(138 days)
The Surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical gowns are single use, disposable medical devices, provided sterile.
The Surgical gowns is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
The provided text is a 510(k) summary for a medical device, specifically Surgical Gowns. It details the device's characteristics, intended use, and comparative testing against a predicate device to demonstrate substantial equivalence.
However, the request asks for information relevant to the acceptance criteria and the study that proves a device (likely an AI/ML powered device for diagnosis or similar application) meets those criteria. The provided document does not describe an AI/ML powered device, nor does it detail a study involving expert readers or AI assistance. Instead, it focuses on non-clinical performance testing of a physical product (surgical gowns) based on recognized standards.
Therefore, most of the specific points requested (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to the content of this document.
I will attempt to answer the parts that are applicable based on the provided document, interpreting "acceptance criteria" as the performance requirements for the surgical gowns and "study" as the non-clinical performance testing conducted.
Here's an adaptation based on the provided document, acknowledging the limitations:
Acceptance Criteria and Device Performance for Surgical Gowns (K212718)
This document describes the non-clinical performance testing of surgical gowns (K212718) to demonstrate substantial equivalence to a predicate device, rather than a clinical study of an AI/ML device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., expert readers, MRMC studies, ground truth for training) are not applicable.
Below is a table summarizing the acceptance criteria (performance requirements based on standards) and the reported device performance for the surgical gowns.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Item | Acceptance Criteria (Standard Requirement/Predicate Performance) | Reported Device Performance (K212718) |
|---|---|---|
| AAMI Level 3 Barrier Protection | Meets AAMI Level 3 per ANSI/AAMI PB70:2012 | Meets AAMI Level 3 per ANSI/AAMI PB70:2012 |
| Impact Penetration | Typically a low value (e.g., 0.0-0.10 g for predicate) | 50cmH2O |
| Resistance to Blood and Liquid Penetration | Level 3 per PB70 | Level 3 per PB70 |
| Tensile Strength (Machine Direction) | Predicate: 21.57 lbf (approx. 95.9 N) | 252N |
| Tensile Strength (Cross Direction) | Predicate: 13.6 lbs (approx. 60.5 N) | 121N |
| Tear Resistance (Fabric direction A) | Predicate: 3.47 lbf (approx. 15.4 N) | 91N |
| Tear Resistance (Fabric direction B) | Predicate: 5.63 lbs (approx. 25.0 N) | 34.5N |
| Flame Spread | Class 1, Non Flammable | Class 1, Non Flammable |
| Sterility Assurance Level (SAL) | 10^-6 | 10^-6 |
| Shelf Life | Not identified for predicate | 2 years |
| Cytotoxicity | Noncytotoxic (Comply with ISO 10993-5) | Noncytotoxic (Pass) |
| Irritation | Nonirritating (Comply with ISO 10993-10) | Nonirritating (Pass) |
| Sensitization | Nonsensitizing (Comply with ISO 10993-10) | Nonsensitizing (Pass) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (e.g., number of gowns) used for each non-clinical performance test. The data provenance is implied to be from the manufacturer's testing of their product. The testing is non-clinical performance testing, not a human study, and therefore terms like "retrospective or prospective" are not directly applicable in the typical sense for clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a physical product (surgical gowns) and its performance is evaluated through standardized laboratory tests, not by human expert assessment of diagnostic outputs.
4. Adjudication Method for the Test Set:
Not applicable. Performance is determined by objective measurements according to recognized standards (e.g., AATCC 42, AATCC 127, ASTM D5034, ASTM D5733, 16 CFR Part 1610, AAMI PB70, ISO 10993).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical product, not an algorithm. The reported performance relates to the gown's material properties and barrier protection.
7. The Type of Ground Truth Used:
The "ground truth" for the surgical gowns' performance is established by the results of standardized laboratory testing (e.g., measurements of impact penetration, hydrostatic resistance, tensile strength, tear resistance, flame spread, and biocompatibility assays). These tests provide objective values that are compared against predefined criteria from recognized industry standards (e.g., AAMI PB70, ASTM, AATCC, ISO standards).
8. The Sample Size for the Training Set:
Not applicable. This is a manufactured product, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is involved for this type of 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.