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510(k) Data Aggregation
(171 days)
The 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 3 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 (AAMI PB70). The Disposable Surgical Gowns are single use, disposable medical devices, provided sterile.
The Disposable Surgical Gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of polyester elastic closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown
This document is a 510(k) Premarket Notification from the FDA regarding a Disposable Surgical Gown. It evaluates the device's substantial equivalence to a legally marketed predicate device. The information provided is about the physical and performance characteristics of a surgical gown, not a diagnostic AI device requiring complex clinical studies or expert ground truth.
Therefore, many of the requested categories for AI/diagnostic device evaluation (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) are not applicable to this type of medical device submission.
The "acceptance criteria" for this device are defined by a series of standardized non-clinical tests that measure physical properties and barrier performance.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 42 | Impact Penetration | Level 3, ≤1.0g | <0.1g |
| AATCC 127 | Hydrostatic Resistance | Level 3, ≥50cm | >70 cm for critical zone |
| ASTM D5034 | Tensile strength | Machine direction mean: ≥18 lbf; Cross direction mean: ≥12 lbf. | Machine direction mean: 21.95 lbf; Cross direction mean: 14.41 lbf. |
| ASTM D5587 | Tear resistance | Fabric direction A mean: ≥4.0 lbf; Fabric direction B mean: ≥2.5 lbf; | Fabric direction A mean: 5.09 lbf; Fabric direction B mean: 3.10 lbf; |
| ASTM D1683 | Seam strength | Shoulder: ≥8.5 lbf; Arm opening: ≥5.5 lbf; Sleeve: ≥8.5 lbf; | Shoulder: 10.8 lbf; Arm opening: 6.4 lbf; Sleeve: 10.2 lbf; |
| ISO 9073-10 | Side A (outside) IPM | Index for Particulate Matter (IPM): ≤2.5 | Index for Particulate Matter (IPM): 2.25 |
| ISO 9073-10 | Side B (inside) IPM | Index for Particulate Matter (IPM): ≤3.0 | Index for Particulate Matter (IPM): 2.85 |
| ISO 9073-10 | Side A&B IPM | Index for Particulate Matter (IPM): ≤3.0 | Index for Particulate Matter (IPM): 2.64 |
| ASTM F2407 | Evaporative resistance | Critical zone: ≥850 g/m²/24hrs; Non-critical zone: ≥850 g/m²/24hrs | Critical zone: 953.8 g/m²/24hrs; Non-critical zone: 930.2 g/m²/24hrs |
| 16 CFR Part 1610 | Flame spread | Class 1, Non Flammable | Class 1, Non Flammable |
| USP42-NF37 <85> | Bacterial Endotoxins | < 20EU | < 20EU |
| ISO 11737-2:2019 | SAL (Sterility Assurance Level) | 10^-6 | 10^-6 |
| Biocompatibility | Cytotoxicity | Under the condition of the test, no potential cytotoxicity | Under the condition of the test, no potential cytotoxicity |
| Biocompatibility | Irritation | Under the condition of the test, no irritation | Under the condition of the test, no irritation |
| Biocompatibility | Sensitization | Under the condition of the test, no sensitization | Under the condition of the test, no sensitization |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes (number of gowns or material samples) used for each physical and performance test. These are standard laboratory tests typically performed on a statistically representative number of samples according to the respective ASTM/ISO standards.
Data Provenance: The device manufacturer is Shandong Zhushi Pharmaceutical Group Co., Ltd in Shandong, China. The testing was non-clinical (laboratory testing of physical properties) and did not involve patient data or retrospective/prospective studies in the sense of a diagnostic AI device.
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):
Not applicable. The "ground truth" for this device is established by the specifications in the recognized consensus standards (e.g., AAMI PB70:2012, ASTM, ISO standards). The tests themselves are objective measurements of physical and barrier properties, not subjective interpretations requiring human experts for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study requiring adjudication of human reader interpretations.
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 not an AI diagnostic tool and does not involve human readers interpreting images.
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. The "standalone" performance is the direct result of the laboratory tests on the gown's material and construction.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" is defined by established, recognized international and national consensus standards for medical textiles and surgical apparel (e.g., ANSI/AAMI PB70:2012, AATCC, ASTM, ISO standards). These standards specify the acceptable physical and barrier performance characteristics (e.g., tensile strength, hydrostatic resistance, bacterial endotoxin limits) that the device must meet.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
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