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510(k) Data Aggregation
(204 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05. The gloves are single use, disposable, and provided non-sterile.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The device in question is "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K242533).
Non-Clinical Performance Data
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions (Length) | Min 220mm for size XS, S; Min 230mm for size M-XXL | Pass |
| ASTM D6319-19 | Physical Dimensions (Palm Width) | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L:110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions (Thickness) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16 | Physical Properties (Tensile Strength & Elongation) | Tensile Strength (Min 14 MPa); Elongation (Before Aging 500% min and after aging 400% min) | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 | Permeation by Chemotherapy Drugs | As specified in the table for each drug (e.g., >240 minutes for most, with specific lower values for Carmustine and Thiotepa, explicitly stating "Do not use" for these). | Pass (as per specific BDTs) |
| ISO 10993-5:2009 | Cytotoxicity | No cytotoxicity reactivity (Note: The device states it is cytotoxic but this concern was addressed by acute systemic toxicity testing.) | The test article scored '4' at 24, 48, and 72 ± 4 hours and is considered cytotoxic under the conditions of this test. Cytotoxicity concern was addressed by acute systemic toxicity testing. |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No skin sensitization and Skin irritation | Under the conditions of this study, there were no evidence of sensitization and irritation. |
| ISO 10993-11:2017 | Acute systemic toxicity study | No adverse biological reaction | Under the conditions of this study, there was no evidence of acute systemic toxicity. |
Clinical Performance Data
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Modified DRAIZE-95 Test to Evaluate Low Dermatitis Potential of Medical Gloves | Demonstrate a reduced potential for sensitizing users to chemical additives. | Under the conditions of this clinical trial, the subject device demonstrated reduced potential for sensitizing users to chemical additives. |
Study Information
Due to the nature of the device (patient examination gloves) and the provided documentation, several sections of your request are not directly applicable or explicitly detailed. This document is a 510(k) summary for a Class I medical device, which typically relies more on performance testing against established standards and equivalence to predicates rather than complex clinical trials like those for novel therapeutic devices.
Here's what can be extracted from the document:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Permeation Tests (ASTM D6978-05): The document does not specify the exact sample size used for the permeation tests for each chemical. The standard ASTM D6978-05 typically outlines the number of replicates required (e.g., three specimens).
- Biocompatibility Tests (ISO 10993 series): Similarly, the sample sizes for these tests are not explicitly stated in the summary but would be specified by the respective ISO standards.
- Clinical Test (Modified DRAIZE-95 Test): A 305-subject study was completed. The country of origin and whether it was retrospective or prospective is not specified, but such a test is typically prospective to evaluate a new or modified device.
- Data Provenance: The document generally refers to testing "under the conditions of this study," without specifying the country of origin for non-clinical tests. The manufacturer is based in China.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the non-clinical tests (physical properties, chemical permeation, biocompatibility), the "ground truth" is established by the standardized methods themselves (ASTM and ISO standards) and objective measurements by qualified laboratory personnel. The number of "experts" and their specific qualifications beyond standard lab certifications are not typically detailed in these summaries.
- For the clinical test on dermatitis potential, the "ground truth" is derived from the subjects' reactions as evaluated by the study investigators. The qualifications of these investigators are not provided.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For the non-clinical tests, adjudication methods like 2+1 or 3+1 are not applicable. Results are based on objective measurements against defined criteria.
- For the clinical test (Modified DRAIZE-95), the document does not specify an adjudication method. Clinical studies of this nature usually involve clinical investigators observing and documenting reactions, and a statistical analysis of the aggregate results.
-
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 device is a physical product (gloves), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical and Chemical Tests: The ground truth is based on the objective measurements of the glove's properties (dimensions, strength, elongation, watertightness, powder residue) and breakthrough detection times for chemicals, all conducted according to recognized ASTM and ISO standards.
- Biocompatibility Tests: Ground truth is determined by the biological response observed in in vitro (cytotoxicity) or in vivo (irritation, sensitization, acute systemic toxicity) models as interpreted against the acceptance criteria of the ISO 10993 standards.
- Dermatitis Potential Clinical Test: The ground truth is the observed clinical reactions of human subjects to the device, evaluated against criteria for allergic contact sensitization.
-
The sample size for the training set:
- Not applicable. This pertains to an algorithm or machine learning model. This device is a physical product.
-
How the ground truth for the training set was established:
- Not applicable. As above, this is for an algorithm or machine learning model.
Ask a specific question about this device
(95 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." It is important to note that this is a 510(k) summary for a medical device (gloves), not an AI/algorithm-driven device. Therefore, many of the requested fields related to AI clinical studies, such as sample sizes for AI test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable.
The studies described are non-clinical performance tests for the gloves themselves, not an AI system.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions - Length (ASTM D6319-19) | Min 220mm for size XS, S; Min 230mm for size M-XXL | Pass |
| Physical Dimensions - Palm Width (ASTM D6319-19) | XS: 70±10 mm; S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm; XXL: 130±10 mm | Pass |
| Physical Dimensions - Thickness (ASTM D6319-19) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| Physical Properties (ASTM D6319-19, ASTM D412-16(2021)) | Tensile Strength (Min 14 MPa); Elongation (Before Aging 500% min and After Accelerated Aging 400% min) | Pass |
| Water Leak Test (ASTM D6319-19, ASTM D5151-19) | AQL 2.5 (ISO 2859-1) | Pass |
| Powder Residue (ASTM D6319-19, ASTM D6124-06 (2017)) | Max 2mg/glove | Pass |
| Permeation by Chemotherapy Drugs (ASTM D6978-05 (2019)) | Refer to the detailed table (reproduced below) | Pass |
| Irritation and Skin Sensitization (ISO 10993-10:2010) | Is non-sensitization and non-irritation | Is non-sensitization and Non-irritation |
| Cytotoxicity (ISO 10993-5:2009) | Cytotoxicity reactivity | showed potential toxicity to L929 cells (Note: addressed by acute systemic toxicity testing) |
| Acute Systemic Toxicity Study (ISO 10993-11:2017) | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity |
Detailed Chemotherapy Drug Permeation and Fentanyl Citrate Comparison Claim (Subject device K232266 performance):
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.8 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade, 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Warning: Do not use with Carmustine (22.8 minutes) and Thiotepa (46.9 minutes).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify general "sample sizes" for the test set in terms of medical images or patient data. Instead, it refers to standardized testing methodologies for physical and chemical properties of gloves. For instance, ASTM D5151 for water leak test would involve a certain number of gloves per batch as per AQL (Acceptable Quality Limit) standards, but the specific quantity is not stated in this summary. The data provenance is generally implied to be from laboratory testing conforming to the cited ASTM and ISO standards. The country of origin of the device manufacturer is China. These are prospective tests performed on the manufactured product.
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)
Not applicable. This is not an AI or diagnostic device that requires expert ground truth for interpretation of medical images or patient data. The "ground truth" for the device's performance is established by the specified pass/fail criteria of the ASTM and ISO standards for glove manufacturing and material properties. The tests are laboratory-based and measure physical/chemical attributes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic or screening studies, not for the physical and chemical testing of medical gloves.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on standardized test methods and predetermined acceptance criteria defined by international and national standards organizations such as ASTM and ISO. These standards dictate acceptable physical dimensions, mechanical properties, chemical permeation resistance, and biological safety (e.g., irritation, sensitization, systemic toxicity) for medical examination gloves. For instance, for chemotherapy drug permeation, the "ground truth" is the measured breakthrough detection time according to ASTM D6978-05(2019).
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As this is not an AI device, there is no "training set" or ground truth established in that context.
Ask a specific question about this device
(219 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is non-sterile and disposable medical glove intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is made of nitrile butadiene rubber (NBR), as per standard meets ASTM D6319-10(Reapproved 2015).
The proposed device is Powder Free Nitrile Examination and variants of different sizes, such as size S/M/L/XL. All variants share the same color, blue.
The provided text describes the 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color" (K211864). This document primarily focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device. It specifically states that "Clinical testing is not needed for this device." Therefore, the requested information pertaining to AI/ML device studies, such as multi-reader multi-case studies, expert adjudication, training/test set ground truth establishment, or sample sizes for AI model development, is not applicable to this submission.
The document outlines the acceptance criteria and reported device performance based on non-clinical tests.
Here is the table summarizing the acceptance criteria and stated performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D 6319-06 (Reapproved 2015) | Dimension Length | ≥ 230mm | 237 mm min for all sizes | Pass |
| Dimension Width | Small 70-90 mm | 85-87 mm | Pass | |
| Medium 85-105mm | 95-97 mm | Pass | ||
| Large 100-120mm | 105-107mm | Pass | ||
| X large 110-130 mm (from comparison table) | 115-117 mm (from comparison table) | Pass | ||
| Thickness | Fingertip ≥ 0.05 mm | 0.091mm | Pass | |
| Palm ≥ 0.05 mm | 0.072mm | Pass | ||
| ASTM D 6319-06 (Reapproved 2015) | Physical Properties: Tensile strength (Before & After aging) | ≥14MPa | 16.5-19.3 MPa | Pass |
| Physical Properties: Before aging Elongation | ≥500% | 526-560% | Pass | |
| Physical Properties: After aging Elongation | ≥400% | 432-492% | Pass | |
| • 21 CFR 800.20, • ASTM D 6319-06 (Reapproved 2015), • ASTM D5151-19 | Freedom from pinholes: Water leakage test | Inspection Level I, AQL2.5, and Accept/Reject criteria of 10/11. | 2 noncompliance is allowed. | Pass |
| • ASTM D6319-10 (Reappr oved 2015), • ASTM D6124-06 (Reapproved 2017) | Powder Residual | <2mg/glove | Mean: 0.6-0.9 mg/pcs | Pass |
| Primary Skin Irritation in rabbits ISO 10993-10: 2010-08-01 | Biocompatibility | Under the conditions of the study, the subject device is not a primary skin irritant. | Passes | Pass |
| Dermal sensitization in the guinea pig ISO 10993-10: 2010-08-01 | Biocompatibility | Under the conditions of the study, the subject device is not a skin sensitizer. | Passes | Pass |
| The test article was added to L929 cells measured by MTT assay ISO 10993-5: 2009 | Biocompatibility | Under the conditions of this study, the test article was non-cytotoxicity to L-929 cells. | Cytotoxic. Additional testing performed to determine if this was a systemic toxicity concern. | See Note below |
| Acute Systemic Toxicity Systemic injection in mice ISO 10993-11: 2017 | Biocompatibility | Under the conditions of study the device extracts do not pose a systemic toxicity concern. | Pass | Pass |
Note on Biocompatibility (Cytotoxicity): The device was found to be "cytotoxic" in the initial ISO 10993-5 test. However, the subsequent Acute Systemic Toxicity test (ISO 10993-11) passed, indicating that despite the in-vitro cytotoxicity, the device extracts do not pose a systemic toxicity concern in vivo. The document explicitly states: "Under the conditions of this study, the test article was shown potential toxicity to L-929 cells," but then for Acute Systemic Toxicity, it states, "Under the conditions of study, the device extracts do not pose a systemic toxicity concern (ISO 10993-11:2017)." This implies that the initial cytotoxicity finding was addressed and deemed not to be a safety concern in the context of systemic exposure.
Regarding the other requested information (2-9), as a 510(k) for a Class I medical device (patient examination gloves) that explicitly states "Clinical testing is not needed for this device," the following items are not applicable or not detailed in this submission because they are typically relevant for AI/ML-driven or image-analysis medical devices, which these gloves are not:
- Sample size used for the test set and the data provenance: Not applicable. These are physical product tests, not data-driven AI model tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (like glove dimensions, tensile strength, pinholes) is established by adherence to specified ASTM and ISO testing standards, not by expert consensus readings of images or data.
- Adjudication method 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 not an AI-assisted device.
- 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.): Ground truth for these tests is defined by established international standards (ASTM, ISO) for physical and chemical properties of gloves.
- The sample size for the training set: Not applicable. There is no AI model involved.
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
(240 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided text is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color," which is a Class I medical device. This type of device does not typically involve complex algorithms or AI; instead, its performance is evaluated based on physical characteristics and material biocompatibility against established standards. Therefore, the requested information regarding AI-specific evaluation criteria (like multi-reader multi-case studies, expert adjudication, AI effect size, training set details) is not applicable to this submission.
Here's a breakdown of the acceptance criteria and study information that is relevant and available in the document:
1. A table of acceptance criteria and the reported device performance
| Feature/Test | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Dimensions - Length (ASTM D6319-10) | ≥230mm min | 232 mm min for all sizes | Similar |
| Dimensions - Width (ASTM D6319-10) | Small: 70-90mmMedium: 85-105mmLarge: 100-120mmX large: 110-130mm | Small: 76-90 mmMedium: 87-102 mmLarge: 108-119mmX large: 115-128 mm | Similar |
| Dimensions - Thickness (ASTM D6319-10) | Finger: 0.05mm min.Palm: 0.05mm min. | Fingertip: ≥0.08mmPalm: ≥0.08mm | Similar |
| Physical Properties - Tensile Strength (Before & After aging) (ASTM D6319-10) | ≥ 14MPa | Before Aging: 18-25 MPaAfter Aging: 17-22 MPa | Similar |
| Physical Properties - Elongation (Before aging) (ASTM D6319-10) | ≥500% | Before Aging: 550-610% | Similar |
| Physical Properties - Elongation (After aging) (ASTM D6319-10) | ≥400% | After Aging: 450-570% | Similar |
| Freedom from Pinholes (21 CFR 800.20, ASTM D6319-10) | Inspection Level I AQL2.5; Accept/Reject criteria of 10/11 (Predicate) | Water leakage test: 5 noncompliance is allowed. | Similar |
| Residual Powder (ASTM D6124-06) | Below 2mg of residual powder | Mean: 0.1mg/pcs | Pass |
| Biocompatibility - Primary Skin Irritation (ISO 10993-10:2010) | Non-irritant | Under the conditions of the study, the subject device is not a primary skin irritant. | Passes |
| Biocompatibility - Dermal Sensitization (ISO 10993-10:2010) | Non-sensitizer | Under the conditions of the study, the subject device is not a skin sensitizer. | Passes |
| Biocompatibility - Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxicity to L-929 cells | Under the conditions of this study, the test article was non-cytotoxicity to L-929 cells. | Pass |
| Biocompatibility - Acute Systemic Toxicity (ISO 10993-11:2017) | No systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern. | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each physical test. However, it indicates general inspection levels where applicable, such as "ILS-2 AQL4.0" for dimensions and "Inspection Level I AQL2.5" for freedom from pinholes. For residual powder, it states "Checked on 5pcs sub-samples (N=5)."
The provenance of the data is from non-clinical laboratory testing performed by the manufacturer to demonstrate compliance with relevant ASTM and ISO standards. The document does not specify the country of origin of the raw data, but the manufacturer is Shandong Shangwei Medical Products Co.,Ltd, located in China. The studies are prospective in nature, as they are specifically conducted to test the performance of the device against predefined criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device is based on objective measurements against established international and national standards (ASTM, ISO, CFR) for physical properties and biocompatibility. It does not involve expert interpretation or subjective assessment of medical images or patient conditions.
4. Adjudication method for the test set
Not applicable. As described above, this is not an AI or diagnostic device requiring expert adjudication. Test results are quantitative measurements compared against predefined thresholds in 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
Not applicable. This device is a patient examination glove and does not involve AI or human "readers" in a diagnostic capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm for this device.
7. The type of ground truth used
The ground truth used for this device's evaluation is based on established industry standards and objective laboratory measurements. These include:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) for dimensions and physical properties.
- 21 CFR 800.20 and ASTM D5151-19 for freedom from pinholes.
- ASTM D6124-06 for residual powder.
- ISO 10993-5, ISO 10993-10, and ISO 10993-11 for biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity).
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
(232 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves. It details the device's characteristics and compares them to a predicate device to establish substantial equivalence.
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The device's performance is compared against established standards, primarily ASTM D6319-10 (Reapproved 2015) for Nitrile Examination Gloves for Medical Application, along with other ISO and ASTM standards for biocompatibility and specific tests.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D 6319-06 (Reapproved 2015) | Dimension | ||
| - Length | ≥230mm min | 232 mm min for all sizes (Similar to predicate) | |
| - Width | Small: 70-90 mmMedium: 85-105mmLarge: 100-120mmX large: 110-130 mm | Small: 75-90 mmMedium: 88-102 mmLarge: 107-117mmX large: 114-128 mm (Similar to predicate) | |
| - Thickness | Fingertip: ≥0.05mm min.Palm: ≥0.05mm min. | Fingertip: ≥0.08mmPalm: ≥0.08mm (Similar to predicate) | |
| ASTM D 6319-06 (Reapproved 2015) | Physical Properties | ||
| - Tensile strength (Before & After aging) | ≥ 14MPa | 17-24 (Before Aging), 17-22 (After Aging) (Similar to predicate) | |
| - Before aging Elongation | ≥500% | 540-610 (Similar to predicate) | |
| - After aging Elongation | ≥400% | 460-570 (Similar to predicate) | |
| 21 CFR 800.20ASTM D 6319-06 (Reapproved 2015)ASTM D5151-19 | Freedom from pinholes | Water leakage test: Inspection Level I, AQL 2.5, and Accept/Reject criteria of 10/11. | 5 noncompliance is allowed (Similar to predicate) |
| ASTM D6319-10 (Reapproved 2015)ASTM D6124-06 (Reapproved 2017) | Powder Residual | <2mg/glove | Mean: 0.1mg/pcs (Similar to predicate) |
| Biocompatibility (ISO 10993-10:2010-08-01 - Primary Skin Irritation/Dermal Sensitization) | Biocompatibility | Non-irritant or non-sensitizer | Pass (Non-irritant, non-sensitizer) (Similar to predicate) |
| Biocompatibility (ISO 10993-5:2009 - Cytotoxicity) | Biocompatibility | Non-cytotoxicity to L-929 cells. | Cytotoxic (requires additional testing to assess systemic toxicity concern) (Different from predicate, further tested) |
| Biocompatibility (ISO 10993-11:2017 - Acute Systemic Toxicity) | Biocompatibility | Device extracts do not pose a systemic toxicity concern. | Pass (Device extracts do not pose a systemic toxicity concern) (Different from predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific numerical sample size for each test. However, it references industry standards like Inspection Level I, AQL 2.5, for Freedom from Pinholes which implies a statistically determined sample size for quality control testing of physical properties. For residual powder, it states "Checked on 5pcs sub-samples (N=5)".
- Data Provenance: The document does not explicitly state the country of origin of the data collection or if the studies were retrospective or prospective. Given the nature of a 510(k) submission and the tests performed (material properties, biocompatibility), these are typically controlled laboratory tests conducted during the device's development phase, likely in China where the manufacturer is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This 510(k) submission is for patient examination gloves, which are assessed based on established physical, chemical, and biological performance standards (e.g., ASTM, ISO). The "ground truth" is defined by meeting these predefined quantitative criteria. Therefore, there isn't a concept of "experts establishing ground truth" in the same way as with diagnostic AI. The performance is objectively measured against the specified thresholds in the standards by qualified testing laboratories.
4. Adjudication Method for the Test Set:
Not applicable in this context. The testing involves objective measurements against pre-defined numerical and qualitative standards, not human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a medical device (patient examination gloves) that does not involve diagnostic interpretation or human-in-the-loop performance improvement in the typical sense of an AI/imaging device. Clinical testing was explicitly stated as "not needed for this device."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a physical product, not a software algorithm. The "performance" is its intrinsic physical and biological characteristics.
7. The Type of Ground Truth Used:
The ground truth is based on established industry standards and regulatory requirements (e.g., ASTM D6319, ISO 10993, 21 CFR 800.20) for physical properties, chemical composition, and biocompatibility of patient examination gloves. These are objective, measurable performance criteria.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a "training set." The device's characteristics are determined by its manufacturing process and tested against objective standards, not by an algorithm learning from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reason stated in point 8.
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(58 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
This document is a 510(k) Premarket Notification summary for Powder Free Nitrile Patient Examination Gloves, Blue Color. It does not describe an AI medical device or a study involving human readers. Therefore, I cannot provide details on acceptance criteria or an AI-related study as described in your request.
The provided text details the submission of a medical device (nitrile examination gloves) for regulatory clearance. The core of the submission, and the content of the "Acceptance Criteria" table, relates to physical and chemical properties of the gloves, and biocompatibility, as tested against established ASTM and ISO standards.
Here's an analysis of the existing content in relation to your request, highlighting what's present and what's missing:
1. A table of acceptance criteria and the reported device performance
The provided text contains a comprehensive table on page 4 titled "Features & Description" which functions as the acceptance criteria and reported device performance.
| Features & Description | Acceptance Criteria (from Subject Device) | Reported Performance (from Subject Device) |
|---|---|---|
| Dimension - Length | ≥230mm min (from predicate guidance) | 232 mm min for all sizes |
| Dimension - Width | Small 75-90 mm, Medium 87-102 mm, Large 107-119mm, X large 114-128 mm | Measured values for each size fall within these ranges (implied by "Similar" and comparison to predicate values) |
| Dimension - Thickness | Fingertip ≥0.08mm min, Palm ≥0.08mm min | Fingertip 0.08mm min, Palm 0.08mm min (reported as "Similar" to predicate which implies meeting criteria) |
| Physical Properties - Tensile strength (Before & After aging) | ≥14MPa | Before Aging: 19-25 MPa; After Aging: 17-23 MPa |
| Physical Properties - Elongation (Before aging) | ≥500% | 560-610 % |
| Physical Properties - Elongation (After aging) | ≥400% | 460-570 % |
| Freedom from Pinholes (Water leakage test) | Inspection Level I, AQL2.5, Accept/Reject criteria of 10/11. 5 noncompliance is allowed. | Meets criteria (implied by "Similar" and no reported failure) |
| Residual Powder | <2mg/glove | Mean: 0.1mg/pcs |
| Biocompatibility - Primary Skin Irritation | Not a primary skin irritant | Passes |
| Biocompatibility - Dermal Sensitization | Not a skin sensitizer | Passes |
| Biocompatibility - Cytotoxicity | Non-cytotoxicity to L-929 cells | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The sample sizes are generally specified by the ASTM and ISO standards referenced. For instance, "Freedom from Pinholes" specifies "Inspection Level I, AQL2.5, and Accept/Reject criteria of 10/11," which implies a specific sampling plan based on lot size. "Residual Powder" states "Checked on 5pcs sub-samples (N=5)."
- Data Provenance: The document does not explicitly state the country of origin of the data itself, but the applicant company (Anhui Powerguard Technology Co., Ltd.) is from China. The tests are "Non-clinical tests" conducted to verify compliance with design specifications. It is a prospective study as the tests are conducted on the new device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a physical product (gloves) and not an AI or diagnostic device that requires expert interpretation for ground truth. The "ground truth" is established by direct physical, chemical, and biological testing according to validated standard protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical product; no human adjudication is involved in the performance testing of gloves.
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 a clearance for a physical medical device (gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm in this submission.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth is established by objective, standardized laboratory tests (e.g., tensile strength testing, water leakage test, chemical analysis for residual powder, in vitro and in vivo biocompatibility assays) as defined by ASTM and 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.
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(265 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided text is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color," a Class I medical device. This document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate substantial equivalence to a predicate device already on the market.
It's important to understand that a 510(k) submission for a Class I device like examination gloves does not involve the kind of "AI-driven medical device" performance evaluation that the prompt is asking for (e.g., acceptance criteria for AI model performance, human reader improvement studies, ground truth establishment for complex image analysis).
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to physical and biological performance standards for gloves, not the performance of an AI algorithm. Therefore, I cannot fulfill most of the prompt's requests because they are not applicable to the device described in the document.
Here's how the provided information relates to the prompt, and why most points cannot be answered based on this document:
1. A table of acceptance criteria and the reported device performance
The document provides a "Technological Characteristic Comparison Table" (Section 6.0) that lists various physical and chemical properties of the gloves and compares them to the predicate device. These are the "acceptance criteria" for this type of device.
| Features & Description | Acceptance Criteria (Predicate Device K120970, based on ASTM D6319-10/21 CFR 800.20/ASTM D6124-06) | Reported Device Performance (Subject Device K181106) |
|---|---|---|
| Product name | Powder Free Nitrile Patient Examination Glove, Blue Color | Powder Free Nitrile Patient Examination Gloves, Blue Color |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 |
| Product Code | LZA | LZA |
| Color | Blue | Blue |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large |
| Indications for Use | Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |
| Device Description & Specs | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Dimensions -- Length (ILS-2 AQL4.0) | Meets ASTM D6319-10; ≥230mm min. | 232 mm min for all sizes |
| Dimensions -- Width (ILS-2 AQL4.0) | Meets ASTM D6319-10; Small 70-90 mm, Medium 85-105mm, Large 100-120mm, X large 110-130 mm | Small 76-90 mm, Medium 89-102 mm, Large 108-119mm, X large 115-128 mm |
| Dimensions -- Thickness (ILS-2 AQL4.0) | Meets ASTM D6319-10; Finger 0.05mm min., Palm 0.05mm min. | Finger 0.08 mm min., Palm 0.08 mm min. |
| Physical Properties (Before Aging) | Tensile Strength ≥14MPa, Elongation ≥500% | Tensile Strength: 18-25 MPa, Elongation: 550-600% |
| Physical Properties (After Aging) | Tensile Strength ≥14MPa, Elongation ≥400% | Tensile Strength: 17-22 MPa, Elongation: 450-570% |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D6319-10; Inspection Level I AQL2.5, Accept/Reject criteria of 10/11; Water leakage test: 5 noncompliance allowed. (Predicate) | 1) Inspection Level I AQL2.5, and Accept/Reject criteria of 10/11; 2) Water leakage test: 5 noncompliance is allowed. (Subject) |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011); below 2mg of residual powder | Checked on 5pcs sub-samples (N=5). Mean: 0.1mg/pcs |
| Materials used to fabricate | Nitrile | Nitrile |
| Single Patient Use | Single Patient Use | Single Patient Use |
| Biocompatibility | Non-irritant or non-sensitizer (Predicate) | Non-irritant or non-sensitizer; non-cytotoxicity to L-929 cells (Subject) |
| Labeling | -Powder Free, -Patient Examination Glove, -Single Use Only, -Manufactured For:, -Lot, -Blue color | -Powder Free, -Patient Examination Glove, -Single Use Only, -Manufactured For:, -Lot, -Blue color |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions a specific sample size for "Residual Powder" (5 sub-samples) and implies inspection levels for Length, Width, Thickness, and Pinholes (e.g., ILS-2 AQL 4.0, Inspection Level I AQL 2.5). These refer to standardized statistical sampling plans for quality control in manufacturing, not a clinical "test set" for an algorithm.
- Data Provenance: The tests are "non-clinical tests" conducted to verify the device meets acceptance criteria. The manufacturer is JiangSu DongXin Medical Technology Co., Ltd in China. The "data provenance" would be in-house laboratory testing based on specified ASTM and ISO standards. These are prospective quality control tests for manufacturing, not retrospective/prospective clinical data collection.
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)
- Not applicable. "Ground truth" in this context refers to the measured physical and chemical properties of the gloves conforming to established standards, not expert interpretations of images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is for assessing inter-reader variability in clinical image interpretation, not for glove testing.
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 device is a physical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. No algorithm is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is adherence to established international standards (ASTM D6319-10 for examination gloves, ISO 10993 for biocompatibility, etc.) and direct physical/chemical measurements (e.g., tensile strength, elongation, dimensions, residual powder weight, water leakage). It's based on quantitative and qualitative measurements against predefined physical and biological acceptance criteria outlined in consensus standards.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set.
In summary, the provided document details the regulatory clearance of medical examination gloves, which are tested against physical and biocompatibility standards, not AI performance metrics.
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(235 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
The provided document describes the acceptance criteria and the study results for the "Powder Free Nitrile Patient Examination Gloves, Blue Color" (subject device) which is seeking substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Characteristics | Standard (Acceptance Criteria) | Device Performance (Subject Device) |
|---|---|---|
| Dimension | ASTM standard D 6319-10. | |
| Length | ≥230mm | 234-243mm |
| Width (Small) | 70-90 mm | 78-85mm |
| Width (Medium) | 85-105mm | 95-99mm |
| Width (Large) | 100-120mm | 108-113mm |
| Width (X large) | 110-130 mm | 117-126mm |
| Thickness (Fingertip) | ≥0.05mm | 0.08-0.11 mm |
| Thickness (Palm) | ≥0.05mm | 0.08-0.12 mm |
| Physical Properties | ASTM standard D 6319-10. | |
| Tensile strength (Before aging) | ≥14MPa (based on predicate comparison) | 20-23MPa |
| Tensile strength (After aging) | ≥14MPa | 18-21 MPa |
| Elongated rate (Before aging) | ≥500% | 560-600% |
| Elongated rate (After aging) | ≥400% | 530-580% |
| Freedom from pinholes | • 21 CFR 800.20• ASTM standard D 6319-10.• Test method in accordance with ASTM D5151-06(Reapproved 2011) | Passed Standard Acceptance Criteria (Tested in accordance with ASTM D5151 (Reapproved 2011) with acceptable results) |
| Powder Residual | ASTM standard D 6319-10.Test method in accordance with D6124-06 (Reaffirmation 2011)below 2mg of residual powder (based on predicate comparison) | 0.1mg/glove (Results generated values below 2mg of residual powder) |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10: Third Edition 2010-08-01) | Under the conditions of the study, the device was a non-irritant. |
| Dermal sensitization in the guinea pig (ISO 10993-10: Third Edition 2010-08-01) | Under the conditions of the study, the device was a non-sensitizer. |
2. Sample size 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., number of gloves tested for dimensions, tensile strength, pinholes). However, it implies testing was conducted on samples derived from the "Powder Free Nitrile Patient Examination Gloves, Blue Color."
The data provenance is from China, as the submitter, Suqian Xingye Glove Co,Ltd, is located in Suqian City, Jiangsu Province, China. The studies appear to be prospective as they were conducted to obtain data for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to this submission. The "ground truth" for glove performance is established by standardized testing methods (ASTM, CFR, ISO) rather than expert consensus on medical images or diagnoses.
4. Adjudication method for the test set:
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., diagnostic image reading) where there might be disagreement among experts. For performance testing of medical gloves, the results are determined by objective measurements against established 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:
This is not applicable. MRMC studies are relevant for AI-powered diagnostic tools or decision support systems. This submission concerns the physical and biological properties of patient examination gloves, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. There is no AI algorithm involved in the performance of patient examination gloves. The device's performance is standalone in the sense that its physical properties are measured directly.
7. The type of ground truth used:
The ground truth used for these studies are:
- Standardized specifications: Primarily ASTM standards (e.g., D6319-10, D5151-06, D6124-06) and FDA regulations (21 CFR 800.20) for physical properties.
- Biological safety standards: ISO 10993-10: Third Edition 2010-08-01 for biocompatibility.
- These standards define the acceptable range or threshold for each characteristic (e.g., minimum length, maximum powder residual, non-irritant/non-sensitizer).
8. The sample size for the training set:
This is not applicable. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device (gloves) and does not involve AI or machine learning.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for a machine learning model.
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(65 days)
A Powder Free Nitrile Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.
The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83
The Perusahaan Getah Asas Sdn. Bhd. Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) demonstrates compliance with established acceptance criteria through a series of tests as detailed in the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00aε,3 | Meets |
| Physical Properties | ASTM D 412-98 | Meets |
| Freedom from pin-holes | ASTM D 5151-99 | Meets |
| Powder Free Residue | ASTM D 6124-01 | Meets |
| Biocompatibility (Dermal Sensitization) | Dermal Sensitization (as per ASTM F-720-81) | Not a contact skin sensitizer |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation Test (as per 16 CFR Part 1500) | Not a primary skin irritant |
| Biocompatibility (Cytotoxicity) | Cytotoxicity Test (as per ISO 10993-5) | Non cytotoxic |
| Low Dermatitis Potential | Modified Draize Test | Did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects. |
| Chemotherapy Drugs Permeation Test | ASTM F 739 (average normalized breakthrough time in minutes) | Carmustine (3.3 mg/mL): 137 min |
| Cisplatin (1.0 mg/mL): >240 min | ||
| Cyclophosphamide (20.0 mg/mL): >240 min | ||
| Dacarbazine (DTIC) (10.0 mg/mL): >240 min | ||
| Doxorubicin Hydrochloride (2.0 mg/mL): >240 min | ||
| 5-Fluorouracil (50.0 mg/mL): >240 min | ||
| Etoposide (20.0 mg/mL): >240 min | ||
| Paclitaxel (Taxol) (6.0 mg/mL): >240 min | ||
| Thio-Tepa (10.0 mg/mL): >240 min |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each individual test conducted to demonstrate device performance. However, the data provenance is implied to be from testing conducted by or for Perusahaan Getah Asas Sdn. Bhd., a company located in Malaysia. The studies are all retrospective in the sense that the data is presented post-hoc to demonstrate compliance with pre-defined standards. The data itself would have been generated through prospective experimental testing in a laboratory or clinical setting (e.g., the Modified Draize Test would involve human subjects in a prospective manner).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
For the most part, the "ground truth" for the performance tests (e.g., dimensions, physical properties, freedom from pin-holes, powder-free residue, chemotherapy drug permeation) is established by standardized laboratory methods and instrumentation, not by human expert consensus in the way a medical image interpretation might be. These are objective measurements against established ASTM and ISO standards.
For Biocompatibility tests (Dermal Sensitization, Primary Skin Irritation, Cytotoxicity, and the Modified Draize Test for Low Dermatitis Potential), experts would have been involved in the design, execution, and interpretation of these studies. However, the exact number and qualifications of these experts (e.g., toxicologists, dermatologists, clinical researchers) are not specified in the provided document. The Modified Draize test, by its nature, would typically involve at least one qualified dermatologist or clinician to assess skin reactions.
4. Adjudication Method for the Test Set:
For the physical and chemical property tests, adjudication is not typically applicable in the same way as for medical image interpretation or clinical trials involving subjective assessment. The results are generally objective measurements against established thresholds according to the given standards.
For the biocompatibility and low dermatitis potential tests, if multiple assessors were involved in evaluating skin reactions in the Modified Draize Test, their findings would likely be subject to an adjudication process to reach a consensus, but the document does not specify any adjudication method. It only states the conclusive finding ("Did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.").
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a patient examination glove, and its performance is evaluated through physical, mechanical, and biological properties, not through human interpretation of cases.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical product (a glove), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only) performance" does not apply. The device's performance is inherently "standalone" in the sense that it is measured directly without human-in-the-loop interpretation.
7. Type of Ground Truth Used:
The ground truth for most of the performance criteria (dimensions, physical properties, pin-holes, powder residue) is based on objective measurements against publicly recognized and established industry standards (ASTM, ISO, CFR).
For biocompatibility and low dermatitis potential, the ground truth is established through experimental results from standardized in-vitro and in-vivo tests designed to assess biological responses, with clinical observations (for the Modified Draize Test) serving as the ultimate verification of safety for skin contact.
8. Sample Size for the Training Set:
Not applicable. This device is a physical product, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The manufacturing process and quality control would involve ongoing testing, but this is not analogous to an AI training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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