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510(k) Data Aggregation
(198 days)
Medical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
The Medical mask are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane), and a malleable nosepiece which is placed within the binding for comfort and individualized fit. The mask not made with latex materials, and all materials are being used in currently marketed devices. The mask will be provided in white. The masks are single-use, disposable devices, provided non-sterile.
The provided document is a 510(k) Premarket Notification for a Medical Mask (Model: KKF-1A). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than an AI-powered medical device.
Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for AI test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this document. The document describes a traditional medical device (a mask) and standard testing for physical properties and biological safety.
However, I can extract the acceptance criteria and performance data for the medical mask based on the provided tables.
Acceptance Criteria and Reported Device Performance for the Medical Mask (Model: KKF-1A)
| Item (Performance Test) | Acceptance Criteria for Level 1 (ASTM F2100-19) | Reported Device Performance (Test Results) |
|---|---|---|
| Fluid Resistance Performance (mmHg) ASTM F1862 | 29 out of 32 pass at 80 mmHg | Passed at 80 mmHg |
| Particulate Filtration Efficiency Performance (%) ASTM F2299 | ≥ 95% | Passed at 99.3% |
| Bacterial Filtration Efficiency Performance (%) ASTM F2101 | ≥ 95% | Passed at 98.1% |
| Differential Pressure (Delta-P) (mm H2O/cm²) MIL-M-36954C | < 5.0 mm H2O/cm² | Passed at 4.8 mm H2O/cm² |
| Flammability class Class 1 (16 CFR 1610) | Class 1 | Class 1 |
Biocompatibility Testing Summary (based on ISO 10993-1: 2018)
| Test Item | Acceptance Criteria (Implied: Non-cytotoxic, Non-irritating, Non-sensitizing) | Reported Device Performance (Result) |
|---|---|---|
| Cytotoxicity | Non-cytotoxic | PASS (non-cytotoxic) |
| Irritation | Non-irritating | PASS (non-irritating) |
| Sensitization | Non-sensitizing | PASS (non-sensitizing) |
Since this document pertains to a physical medical mask rather than an AI/ML device, the following points are not present or not applicable in the provided text:
- Sample sized used for the test set and the data provenance: Not applicable. These are physical tests on the mask material, not an AI test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as ground truth is established via standardized physical and chemical tests, not expert consensus on medical images or outcomes.
- 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. This is for AI-assisted diagnostic devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth here is the results of standardized physical and chemical tests as per ASTM, EN, and ISO standards (e.g., specific filtration percentages, pressure values, and biological reaction classifications).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
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(149 days)
The Procedure face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are 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 non-sterile.
The Procedure face mask is a three-layer, flat-pleated style mask with ear loops and nose piece design for fitting the face mask around the nose and mouth. The proposed device is manufactured with three layers, the inner (Layer #3) and outer (Layer #1) layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of melt-blown polypropylene. The ear loops are made of Polyester & elastane, and the nose piece is made of Malleable polyethylene wire. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. which is made of malleable polyethylene wire. The face masks will be provided in blue. The face masks are sold non-sterile and are intended to be single-use, disposable devices.
This document describes the premarket notification for a procedure face mask (Model: KKF-2A) and its substantial equivalence to a predicate device. The information provided heavily focuses on non-clinical performance testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria for Level 2 | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance (mmHg) | 29 out of 32 pass at 120 mmHg | Passed at 120mm Hg | PASS |
| Particulate Filtration Efficiency Performance (%) | ≥ 98% | Passed at 99.8% | PASS |
| Bacterial Filtration Efficiency Performance (%) | ≥ 98% | Passed at 99.8% | PASS |
| Differential Pressure (Delta-P) (mm H2O/cm²) | <6.0 mm H2O/cm² | Passed at 3.8 mmH2O/cm² | PASS |
| Flammability class | Class 1 | Class 1 | PASS |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | PASS |
| Irritation | Non-irritating | Non-irritating | PASS |
| Sensitization | Non-sensitizing | Non-sensitizing | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set for the performance tests beyond the "29 out of 32 pass" for Fluid Resistance Performance. The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. However, tests were conducted to demonstrate that the device is biocompatible and safe.
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)
This information is not applicable and not provided in the document. The testing described is non-clinical performance testing for a face mask, which relies on standardized test methods and criteria rather than expert interpretation of medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document. As mentioned above, the evaluation is based on objective performance standards rather than expert adjudication.
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 information is not applicable. This submission is for a medical device (face mask), not an AI-powered diagnostic or assistive technology that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This submission is for a medical device (face mask), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance tests is based on established industry standards and regulatory requirements (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610 for performance; ISO 10993-1: 2018 for biocompatibility). These standards define objective criteria for mechanical, filtration, and biocompatibility properties.
8. The sample size for the training set
This information is not applicable. This submission is for a medical device (face mask) and does not involve a training set as would be used for machine learning models.
9. How the ground truth for the training set was established
This information is not applicable. This submission is for a medical device (face mask) and does not involve a training set or ground truth establishment in the context of machine learning.
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