(64 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 base layer of degradable spunlaced nonwoven fabric in gown configurations of unreinforced, fabric reinforced and poly-reinforced. The fabric reinforced gown contains an additional layer of spunlaced nonwoven fabric in the chest and sleeves area. The poly-reinforced gown contains an additional layer of polyolefin film in the chest and sleeves of the gown.
This document describes the "Convertors® Surgical Gowns" manufactured by Allegiance Healthcare Corporation. The information provided focuses on the regulatory submission (510(k)) for this medical device, which is a Class II device (per 21 CFR § 878.4040) used as surgical apparel.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of specific, quantifiable acceptance criteria with corresponding performance data. Instead, it describes general categories of testing and statements of acceptability, primarily focused on biocompatibility and general performance as compared to a predicate device.
| Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|
| Biocompatibility (Safety) | All materials used in the fabrication of Convertors® Surgical Gowns were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices." The biocompatibility tests performed were cytotoxicity, sensitization, and primary skin irritation. These materials were found to be acceptable for the intended use. |
| Performance Attributes (Protective Barrier) | The performance attributes are similar to the predicate device (Isolyser Industries Enviroguard Surgeons Gowns). This implies meeting the functional requirements for surgeons' gowns, such as protection against the transfer of microorganisms, body fluids, and particulate material. The term "similar" suggests that the Convertors® gowns perform comparably in these aspects to the predicate device. The document does not provide specific quantitative metrics (e.g., AAMI barrier levels, tear strength, linting) for either the acceptance criteria or reported performance. |
| Intended Use Equivalence | The intended use is the same as the predicate device (Isolyser Enviroguard gowns). This is explicitly stated as a point of substantial equivalence. The intended use is "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." |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample size used for the test set(s) for either biocompatibility or performance testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for a non-active medical device like a surgical gown, testing would typically be conducted under controlled laboratory conditions, and the data would likely be prospective from these dedicated tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. For device testing (e.g., biocompatibility, protective barrier), the "ground truth" is typically established by recognized standards and validated test methods, not necessarily by experts reviewing individual test results in a consensus manner. The "experts" in this context would be the technicians and scientists performing the tests and interpreting the results according to the test standards.
4. Adjudication Method for the Test Set:
This information is not provided and is generally not applicable to the type of device testing described (biocompatibility, material performance). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where subjective interpretation plays a significant role.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving interpretation by human readers (e.g., radiologists, pathologists) where AI might assist in improving performance. Surgical gowns do not fit this category.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No standalone (algorithm-only) performance was done. This is not applicable to a surgical gown, which is a physical barrier device, not an algorithm-driven diagnostic or treatment device.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is established by:
- Biocompatibility Standards: Specifically, ISO 10993 Part-1 "Biological Evaluation of Medical Devices" for cytotoxicity, sensitization, and primary skin irritation tests. The "ground truth" here is the pass/fail criteria defined within these international standards.
- Industry Recognized Test Methods: For other performance attributes (e.g., barrier effectiveness, strength), the document mentions testing in accordance with "industry recognized test methods." The "ground truth" would be the established performance thresholds or benchmarks within those specific test methods.
- Predicate Device Equivalence: A significant part of the "ground truth" for substantial equivalence is the demonstration that the new device's intended use and performance are "similar" to a legally marketed predicate device (Isolyser Industries Enviroguard Surgeons Gowns).
8. The Sample Size for the Training Set:
This information is not provided. This concept is primarily relevant for machine learning algorithms, which are not applicable to the testing of a surgical gown.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided, as the concept of a "training set" and establishing its ground truth is not applicable to the evaluation of a surgical gown.
§ 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.