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Found 57 results
510(k) Data Aggregation
(98 days)
Hartalega SDN BHD
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs. These gloves were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination.
Here's the analysis of the provided text regarding acceptance criteria and the study:
The provided document is an FDA 510(k) clearance letter for a medical device: "Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs".
The document does not describe a study that uses an AI/ML algorithm, nor does it involve human readers, ground truth establishment through expert consensus or pathology for a diagnostic imaging device. Instead, it describes a physical characteristic test for a surgical glove.
Therefore, many of the requested points are not applicable to this document. I will focus on what is relevant to the provided text.
This document describes the testing performed on a surgical glove to assess its permeation by chemotherapy drugs.
1. A table of acceptance criteria and the reported device performance
Based on the provided information, the acceptance criteria are not explicitly stated as quantitative thresholds for "minimum breakthrough detection time" in a formal table like in a software performance study. Instead, the performance is reported against a specific standard and then followed by a warning. The implication is that a higher breakthrough time is better.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Implicit) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (3.3 mg/ml) | Acceptable for use (prior to warning) | 13.1 |
| Cisplatin (1.0 mg/ml) | Acceptable for use | >240 |
| Cyclophosphamide (20.0 mg/ml) | Acceptable for use | >240 |
| Dacarbazine (10.0 mg/ml) | Acceptable for use | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Acceptable for use | >240 |
| Etoposide (20.0 mg/ml) | Acceptable for use | >240 |
| Fluorouracil (50.0 mg/ml) | Acceptable for use | >240 |
| Methotrexate (25.0 mg/ml) | Acceptable for use | >240 |
| Mitomycin C (0.5 mg/ml) | Acceptable for use | >240 |
| Paclitaxel (6.0 mg/ml) | Acceptable for use | >240 |
| Thiotepa (10.0 mg/ml) | Acceptable for use (prior to warning) | 15.7 |
| Vincristine Sulfate (1.0 mg/ml) | Acceptable for use | >240 |
Note regarding acceptance criteria: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of 13.1 minutes and 15.7 minutes respectively. WARNING: Do Not Use With: Carmustine and Thiotepa." This implies that while the gloves were tested with these drugs, their performance was deemed insufficient for safe use, leading to a "Do Not Use" warning. Therefore, for Carmustine and Thiotepa, the implicitly accepted performance might be "not usable," despite the test results being reported. For other drugs, ">240 minutes" is the reported performance and implicitly acceptable for use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to the "Latex Powder Free Surgical Glove" as a single device type. It does not provide specifics on the sample size (e.g., number of gloves tested) for the chemotherapy drug permeation test.
The testing method referenced is ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This is a standardized, laboratory-based physical test.
The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer's testing to support the 510(k) submission. This is a prospective test in the sense that the testing was performed specifically to evaluate the device against this standard.
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. This is a physical test of a device's barrier properties, not a diagnostic or AI/ML study requiring expert ground truth establishment. The "ground truth" is determined by the objective measurement of breakthrough time according to the ASTM standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for human-interpreted data, such as medical image analysis, not for standardized physical property testing of a device.
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 is a physical product, not an AI/ML algorithm or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm. The "standalone performance" here would be the glove's permeation resistance under the specified test conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this test is established by the objective measurement of chemical permeation through the glove material using a standardized laboratory method (ASTM D6978-05). It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable. There is no AI/ML algorithm involved, and therefore no training set.
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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(58 days)
Hartalega SDN. BHD.
The Sterile NItrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. The gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
The provided document is a 510(k) premarket notification for a medical device: "Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)".
This document is a regulatory approval and does not describe an AI medical device or an AI performance study. It details the resistance of medical gloves to permeation by chemotherapy drugs and Fentanyl Citrate, which is a chemical and material performance test, not an AI efficacy study.
Therefore, I cannot provide information on the acceptance criteria, study details, and related AI performance metrics as requested in the prompt, because the document describes a physical medical device (gloves) and not an AI-powered device.
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(59 days)
Hartalega SDN. BHD.
The Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs.
The Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs.
Not Found
This document describes the FDA's 510(k) premarket notification for Polyisoprene Powder Free Surgical Undergloves and Surgical Gloves for Use with Chemotherapy Drugs. The study focuses on the gloves' resistance to permeation by chemotherapy drugs, as opposed to an AI/algorithm-based study. Therefore, typical AI/ML study components like MRMC, training sets, and expert consensus for ground truth are not applicable.
Here's an analysis of the provided text in relation to your request, focusing on the appropriate acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for these gloves are defined by their resistance to permeation by various chemotherapy drugs, measured by "Minimum Breakthrough Detection Time in Minutes" as per ASTM D6978-05 (Reapproved 2019). While the document doesn't explicitly state quantitative acceptance thresholds for each drug (e.g., "must be greater than X minutes"), the reported performance is the data by which acceptance is demonstrated. The implication is that the breakthrough times must be sufficiently high to offer protection, and the "Note" highlighting low times for Carmustine and Thiotepa indicates they are acknowledging these specific drugs are exceptions with shorter protection times.
Therefore, the table below lists the performance, which serves as the fulfillment of the "acceptance criteria" for demonstrating drug permeation resistance.
Table of Reported Device Performance against Chemotherapy Drugs
| Chemotherapy Drug and Concentration | Polyisoprene Powder Free Surgical Underglove (Blue) - Minimum Breakthrough Detection Time in Minutes | Polyisoprene Powder Free Surgical Glove (Natural) - Minimum Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (3.3 mg/ml) | 13.4 | 14.5 |
| Cisplatin (1.0 mg/ml) | >240 | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 | >240 |
| Dacarbazine (10.0 mg/ml) | >240 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | >240 |
| Etoposide (20.0 mg/ml) | >240 | >240 |
| Fluorouracil (50.0 mg/ml) | >240 | >240 |
| Methotrexate (25.0 mg/ml) | >240 | >240 |
| Mitomycin C (0.5 mg/ml) | >240 | >240 |
| Paclitaxel (6.0 mg/ml) | >240 | >240 |
| Thiotepa (10.0 mg/ml) | 15.2 | 23.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 | >240 |
Note: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of 13.4 minutes and 15.2 minutes respectively." (This note appears the same for both glove types, although for the "Natural" glove, Thiotepa is 23.5 minutes, so the specific wording might be a copy-paste error in the original document, but the point is these are recognized as lower performance points). This serves as a critical piece of information for users to be aware of the limited protection time for these specific drugs.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size (number of gloves tested) for the permeation tests. It only lists the results.
The data provenance is implied to be from Hartalega SDN. BHD., located in Malaysia, as they are the submitter of the 510(k). The tests are based on an industry standard (ASTM D6978-05), which implies a standardized, retrospective testing process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" is established by the physical and chemical properties of the gloves and their interaction with the specified chemotherapy drugs, measured according to a standard laboratory protocol (ASTM D6978-05). It does not involve human expert interpretation of images or other subjective data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a laboratory-based objective measurement of material properties, not an interpretative study 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
Not applicable. This device is a surgical glove, not an AI/ML-driven diagnostic or assistive tool. There are no "human readers" in this context, nor any AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm; it's a physical product assessed for its barrier properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is established by standardized laboratory testing and measurement based on direct observation of breakthrough time using the ASTM D6978-05 (Reapproved 2019) protocol. This is an objective, quantitative measurement of material performance.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. Since there's no training set for an AI/ML model, there's no ground truth established for it.
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(249 days)
Hartalega Sdn Bhd
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs -(Lemon Green) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below:
Carmustine (3.3 mg/ml) 5.4 minutes
Cisplatin (1.0 mg/ml) > 240 minutes
Cyclophosphamide (20.0 mg/ml) > 240 minutes
Dacarbazine (10.0 mg/ml) > 240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes
Etoposide (20.0 mg/ml) > 240 minutes
Fluorouracil (50.0 mg/ml) > 240 minutes
Methotrexate (25.0 mg/ml) > 240 minutes
Mitomycin C (0.5 mg/ml) > 240 minutes
Paclitaxe 1 (6.0 mg/ml) > 240 minutes
Thiotepa (10.0 mg/ml) 35.2 minutes
Vincristine Sulfate (1.0 mg/ml) > 240 minutes
Please note that Carmustine and Thiotepa have extremely low permeation times of 5.4 minutes
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)". This document primarily concerns the regulatory approval of medical gloves and does not contain any information about an AI/ML-based medical device, its acceptance criteria, or studies proving its performance.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI/ML device from this document. The information requested (acceptance criteria, sample sizes, expert qualifications, ground truth establishment, MRMC studies, etc.) is specific to the development and validation of AI/ML algorithms in medical devices, which is not covered in this regulatory document for examination gloves.
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(221 days)
HARTALEGA SDN. BHD.
The Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)-Extended Cuff is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
The Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue (ABLU) is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for medical gloves. It describes the "Indications for Use" for two types of gloves: "Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)- Extended Cuff" and "Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue (ABLU)".
The acceptance criteria for the devices are based on their resistance to permeation by various chemotherapy drugs, measured by breakthrough time. The study conducted to prove the devices meet these criteria is a chemotherapy drug permeation test.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Device: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)- Extended Cuff
| Chemotherapy Drug (Concentration) | Acceptance Criteria (Breakthrough Time) | Reported Device Performance |
|---|---|---|
| Carmustine (3.3 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | 20.3 minutes |
| Cisplatin (1.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Cyclophosphamide (20 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Dacarbazine (10.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Doxorubicin HCl (2.0mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Etoposide (20.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Methotrexate (25 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Paclitaxel (6.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Thiotepa (10.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | 100.6 minutes |
| Vincristine Sulfate (1.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
Device: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue (ABLU)
| Chemotherapy Drug (Concentration) | Acceptance Criteria (Breakthrough Time) | Reported Device Performance |
|---|---|---|
| Carmustine (3.3 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | 43.8 minutes |
| Cisplatin (1.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Cyclophosphamide (20 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Dacarbazine (10.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Doxorubicin HCl (2.0mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Etoposide (20.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Methotrexate (25 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Paclitaxel (6.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
| Thiotepa (10.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | 97.8 minutes |
| Vincristine Sulfate (1.0 mg/ml) | Not explicitly stated as "acceptance criteria", but the measured time is the performance. | > 240 minutes |
Note: The document states "Please note that Carmustine and Thiotepa have extremely low permeation times of 20.3 minutes and 100.6 minutes" for VBLU gloves, and "Please note that Carmustine and Thiotepa have extremely low permeation times of 43.8 minutes" for ABLU gloves. This implies that while these times are lower than other drugs, they are considered acceptable for appropriate use with awareness of the breakthrough time.
The provided document does not contain the following information typically associated with AI/software medical device studies:
- 2. Sample size used for the test set and the data provenance (This is a physical product test, not an AI model test.)
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable to a physical product permeation test.)
- 4. Adjudication method (Not applicable.)
- 5. Multi-reader multi-case (MRMC) comparative effectiveness study (Not applicable, as this is not an AI diagnostic device.)
- 6. Standalone (algorithm only without human-in-the-loop performance) study (Not applicable, as this is not an AI algorithm.)
- 7. The type of ground truth used (For this type of device, the "ground truth" is the empirically measured breakthrough time of the chemical through the glove material under controlled laboratory conditions, typically following standards like ASTM D6978. The document does not specify the exact standard or methodology, but it's an objective measurement.)
- 8. The sample size for the training set (Not applicable, as this is not an AI model.)
- 9. How the ground truth for the training set was established (Not applicable.)
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(277 days)
Hartalega Sdn. Bhd.
The Biodegradable Nitrile Powder Free Examination Glove (Blue) is a non-sterile disposable device intended for medical purpose that is worn on examinet's hand to prevent contamination between patient and examiner.
Biodegradable Nitrile Powder Free Examination Glove (Blue)
This document is a 510(k) premarket notification letter from the FDA regarding a Biodegradable Nitrile Powder Free Examination Glove (Blue). It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It primarily deals with the regulatory classification, general controls, and other administrative information for getting the device approved for marketing.
Therefore, based on the provided text, I cannot extract the requested information about acceptance criteria and a study proving the device meets those criteria.
This type of information is typically found in the 510(k) summary or detailed test reports, which are not part of this specific letter.
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(151 days)
Hartalega Sdn Bhd
The Nitrile Powder Free Examination Glove with Colloidal Oatmeal - Lemon Green is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Powder Free Examination Glove with Colloidal Oatmeal - Lemon Green
The provided text describes an FDA 510(k) clearance for "Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green." This document is a regulatory approval for a medical device (patient examination gloves). It does NOT contain information about an AI/ML-based medical device, a study proving device performance against acceptance criteria for an AI/ML system, or details about the development and testing of an AI algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment the way you would for an AI/ML device.
The information in the provided text relates to:
- Device Name: Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
- Regulation Number: 21 CFR 880.6250 (Patient Examination Glove)
- Regulatory Class: Class I
- Product Code: LZA
- Indications for Use: Non-sterile disposable device intended for medical purpose, worn on the examiner's hand to prevent contamination between patient and examiner.
- Use Type: Over-The-Counter Use
This is a clearance for a physical medical device, not a software or AI/ML-based device. If you have a different document describing an AI/ML device and its validation study, please provide that text.
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(108 days)
Hartalega Sdn. Bhd.
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Is it also tested to be used against Chemotherapy Drugs.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below;
Carmustine (3.3 mg/ml) 17.2 minutes
Cisplatin (1.0 mg/ml) >240 minutes
Cyclophosphamide (20 mg/ml) > 240 minutes
Dacarbazine (10.0 mg/ml) >240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes
Etoposide (20 mg/ml) > 240 minutes
Fluorouracil (50 mg/ml) > 240 minutes
Methotrexate (25 mg/ml) > 240 minutes
Mitomycin C (0.5 mg/ml) > 240 minutes
Paclitaxel (6.0 mg/ml) > 240 minutes
Thiotepa (10.0 mg/ml) 36.1 minutes
Vincristine Sulfate (1.0 mg/ml) >240 minutes
Do not use with Carmustine. Do not use with Thiotepa.
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White)
This document is a 510(k) premarket notification decision letter from the FDA for a Nitrile Powder Free Examination Glove. It is not a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot extract the requested information like "acceptance criteria and the reported device performance," "sample size used for the test set," "number of experts used to establish ground truth," "multi reader multi case (MRMC) comparative effectiveness study," or "sample size for the training set." These concepts are relevant to the evaluation of AI/ML software, not a physical medical device like a glove, which is evaluated against different types of performance standards (e.g., physical properties, barrier protection, biocompatibility, chemical resistance).
The provided text only includes:
- Trade/Device Name: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
- Regulation Number: 21 CFR 880.6250
- Regulation Name: Patient Examination Glove
- Regulatory Class: Class I
- Product Code: LZA, LZC
- Indications for Use: "Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Is it also tested to be used against Chemotherapy Drugs."
- Chemotherapy Drugs Tested with Breakthrough Times: A table listing specific chemotherapy drugs and their breakthrough times in minutes. This table serves as performance data for the glove's resistance to certain chemicals, but it does not represent "acceptance criteria" in the AI/ML context nor is the study design detailed for how these breakthrough times were determined (e.g., sample size of gloves tested).
- Cautions: "Do not use with Carmustine. Do not use with Thiotepa." (These warnings are based on the breakthrough times being short).
To answer your prompt for an AI/ML device, I would need a different type of document, specifically a study report or a 510(k) submission for an AI/ML product.
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(74 days)
Hartalega Sdn. Bhd.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Is it also tested to be used against Chemotherapy Drugs.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
This document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)". It is not a study report for an AI/ML powered device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.
The document primarily focuses on establishing substantial equivalence for a physical medical glove. The key "performance" aspect here is the glove's resistance to chemotherapy drugs, which is presented as part of its "Indications for Use."
Here's the information that can be extracted or inferred from the provided text, related to the device and its claimed performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated as Breakthrough Time Thresholds) | Reported Device Performance (Breakthrough Time) |
|---|---|
| Sufficient protection against chemotherapy drugs (implied) | Carmustine (3.3 mg/ml): 22.2 minutes |
| Cisplatin (1.0 mg/ml): > 240 minutes | |
| Cyclophosphamide (20 mg/ml): > 240 minutes | |
| Dacarbazine (10.0 mg/ml): > 240 minutes | |
| Doxorubicin Hydrochloride (2.0 mg/ml): > 240 minutes | |
| Etoposide (20 mg/ml): > 240 minutes | |
| Fluorouracil (50 mg/ml): > 240 minutes | |
| Methotrexate (25 mg/ml): > 240 minutes | |
| Mitomycin C (0.5 mg/ml): > 240 minutes | |
| Paclitaxel (6.0 mg/ml): > 240 minutes | |
| Thiotepa (10.0 mg/ml): 37.3 minutes | |
| Vincristine Sulfate (1.0 mg/ml): > 240 minutes |
Note: The document explicitly highlights, "Please note that Carmustine and Thiotepa have extremely low permeation times of 22.2 minutes and 37.3 minutes," which serves as a crucial piece of information for users regarding the limitations of the glove with these specific drugs.
The remaining requested points are not applicable or cannot be determined from the provided text, as they pertain to the evaluation of an AI/ML device, not a physical glove:
- 2. Sample sized used for the test set and the data provenance: Not applicable to a physical glove's chemotherapy resistance testing. The document doesn't detail the number of gloves tested.
- 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 chemotherapy drug breakthrough is based on laboratory testing, not medical expert consensus.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-powered device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the chemotherapy resistance, the ground truth is established through laboratory testing to determine breakthrough times.
- 8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable.
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(111 days)
HARTALEGA SDN. BHD.
The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use with Chemotherapy Drugs (Dawn Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use with Chemotherapy Drugs (Dawn Blue)
The provided document is a 510(k) Premarket Notification for a Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue). It is not a document detailing the acceptance criteria and study for an AI/ML medical device.
Therefore, the information requested in your prompt regarding acceptance criteria, study methodologies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML devices is not available in this document.
This document pertains to the regulatory clearance of a physical medical device (gloves) based on substantial equivalence to predicate devices, and its testing involves physical properties like resistance to chemotherapy drugs, not AI/ML performance.
To directly answer your prompt based on the provided document: None of the requested information regarding AI/ML device acceptance criteria and study methods is present.
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