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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows :

Please note that Carmustine and Thiotepa have extremely low permeation times of 3,6 minutes, respectively

WARNING: Do Not Use With : Carmustine, ThioTEPA

The subject device in this 510(k) Notification is a Purple Nitrile Examination glove tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from nitrile compound, Purple color, powder free and non-sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This device also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05.

The provided document pertains to a 510(k) premarket notification for "BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS." This is a Class I medical device, and the submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K992162 Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim).

The document does not describe an AI/ML-based device or a study involving human readers and AI assistance for medical image analysis. Instead, it details the physical and chemical properties of examination gloves, their resistance to chemotherapy drugs, and their biocompatibility, as per standard testing protocols for such devices.

Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for AI test and training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, AI effect size) are not applicable to this document.

However, I can extract the acceptance criteria and performance data relevant to this specific device (examination gloves):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards as outlined in the document, and demonstrating performance comparable to the predicate device. The reported performance indicates compliance with these standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the specific number of gloves (sample size) for each particular test. However, it references standards like ASTM D6319-10 and ISO 2859 (Sampling Procedures and Tables for Inspection by Attributes), which would dictate the appropriate sample sizes for the various tests (e.g., tensile strength, dimensions, pinholes, chemotherapy drug permeation). For example, ASTM D6978-05 for chemotherapy drug permeation typically involves testing a specified number of samples (often 3 replicates) per drug, which are then averaged or used to determine breakthrough time.
• Data Provenance: The testing was "non-clinical performance data" (Section 7). The manufacturing company, Brightway Holdings Sdn. Bhd., is located in Malaysia (Section 3). The testing was conducted according to international standards (ASTM, ISO), meaning the data provenance is from laboratory tests, not from human retrospective or prospective clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not Applicable. This is a physical device being tested against established ASTM and ISO standards in a laboratory setting. There is no concept of "ground truth" derived from human expert interpretation (like medical images) for this type of product. The "ground truth" is defined by the objective measurements and protocols outlined in the referenced standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this involves laboratory testing against objective standards (e.g., measuring breakthrough time, tensile strength), there is no human adjudication process involved in establishing "ground truth" or test results in the way it would be for interpreting medical images. The measurements are taken by lab technicians and reported against the standard's pass/fail criteria or quantitative thresholds.

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 document is for examination gloves, not an AI/ML device. Therefore, no MRMC study with human readers or AI assistance was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is for examination gloves, not an AI/ML algorithm.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" for this device is defined by objective, standardized measurements and laboratory test results as per recognized ASTM and ISO international standards.
  • For chemotherapy drug permeation: Breakthrough time measured according to ASTM D6978-05.
  • For physical properties (tensile strength, elongation, dimensions, holes): Measured according to ASTM D6319-10 and its referenced sub-standards (e.g., ASTM D412, D5151).
  • For biocompatibility: Biological responses (irritation, sensitization, systemic toxicity) measured according to ISO 10993-10 and ISO 10993-11.

8. The Sample Size for the Training Set

• Not Applicable. As this is not an AI/ML device, there are no training sets in the context of machine learning. The "training" for manufacturing occurs through process control and quality management systems to ensure consistent product performance.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. No AI/ML training set is involved.

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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

• Arsenic Trioxide (0.1mg/ml),(100ppm) >240 Minutes
• Bleomycin Sulfate (15mg/ml),(15,000 ppm) >240 Minutes
• Busulfan(6mg/ml),(6,000 ppm) >240 Minutes
• Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) 127.5 Minutes
• Cisplatin (1.0mg/ml), (1,000 ppm) >240 Minutes
• Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) >240 Minutes
• Cytarabine(100mg/ml), (100,000 ppm) >240 Minutes
• Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) >240 Minutes
• Daunorubicin(5mg/ml), (5,000 ppm) >240 Minutes
• Docetaxel(10mg/ml), (10,000 ppm) >240 Minutes
• Doxorubicin HCL(2mg/ml),(2,000 ppm) >240 Minutes
• Ellence (2mg/ml), (2,000 ppm) >240 Minutes
• Etoposide /Toposar (20mg/ml), (20,000 ppm) >240 Minutes
• Fludarabine (25mg/ml), (25,000 ppm) >240 Minutes
• Fluorouracil(50mg/ml), (50,000 ppm) >240 Minutes
• Gemcitabine/Gemzar (38mg/ml), (38,000 ppm) >240 Minutes
• Idarubicin (1.0mg/ml), (1,000 ppm) >240 Minutes
• Ifosfamide (50mg/ml), (50,000 ppm) >240 Minutes
• Irinotecan(20mg/ml), (20,000 ppm) >240 Minutes
• Mechlorethamine HCI(1.0mg/ml), (1,000 ppm) >240 Minutes
• Melphalan(5mg/ml), (5,000 ppm) >240 Minutes
• Methotrexate(25mg/ml),(25,000 ppm) >240 Minutes
• Mitomycin C(0.5 mg/ml), (500 ppm) >240 Minutes
• Mitoxantrone(2mg/ml),(2,000 ppm) >240 Minutes
• Paclitaxel(6.0mg/ml),(6,000 ppm) >240 Minutes
• Paraplatin (10mg/ml),(10,000 ppm) >240 Minutes
• Rituximab(10mg/ml),(10,000 ppm) >240 Minutes
• Thiotepa (10mg/ml),(10,000 ppm) >240 Minutes
• Trisenox(0.1mg/ml), (100 ppm) >240 Minutes
• Vincristine Sulfate(1.0mg/ml).(1.000 ppm) >240 Minutes

Please note that the following drug noted permeation times below 240 mins: Carmustine (BCNU) 127.50 mins.

The subject device in this 510(k) Notification is a Purple Nitrile Examination gloves, tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from nitrile compound, Purple in color, powder free and non sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This device also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy drugs as per ASTM D6978-05

This document describes the premarket notification (510(k)) for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS, seeking to prove substantial equivalence to a predicate device. The "acceptance criteria" here refers to the performance standards and regulatory requirements that the device must meet to be considered substantially equivalent to a legally marketed predicate device, rather than specific AI/ML performance metrics. Similarly, the "study" proving the device meets these criteria refers to the non-clinical testing performed on the gloves.

Given the nature of the device (examination gloves), the concepts of "AI assistance," "human observers," "training set," and "ground truth" (in the context of expert consensus or pathology for medical images/diagnoses) are not applicable. The "study" here is a series of non-clinical, laboratory-based tests to demonstrate the physical properties, biocompatibility, and chemical permeation resistance of the gloves.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by recognized industry standards (ASTM, ISO) and FDA regulations. The reported device performance is the outcome of testing against these standards.

Table of Acceptance Criteria and Reported Device Performance

Study Information (Non-Clinical Testing for Gloves)

Since this is a filing for medical examination gloves, the concepts below regarding AI/ML studies are not directly applicable. However, I will interpret them in the context of the testing performed on these physical devices.

1. 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 does not explicitly state the number of gloves tested for each characteristic (e.g., how many gloves were tested for pinholes, or how many samples for tensile strength). The standards referenced (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, ASTM D6978-05) would specify the required sample sizes for each test.
   • Data Provenance: The testing was performed according to international harmonized standards (ASTM, ISO). The manufacturer is Brightway Holdings Sdn Bhd. from Malaysia (Lot 1559, Jalan Istimewa, Batu Belah Klang, Selangor, 42100 MY). The data is implicitly prospective, as it was generated specifically for this 510(k) submission.

2. 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 in the AI/ML context. For physical device testing, the "ground truth" is established by the test methods themselves, defined by standards organizations (ASTM, ISO). The "experts" would be the certified laboratory technicians and engineers who perform the tests according to the standard operating procedures and interpret the results against the specified criteria. Their qualifications would be in laboratory science, materials testing, and adherence to quality systems.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable in the AI/ML context. For physical device testing, results are typically quantitative measurements or pass/fail determinations based on predefined criteria in the standards. Discrepancies would be resolved through re-testing or investigation into the test methodology, not through human consensus or adjudication of interpretations.

4. 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 physical medical device (examination glove), not an AI/ML diagnostic or assistive tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • The "ground truth" is based on standardized test methods and predefined quantitative/qualitative thresholds set by organizations like ASTM and ISO. For example, for "Freedom from Pinholes," the ground truth is a "Pass" or "Fail" based on a specified water leak test (FDA 1000ml water leak test) as incorporated into ASTM 6319-10. For chemotherapy permeation, the ground truth is the "breakthrough detection time" measured in minutes. Biocompatibility tests rely on established in-vitro and in-vivo assays with pass/fail criteria for irritation, sensitization, and toxicity.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML model that requires a training set. The manufacturing process is consistent, and quality control ensures consistency, but there isn't a "training set" in the AI sense.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

The product has been tested with chemotherapy drugs in accordance with ASTM D6978. The breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration Minimum Breakthrough Detection Time Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) ● 4.3 Minutes >240 Minutes

240 Minutes

240 Minutes

240 Minutes

240 Minutes

240 Minutes

240 Minutes

240 Minutes

240 Minutes

10.9 Minutes

240 Minutes

• Cisplatin(1.0mg/ml), (1,000 ppm)
• Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm)
• Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) ●
• Doxorubicin HCL(2mg/ml),(2,000 ppm)
• Etoposide /Toposar (20mg/ml), (20,000 ppm)
• Fluorouracil(50mg/ml), (50,000 ppm)
• Ifosfamide (50mg/ml), (50,000 ppm)
• Mitoxantrone(2mg/ml),(2,000 ppm)
• Paclitaxel(6.0mg/ml),(6,000 ppm)
• Thiotepa (10mg/ml),(10,000 ppm)
• . Vincristine Sulfate(1.0mg/ml),(1,000 ppm)

Please note that Carmustine and Thiotepa have extremely low permeation times of 4.3 minutes and 10.9 minutes, respectively.

Warning: Do not use with Carmustine and Thiotepa.

The subject device in this 510(k) Notification is Sterling/Grey coloured Nitrile Examination gloves, with claims and tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from nitrile compound, Sterling or Grey in colour, powder free and non sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This device also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy drugs as per ASTM D6978-05

The provided text describes the acceptance criteria and the study that proves the BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM meets these criteria.

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each test mentioned (e.g., how many gloves were tested for pinholes, tensile strength, or chemotherapy permeation). It references standards like ASTM D6319-10 and ASTM D6978-05, which would have their own defined sample size requirements.

The data provenance is from Malaysia, as the submitter, BRIGHTWAY HOLDINGS SDN. BHD., is located in Klang, Selangor Darul Ehsan, Malaysia. The data appears to be prospective as it involves direct testing of the device against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The acceptance criteria and performance are based on recognized industry standards (ASTM, ISO), meaning the "ground truth" is defined by these standards rather than expert consensus on specific cases. The testing was performed according to these established protocols.

4. Adjudication method for the test set

This information is not applicable/not provided as the evaluation is based on objective measurements against predefined standards (ASTM, ISO) rather than subjective assessment requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an examination glove, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an examination glove, not an algorithm.

7. The type of ground truth used

The ground truth used is based on established industry standards and regulatory requirements. Specifically:

• Physical properties (tensile strength, elongation, dimensions, freedom from pinholes, residual powder) are compared against specifications in ASTM D6319-10.
• Biocompatibility (primary skin irritation, dermal sensitization, systemic toxicity) is evaluated against ISO 10993-10 and ISO 10993-11 requirements.
• Resistance to chemotherapy drug permeation is tested according to ASTM D6978-05.
• The overall criteria for patient examination gloves are also linked to FDA 21 CFR 880.6250.

8. The sample size for the training set

This is not applicable. The device is a physical product (gloves), not a machine learning model that requires a training set. The "training" in this context refers to the manufacturing process and quality control, not data training for an algorithm.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE] is a disposable device intended for medical purpose to be worn on the examiners hand or finger to prevent contamination between the patient and the examiner.

The subject device in this 510(k) Notification is a Blue Examination Glove. The subject device is a patient examination glove made from a Nitrile compound, Blue in colour, powder free and non sterile (as per 21 CFR 880.6250, class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device that meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10 ; Standard specification for Nitrile Examination Gloves.

The provided text describes the acceptance criteria and the study conducted for the Brightway Nitrile Examination Glove, powder-free (blue).

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally based on the ASTM D6319-10 standard for Nitrile Examination Gloves. The device performance is reported as meeting these specifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Dimension Measurement: 20 pieces per batch. Random Sampling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2. Data provided is for Batch No: 6H10 03.
• Water-tight Test (Freedom from Holes): 200 pieces per batch. Random Sampling based on ISO2859-1:1999; G2 AQL 1.0, Ac=5 Rej=6.
• Physical Properties (Tensile Strength, Ultimate Elongation): 20 samples (1 sample for each size XS, S, M, L, XL x 4 replicates per size, but the table shows 20 distinct samples with sizes varying, suggesting 4 per size covering XS-XL). Sampling Plan: Single Normal S2 AQL: 2.5 Acc/Rej: 1/2.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Systemic Toxicity): Specific sample sizes are not explicitly stated for these tests within the provided document, but the tests were performed "under the conditions of the studies."
• Data Provenance: The tests were conducted by Brightway Holdings Sdn Bhd, which is based in Malaysia. The testing certificates are dated August 22, 2016, and the overall submission is dated March 24, 2017. This indicates the studies were conducted prior to the submission, likely as part of the device development and verification, making them retrospective in the context of this submission.

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 device is a patient examination glove. The "ground truth" for its performance is established by adherence to recognized industry standards (like ASTM D6319-10, ASTM D5151-06, ISO 10993-10). These standards define objective, measurable physical, chemical, and biological properties. Therefore, no human experts (like radiologists) are typically involved in establishing a "ground truth" for the physical and biological characteristics of a glove. The "ground truth" is the quantitative measurement against the standard specification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Since the assessment relies on objective measurements against predefined standards (e.g., tensile strength, dimensions, water leak test), there is no adjudication method described or required by human experts. The results are quantitative and directly compared to the specified limits.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (examination glove), not an AI-powered diagnostic tool, and therefore, an MRMC study is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical examination glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on objective measurements and laboratory test results compared against established international and national standards for medical gloves. This includes:

• Physical properties (e.g., length, width, thickness, weight, tensile strength, ultimate elongation)
• Barrier integrity (e.g., freedom from pinholes via water leak test)
• Chemical properties (e.g., residual powder)
• Biocompatibility (e.g., primary skin irritation, dermal sensitization, systemic toxicity).

8. The sample size for the training set

Not applicable. This device is a physical medical device (examination glove), not a machine learning model, and therefore does not have a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established

Not applicable. As stated above, this device does not use a training set.

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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is a Lavender Examination Glove. The subject device is a patient examination glove made from a Nitrile compound, Lavender in colour, powder free and non sterile (as per 21 CFR 880.6250, class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device that meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10 ; Standard specification for Nitrile Examination Gloves.

Here's a breakdown of the acceptance criteria and study information for the Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender), based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • Dimension Measurement: 20 pieces per batch. Random Sampling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2.
   • Water-tight Test: 200 pieces per batch. Random Sampling based on ISO2859-1:1999; G2 AQL 1.5, Ac=7 Rej=8.
   • Physical Properties Analysis: Not explicitly stated but "Single Normal S2 AQL: 2.5 Acc/Rej : 1/2" for sampling plan. Given that 20 samples were tested and individual results are shown, it seems 20 samples were used for the physical properties test.
   • Biocompatibility Studies (Primary Skin Irritation, Dermal Sensitization, Systemic Toxicity): Sample sizes for these tests are not provided in the document.
   • Data Provenance: The tests were conducted by Brightway Holdings Sdn Bhd (the manufacturer) in Malaysia. The document does not specify if the data is retrospective or prospective, but as it's part of a 510(k) submission for a new device, it would typically involve prospective testing of newly manufactured devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This information is not applicable to the device described. The "ground truth" for examination gloves is established by standardized physical and chemical testing methods (ASTM, ISO), not by expert consensus or interpretations.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. Performance is measured against objective standards, not subjective interpretations requiring adjudication.

4. 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 an examination glove, not an AI-powered diagnostic or assistive tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is an examination glove, not an algorithm.

6. 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 tests outlined in recognized standards such as ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves), ASTM D5151 (Water Leak Test), ASTM D6124 (Residual Powder), and ISO 10993 (Biocompatibility).

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This device is not an AI/machine learning model.

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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration

• · Carmustine (BCNU) (3.3mg/ml),(3.300 ppm)
• · Cisplatin(1.0mg/ml), (1,000 ppm)
• · Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm)
• · Dacarbazine(DTIC) 10mg/ml, (10,000 ppm)
• · Doxorubicin HCL(2mg/ml),(2,000 ppm)
• · Etoposide /Toposar (20mg/ml), (20,000 ppm)
• · Fluorouracil(50mg/ml), (50,000 ppm)
• · Ifosfamide (50mg/ml), (50,000 ppm)
• · Mitoxantrone(2mg/ml),(2,000 ppm)
• · Paclitaxel/Taxol(6.0mg/ml),(6.000 ppm)
• · Thiotepa (10mg/ml),(10,000 ppm)
• · Vincristine Sulfate(1.0mg/ml),(1,000 ppm)

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes.

Minimum Breakthrough Detection Time
5.4 Minutes

240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
40.4 Minutes
240 Minutes

The subject device in this 510(k) Notification is a Sterling/Grey Nitrile Examination gloves, with claims and tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from nitrile compound, Sterling or Grev in color, powder free and non sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This device is manufactured in facilities compliant to ISO 9001:2008 certified in Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath

The device is manufactured to comply with ISO 13485:2003 / EN ISO 13485:2012 Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination & Sterile Surgical Gloves

This document describes the premarket notification (510(k)) for "BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS". The acceptance criteria and the study proving the device meets these criteria are outlined through a comparison with a legally marketed predicate device (K151750).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for the various tests (e.g., pinhole, chemotherapy permeation, physical properties, biocompatibility). It references standardized test methods (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, 16 CFR Part 1500.41) which typically define appropriate sample sizes. The data provenance is non-clinical performance data, likely generated prospectively by the manufacturer and/or a testing laboratory contracted by the manufacturer. The country of origin of the data is not specified beyond the manufacturer being based in Malaysia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The device is a patient examination glove, and its performance is evaluated against objective, standardized physical, chemical, and biological tests, not against expert interpretation of medical images or other diagnostic data where ground truth would be established by human experts.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, often in clinical trials or comparative imaging studies. The testing described here is based on objective, standardized laboratory methods.

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 section is not applicable. MRMC studies and the concept of AI assistance for human readers are relevant for diagnostic devices (e.g., AI for radiology interpretation). The device in question is a medical glove, for which such a study design is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance claims of this device is established through:

• Standardized Test Methods and Specifications: Adherence to ASTM D6319-10 (Standard specification for Nitrile Examination Gloves), ASTM D5151-06 (standard for pinholes), ASTM D6124-06 (standard for powder residue), ISO 10993-10:2010 (biocompatibility - irritation and sensitization), ISO 10993-11 (biocompatibility - systemic toxicity), and 16 CFR Part 1500.41 (flammability).
• Predicate Device Performance: The performance of the legally marketed predicate device (K151750) serves as a benchmark for substantial equivalence, particularly concerning chemotherapy drug permeation.

8. The sample size for the training set

This section is not applicable. A "training set" refers to data used to train machine learning models. This device is a physical product and does not involve AI or machine learning algorithms.

9. How the ground truth for the training set was established

This section is not applicable for the reasons stated in point 8.

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Brightway TM Brand Nitrile Examination Gloves, Powder Free, Non - Sterile (Grey Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

Brightway ™ Brand Nitrile Examination Gloves, Powder Free, Non-Sterile. (Grey Color)

This looks like a 510(k) clearance letter from the FDA for medical gloves, and as such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device isn't directly applicable here.

This document pertains to a Class I medical device (patient examination gloves), which are largely regulated based on established standards for manufacturing, materials, and basic performance rather than clinical efficacy studies and "acceptance criteria" of an AI algorithm.

Therefore, many of the specific questions you've asked regarding AI/ML studies (like effect size of AI assistance, sample size for training/test sets, ground truth methodology, and expert qualifications for adjudication) do not apply to this type of device.

If you are looking for an example of a device with such details, this document is not the right source.

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BRIGHTWAY™ Brand Nitrile Examination Glove ( Powder Free, Chlorinated, Black Color ) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

BRIGHTWAY™ Brand Nitrile Examination Gloves (Powder Free, Chlorinated, Black Colour)

Here's an analysis of the provided text regarding acceptance criteria and study information:

The provided text describes two distinct medical devices and their respective 510(k) submissions. I will analyze the information for each separately as they don't seem to be related.

Device 1: SafeTip Safety Syringe (KOGO402)

This document mentions testing in a very general way and does not provide specific acceptance criteria or detailed study information. It states:

"The Devon SafeTip Safety Syringe has been shown to meet internationally recognized standards for syringe performance and labeling characteristics. Simulated clinical use testing has demonstrated the performance of the SafeTip syringe and reliability of the safety feature in accordance with the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005."

From this, we can infer that the device was tested against "internationally recognized standards for syringe performance" and the "FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005." However, the specific metrics, thresholds, or details of the study itself are not present.

Given the information provided, it's impossible to fill out the requested table and answer many of the specific questions.

Device 2: BRIGHTWAY™ Brand Nitrile Examination Gloves (K060402)

This document is a 510(k) clearance letter for examination gloves. It does not contain any information about specific acceptance criteria or performance studies of the device. It primarily details the regulatory clearance process and refers to general controls. The "Indications for Use" section simply describes the intended use of the gloves.

Therefore, for this device, it's also impossible to fill out the requested table and answer the specific questions about acceptance criteria and studies.

Summary of Missing Information for BOTH Devices:

The provided texts are regulatory submission documents (or summaries thereof) that indicate a device has undergone testing and met certain standards, but they do not include the specific details of those tests, acceptance criteria, or study methodologies. To answer your questions fully, you would need access to the actual test reports or detailed study summaries that would have been part of the full 510(k) submission.

Attempting to fill what little can be inferred from the "SafeTip Safety Syringe" document, with heavy caveats:

1. Table of Acceptance Criteria and Reported Device Performance

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BRIGHTWAY™ Brand Latex Examination Glove ( Powder Free, Black Color ) containing 50 µgm or less of water extractable protein per gram is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding "BRIGHTWAY™ Brand Latex Examination Gloves (Power Free, Black Color) Containing 50 ug or Less of water Extractable Protein Per Gram". It details the FDA's determination of substantial equivalence to legally marketed predicate devices.

However, the provided text does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, expert ground truth establishment, or any details about a study and its methodology as requested in your prompt. The document is an administrative approval letter, not a scientific study report.

Therefore, I cannot populate the table or answer the subsequent questions based on the information provided in the input.

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