(120 days)
THE SURGICAL GOWN/TOGA IS INTENDED TO BE WORN Room BOTH THE SURG PROCEDURES TO PROTE RODM PERSONAL TRANSFER OF MICROORGANIST ARTICULATE MATER MATERIAL
The Microtek gown/toga consists of a non-woven material and woven cuff material manufactured to protect the wearer and patient from contamination during various procedures throughout the clinical setting. This gown/toga is similar to other gowns/togas currently being marketed for the same intended use.
The provided text describes a 510(k) premarket notification for a surgical gown/toga. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive performance studies as might be required for a novel device. Therefore, the information provided does not fully align with all the questions typically asked about acceptance criteria and detailed study designs for AI/ML devices.
However, based on the available text, here's an attempt to answer the questions within the given context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured Performance Standard) | Reported Device Performance (Reference to Standard) |
|---|---|
| Viral Penetration Resistance (ASTM Method F 1671) | Conforms to ASTM Method F 1671 (Material tested alone and together) |
| Flammability | Conforms to Flammability testing (Material tested alone and together) |
| Overall Product Performance Standard | Conforms to ANSI/AAMI PB-70:2003 (Final finished product) |
| Biocompatibility (ISO 10993-1) | Conforms to ISO 10993-1 (Materials tested alone and together) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for the testing of the materials or the final product. It only states that the "materials have been tested alone and together" and the "final finished product conforms" to the standards. The data provenance (country of origin, retrospective/prospective) is not mentioned.
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 applicable and not provided in the document. The performance evaluation relies on standardized laboratory testing (e.g., ASTM, ISO, ANSI/AAMI) for physical properties and barrier effectiveness, rather than expert judgment on a dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. The testing involves objective measurements against established standards, not subjective adjudication of cases.
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 is a surgical gown, not an AI/ML-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical product (surgical gown) and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by the objective pass/fail criteria of the referenced industry and international standards (e.g., ASTM F1671 for viral penetration, ISO 10993-1 for biocompatibility, ANSI/AAMI PB-70:2003 for general product performance). These standards dictate the methodologies and acceptable limits for various physical and biological properties.
8. The sample size for the training set
This question is not applicable. There is no "training set" for a physical medical device like a surgical gown.
9. How the ground truth for the training set was established
This question is not applicable. There is no "training set" for this device.
§ 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.