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510(k) Data Aggregation
(118 days)
The Disposable 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 matter. This is a single use, disposable device, provided sterile.
The proposed device Disposable Surgical Gowns have body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The Disposable Surgical Gowns are blue color, sterilized by ethylene oxide gas, single use and disposable medical device. The proposed device is available in S (115×140cm), M (120×150cm), L (130×160cm), XL (140×170cm), XXL (150×175cm), and XXXL (170×180cm).
This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
This document is a 510(k) Premarket Notification from the FDA for Disposable Surgical Gowns. It details the device, its intended use, comparison to a predicate device, and results of non-clinical tests.
Here's the breakdown of the acceptance criteria and study information, based on your request, extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Seam strength (ASTM D1683M-17) | ASTM D1683M-17 | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (77.54 N) - Average result from 10 samples |
| Breaking strength (ASTM D5034-09) | ASTM D5034-09 (2017) | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (MD: 156.87N, CD: 125.20N) - Average result from 10 samples |
| Tear strength (ASTM D5587-15) | ASTM D5587: 2015(2019) | ≥10N | PASS (MD: 66.34N, CD: 38.44N) - Average result from 10 samples |
| Lint and other generation in the dry state (ISO 9073-10:2003(E)) | ISO 9073-10: 2003 | Log10(particle count) < 4 | PASS (2.6) - Average result from 10 samples |
| Flammability (CPSC 16 CFR Part 1610-2008) | CPSC 16 CFR Part 1610-2008 | Class I | PASS (Class I) |
| Water Penetration Resistance (AATCC 42-2013) | AATCC 42: 2013 | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 | PASS (≤1.0g) |
| Static hydrostatic resistance (AATCC 127-2014) | AATCC 127: 2014 | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | PASS (≥50 cm) |
| EO and ECH sterilization residual (ISO 10993-7:2008) | ISO 10993-7:2008 | EO ≤ 4mg/d, ECH ≤ 9mg/d | PASS (EO ≤ 4mg/d, ECH ≤ 9mg/d) |
| Cytotoxicity (ISO 10993-5) | Not explicitly stated as a separate "Test Standard" column, but referenced ISO | Non-Cytotoxic | PASS (Under the conditions of the study, the device is non-cytotoxic) |
| Irritation (ISO 10993-10) | Not explicitly stated as a separate "Test Standard" column, but referenced ISO | Non-Irritating | PASS (Under the conditions of the study, the device is non-irritating) |
| Sensitization (ISO 10993-10) | Not explicitly stated as a separate "Test Standard" column, but referenced ISO | Non-Sensitizing | PASS (Under the conditions of the study, the device is non-sensitizing) |
2. Sample Size Used for the Test Set and Data Provenance
For the performance tests (Seam strength, Breaking strength, Tear strength, Lint generation), the reported sample size is 10 samples for which an average result is provided for each.
For Water Penetration Resistance, Static hydrostatic resistance, EO/ECH residuals, and Flammability, a specific sample size isn't explicitly stated but the results are indicated as "PASS."
For Biocompatibility (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly mentioned, but the statements refer to "the conditions of the study" and "the device extract."
The data provenance is from Xiamen Probtain Medical Technology Co., Ltd. in Xiamen, Fujian, China. The studies are non-clinical tests conducted to verify that the proposed device met design specifications. The document does not specify whether the tests were retrospective or prospective, but as they are laboratory performance and material tests for a new device submission, they would typically be conducted prospectively on newly manufactured samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this document. The "device" in question is a surgical gown, and the testing involves physical material properties and biological compatibility, not an AI/diagnostic device that would require human experts to establish ground truth from medical images or clinical data. The acceptance criteria are based on established industry standards (e.g., ASTM, ISO, AAMI, CPSC) and regulatory requirements for medical devices.
4. Adjudication Method for the Test Set
This is not applicable. As this is not an AI/diagnostic device, there is no human interpretation or adjudication of outputs against a ground truth. The results are based on objective measurements from standardized tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
This is not applicable. This document evaluates a physical medical device (surgical gown), not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not applicable. This document evaluates a physical medical device (surgical gown), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by validated test methods and industry standards. For example:
- Physical properties: ASTM standards (D1683M-17, D5034-09, D5587-15) define how to measure properties like seam strength, breaking strength, and tear strength, and define passing criteria.
- Barrier performance: ANSI/AAMI PB70:2012 specifies the liquid barrier performance and classification for protective apparel, which dictates the acceptable levels for water penetration and hydrostatic pressure.
- Flammability: CPSC 16 CFR Part 1610-2008 sets the standard for flammability of clothing textiles.
- Biocompatibility: ISO 10993 series (ISO 10993-5, ISO 10993-10) defines the methods and acceptance criteria for cytotoxicity, irritation, and sensitization.
- Sterilization residuals: ISO 10993-7:2008 sets the acceptable limits for ethylene oxide and ethylene chlorohydrin residuals.
8. The Sample Size for the Training Set
This is not applicable. This document describes performance testing for a physical medical device, not the development or validation of an AI model with a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As there is no AI model or training set involved, the concept of establishing ground truth for a training set does not apply here.
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