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510(k) Data Aggregation
(86 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
White Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
The provided document describes the acceptance criteria and performance data for the "White Nitrile Powder-Free Patient Examination Glove, Non Sterile" (K222713). This medical device is a patient examination glove and the testing performed aligns with engineering and material specifications, rather than AI/software performance. Therefore, many of the requested fields related to AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set information) are not applicable to this submission.
Here's the relevant information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Test Method | Acceptance Criteria | Reported Device Performance (K222713) | Status |
|---|---|---|---|---|
| Physical Properties | ASTM D412 (Vulcanized Rubber and Thermoplastic Elastomers—Tension) | Tensile Strength: Before aging: Min 14.0 MPa; After aging: Min 14.0 MPa Ultimate Elongation: Before aging: Min 500%; After aging: Min 400% | Tensile Strength: Before aging: XS – 28.8 MPa, S – 28.6 MPa, M – 28.9 MPa, L – 28.1 MPa, XL – 28.7 MPa After aging: XS – 30.8 MPa, S – 31.1 MPa, M – 31.8 MPa, L – 31.9 MPa, XL – 30.8 MPa Ultimate Elongation: Before aging: XS – 540%, S – 540%, M – 530%, L – 540%, XL – 540% After aging: XS – 460%, S – 480%, M – 480%, L – 480%, XL – 480% | Pass |
| Dimension | ASTM D3767 (Rubber—Measurement of Dimensions) | Length: Min 240 mm Width: XS: 70 ± 10 mm S: 80 ± 10 mm M: 95 ± 10 mm L: 110 ± 10 mm XL: 120 ± 10 mm Thickness (Finger & Palm): Min 0.05 mm | Length: XS: 248 mm, S: 245 mm, M: 244 mm, L: 248 mm, XL: 244 mm Width: XS: 75 mm, S: 85 mm, M: 95 mm, L: 106 mm, XL: 116 mm Thickness: Finger: 0.09 mm (all sizes) Palm: 0.06 mm (all sizes) | Pass |
| Watertight | ASTM D5151 (Detection of Holes in Medical Gloves) | Sample size: 315 pcs (Inspection level G1, AQL 1.5, Acceptance No. 10) | Results for 315 pieces (Batch size 150,001 to 500,000): XS: 1 piece with leaks S: 2 pieces with leaks M: 2 pieces with leaks L: 4 pieces with leaks XL: 3 pieces with leaks (All within the acceptance criteria of 10 leaks or less for the sample size.) | Pass |
| Residual Powder | ASTM D6124 (Residual Powder on Medical Gloves) | Less than 2 mg per glove (< 2 mg/glove) | Results (5 pcs sample size): XS: 0.24 mg/glove S: 0.28 mg/glove M: 0.34 mg/glove L: 0.32 mg/glove XL: 0.38 mg/glove | Pass |
| Biocompatibility | ISO 10993 Part 10 (Irritation and Sensitization), 16 CFR Part 1500 (Consumer Product Safety Commission) | Primary Skin Irritation: Non-irritant or non-sensitizer Dermal Sensitization: Non-irritant or non-sensitizer | Primary Skin Irritation: Test material did not cause an irritant response; deemed 'Negligible' Dermal Sensitization: Test material did not produce a skin sensitization effect in guinea pigs | Pass |
| Biocompatibility | ISO 10993 Part 11 (Systemic Toxicity) | No acute systemic toxicity | Test item did not induce any acute systemic toxicity in Swiss albino mice. | Pass |
2. Sample size used for the test set and the data provenance:
- Physical Properties (Tensile Strength, Elongation): Not explicitly stated how many gloves were tested for each size, but results are shown for each of the 5 sizes (XS, S, M, L, XL).
- Dimension (Length, Width, Thickness): Not explicitly stated how many gloves were tested for each size, but results are shown for each of the 5 sizes (XS, S, M, L, XL).
- Watertight: A sample size of 315 pieces per batch was used, adhering to a single sampling plan G1 for a batch size of 150,001 to 500,000.
- Residual Powder: A sample size of 5 pieces per size was used.
- Biocompatibility: The standard test methods (ISO 10993-10 for irritation/sensitization, ISO 10993-11 for systemic toxicity) imply specific animal models (e.g., guinea pigs for sensitization, Swiss albino mice for systemic toxicity), but the exact number of animals is not detailed in this summary.
Data Provenance: The document does not specify the country of origin for the test data, nor does it explicitly state whether the studies were retrospective or prospective, although laboratory testing like this is typically prospective.
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 ground truth for device performance in this context is established by adherence to recognized international technical standards (ASTM, ISO) and specific criteria outlined for physical, chemical, and biological properties, not by expert consensus on clinical cases.
4. Adjudication method for the test set:
This is not applicable as the tests are objective measurements against defined 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 as the device is a patient examination glove, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a patient examination glove, not an AI/ML algorithm.
7. The type of ground truth used:
The ground truth used for this device is based on objective measurements and laboratory testing results compared against established international consensus standards (ASTM, ISO) for physical properties, dimensions, watertight integrity, residual powder, and biocompatibility.
8. The sample size for the training set:
This is not applicable as the device is a patient examination glove and does not involve an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
This is not applicable.
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(86 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
Based on the provided document, the device in question is a Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile. This is not a medical imaging AI device or a diagnostic AI device. The document is a 510(k) Premarket Notification summary for a medical glove, which is a physical device, and the testing conducted is for physical and chemical properties, not algorithmic performance.
Therefore, the requested information, which pertains to the acceptance criteria and study designs for AI/ML device performance (e.g., sample size for test set, expert ground truth, MRMC studies, standalone performance, training set details), is not applicable to this document.
The document describes non-clinical testing for the glove, focusing on properties like tensile strength, elongation, dimensions, watertight integrity, residual powder, and biocompatibility.
However, I can extract and present the acceptance criteria and performance data as per the document's content, formatted as a table, making it clear that this applies to a physical device and not an AI/ML system.
Acceptance Criteria and Device Performance for Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile (K222720)
The following table summarizes the non-clinical acceptance criteria and the reported performance of the device. It's crucial to understand that this concerns the physical and chemical properties of a medical glove, not the performance of an AI/ML algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Test Method | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties | ||||
| Tensile Strength | ASTM D412 | Before Aging: Min 14.0 MPa | Before Aging: XS - 28.1 MPa, S - 28.4 MPa, M - 29.2 MPa, L - 28.0 MPa, XL - 28.9 MPa | Pass |
| After Aging: Min 14.0 MPa | After Aging: XS - 31.2 MPa, S - 30.9 MPa, M - 32.3 MPa, L - 31.0 MPa, XL - 31.3 MPa | Pass | ||
| Ultimate Elongation | ASTM D412 | Before Aging: Min 500% | Before Aging: XS - 540%, S - 530%, M - 550%, L - 540%, XL - 540% | Pass |
| After Aging: Min 400% | After Aging: XS - 460%, S - 460%, M - 470%, L - 490%, XL - 480% | Pass | ||
| Dimensions | ASTM D3767 | |||
| Length (all sizes) | Min 240 mm | XS - 244 mm, S - 242 mm, M - 242 mm, L - 243 mm, XL - 244 mm | Pass | |
| Width | XS: $70 \pm 10$ mm; S: $80 \pm 10$ mm; M: $95 \pm 10$ mm; L: $110 \pm 10$ mm; XL: $120 \pm 10$ mm | XS - 74.0 mm, S - 85.0 mm, M - 95.0 mm, L - 106 mm, XL - 115 mm | Pass | |
| Thickness (Finger) | Min 0.05 mm | All sizes (XS, S, M, L, XL) - 0.10 mm | Pass | |
| Thickness (Palm) | Min 0.05 mm | All sizes (XS, S, M, L, XL) - 0.06 mm | Pass | |
| Watertight Integrity | ASTM D5151 | AQL 1.5, Acceptance No. 10 (for sample size 315 pcs) | For sample size 315 pcs (batch size 150,001 to 500,000): XS - 4 leaks, S - 2 leaks, M - 3 leaks, L - 1 leak, XL - 2 leaks. All within acceptance criteria. | Pass |
| Residual Powder | ASTM D6124 | Less than 2 mg per glove (<2mg/glove) | XS - 0.30 mg/glove, S - 0.26 mg/glove, M - 0.34 mg/glove, L - 0.38 mg/glove, XL - 0.40 mg/glove. All are below 2 mg/glove. | Pass |
| Biocompatibility | ISO 10993-10, 16 CFR Part 1500 | Not an irritant | The test material did not cause an irritant response. Primary Irritant Response Category deemed 'Negligible'. | Same |
| Primary Skin Irritation | ISO 10993-10, 16 CFR Part 1500 | Not a sensitizer | The test material did not produce a skin sensitization effect in guinea pigs. | Same |
| Dermal Sensitization | ISO 10993-11 | Device extracts do not pose a systemic toxicity concern | The test item did not induce any systemic toxicity in Swiss albino mice. | Same |
| Acute Systemic Toxicity |
Regarding the AI/ML specific questions (2-9):
The device is a non-AI medical product (patient examination glove). Therefore, the concepts and requirements typically associated with AI/ML device evaluations (such as sample size for AI test and training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this 510(k) submission. No AI or machine learning components are mentioned or implied in the document for this device. The testing conducted is traditional non-clinical performance testing for a physical product.
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(86 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
The provided document describes the non-clinical performance testing for a medical device: "Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile." This submission is a 510(k) premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Test Method | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties | ||||
| Before Aging Tensile Strength | ASTM D412, ASTM D6319 | Min 14.0 MPa | XS: 28.9 MPa, S: 27.8 MPa, M: 28.7 MPa, L: 28.3 MPa, XL: 28.0 MPa | Pass |
| Before Aging Ultimate Elongation | ASTM D412, ASTM D6319 | Min 500% | XS: 540%, S: 530%, M: 560%, L: 540%, XL: 540% | Pass |
| After Aging Tensile Strength | ASTM D412, ASTM D6319 | Min 14.0 MPa | XS: 31.7 MPa, S: 32.1 MPa, M: 32.4 MPa, L: 31.9 MPa, XL: 31.5 MPa | Pass |
| After Aging Ultimate Elongation | ASTM D412, ASTM D6319 | Min 400% | XS: 480%, S: 470%, M: 490%, L: 480%, XL: 490% | Pass |
| Dimensions (ASTM D3767) | ||||
| Length (all sizes) | Min 240 mm | XS: 244 mm, S: 245 mm, M: 244 mm, L: 243 mm, XL: 242 mm | Pass | |
| Width | ||||
| XS | $70 \pm 10$ mm | 74.0 mm | Pass | |
| S | $80 \pm 10$ mm | 85.0 mm | Pass | |
| M | $95 \pm 10$ mm | 95.0 mm | Pass | |
| L | $110 \pm 10$ mm | 106 mm | Pass | |
| XL | $120 \pm 10$ mm | 117 mm | Pass | |
| Thickness - Finger (all sizes) | Min 0.05 mm | 0.10 mm (for XS, S, M, L, XL) | Pass | |
| Thickness - Palm (all sizes) | Min 0.05 mm | 0.06 mm (for XS, S, M, L, XL) | Pass | |
| Watertight | ASTM D5151, ISO 2859 | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | The test found 1 leak for XS, 3 for S, 2 for M, 3 for L, and 1 for XL. All are within the acceptance criteria (total max 10 leaks for the batch size). | Pass |
| Residual Powder | ASTM D6124 | Less than 2 mg per glove | XS: 0.26 mg/glove, S: 0.32 mg/glove, M: 0.28 mg/glove, L: 0.34 mg/glove, XL: 0.38 mg/glove | Pass |
| Biocompatibility | ||||
| Primary Skin Irritation | ISO 10993-10:2010, CPSC 16 CFR 1500 | Passes | The test material did not cause an irritant response. Primary Irritant Response Category deemed 'Negligible'. | Pass |
| Dermal Sensitization | ISO 10993-10:2010, CPSC 16 CFR 1500 | Passes | The test material did not produce a skin sensitization effect in the guinea pigs. | Pass |
| Cytotoxicity - MEM Elution | ISO 10993-5:2009 | Passes | The Systemic Toxicity study was conducted as the accepted alternative to the cytotoxic test. | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Not explicitly stated as "Passes" in a single column but the predicate did not test this; results show device passed. | The test item did not induce any systemic toxicity in Swiss albino mice. | Pass |
2. Sample Sizes and Data Provenance:
- Test Set (Current Device):
- Physical Properties (Tensile Strength, Ultimate Elongation): Not explicitly stated, but tests were performed for different glove sizes (XS, S, M, L, XL). ASTM D412 and D6319 typically specify sample sizes.
- Dimensions (Length, Width, Thickness): Not explicitly stated, but performed for all glove sizes (XS, S, M, L, XL). ASTM D3767 specifies measurement practices.
- Watertight: 315 pieces (for a batch size of 150,001 to 500,000).
- Residual Powder: 5 pieces.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity): Not explicitly stated for each test, but typically involves animal subjects (e.g., guinea pigs for sensitization, Swiss albino mice for systemic toxicity).
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would be prospective for this specific device.
3. Number of Experts and Qualifications for Ground Truth for the Test Set:
This document describes non-clinical performance testing of a physical medical device (gloves). The ground truth for this type of device is established through standardized laboratory tests according to recognized ASTM and ISO standards, not via expert consensus or clinical evaluation in the same way as, for example, an AI diagnostic tool. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in this context doesn't directly apply as it would for a clinical study or AI performance evaluation. The "experts" are implicitly the technicians and scientists performing the tests according to the defined standards.
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements and evaluations against specified pass/fail criteria from recognized standards (ASTM, ISO). There is no "adjudication" between multiple human readers or interpretations.
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 specifically relevant for AI-powered diagnostic devices or imaging tools where human readers are involved in interpreting results. This submission is for a physical medical device (gloves) and focuses on non-clinical performance characteristics.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device, not an algorithm or AI.
7. Type of Ground Truth Used:
The ground truth used is based on:
- Standardized Test Methods: Adherence to established and recognized ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards.
- Quantitative Measurements: Direct measurements of physical properties (tensile strength, elongation, dimensions, powder content).
- Qualitative Assessments: Outcomes of biocompatibility tests (irritation, sensitization, toxicity) as defined by ISO standards on animal models.
- Statistical Sampling: For watertightness, an Acceptance Quality Limit (AQL) statistical sampling plan (ISO 2859) is used.
8. Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" for this type of medical device which undergoes standardized physical and chemical testing. This is not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set. The device's performance is evaluated directly against pre-established, widely accepted industry standards and regulatory requirements for medical examination gloves.
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(40 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM D6319 standard and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
The provided text describes the acceptance criteria and performance data for a medical device: "Violet Nitrile Powder Free Patient Examination Glove, Non Sterile" (K222721). This is a physical product, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," or "sample size for the training set," are not applicable.
Here's the relevant information based on the provided text, primarily derived from the "Summary of Non-Clinical Testing" (Section 7.0) and "Comparison of the Technological Characteristics of the Device" (Table 1):
1. A table of acceptance criteria and the reported device performance
| Test Method (Standard) | Purpose of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties (ASTM D412) | To evaluate the tensile (tension) properties of glove. | ||
| - Tensile Strength (Before Aging) | Min 14.0 MPa | XS – 28.8 MPa; S – 29.2 MPa; M – 28.0 MPa; L – 27.2 MPa; XL – 26.8 MPa | |
| - Tensile Strength (After Aging) | Min 14.0 MPa | XS – 30.8 MPa; S – 32.2 MPa; M – 31.0 MPa; L – 31.6 MPa; XL – 30.6 MPa | |
| - Ultimate Elongation (Before Aging) | Min 500% | XS – 520%; S – 550%; M – 540%; L – 560%; XL – 540% | |
| - Ultimate Elongation (After Aging) | Min 400% | XS – 460%; S – 470%; M – 480%; L – 460%; XL – 450% | |
| Dimension (ASTM D3767) | To measure the length, width and thickness of glove | ||
| - Length | Min 240 mm (for sizes S, M, L, XL), 243 mm (for XS) | XS: 243 mm; S: 243 mm; M: 243 mm; L: 242 mm; XL: 248 mm | |
| - Width | 70 ± 10 mm (XS); 80 ± 10 mm (S); 95 ± 10 mm (M); 110 ± 10 mm (L); 120 ± 10 mm (XL) | XS: 75.0 mm; S: 85.0 mm; M: 95.0 mm; L: 106 mm; XL: 115 mm | |
| - Finger Thickness | Min 0.05 mm | XS: 0.10 mm; S: 0.10 mm; M: 0.10 mm; L: 0.10 mm; XL: 0.10 mm | |
| - Palm Thickness | Min 0.05 mm | XS: 0.06 mm; S: 0.06 mm; M: 0.06 mm; L: 0.06 mm; XL: 0.06 mm | |
| Watertight (ASTM D5151) | To detect holes that leak water | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | For Size XS: 3 pieces with leaks; For Size S: 1 piece with leaks; For Size M: 2 pieces with leaks; For Size L: 2 pieces with leaks; For Size XL: 1 piece with leaks. All these results fall within the acceptance criteria. |
| Residual Powder (ASTM D6124) | To determine the amount of residual powder | Less than 2 mg per glove (< 2mg/glove) | XS: 0.33 mg/glove; S: 0.28 mg/glove; M: 0.26 mg/glove; L: 0.30 mg/glove; XL: 0.34 mg/glove (Note: Document has two entries for XL, selecting the lowest one for consistency) |
| Biocompatibility | |||
| - Primary Skin Irritation (ISO 10993-10) | Evaluate irritant response | "Under the conditions of this study, the device is non-irritant and non-sensitizer" (Predicate criteria) | "Under conditions of this study, the test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible'." (Current device) |
| - Dermal Sensitization (ISO 10993-10) | Evaluate skin sensitization effects | "Under the conditions of this study, the test device is non-irritant and non-sensitizer." (Predicate criteria) | "Under conditions of this study, the test material did not produce a skin sensitization effect in the guinea pigs." (Current device) |
| - Acute Systemic Toxicity (ISO 10993-11) | Assess systemic toxicity | Not Tested (Predicate) | "Under conditions of this study, the test item did not induce any systemic toxicity in Swiss albino mice." (Current device) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Physical Properties (Tensile Strength, Ultimate Elongation): The sample sizes are specified by size (XS, S, M, L, XL) with individual results reported. However, the exact number of gloves tested for each size isn't explicitly stated in the summary, only the aggregate outcome for each size category.
- Dimension: Results are reported for each glove size (X-Small, Small, Medium, Large, X-Large), but the specific sample size for each dimension measurement per size is not explicitly stated in the summary.
- Watertight: The sample size was 315 pieces per size, for an AQL (Acceptable Quality Limit) test, based on a batch size of 150,001 to 500,000.
- Residual Powder: The sample size was 5 pieces per glove size.
- Biocompatibility (Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity): The sample sizes for these biological tests are not specified in the provided tables, but "guinea pigs" and "Swiss albino mice" are mentioned as test subjects for sensitization and systemic toxicity, respectively.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated in this summary. The submitter is "Safeskin Retailing (HK) Limited" (Hong Kong), but where the actual testing took place or the data was collected isn't detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the device is a physical glove, not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests are objective measurements according to established ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is for a physical device and not an AI/ML diagnosis/detection system where adjudication of expert opinions would be necessary. The tests are objective measurements against defined 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 is for an AI/ML powered medical device. The submitted device is a physical examination glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for an AI/ML powered medical device. The submitted device is a physical examination glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" is established by adherence to recognized international standards and specifications for medical gloves, such as:
- ASTM D412: Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers—Tension.
- ASTM D3767: Standard Practice for Rubber—Measurement of Dimensions.
- ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ISO 10993-10: Biological evaluation of medical devices – Tests for irritation and skin sensitization.
- ISO 10993-11: Biological evaluation of medical devices – Tests for systemic toxicity.
- ISO 2859: Sampling Procedures and Tables for Inspection by Attributes.
These standards define objective measurement methodologies and acceptable ranges for various physical and biocompatibility properties.
8. The sample size for the training set
Not applicable. This is a physical device, and AI/ML "training sets" are not part of its development or testing for this submission.
9. How the ground truth for the training set was established
Not applicable. This refers to AI/ML development.
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