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510(k) Data Aggregation
(428 days)
The disposable surgical face mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device, Disposable Surgical Face Mask is a three-layer, flat-folded mask. The mask body is made of 25g/m2 polypropylene (PP) non-woven cloth. The mask contains tie strings or ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Polyurethane and spandex, and tie strings are made of polypropylene nonwoven cloth. The nose clip which is made of Iron-Zinc strip covered by polyethylene terephthalate (PET) covering. The disposable surgical face mask is available in two different specifications: 17.5×9.5cm and 16.5×8.5cm. The device is single use and provided sterile.
The document describes the testing and acceptance criteria for a "Disposable Surgical Face Mask" (K212649). This is a medical device, not an AI/ML device, therefore, many of the requested categories such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set" are not applicable.
Here's the information extracted and organized as requested, with "N/A" for sections not relevant to a non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| No | Item | Test Method/Standard | Type | Acceptance Criteria | Reported Performance for Ear Loop Type | Reported Performance for Tie-on Type |
|---|---|---|---|---|---|---|
| 1 | Particulates Filtration Efficiency | ASTM F2299/F2299M-03(2017) | Ear loop | ≥98% | Lot 1: 98.81%Lot 2: 98.78%Lot 3: 98.8% | N/A (listed separately below) |
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 98.82%Lot 2: 98.78%Lot 3: 98.79% | |||
| 2 | Bacterial Filtration Efficiency | ASTM F2101-19 | Ear loop | ≥98% | Lot 1: 99.9%Lot 2: 99.91%Lot 3: 99.91% | N/A (listed separately below) |
| Tie-on | ≥98% | N/A (listed above) | Lot 1: 99.91%Lot 2: 99.9%Lot 3: 99.91% | |||
| 3 | Fluid Resistance | ASTM F1862/F1826M-17 | Ear loop | 120 mmHg | Lot 1: No penetration at 120 mmHgLot 2: No penetration at 120 mmHgLot 3: No penetration at 120 mmHg | N/A (listed separately below) |
| Tie-on | 120 mmHg | N/A (listed above) | Lot 1: No penetration at 120 mmHgLot 2: No penetration at 120 mmHgLot 3: No penetration at 120 mmHg | |||
| 4 | Differential Pressure | EN 14683:2019 | Ear loop | △P<6.0 mm H2O/cm2 | Lot 1: 3.59Lot 2: 3.59Lot 3: 3.59 | N/A (listed separately below) |
| Tie-on | △P<6.0 mm H2O/cm2 | N/A (listed above) | Lot 1: 3.61Lot 2: 3.59Lot 3: 3.61 | |||
| 5 | Flammability | ASTM F2100-19 | Ear loop | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 | N/A (listed separately below) |
| Tie-on | Class 1 | N/A (listed above) | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 |
Biocompatibility Tests:
| No | Item | Test Method/Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Pass (No potential toxicity) |
| 2 | Irritation | ISO 10993-10 | Non-irritating | Pass (No Irritation) |
| 3 | Skin Sensitization | ISO 10993-10 | Non-sensitizing | Pass (No Sensitization) |
2. Sample Size Used for the Test Set and the Data Provenance
For all performance tests (Particulates Filtration Efficiency, Bacterial Filtration Efficiency, Fluid Resistance, Differential Pressure, Flammability):
- Sample Size: 3 non-consecutive lots were tested for each type (Ear loop and Tie-on). For each lot, a sample size of 125 was used.
- Data Provenance: Not explicitly stated as country of origin, but the submission is from Lyncmed Medical Technology (Beijing) Co., Ltd. in China, implying testing was likely conducted in or for the company's region. The tests are described as "Non-Clinical Test Conclusion," meaning they were laboratory tests, not clinical studies involving human patients. The report does not specify if the provenance is retrospective or prospective for the samples used for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- N/A. This is a physical medical device, and the acceptance criteria are based on standardized performance tests (e.g., ASTM, EN, ISO standards), not on human expert interpretation of data or images.
4. Adjudication Method for the Test Set
- N/A. As above, the acceptance criteria are based on objective physical and material performance standards.
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
- N/A. This is a physical medical device, not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This is a physical medical device. No algorithm is involved.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance is defined by the objective measurement criteria and threshold values specified in various international and national standards (e.g., ASTM F2299, ASTM F2101, ASTM F1862, EN 14683, ASTM F2100 for performance and ISO 10993 for biocompatibility). These standards set the quantitative benchmarks that the device must meet.
8. The Sample Size for the Training Set
- N/A. This is a physical medical device, not an AI/ML device. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
- N/A. This is a physical medical device. There is no "training set" and therefore no ground truth establishment for it.
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(161 days)
The Nitrile Examination Gloves is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The proposed device, Nitrile Examination Gloves (Blue, Violet) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The color of the proposed device is Blue and Violet. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.
This document describes the performance testing for Nitrile Examination Gloves (Blue, Violet). Here's a breakdown of the acceptance criteria and study details:
Acceptance Criteria and Reported Device Performance
Device: Nitrile Examination Gloves (Blue, Violet)
Purpose: Non-sterile disposable device worn to prevent contamination between patient and examiner.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom from Holes | Freedom from holes AQL 2.5 | Blue Color: No water leakage inspected from 200 samplesViolet Color: No water leakage inspected from 200 samples |
| ASTM D6124 | Determine the powder residue for powder free gloves | < 2.0 mg per glove | Blue Color: Residual Powder: Average 0.05 – 0.10 mgViolet Color: Residual Powder: Average 0.04 – 0.10 mg |
| ASTM D412, ASTM D573 | Testing for Physical Property Characteristics | Before Aging: Tensile Strength: 14 MPa min., Ultimate Elongation: 500% min.After Aging: Tensile Strength: 14 MPa min., Ultimate Elongation: 400% min. | Blue Color:- XS: Before Aging: Tensile Strength: ≥ 31.1 MPa, Ultimate Elongation: ≥ 505 %; After Aging: Tensile Strength: ≥ 30.1 MPa, Ultimate Elongation: ≥ 460%.- S: Before Aging: Tensile Strength: ≥ 31.3 MPa, Ultimate Elongation: ≥ 507 %; After Aging: Tensile Strength: ≥ 32.1 MPa, Ultimate Elongation: ≥ 457%.- M: Before Aging: Tensile Strength: ≥ 31.2 MPa, Ultimate Elongation: ≥ 506 %; After Aging: Tensile Strength: ≥ 28.2 MPa, Ultimate Elongation: ≥ 447%.- L: Before Aging: Tensile Strength: ≥ 30.9 MPa, Ultimate Elongation: ≥ 506 %; After Aging: Tensile Strength: ≥ 27.9 MPa, Ultimate Elongation: ≥ 426%.- XL: Before Aging: Tensile Strength: ≥ 31.0 MPa, Ultimate Elongation: ≥ 508 %; After Aging: Tensile Strength: ≥ 25.1 MPa, Ultimate Elongation: ≥ 408%. Violet Color:- XS: Before Aging: Tensile Strength: ≥ 24.1 MPa, Ultimate Elongation: ≥ 510 %; After Aging: Tensile Strength: ≥ 28.6 MPa, Ultimate Elongation: ≥ 408%. - S: Before Aging: Tensile Strength: ≥ 26.5 MPa, Ultimate Elongation: ≥ 515 %; After Aging: Tensile Strength: ≥ 29.8 MPa, Ultimate Elongation: ≥ 436%.- M: Before Aging: Tensile Strength: ≥ 26.3 MPa, Ultimate Elongation: ≥ 515 %; After Aging: Tensile Strength: ≥ 26.7 MPa, Ultimate Elongation: ≥ 462%.- L: Before Aging: Tensile Strength: ≥ 25.9 MPa, Ultimate Elongation: ≥ 510 %; After Aging: Tensile Strength: ≥ 25.6 MPa, Ultimate Elongation: ≥ 457%.- XL: Before Aging: Tensile Strength: ≥ 26.5 MPa, Ultimate Elongation: ≥ 517 %; After Aging: Tensile Strength: ≥ 25.0 MPa, Ultimate Elongation: ≥ 453%. |
| ASTM D412, ASTM D3767 | Testing for Physical Dimensions Specification | Length: 220 mm min. for size (XS, S); 230 mm min. for size (M, L, XL); Width: 70±10 mm for XS; 80±10 mm for S; 95±10 mm for M; 110±10 mm for L; 120±10 mm for XL; Finger Thickness: ≥0.05 mm; Palm Thickness: ≥0.05 mm. All acceptance criteria meet ASTM D6319. | Blue Color:- XS: Length: ≥ 225mm; Width: 70±8 (77-78) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.07 mm.- S: Length: ≥ 246mm; Width: 80±7 (86-87) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.07 mm.- M: Length: ≥ 240 mm; Width: 95±4 (98-99) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm.- L: Length: ≥ 243mm; Width: 110±3 (107-108) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm.- XL: Length: ≥ 243mm; Width: 120±6 (114-116) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm.Violet Color:- XS: Length: ≥ 225mm; Width: 70±8 (77-78) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.07 mm.- S: Length: ≥ 246mm; Width: 80±7 (86-87) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.07 mm.- M: Length: ≥ 240 mm; Width: 95±4 (98-99) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm.- L: Length: ≥ 242mm; Width: 110±3 (107-108) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm.- XL: Length: ≥ 243mm; Width: 120±6 (114-116) mm; Palm Thickness: ≥0.06 mm; Finger Thickness: ≥0.08 mm. |
| ISO 10993-11 | Evaluate systemic toxicity for biocompatibility | The test article showed no evidence of systemic toxicity potential from the extract. | The test article showed no evidence of systemic toxicity from the extract. |
| ISO 10993-10 | Evaluate irritation for biocompatibility; Evaluate sensitization for biocompatibility | The response of the test article extract is negligible. The test article showed no evidence of causing delayed dermal contact sensitization. | The test result showed that the response of the test article extract was categorized as negligible under the test condition. The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. |
Study Information:
Based on the provided document, the device in question is Nitrile Examination Gloves, and the studies performed are non-clinical performance tests for medical gloves. The document focuses on demonstrating substantial equivalence to a predicate device through adherence to established ASTM and ISO standards for physical properties and biocompatibility.
Here's the breakdown of the requested information, where applicable:
-
A table of acceptance criteria and the reported device performance: This is provided in the comprehensive table above.
-
Sample size used for the test set and the data provenance:
- Freedom from holes (ASTM D5151): 200 samples were inspected for both Blue and Violet colored gloves.
- Other tests (Physical properties, Dimensions, Biocompatibility): The exact sample sizes for these tests are not explicitly stated in the provided text, beyond the "200 samples" for the pinhole test. However, it's inferred that sufficient samples were tested to meet the requirements of the respective ASTM and ISO standards.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission, these are typically pre-market, prospective tests conducted by the manufacturer or accredited labs.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For performance testing of medical gloves, "ground truth" is established by adherence to specified scientific and engineering standards (ASTM and ISO). This does not typically involve human expert consensus in the way an AI diagnostic algorithm for medical imaging would. The expertise lies in the certified laboratories and personnel performing the standardized tests according to the laid-out protocols. The document does not specify the number or qualifications of experts involved in setting the ground truth beyond conforming to the cited standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of performance testing. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data (e.g., medical image interpretation) to establish ground truth for algorithm training or evaluation. Here, the ground truth is defined by objective physical and chemical testing standards.
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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 a submission for a medical device (nitrile gloves), not an AI algorithm for diagnosis or interpretation. Therefore, no MRMC study or AI assistance evaluation would be performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for a non-diagnostic physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on established industry standards and test methodologies for physical properties, dimensions, and biocompatibility, as defined by ASTM International and ISO. This is a form of objective, standardized measurement, not expert consensus or clinical outcomes data in the traditional sense for diagnostic devices.
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The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a "training set." The listed tests are for product validation, not algorithm development.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
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