Search Results

Jiangsu Guangda's Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.

Jiangsu Guangda's Disposable XLarge Reinforced Surgical Gowns, Model Number GD-SG-01, are made from SMS fabrics and PE + PP two layer compound protective reinforcement with 100% white Terylene cuffs to provide user protection in surgical settings.

The provided document describes the acceptance criteria and the performance of a surgical gown (Jiangsu Guangda Surgical Gown, Model Number GD-SG-01), not a diagnostic device. Therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of device submission.

Here is the information derived from the provided text, primarily focusing on the requested table and the study details that are relevant for a surgical gown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not explicitly stated as a numerical value for each test. The document mentions "All were >20" for Hydrostatic Pressure and "All were ≤1" for Impact Penetration and Resistance by Blood-Borne Pathogen, indicating multiple samples were tested. For other tests like Resistance by Synthetic Blood, Breaking Strength, Tearing Strength, Seam Strength, Cytotoxicity, Irritation, and Sensitization, the result is simply "Passed." The exact number of units or replicates tested is not detailed.
• Data provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. This type of bench testing is typically conducted in a laboratory setting.

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

• Not applicable. The "ground truth" for this device involves established engineering and biological performance standards, not expert clinical interpretation. The performance is determined by standardized laboratory tests.

4. Adjudication method for the test set

• Not applicable. Performance is determined by meeting objective criteria in standardized tests, not by 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

• Not applicable. This is a surgical gown, not an AI-powered diagnostic device involving human readers.

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

• Not applicable. This is a physical medical device (surgical gown), not an algorithm or software device.

7. The type of ground truth used

• The "ground truth" (or more accurately, the standard for evaluation) used for the surgical gown is established by international and national standards for medical device performance, specifically for surgical apparel. These standards include:
  • ASTM-F2407-06 (Standard Specification for Surgical Gowns)
  • AAMI/ANSI/ISO 10993 series (Biological evaluation of medical devices)
  • ANSI/AAMI PB70:2003 (Liquid Barrier Performance and Classification)
  • AATCC Test Method 127 and 42 (Water Resistance)
  • ASTM-F1671 and F1670 (Resistance to Penetration by Blood-Borne Pathogen/Synthetic Blood)
  • ASTM-D5034, D5733, D1683 (Tensile, Tearing, Seam Strength)
  • CPSC CS-191-53 Flammability Test Method (16 CFR 1610)

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not applicable. (See answer to #8).

Ask a specific question about this device

Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are sterile or nonsterile single use 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. The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization

Exact Medical Manufacturing Surgical Gown SMS w/PE Layer has the same design, material and performance characteristics of the predicate device.

The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer met the acceptance criteria by demonstrating substantial equivalence to its predicate device (K023117) through a series of non-clinical performance tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

All results of the testing met acceptance criteria.

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

• Sample Size: Not explicitly stated. The document mentions "All results of the testing met acceptance criteria," implying that sufficient samples were tested for each criterion according to standard testing protocols for medical devices.
• Data Provenance: The data is generated from non-clinical performance testing conducted by Exact Medical Manufacturing, Inc. It is internal testing performed for regulatory submission.

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

• This is a non-clinical device (surgical gown) and does not involve human interpretation of data where expert consensus would be required to establish ground truth such as in diagnostic imaging. The "ground truth" is established by adherence to recognized national and international standards (e.g., ISO 10993, AAMI PB:70).

4. Adjudication method for the test set:

• Not applicable. As noted above, this involves objective, quantifiable laboratory tests against established standards, not interpretation or adjudication by experts.

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:

• Not applicable. This device is a surgical gown, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is a surgical gown, not an algorithm.

7. The type of ground truth used:

• The ground truth is based on accepted national and international standards and specifications for surgical gowns and medical device materials, including:
  • ISO 10993 for biocompatibility.
  • AAMI PB:70 for barrier properties (Level 3).
  • Other specific test methods for tensile strength, tear strength, flammability, linting, and sterility.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

• Not applicable, for the reason stated above.

Ask a specific question about this device