Search Results

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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 layer of spunlaced nonwoven fabric with a polyethylene reinforcement in the chest area and a breathable monolithic film in the sleeves.

The information provided describes the acceptance criteria and the study conducted for the Convertors® Surgical Gowns.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance

• Sample Size: The document does not specify a distinct "test set" sample size in terms of number of gowns. Instead, it states that "All materials used in the fabrication of this Convertors® Gowns were evaluated." This implies that material samples, rather than a fixed number of complete gowns, were subjected to the tests.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by or on behalf of Allegiance Healthcare Corporation. The study appears to be prospective in the sense that the new gown design was tested for safety and performance.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

• This information is not provided in the document. The tests performed are laboratory-based biological and performance assessments, not subjective evaluations requiring expert consensus on a "ground truth" for individual cases.

4. Adjudication method for the test set

• This information is not applicable as the tests performed are objective laboratory assessments (e.g., cytotoxicity, sensitization, irritation, physical performance attributes). There is no mention of human adjudication for these types of tests.

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 (surgical gowns) is not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No, a standalone algorithm performance study was not done. This device is a physical product (surgical gown) and does not involve an algorithm.

7. The type of ground truth used

• The "ground truth" for the performance and safety of the surgical gowns was established based on adherence to recognized industry standards (e.g., ISO 10993 Part-1 for biological evaluation) and approved test methods for material properties. The results of these objective laboratory tests served as the basis for determining acceptability.

8. The sample size for the training set

• This information is not applicable. The context is the testing of a physical medical device (surgical gown), not a machine learning model. Therefore, there is no "training set" in the sense of data used to train an algorithm.

9. How the ground truth for the training set was established

• This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The Convertors® Fabric-Reinforced 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 layer of Optima® as the base fabric. The gowns are fabric-reinforced with a layer of nonwoven in the body area.

The provided text describes a 510(k) summary for "Convertors® Fabric-Reinforced Gowns" and focuses on their substantial equivalence to a predicate device, as well as biocompatibility testing of the materials. It does not contain information about acceptance criteria or a study demonstrating the device meets those criteria in the context of device performance as would typically be presented for efficacy or diagnostic accuracy.

Therefore, many of the requested sections regarding device performance, sample sizes, expert ground truth, adjudication, MRMC studies, and standalone algorithm performance cannot be extracted from this document as they are not present.

However, I can provide what is available regarding testing and equivalence:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for device performance (e.g., barrier effectiveness, strength) or report specific device performance metrics against such criteria in a measurable way. Instead, it states that:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document only mentions "All materials used...were evaluated through biological qualification safety tests" and "materials also were tested in accordance with industry recognized test methods." No details on sample sizes or data provenance are given for these tests.

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 provided in the document. The tests mentioned (biocompatibility, industry-recognized methods) would typically involve laboratory analysis and standardized protocols rather than expert clinical assessment of "ground truth" in the way it's usually defined for AI/diagnostic devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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 as the device is a surgical gown, not an AI-assisted diagnostic or decision-making tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a surgical gown, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the biocompatibility tests, the "ground truth" would be the results of standardized biological assays (e.g., cell viability in cytotoxicity, skin reaction in sensitization/irritation). For the "industry recognized test methods," the ground truth would be the results of those specific physical/barrier property tests, compared against established standards. The document does not provide details on these specific standards or assay results.

8. The sample size for the training set

This is not applicable as the device is a surgical gown and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This is not applicable as the device is a surgical gown and does not involve a "training set" or ground truth establishment in the context of machine learning or AI.

Ask a specific question about this device