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510(k) Data Aggregation
(270 days)
Disposable Medical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided as sterile.
The Disposable Medical Mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into four layers, the inner, second and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of galvanized iron wire, the ear loops are made of polyester and spandex, and the ties are made of polypropylene. The Medical Surgical Mask will be provided in green. The Disposable Medical Mask is sold as sterile and are intended to be single use, disposable devices.
This document primarily details the non-clinical testing and substantial equivalence determination for a Disposable Medical Mask (K222545) in comparison to a predicate device (K211454). It is not a study that proves a device meets acceptance criteria through a clinical or reader study involving human interpretation of AI results.
This submission is for a medical mask, which is a physical device, and the "acceptance criteria" discussed are primarily related to its physical and biological performance characteristics (e.g., filtration efficiency, fluid resistance, biocompatibility), not the performance of an AI algorithm. Therefore, many of the requested points, such as those related to AI algorithm performance, human expert adjudication, MRMC studies, and ground truth establishment for AI training/testing, are not applicable to this document.
However, I can extract the relevant information regarding the acceptance criteria and performance of the mask itself based on the provided text.
Acceptance Criteria and Device Performance (Applicable to the physical mask device)
The document details the performance testing of the Disposable Medical Mask against established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Synthetic Blood Penetration (ASTM F1862) | Demonstrate resistance to liquid penetration | Level 3 pass at 160mmHg (AQL 4%) | Pass (32 out of 32 pass at 160 mmHg) |
| Particulate Filtration Efficiency (ASTM F2299) | Demonstrate particulate filtration | Level 3 pass at ≥98% | Pass (Filtration Efficiency ≥ 99.80%) |
| Bacterial Filtration Efficiency (ASTM F2101) | Demonstrate bacterial filtration | Level 3 pass at ≥98% | Pass (Percent BFE ≥ 99.80%) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | Demonstrate breathability | Level 3 pass at ≤ 6.0 mmH2O/cm² | Pass (Average 4.2 mm H2O/cm²) |
| Flammability (16 CFR 1610) | Demonstrate flame resistance | Class I | Pass |
| Cytotoxicity | Biocompatibility | Non-cytotoxic | Pass (Non-cytotoxic) |
| Irritation | Biocompatibility | Non-irritating | Pass (Non-irritating) |
| Sensitization | Biocompatibility | Non-sensitizing | Pass (Non-sensitizing) |
2. Sample size used for the test set and the data provenance:
- Synthetic Blood Penetration: 32 samples (stated as "32 out of 32 pass at 160 mmHg"). For acceptance, it states "29 samples out of 32 pass (AQL 4%)".
- Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): Specific sample sizes are not explicitly stated for each test, but standard test methods (e.g., ASTM, ISO) typically specify the number of samples required.
- Data Provenance: Not explicitly stated as retrospective or prospective given this is laboratory testing of a physical product. The manufacturer is Guangzhou Fuzelong Hygiene Material Co., Ltd, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes laboratory performance testing of a physical medical device (a mask), not the evaluation of an AI algorithm's diagnostic performance requiring human expert ground truth. The "ground truth" here is the objective measurement of the mask's physical properties against defined standards.
4. Adjudication method for the test set:
- Not applicable. See point 3.
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:
- No. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
7. The type of ground truth used:
- The "ground truth" for the mask's performance is based on objective measurements against pre-defined international and national standards (e.g., ASTM, EN, ISO, 16 CFR). For example, "Level 3 pass at ≥98%" for filtration efficiency is the acceptance criterion acting as the "ground truth."
8. The sample size for the training set:
- Not applicable. This is not an AI device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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(170 days)
The 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 ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.
The 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 SMS nonwoven material, in a blue color. It has been tested according to AAMI PB70:2012 and meet AAMI Level 4 barrier level protection for a surgical gown. The proposed devices are single use, disposable medical devices and EO that sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL
This document describes the safety and performance of a Surgical Gown, not an AI-powered medical device. Therefore, many of the requested details about acceptance criteria for AI model performance and ground truth establishment are not applicable.
However, I can extract the relevant acceptance criteria and the reported device performance for the physical surgical gown based on the provided text.
Device: Surgical Gown (K222403)
Intended Use: To protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures, meeting AAMI Level 4 barrier protection.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is assessed through non-clinical laboratory tests.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| AATCC 42 | Assess resistance to water impact penetration | Level 4, ≤1.0g | Pass |
| AATCC 127 | Assess hydrostatic resistance | Level 4, ≥50cm | Pass |
| ASTM D5034 | Assess adequate tensile strength | Warp/Length ≥ 30N; Weft/Width ≥ 30N | Pass |
| ASTM D5587 | Assess adequate tear resistance | Warp/Length ≥ 10N; Weft/Width ≥ 10N | Pass |
| ASTM D1683 | Assess adequate seam strength | Sleeve Seam: ≥ 30N; Armhole Seam: ≥ 30N; Shoulder Seam: ≥ 30N | Pass |
| ASTM F1868 | Assess evaporative resistance of fabrics | (Ref)≥0.06(kPa·m²/W) | Pass |
| ASTM F1671 | Resistance to Penetration by Blood-Borne Pathogens using Phi-X174 Bacteriophage | No penetration (Assay Titer < 1 PFU/ml) | Pass |
| ISO 9073-10 | Assess acceptable lint and other particles generation in the dry state | Log10 < 4 | Pass |
| 16 CFR Part 1610 | Flammability testing | Class 1 | Pass |
| ISO 11737-2 | Sterility assurance | 10-6 | Pass |
| ISO 10993-5 | Biocompatibility - cytotoxicity | Non-cytotoxic | Pass |
| ISO 10993-10 | Biocompatibility - irritation | Non-irritating | Pass |
| ISO 10993-10 | Biocompatibility - sensitization | Non-sensitizing | Pass |
| ISO 10993-7 | Verify acceptable sterilant residuals | EO residual ≤ 4 mg/device; ECH residual ≤ 0 mg/device | Pass |
Missing/Not Applicable Information (for AI/Software Device)
The following points are not applicable to this submission as it concerns a physical medical device (surgical gown) rather than a software or AI-powered device. The document explicitly states "No clinical study is included in this submission."
- Sample size used for the test set and the data provenance: Not applicable. Tests are performed on physical samples of the surgical gown materials and finished products, not a "test set" of data in the AI sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is established by standardized material testing methods, not expert human interpretation of data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this device, the "ground truth" is defined by the performance standards of the physical and chemical tests listed (e.g., specific thresholds for water penetration, tensile strength, sterility, biocompatibility).
- The sample size for the training set: Not applicable (no AI training involved).
- How the ground truth for the training set was established: Not applicable.
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