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510(k) Data Aggregation
(222 days)
The Dream Medi Sterile 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.
In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.
Dream Medi Surgical Gowns are made from SMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They provide AAMI Level-3 protection.
The Level 3 Gowns have five different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL).
SMS is a multi-ply material consisting of layers of spunbond and meltblown polypropylene.
The body is made from 44g Blue SMS and the sleeve is made from 54g Blue SMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. All gowns are sterilized with ethylene oxide.
This document, a 510(k) Clearance Letter, describes the regulatory approval of a surgical gown (Dream Medi Sterile Surgical Gown), not a medical device that relies on complex algorithms, image analysis, or AI. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-driven device (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance of the surgical gown against established standards for protective apparel, as detailed in Section 8.0 "Summary of Non-Clinical Testing."
Here's a breakdown of the relevant information from the provided document, addressing the prompt as best as possible given the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Purpose | Test | Acceptance Criteria (from AAMI Level 3) | Reported Device Performance (Results) |
|---|---|---|---|
| Impact Penetration | AATCC 42 | Level 3, ≤1.0 g | Pass |
| Hydrostatic Resistance | AATCC 127 | Level 3, ≥50 cm | Pass |
| Tensile strength | ASTM D5034 | ≥30 N (≥ 7 lbf) | Pass |
| Tear resistance | ASTM D5587 | ≥10 N (≥ 2.3 lbf) | Pass |
| Seam strength | ASTM D1683 | ≥30 N (≥ 7 lbf) | Pass |
| Lint and Other particles generation in the dry state | ISO 9073-10 | Log 10 < 4 | Pass |
| Flammability testing | 16 CFR Part 1610 | Class 1 | Pass |
| Biocompatibility cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass |
| Biocompatibility irritation | ISO 10993-23 | Non-irritant | Pass |
| Biocompatibility Sensitization | ISO 10993-10 | Non-sensitizing | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact sample size for each non-clinical test. However, these tests are typically performed on a statistically representative number of units according to the respective ASTM, AAMI, and ISO standards (e.g., a certain number of specimens cut from gowns for tensile strength, tear resistance, etc.).
- Data Provenance: The tests were performed to confirm the device met design specifications and acceptance criteria. The document states the manufacturer is Dae Myung Chemical Co., Ltd. in Vietnam. The testing itself is non-clinical, meaning it's laboratory-based performance testing rather than patient data. It is inherently "prospective" in the sense that the gowns were produced and then tested to confirm properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a surgical gown, "ground truth" is established by the standardized test methods themselves (e.g., AATCC 42 for impact penetration, ISO 10993-5 for cytotoxicity). These are objective measurements following established protocols, not subjective interpretations by human experts in the way that ground truth for medical image analysis would be.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in human expert interpretations (e.g., in radiology studies). For physical product testing against objective criteria, there is no such adjudication method. Results are either within the specified limits ("Pass") or not.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This type of study involves human readers (e.g., radiologists) interpreting cases with and without AI assistance to measure improvement in diagnostic accuracy or efficiency. It is entirely irrelevant for a sterile surgical gown.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This concept applies to AI algorithms. A surgical gown has no algorithm.
7. The type of ground truth used
- Standardized Test Methods and Biocompatibility Assessment: The "ground truth" here is adherence to the performance requirements specified in recognized industry standards (e.g., AAMI PB70, ASTM, ISO, 16 CFR Part 1610) for fluid barrier protection, physical strength, flammability, and biocompatibility. These are objective, measurable properties.
8. The sample size for the training set
- Not Applicable. There is no "training set" for a surgical gown. The device is manufactured, and select samples are tested for quality control and regulatory submission.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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