact Penetration | Achieved acceptable results throughout 125 wash/dry/steam autoclave cycles. |
| AATCC 127-Water Resistance: Hydrostatic Pressure Test | Achieved acceptable results throughout 125 wash/dry/steam autoclave cycles. | |
| Physical Properties | Spray Test | Evaluated using recognized industry standards following 125 cycles. Conclusions drawn to substantiate comparability to currently marketed gowns. |
| ASTM D3776-96 (mass per unit area) | Evaluated using recognized industry standards following 125 cycles. Conclusions drawn to substantiate comparability to currently marketed gowns. | |
| ASTM D5035-95 (breaking force/elongation) | Evaluated using recognized industry standards following 125 cycles. Conclusions drawn to substantiate comparability to currently marketed gowns. | |
| ASTM D5587-96 (water vapor transmission) | Evaluated using recognized industry standards following 125 cycles. Conclusions drawn to substantiate comparability to currently marketed gowns. | |
| IES-RP-CC003.3-93 (Helmke drum test) | Evaluated using recognized industry standards following 125 cycles. Conclusions drawn to substantiate comparability to currently marketed gowns. | |
| Sterilization | ANSI/AAMI/ISO 11134:1993 | Validated to meet a Sterility Assurance Level of 10⁻⁶. |
| Care and Handling | ANSI/AAMI ST65: 2000 | Shall be processed in accordance with requirements, manufacturer's instructions, and internal quality system procedures. |
Information Not Applicable or Not Provided in the Document (due to the nature of the device as a non-AI product):
- Sample size used for the test set and the data provenance: Not applicable/Not specified for an AI device. The document mentions "125 wash/dry/steam autoclave cycles" for barrier performance and physical properties testing, which describes the conditions and extent of physical testing, not a dataset for an algorithm. Data provenance (country, retrospective/prospective) is not relevant for this type of testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI devices (e.g., expert annotations on images) is not relevant to testing a surgical gown's physical properties.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 for AI-assisted diagnostic or decision-making systems.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. The ground truth for this device is established by objective standardized test methods (e.g., AATCC, ASTM, ISO) measuring physical and biological properties.
- The sample size for the training set: Not applicable. This device is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable. This device is not an AI algorithm.
§ 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.