(240 days)
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
| Test | Acceptance Criteria | Reported Device Performance (Jiangsu Guangda Surgical Gown, Model Number GD-SG-01) |
|---|---|---|
| Liquid Barrier Performance: | ||
| Hydrostatic Pressure (AATCC Test Method 127) | Has met acceptance criteria (Predicate) | All were >20 |
| Impact Penetration (AATCC Test Method 42) | Has met acceptance criteria (Predicate) | All were ≤1 |
| Resistance by Blood-Borne Pathogen (ASTM- F1671) | Unknown (Predicate) | All were ≤1 |
| Resistance by Synthetic Blood (ASTM- F1670) | Has met acceptance criteria (Predicate) | Passed |
| Physical Specifications: | ||
| Breaking Strength (ASTM-D5034) | Has met acceptance criteria (Predicate) | Passed |
| Tearing Strength (ASTM-D5733) | Has met acceptance criteria (Predicate) | Passed |
| Flammability Test Method (16 CFR 1610) | Has met acceptance criteria (Predicate) | Class I |
| Seam Strength (ASTM-D1683) | Has met acceptance criteria (Predicate) | Passed |
| Biocompatibility: | ||
| Cytotoxicity (ISO 10993-5) | Has met acceptance criteria (Predicate) | Passed |
| Irritation (ISO 10993-10) | Has met acceptance criteria (Predicate) | Passed |
| Sensitization (ISO 10993-10) | Has met acceptance criteria (Predicate) | Passed |
| Sterilization: | ||
| EO and ECH Residual | Unknown (Predicate) | Conforms to ISO 10993-7 |
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).
§ 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.