(62 days)
This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids and particulate matter.
Surgical Gowns including various sizes and material.
The provided document describes the safety and effectiveness of the IMC Surgical Gown. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical way for each test. Instead, it lists the tests performed and the standards they adhere to, implying that meeting these standards constitutes acceptable performance. The document states "All material used in the fabrication of the IMC Surgical Gowns were evaluated for:" followed by the table. This suggests the reported device performance is that it met these standards.
| Test | Standard | Reported Device Performance (Implied) |
|---|---|---|
| Cytotoxicity | ISO 10993 - Part 5 | Met standard |
| Skin Irritation | ISO 10993 - Part 10 | Met standard |
| Skin Sensitivity | ISO 10993 - Part 11 | Met standard |
| Systemic Toxicity | ISO 10993 - Part 11 | Met standard |
| Flammability | 16 CFR Part 1610 | Met standard |
| Hydrostatic Pressure | AATCC 127 | Met standard |
| Impact Penetration | AATCC 42 | Met standard |
| Lint | IST 160.1 | Met standard |
| Tensile Strength | ASTM D5034 | Met standard |
2. Sample size 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 sample size used for the biological (cytotoxicity, irritation, sensitivity, systemic toxicity) and physical (flammability, hydrostatic pressure, impact penetration, lint, tensile strength) tests performed on the surgical gown material.
The data provenance is not explicitly mentioned. It's an FDA submission in the USA, so it's likely the testing was conducted to meet US regulatory requirements, but the origin of the raw data/testing facilities is not stated. The document does not indicate if the data is retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the evaluation relies on standardized laboratory tests and not expert consensus on medical images or clinical outcomes. The "ground truth" for these tests are the established parameters and methodologies defined by the cited ISO, CFR, AATCC, IST, and ASTM standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. The methods for evaluating the material properties are defined by the referenced standards (e.g., ISO 10993, AATCC 127), which involve specific measurement techniques rather than expert adjudication.
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. The device is a surgical gown, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to its evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical product (surgical gown), not an algorithm or software. Its performance is evaluated through material testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance relies on objective measurements and procedures defined by established industry and regulatory standards. For example:
- Biological Endpoints: The "ground truth" for cytotoxicity, skin irritation, skin sensitization, and systemic toxicity is determined by the specific protocols and criteria outlined in various parts of ISO 10993.
- Physical Properties: The "ground truth" for flammability, hydrostatic pressure, impact penetration, lint, and tensile strength is based on the quantitative measurements and methodology described in standards like 16 CFR Part 1610, AATCC 127 & 42, IST 160.1, and ASTM D5034.
8. The sample size for the training set:
This is not applicable. The document describes the evaluation of a physical medical device (surgical gown) through laboratory testing, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
This is not applicable as there is no training set.
§ 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.