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510(k) Data Aggregation
(517 days)
The Bodygard SFS Surgical Gown Level 3 is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Bodygard SFS Surgical Gown Level 3 met the requirements for Level 3 classification.
The Bodygard SFS Surgical Gown Level 3 is a poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 3 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 3 is manufactured using ultrasonic bonding technique and are available in four different sizes (M, L, XL, and XXL).
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The Bodygard SFS Surgical Gown Level 3, meets the requirements for Level 3 classification, are disposable medical devices and provided in sterile.
The provided document is limited to a 510(k) summary for a surgical gown (Bodygard SFS Surgical Gown Level 3). It details non-clinical performance and substantial equivalence to a predicate device, but it does not contain information on clinical studies, AI algorithms, or human reader performance. Therefore, I cannot answer questions related to those topics.
Here's a breakdown of what can be extracted from the document regarding acceptance criteria and non-clinical studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Purpose) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| AATCC 127 (Water resistance Hydrostatic Pressure) | >50cmH2O (AQL 4%, RQL=20%) | All were > 50cmH2O |
| AATCC 42 (Water Resistance impact penetration) | <1.0 g penetration (AQL 4%, RQL=20%) | All were < 1 g penetration |
| ASTM D 5034-09 (Breaking Strength) | >30 N (AQL 4%, RQL=20%) | All were >30N |
| ASTM D5587-14 (Tearing Strength) | >20 N (AQL 4%, RQL=20%) | All were >20 N |
| 16 CFR 1610 (Flammability testing) | Class I | Meets Class I |
| ASTM D4169-16 (Seam Strength) | >50 N (AQL 4%, RQL=20%) | All were >50 N |
| D6701-16 (Water vapor transmission of Nonwoven and plastic Barriers) | >500 gram/m2 Day WVTR | Passed |
| ASTM D3776/D (Mass Per Area (Weight) of fabric) | - | Has met acceptance criteria |
| ASTM F1670 (Resistance by synthetic Blood) | No Penetration at 2 psi (13.8 kPA) | Passed |
| ISO 9073-10:2003 (Lint and Other particles generation in the dry state) | Log 10<4 | Below Log10<4 Passed |
| ASTM D4169-16 (Performance testing of shipping containers and systems) | Products must withstand the distribution environment | Passed |
| ASTM F88-07A (Seal strength of Flexible Barrier Materials) | Package Seal integrity must be intact. | Passed |
| ASTM F2096-04 (Detecting Gross Leaks in medical packaging by in-ternal pressurization (Bubble test)) | Package integrity must be intact with- out failed seal locations. | Passed |
| ASTM F1980-07 (Accelerated Aging of Sterile Barrier Systems for medical devices) | Package integrity must be intact after accelerated aging | Passed |
| ISO 10993-5 (Biological Evaluation of medical devices - Part 5: tests for In vitro cytotoxicity of medical devices) | Device must not be cytotoxic | Device is noncytotoxic |
| ISO 10993-10 (Biological Evaluation of medical devices — Part 10: Tests for irritation and skin sensitization / Irritation) | Device must not be irritant | Device is not an irritant |
| ISO 10993-10 (Biological Evaluation of medical devices — Part 10: Tests for irritation and skin sensitization / sensitization) | Device must not be sensitizer | Device is not a sensitizer |
| ISO 10993-7 (Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals) | Residual Ethylene oxide levels must be below limits | Ethylene Oxide residual levels are below limitations |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical test. The acceptance criteria for many tests mention "AQL 4%, RQL=20%", which refers to Acceptance Quality Limit and Rejection Quality Limit, indicating a statistically driven sampling plan, but the specific number of units tested is not provided.
The data provenance is from non-clinical laboratory tests conducted for the purpose of demonstrating device performance against established standards for surgical gowns. No details about country of origin of data are provided beyond the manufacturer and contact person being in Turkey and Virginia, respectively. All tests appear to be prospective as they were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The product is a physical medical device (surgical gown), not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" for these tests are the objective measurements and pass/fail criteria of the specified ASTM, AATCC, ISO, and CFR standards.
4. Adjudication method for the test set
This question is not applicable. There is no expert review or adjudication process described for these non-clinical physical and chemical tests. The results are typically objectively measured against the specified acceptance criteria.
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
This question is not applicable. The document describes a physical medical device (surgical gown), not an AI-powered diagnostic or assistive technology. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable, as the device is a physical surgical gown and does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical tests are the established international and national standards and test methods (e.g., AATCC, ASTM, ISO, CFR) for the performance and safety of surgical apparel. These standards define objective pass/fail criteria based on physical, chemical, and biological properties.
8. The sample size for the training set
This question is not applicable. The device is a physical product and does not involve an AI algorithm with a training set.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for a physical surgical gown.
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