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510(k) Data Aggregation
(105 days)
Disposable Surgical Gown is 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 material. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It is single use, disposable medical devices, provided sterile.
The subject devices 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 materials.
In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The proposed device is single use, disposable medical devices and provided sterile.
The main materials of device are SMS nonwoven +TPU membrane, PP and Polyester fiber, and the main manufacturing technique are Ultrasonic welding and Sewing.
The provided text is a 510(k) Summary for a medical device (Disposable Surgical Gown) and does not describe an AI/ML-driven device or study. Therefore, most of the requested information regarding acceptance criteria, training/test sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable.
Instead, the document details the device's physical properties, material composition, and performance against established industry standards for surgical gowns. The "study" mentioned is a series of non-clinical tests to verify the device meets design specifications and relevant standards.
Here's a breakdown of the relevant information from the document, tailored to the non-AI/ML context:
Device Description: Disposable Surgical Gown
Purpose of the "Study" (Non-Clinical Testing): To verify that the proposed device (Disposable Surgical Gown) meets all design specifications and complies with relevant standards for surgical gowns, demonstrating its safety and effectiveness compared to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table of non-clinical tests conducted, their purpose, acceptance criteria, and results.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 127 | Water resistance Hydrostatic Pressure | >50 cm | Passed |
| AATCC 42 | Water Resistance impact penetration Nonwoven and plastic Barriers | ≤1.0 g | Passed |
| ASTM D5034-09 | Tensile Strength | MD Mean≥30 lbs; CD Mean≥25 lbs | Passed |
| ASTM D5587-19 | Tearing Strength | MD Mean≥9 lbs; CD Mean≥18 lbs | Passed |
| ASTM F1868-17 | Evaporative Resistance of fabrics | Mean Evaporative Resistance (Ref)≥0.06(kPa·m2/W). | Passed |
| 16 CFR 1610 | Flammability testing | Meets requirements of Flame Resistant CPSC 1610 Class 1 | Meets requirements |
| ASTM D1683-17 | Seam Strength | >50N | Passed |
| ASTM F1671 | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage | No virus through, “None Seen” | Passed |
| ISO 9073-10:2003 | Lint and Other particles generation in the dry state | Log 10 < 4 | Passed |
| ISO 10993-5 | Tests for In vitro cytotoxicity | Device must not be cytotoxic | Device is noncytotoxic |
| ISO 10993-10 | Tests for irritation and skin sensitization (Irritation) | Device must not be irritant | Device is not an irritant |
| ISO 10993-10 | Tests for irritation and skin sensitization (Sensitization) | Device must not be sensitizer | Device is not a sensitizer |
| ISO 10993-7 | Ethylene Oxide Sterilization Residuals | Residual Ethylene oxide levels must be below limits | Ethylene Oxide residual levels are below limitations |
| USP43<85> | Bacterial Endotoxin Test | <20EU/piece | Passed |
Additional Performance Claim: The device also meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. This is a key difference and perceived improvement over the predicate device, which met Level 3.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test, nor does it detail the provenance of the materials tested (e.g., country of origin). However, it implies standardized testing conducted to meet regulatory and industry standards. The tests are "non-clinical" and laboratory-based, focused on material properties of the manufactured gown samples.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable as this is not an AI/ML-driven study requiring expert interpretation of data/images. The "ground truth" is established by the specified industry standards and test methodologies (e.g., ASTM, AAMI, ISO, AATCC, 16 CFR).
4. Adjudication Method for the Test Set:
Not applicable. Performance is determined by standardized physical and chemical tests against defined numerical criteria, not by human adjudication of qualitative data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/ML diagnostic or assistive device. The comparison is between the proposed device's physical properties and the requirements of recognized standards, as well as a direct comparison of specifications with a predicate device.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the performance evaluation is based on established industry standards and test methodologies (e.g., ANSI/AAMI PB70:2012 for liquid barrier performance, ASTM F2407-06 for specifications of surgical gowns, ISO 10993 for biocompatibility). The device must demonstrate that its physical and chemical properties meet or exceed the requirements set forth in these standards.
8. Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" for this type of device and non-clinical testing. The manufacturing process and material selection are validated against the final product specifications.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set. The "ground truth" for establishing the device's design and performance goals is rooted in existing regulatory requirements and recognized consensus standards for surgical apparel.
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