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510(k) Data Aggregation
(459 days)
GX Corporation Sdn Bhd
A Powder Free White Sterilized Polyisoprene Surgical Gloves- Tested for Use with Chemotherapy Drugs is a disposable device intended for invasive surgery procedures that is to be worn on both the hands by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs.
This document is a 510(k) clearance letter for Powder Free White Sterilized Polyisoprene Surgical Gloves. It is for a medical device and not for an AI/ML powered device, therefore no AI-specific performance criteria or studies are present.
Here's an analysis based on the provided text, focusing on the available information regarding device performance and acceptance criteria, even though it's not an AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these surgical gloves relate to their resistance to permeation by chemotherapy drugs, as tested according to ASTM D 6978. The "acceptance criteria" here implicitly refers to showing sufficient resistance, often exceeding a certain time threshold, though the direct numerical acceptance threshold isn't explicitly stated but inferred from the predicate device comparisons and the nature of such testing. For chemotherapy gloves, a breakthrough time of >240 minutes is generally considered ideal for many drugs.
| Chemotherapy Drug Permeation and Concentration | Acceptance Criteria (Implicit) | Reported Device Performance (Average Breakthrough Detection Time) |
|---|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | (Likely >240 min for ideal) | 12.6 min |
| Cisplatin 1.0 mg/ml (1,000ppm) | (Likely >240 min for ideal) | >240 min |
| Cyclophosphamide (Cytoxan) 20mg/ml (20,000ppm) | (Likely >240 min for ideal) | >240 min |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000ppm) | (Likely >240 min for ideal) | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | (Likely >240 min for ideal) | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | (Likely >240 min for ideal) | >240 min |
| Fluorouracil 50.0 mg/ml (50,000ppm) | (Likely >240 min for ideal) | >240 min |
| Ifosfamide 50.0 mg/ml (50,000ppm) | (Likely >240 min for ideal) | >240 min |
| Methotrexate 25 mg/ml (25,000ppm) | (Likely >240 min for ideal) | >240 min |
| Mitomycin C 0.5 mg/ml (500ppm) | (Likely >240 min for ideal) | >240 min |
| Mitoxantrone 2.0 mg/ml (2,000ppm) | (Likely >240 min for ideal) | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | (Likely >240 min for ideal) | >240 min |
| Thio-Tepa 10.0 mg/ml (10,000ppm) | (Likely >240 min for ideal) | 12.0 min |
| Vincristine Sulfate 1.0 mg/ml (1,000ppm) | (Likely >240 min for ideal) | >240 min |
Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes." This suggests that while ideal is >240 min, the device still meets FDA requirements given its overall performance and comparison to predicate devices, and likely appropriate labeling for users about these specific drugs.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the permeation testing (i.e., how many gloves were tested for each drug). The data provenance refers to "as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug," indicating a standardized laboratory test method. It is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the human data sense.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. This is a physical device subject to standardized chemical permeation testing, not a diagnostic device requiring expert opinion for ground truth. The "ground truth" is established by the chemical permeation laboratory measurement according to the ASTM D 6978 standard.
4. Adjudication Method for the Test Set
Not applicable, as the "ground truth" is based on objective chemical permeation measurements rather than subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML-powered diagnostic or interpretive device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth used is objective laboratory measurement of chemotherapy drug permeation, specifically the "Average Breakthrough Detection Time" determined according to ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
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(199 days)
GX Corporation SDN BHD
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Powder Free Blue Nitrile Examination Gloves - Tested for Use with 32 Chemotherapy Drugs and Fentanyl Citrate
The provided document is an FDA 510(k) clearance letter for "Powder Free Blue Nitrile Examination Gloves - Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate." This document primarily focuses on the substantial equivalence determination for a medical device (gloves) and its performance against chemical permeation for certain drugs.
The request asks for information typically found in the clinical validation of AI/ML-based medical devices or diagnostic tools. The provided document does not contain any information related to AI/ML device performance, test sets, ground truth establishment, expert adjudication, or MRMC studies. It is a regulatory clearance for a physical medical device (gloves) based on chemical permeation testing, not an AI system.
Therefore, I cannot provide the requested information. The document details chemical resistance and breakthrough times, not AI algorithm performance.
However, if we were to interpret the document's content as "acceptance criteria" and "device performance" in the context of the gloves' chemical resistance, the information could be presented as follows:
Acceptance Criteria and Device Performance (Based on Chemical Permeation Testing for Gloves)
Given the nature of the device (examination gloves) and the provided data, the "Acceptance Criteria" are implicitly derived from the testing standards for medical gloves' resistance to chemotherapy drugs and fentanyl citrate. The "Device Performance" refers to the measured breakthrough times. For regulated medical gloves, the expectation is generally to demonstrate sufficient resistance (i.e., a "breakthrough detection time" that meets or exceeds a certain threshold, often >240 minutes, indicating prolonged protection).
1. Table of Acceptance Criteria and Reported Device Performance
| Chemotherapy Drugs: | Acceptance Criteria (e.g., Target Breakthrough Time) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|
| 1. Carmustine (BCNU)3.3 mg/ml(3,300 ppm) | To be defined by standard (e.g., >x min) | 54.8 min |
| 2. Cisplatin 1.0 mg/ml (1,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 4. Dacarbazine (DTIC)10.0 mg/ml(10,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 10.Mitomycin C 0.5 mg/ml (500ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | To be defined by standard (e.g., >x min) | 46.9 min |
| 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 15. Amethopterin (Methotrexate) 25 mg/ml, (25,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 16. Bleomycin 15 mg/ml (15,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 17. Busulfan 6 mg/ml (6,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 18. Carboplatin 10 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 19. Cytarabine 100 mg/ml (100.000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 20. Daunorubicin 5 mg/ml (5,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 21. Doxetacel 10.0 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 22. Ellence 2 mg/ml (2,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 23. Fludarabine 25 mg/ml (25,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 24. Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 25. Idarubicin 1 mg/ml (1,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 26. Irinotecan 20.0 mg/ml (20,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 27. Mechloretamine HCL 1.0 mg/ml (1,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 28. Melphalan 5 mg/ml (5,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 29. Oxaliplatin 2.0 mg/ml (2,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 30. Rituximab 10 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 31. Trisonex 0.1 mg/ml (100 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 32. Vinorelbin 10 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| Fentanyl Citrate Injection 100 mcg/2ml | To be defined by standard (e.g., >x min) | >240min |
Note: The document highlights "Please Note that the following Drugs have extremely low permeation times : Carmustine : 54,8 minutes and Thio-Tepa: 46.9 minutes," indicating these may be areas where performance is lower relative to other tested drugs, but still acceptable under relevant standards for their intended use and risk mitigation strategies.
For the remainder of the questions, as stated, the provided document does not contain this information as it pertains to AI/ML device validation, not the direct chemical permeation testing of physical gloves.
- 2. Sample size used for the test set and the data provenance: Not applicable. This refers to the number of gloves tested for chemical resistance, not a dataset for an AI model. The document does not specify the exact number of gloves or samples, nor their country of origin for testing purposes. The testing is laboratory-based chemical permeation.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemical permeation is established by analytical chemistry methods (e.g., spectroscopy) that detect the breakthrough of a chemical through the glove material over time, not by human expert opinion.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Chemical permeation testing uses objective measurement, not human 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: Not applicable. This applies to diagnostic AI, not chemical resistance of gloves.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to diagnostic AI, not chemical resistance of gloves.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for glove performance is the precise measurement of chemical permeation/breakthrough time under controlled laboratory conditions, typically following standards like ASTM D6978.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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(65 days)
GX CORPORATION SDN BHD
This non-sterile glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Glove Coated with Cucumber (Blue & Green)
This document is a 510(k) clearance letter from the FDA for a medical device: "Powder Free Nitrile Examination Glove Coated With Cucumber (Blue & Green)". It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical or performance study report for AI/software-based medical devices.
Instead, this document focuses on confirming that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics. The 510(k) process primarily relies on demonstrating equivalence rather than requiring extensive new clinical performance studies that establish acceptance criteria as you've outlined.
Therefore, I cannot provide the requested information based on this document. The sections you asked for, such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, are typically found in detailed performance studies for devices that require more complex validation, often software or AI-based. This document pertains to a physical medical glove.
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(99 days)
GX CORPORATION SDN BHD
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, Blue (SG).
The provided document is a 510(k) premarket notification letter from the FDA for "Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, Blue (SG)". This document describes the regulatory approval of a medical device (gloves) and not an AI or software device. Therefore, the requested information regarding acceptance criteria and studies for an AI/software device cannot be extracted from this document.
The document mainly focuses on:
- The device being substantially equivalent to legally marketed predicate devices.
- The regulation number, product code, and regulatory class of the device.
- General controls provisions of the Act applicable to the device.
- A list of chemotherapy drugs and the gloves' permeation (breakthrough detection time) for each.
There is no information about:
- AI acceptance criteria or device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone (algorithm-only) performance.
- Type of ground truth used for AI.
- Training set sample size.
- Ground truth establishment for the training set.
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(95 days)
GX CORPORATION SDN BHD
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Latex Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue).
This document is a 510(k) premarket notification approval letter for "Powder Free Latex Examination Gloves, Tested For Use with Chemotherapy Drugs (Blue)". It is not a study that proves the device meets acceptance criteria in the sense of a clinical trial or AI algorithm validation. Instead, it demonstrates substantial equivalence to a predicate device, which includes fulfilling certain performance standards for medical gloves.
Here's an analysis based on the provided document, addressing the requested points where information is available:
1. A table of acceptance criteria and the reported device performance
The document focuses on the chemotherapy drug permeation aspect of the gloves. While it doesn't explicitly state "acceptance criteria" in a separate column, the values presented are the "Average Breakthrough Detection Time in Minutes" for various chemotherapy drugs, which would be compared against a standard or established threshold for acceptable performance. The implicit acceptance criterion is that the breakthrough time should be as long as possible, ideally exceeding the duration of typical exposure.
| Chemotherapy Drug | Reported Device Performance (Average Breakthrough Detection Time in Minutes) | Implicit Acceptance Criteria (based on general medical glove guidelines for chemotherapy) |
|---|---|---|
| Thiotepa (10.0 mg / ml) | 7.71 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Carmustine (BCNU) (3.3 mg / ml) | 63.03 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Dacarbazine (DTIC) (10.0 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Cyclophosphamide (Cytoxan) (20.0 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Doxorubicin Hydrochloride (2.0 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Fluorouracil (50.0 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Cisplatin (1.0 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Etoposide (Toposar) (20.0 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Paclitaxel (Taxol) (6.0 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Ifosfamide (50.0 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Methotrexate (25.0 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Mitomycin C (0.5 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Mitoxantrone (2.0 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
| Vincristine Sulfate (1.0 mg / ml) | > 240 | As high as possible, typically > 30 minutes for limited exposure, > 240 for extended. |
Note: The document explicitly states: "Please note that Thiotepa has an extremely low permeation time of less than 30 minutes." This indicates that for Thiotepa, the performance is below a generally accepted threshold for robust protection and needs careful consideration.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document is an FDA approval letter, not a detailed study report. The results presented in the table are likely summarized from testing conducted by the manufacturer, but the specifics of the sample size (n for each test) and provenance are not included.
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 is not applicable and not provided. This document pertains to the physical performance of a medical device (gloves) against chemical permeation, not a diagnostic or AI-driven system requiring expert interpretation or ground truth establishment in the traditional sense. The "ground truth" here is the objective measurement of chemical breakthrough.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for chemical permeation 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
This is not applicable. This document is for a medical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This document is for a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the chemotherapy drug permeation data would be the objective measurement of the breakthrough time of the specific chemotherapy drugs through the glove material. This is determined by standardized chemical testing protocols (e.g., ASTM D6978 for medical gloves). It does not involve expert consensus, pathology, or outcomes data in this context.
8. The sample size for the training set
This is not applicable and not provided. This is not an AI/machine learning device that requires a training set. The "training" for such a device would be the manufacturing process itself, aiming to meet established performance standards.
9. How the ground truth for the training set was established
This is not applicable and not provided. As explained above, this is not an AI/machine learning device.
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(74 days)
GX CORPORATION SDN BHD (PLANT 1)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Bubble Gum Scented, Blue
The provided text is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth for a medical device or AI system.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about a study that proves the device meets acceptance criteria, as this information is not present in the provided document. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination, not a description of a performance study.
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(189 days)
GX CORPORATION SDN BHD
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Sterile, Powder Free Nitrile Examination Gloves, Blue Tested For Use With Chemotherapy Drugs.
The provided document is a 510(k) premarket notification decision letter for Sterile, Powder Free Nitrile Examination Gloves, Blue, tested for use with chemotherapy drugs. It does not describe an AI/ML powered device, therefore, the information requested in the prompt related to acceptance criteria and studies for such devices cannot be extracted.
The document discusses the substantial equivalence determination for nitrile examination gloves to legally marketed predicate devices. The "Indications for Use" section lists specific chemotherapy drugs and their respective permeation (breakthrough detection) times when tested with the gloves.
Information that CAN be extracted, reorganized from the "Indications for Use" section:
1. A table of specific performance data (permeation times) for the device:
| Chemotherapy Drug | Concentration | Permeation (Breakthrough Detection Time in Minutes) |
|---|---|---|
| Dacarbazine (DTIC) | 10.0 mg/mL | > 240 |
| Mitomycin C | 5.0 mg/mL | > 240 |
| Carmustine (BCNU) | 3.3 mg/mL | 3.57 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/mL | > 240 |
| 5-Fluorouracil | 50.0 mg/mL | > 240 |
| Cisplatin | 1.0 mg/mL | > 240 |
| Etoposide | 20.0 mg/mL | > 240 |
| Paclitaxel (Taxol) | 6.0 mg/mL | > 240 |
| Thio-Tepa | 10.0 mg/mL | 24.39 |
| Vincristine Sulfate | 50.0 mg/mL | > 240 |
| Methotrexate | 25.0 mg/mL | > 240 |
| Mitoxantrone | 100.0 mg/mL | > 240 |
| Ifosfamide (Ifex) | 50.0 mg/mL | > 240 |
| Warning on Labeling: Do Not Use with Thiotepa and Carmustine |
Note: The document does not explicitly state the "acceptance criteria" as a single defined threshold for all drugs, but rather presents the measured performance against a listed set of chemotherapy drugs. The determination of "substantial equivalence" implies that the observed permeation times are considered acceptable compared to predicate devices for the indicated use. The warnings for Thiotepa and Carmustine indicate that the performance for these drugs was deemed insufficient for safe use, despite having measured breakthrough times.
The following information cannot be extracted from the provided text as it pertains to AI/ML device studies, which is not the subject of this document:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
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(119 days)
GX CORPORATION SDN BHD
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Grape Scented, Blue
This document is an FDA 510(k) clearance letter for "Powder Free Nitrile Examination Gloves, Grape Scented, Blue." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the information requested in the prompt. It is a regulatory clearance, not a study report detailing acceptance criteria or device performance data. The letter explicitly states that the FDA's determination of substantial equivalence "does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not specify any performance criteria or reported performance data. For examination gloves, acceptance criteria typically involve physical properties (e.g., tensile strength, elongation), barrier integrity (e.g., freedom from holes), and biocompatibility.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for this type of device and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (gloves), not an AI algorithm.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not applicable, as this is a physical medical device.
- How the ground truth for the training set was established: Not applicable, as this is a physical medical device.
The FDA's 510(k) clearance process for devices like examination gloves typically relies on demonstrating substantial equivalence to a predicate device, often by showing that the new device meets recognized consensus standards (e.g., ASTM standards for medical gloves) and performs similarly to the predicate. The details of these tests and their results would be in the 510(k) submission itself, not in the clearance letter.
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(151 days)
GX CORPORATION SDN BHD
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove is tested for use with Dacarbazine (DTIC), Cyclophosphamide (Cytoxan), Doxorubicin Hydrochloride, 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol)
Warning: Not Recommended For Use With Carmustine and Thio-Tepa
Powder Free Latex Examination Gloves, Blue Tested For Use With Chemotherapy Drugs
This document is a 510(k) clearance letter from the FDA for a medical device: "Powder Free Latex Examination Gloves, Blue Tested for Use With Chemotherapy Drugs".
The document does not contain any information regarding acceptance criteria for a study, reported device performance, sample sizes for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Instead, this letter is an administrative notification that indicates the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It lists the regulation number, regulation name, product code, and the indications for use. It also outlines the manufacturer's responsibilities under the Act.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
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(56 days)
GX CORPORATION SDN BHD
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Orange Scented, Orange Powder Free Nitrile Examination Gloves, Vanilla Scented, White
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves." This document announces the substantial equivalence of the device to legally marketed predicate devices.
It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts), MRMC studies, standalone performance, or training set information for an AI/ML device. The letter pertains to a simple medical device (gloves) and not an AI/ML system.
Therefore, I cannot provide the requested information based on the input document.
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