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510(k) Data Aggregation
(251 days)
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(197 days)
Medical surgical 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 matters. This device is single use and provided non-sterile.
The Medical surgical mask is flat pleated style mask, utilizing ear loops way for wearing, and has nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is provided non-sterile and is intended to be a single use, disposable device.
The document provided relates to a 510(k) premarket notification for a Biodegradable Medical surgical mask (K231155) and is primarily focused on demonstrating substantial equivalence to a predicate device (K201622) through non-clinical performance testing. It does not contain information about the performance of an AI/ML powered device, nor does it describe a study involving human readers or expert ground truth adjudication in the context of diagnostic accuracy.
Therefore, the requested information regarding AI/ML device acceptance criteria, sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML models is not applicable to this document.
The document reports on standard non-clinical performance tests for medical masks. Here is a table summarizing the acceptance criteria and results for these tests:
1. Table of acceptance criteria and the reported device performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bacterial Filtration Efficiency (ASTM F2101) | Measure bacterial filtration efficiency | ≥95% | Pass |
| Differential Pressure (mmH2O/cm²) (EN14683:2019 Annex C) | Determine breathability of the mask | <5.0 mmH2O/cm² | Pass |
| Sub-micron Particulate Filtration Efficiency (ASTM F2299-17) | Measure initial particle filtration efficiency | ≥95% | Pass |
| Resistance to Penetration by Synthetic Blood (ASTM F1862-17) | Evaluate the resistance to penetration by impact of small volume of synthetic blood | 29 out of 32 pass at 80 mmHg | Pass |
| Flammability (16 CFR Part 1610-2008) | Response of materials to heat and flame | Class 1 | Pass |
| In vitro Cytotoxicity (ISO 10993-5) | Verify that the proposed device extract is non-cytotoxic. | The extract is non-cytotoxic under the research conditions. | Pass |
| Skin Irritation (ISO 10993-10) | Verify that the proposed device extract is non-irritating. | The polar and non-polar extracts are non-irritating under the research conditions. | Pass |
| Skin Sensitization (ISO 10993-10) | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts are non-sensitizing under the research conditions. | Pass |
The "Pass" result indicates that the device met the specified acceptance criteria for each test.
The following information is not present in the provided document, as it pertains to AI/ML device studies, which this medical mask submission is not:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
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(295 days)
The biodegradable nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The gloves are offered in six sizes, extra-small (6.5"), small (7"), medium (8"), large (8.5"), extra-large (9"), extra extra-large (9.5"). Three colors are available for all size, includes blue, blue violet and green.
This document, K221983, is a 510(k) Premarket Notification for Biodegradable Powder Free Nitrile Examination Gloves. The device in question is a Class I medical device, meaning it is subject to general controls and typically does not require extensive clinical studies for clearance if substantial equivalence to a predicate device can be demonstrated.
Based on the provided text, the "device" is a Nitrile Examination Glove, not an advanced AI or diagnostic device that would involve AI-assisted reading or complex image analysis. Therefore, the questions related to AI (e.g., effect size of human readers improving with AI, standalone algorithm performance, training set size, adjudication methods, number of experts for ground truth) are not applicable to this type of medical device submission.
The "study" referenced in this document is a series of non-clinical, in-vitro laboratory tests performed to demonstrate that the glove meets established industry standards and specifications, proving its safety and performance equivalence to a legally marketed predicate device.
Here's the information extracted from the document relevant to your request, but tailored to the nature of this Class I device:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length:Extra-Small: ≥ 220mmSmall: ≥ 220mmMedium: ≥ 230mmLarge: ≥ 230mmExtra-Large: ≥ 230mmExtra-Extra-Large: ≥ 230mmWidth:Extra-Small: 70 ± 10 mmSmall: 80 ± 10mmMedium: 95 ± 10mmLarge: 110 ± 10mmExtra-Large: 120 ± 10mmExtra-Extra-Large: ≥120mm | Pass |
| ASTM D6319 | Physical properties (Thickness) | Thickness (mm):Finger: ≥0.05Palm: ≥0.08 | Pass |
| ASTM D6319 | Physical properties (Before Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Pass |
| ASTM D6319 | Physical properties (After Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Pass |
| ASTM D5151 | Freedom from pinholes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | Pass |
| ASTM D6124 | Powder Residue | Meet the requirements of ASTM D6124 < 2.0mg | Pass |
| ISO 10993-10 | To determine if the finished device material is an irritant | Non-irritating | Non-irritant / Pass |
| ISO 10993-10 | To determine if the finished device material is a sensitizer | Non-sensitizing | Non-sensitizer / Pass |
| ISO 10993-11 | To determine if the finished device material extracts pose a systemic toxicity concern | Non-acute systemic toxicity | Non-acute systemic toxicity in vivo / Pass |
2. Sample sized used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes or dimensions). However, the tests are in accordance with the specified ASTM and ISO standards, which typically define appropriate sample sizes for such tests.
Data provenance: The testing was conducted by Guangdong Kingfa Sci. & Tech. Co., LTD., based in China. The data likely comes from laboratory testing conducted directly by or for the manufacturer. The data is retrospective in the sense that it was collected prior to the 510(k) 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 to the device. Ground truth for glove testing is established through physical measurements, chemical analysis, and standardized biological tests conducted in laboratories, not by expert consensus of human readers. The "experts" would be the certified laboratory technicians and scientists performing the tests according to the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations, especially in clinical image reading. The testing for gloves involves objective measurements and standardized protocols.
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
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is based on objective, standardized measurements and laboratory test results defined by internationally recognized standards (ASTM, ISO). For example, a glove has a physical dimension (e.g., length, width), a certain tensile strength, or a specific level of powder residue, as measured by precise instruments and chemical analyses. Biocompatibility (irritation, sensitization, systemic toxicity) is determined by in-vivo/in-vitro assays according to ISO standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this device.
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(87 days)
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The proposed devices are provided with white, black and pink color. There are six sizes, extra-small, medium, large and extra-large, extra extra-large for optional.
This is a 510(k) summary for a medical device (Nitrile Examination Gloves), not for an AI/ML powered device, therefore, the requested information elements related to AI/ML device studies (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable.
The document describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's the table of acceptance criteria and reported device performance based on the provided document:
Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D6319 - Physical Dimensions Test | ||||
| Length (XS) | $\ge$ 220 mm | 226 mm | Pass | |
| Width (XS) | 70 $\pm$ 10 mm | 73 mm | Pass | |
| Length (S) | $\ge$ 220 mm | 225 mm | Pass | |
| Width (S) | 80 $\pm$ 10 mm | 85 mm | Pass | |
| Length (M) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (M) | 95 $\pm$ 10 mm | 98 mm | Pass | |
| Length (L) | $\ge$ 230 mm | 234 mm | Pass | |
| Width (L) | 110 $\pm$ 10 mm | 115 mm | Pass | |
| Length (XL) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (XL) | 120 $\pm$ 10 mm | 123 mm | Pass | |
| Length (XXL) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (XXL) | $\ge$ 120 mm | 124 mm | Pass | |
| Thickness | ||||
| Finger Thickness | $\ge$ 0.08 mm | X-Small: 0.104 mm; Small: 0.106 mm; Medium: 0.104 mm; Large: 0.105 mm; X-Large: 0.106 mm; XX-Large: 0.105 mm | Pass | |
| Palm Thickness | $\ge$ 0.05 mm | X-Small: 0.059 mm; Small: 0.060 mm; Medium: 0.060 mm; Large: 0.062 mm; X-Large: 0.061 mm; XX-Large: 0.058 mm | Pass | |
| Physical Properties (Before Aging) | ||||
| Tensile Strength | $\ge$ 14 MPa | Lot1: 17.6 MPa; Lot2: 18.5 MPa; Lot3: 18.2 MPa | Pass | |
| Ultimate Elongation | $\ge$ 500% | Lot1: 552%; Lot2: 573%; Lot3: 583% | Pass | |
| Physical Properties (After Aging) | ||||
| Tensile Strength | $\ge$ 14 MPa | Lot1: 19.8 MPa; Lot2: 20.3 MPa; Lot3: 20.1 MPa | Pass | |
| Ultimate Elongation | $\ge$ 500% | Lot1: 521%; Lot2: 518%; Lot3: 526% | Pass | |
| ASTM D5151 - Freedom from Pinholes | Freedom from pinholes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | Lot1: $\le$ AQL 2.5; Lot2: $\le$ AQL 2.5; Lot3: $\le$ AQL 2.5 | Pass |
| ASTM D6124 - Powder Residue | Powder Residue | $\le$ 2.0 mg | Lot1: 1.2 mg; Lot2: 1.5 mg; Lot3: 1.2 mg | Pass |
| ISO 10993-10 - Irritation | To determine if the finished device material is an irritant | Non-irritating | Under the conditions of the study, not an irritant | Pass |
| ISO 10993-10 - Sensitization | To determine if the finished device material is a sensitizer | Non-sensitizing | Under conditions of the study, not a sensitizer | Pass |
| ISO 10993-11 - Systemic Toxicity | To determine if the finished device material extracts pose a systemic toxicity concern | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo | Pass |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. These are non-clinical bench tests on physical products, not an AI/ML test set. The tests were performed on "Lots" of the gloves (Lot1, Lot2, Lot3). The specific sample size for each test within these lots is not specified in this document but implied to be sufficient for meeting the ASTM/ISO standards. The data provenance is from non-clinical testing of the manufacturing output.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as these are objective physical and chemical tests, not requiring expert ground truth in the context of AI/ML evaluation.
- Adjudication method for the test set: Not applicable. The results are based on objective measurements against defined standards.
- 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 concerns a physical medical device (gloves), not an AI/ML powered device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concerns a physical medical device (gloves), not an AI/ML powered device.
- The type of ground truth used: For physical/chemical properties (e.g., length, thickness, tensile strength, freedom from pinholes, powder residue), the "ground truth" is the quantitative measurement obtained through standardized test methods (ASTM and ISO standards) and compared against pre-defined numerical or qualitative acceptance criteria. For biocompatibility tests (irritation, sensitization, systemic toxicity), the ground truth is established by the outcome of the biological assays as per ISO 10993 standards.
- 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. This is not an AI/ML device.
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(90 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes
Power-Free Nitrile Examination Gloves(Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, Blue/Blue violet colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in four sizes, small, medium, large and extra-large.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).
The provided document describes the acceptance criteria and the study conducted for "Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs" and "Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs".
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5151 | Water Leak Test | The gloves shall be free from hole when tested in accordance with the method given in ASTM D5151. | pass |
| ASTM D3767 | Dimension | The actual measured dimension of the gloves shall meet the stated tolerance in Table 2 of the ASTM D 6319-19. | pass |
| Before aging ASTM D412, After aging ASTM D573 | Physical Properties (Tensile Strength, Ultimate Elongation) | Before and after accelerated aging, the gloves shall conform to the physical requirements in Table 3 of ASTM 6319-19 (Tensile Strength: Before Aging ≥ 14 MPa, min.; After Aging ≥ 14 MPa, min. Elongation: Before Aging 500%, min.; After Aging 400%, min.). | pass |
| ASTM D6124 | Residual Powder Content | The powder residue content shall be not more than 2mg per gloves. | pass |
| ASTM D6978-05 | Chemotherapy Drugs Permeation Time | Carmustine (BCNU) 3.3 mg/ml: 65.3 minutes Cisplatin 1.0 mg/ml: >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml: >240 minutes Dacarbazine (DTIC)10.0 mg/ml: >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml: >240 minutes Etoposide (Toposar) 20.0 mg/ml: >240 minutes Fluorouracil 50.0 mg/ml: >240 minutes Paclitaxel (Taxol) 6.0 mg/ml: >240 minutes Thiotepa 10.0 mg/ml: 58.3 minutes | pass |
| ISO 10993-10:2010 | Skin Irritation | non-irritating | pass |
| ISO 10993-10:2010 | Skin Sensitization | non-sensitizing | pass |
| ISO 10993-11:2017 | Acute Systemic Toxicity | No acute system toxicity | pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of gloves or individual tests) used for each non-clinical test. It only states that "Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications."
The data provenance is from non-clinical laboratory testing conducted to established international and ASTM standards. The country of origin of the data is not explicitly stated for each test, but the devices are manufactured by GUANGDONG KINGFA SCI. & TECH.CO., LTD. in Qingyuan, Guangdong, China. The testing appears to be prospective as it was performed to verify the device's compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The study involves non-clinical performance testing of medical devices (gloves), not a diagnostic algorithm or human-readable data necessitating expert ground truth establishment. The "ground truth" here is determined by the objective measurements and adherence to the specified ASTM and ISO standards.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data. For non-clinical device testing, the results are objectively measured against predefined 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
There was no MRMC comparative effectiveness study done. This study is for medical gloves, which are physical devices, not an AI or imaging diagnostic tool 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 study concerns a physical medical device (gloves), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this non-clinical testing is based on objective measurements and adherence to established international standards such as ASTM D6319-19, ASTM D6978-05, ISO 10993-10:2010, and ISO 10993-11:2017. These standards define the acceptable physical properties, chemical permeation resistance, and biocompatibility of the gloves.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not a machine learning or AI algorithm development study.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device testing.
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