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510(k) Data Aggregation
(203 days)
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05.
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
The provided document is a 510(k) clearance letter for "Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl." It primarily outlines the regulatory approval and indications for use, including a table of chemotherapy drugs and their breakthrough detection times.
This document does not contain the kind of information typically found in a study proving an AI/ML device meets acceptance criteria. The requested information (e.g., sample size for test set, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, training set details) is specifically relevant to the evaluation of AI/ML-driven medical devices. The device described here is a physical product (nitrile gloves), not an AI/ML device.
Therefore, I cannot extract the requested information from the provided text.
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(112 days)
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, with gastric acid and fentanyl citrate in accordance with ASTM D6978-05.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Fentanyl Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Gastric Acid Permeation Resistance Claims - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This document is a 510(k) premarket notification from the FDA for "Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims."
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are defined by the performance standards outlined for the permeation resistance of the gloves to various drugs. The device performance is reported as the "Breakthrough Detection Time in Minutes." The general implicit acceptance criterion for most drugs appears to be a breakthrough time of "> 240 minutes," indicating that the glove provides protection for at least 4 hours.
Chemotherapy Drug Concentration Acceptance Criteria (Implicit) Reported Device Performance (Breakthrough Detection Time in Minutes) Arsenic Trioxide 1.0 mg/ml > 240 minutes > 240 minutes Azacitidine (Vidaza) 25.0 mg/ml > 240 minutes > 240 minutes Bendamustine HCl 5.0 mg/ml > 240 minutes > 240 minutes Bleomycin Sulfate 15.0 mg/ml > 240 minutes > 240 minutes Busulfan 6.0 mg/ml > 240 minutes > 240 minutes Carboplatin 10.0 mg/ml > 240 minutes > 240 minutes Carmustine (BCNU) 3.3 mg/ml > 240 minutes (Implied) 77.6 minutes Carfilzomib 2.0 mg/ml > 240 minutes > 240 minutes Cisplatin 1.0 mg/ml > 240 minutes > 240 minutes Cladribine 1.0 mg/ml > 240 minutes > 240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 minutes > 240 minutes Cytarabine 100.0 mg/ml > 240 minutes > 240 minutes Dacarbazine 10.0 mg/ml > 240 minutes > 240 minutes Daunorubicin 5.0 mg/ml > 240 minutes > 240 minutes Decitibine 5.0 mg/ml > 240 minutes > 240 minutes Docetaxel 10.0 mg/ml > 240 minutes > 240 minutes Doxorubicin Hydrochloride 2.0 mg/ml > 240 minutes > 240 minutes Epirubicin (Ellence) 2.0 mg/ml > 240 minutes > 240 minutes Etoposide (Toposar) 20.0 mg/ml > 240 minutes > 240 minutes Fludarabine 25.0 mg/ml > 240 minutes > 240 minutes Fluorouracil 50.0 mg/ml > 240 minutes > 240 minutes Gemcitabine (Gemzar) 38.0 mg/ml > 240 minutes > 240 minutes Idarubicin 1.0 mg/ml > 240 minutes > 240 minutes Ifosfamide 50.0 mg/ml > 240 minutes > 240 minutes Irinotecan 20.0 mg/ml > 240 minutes > 240 minutes Mechlorethamine HCl 1.0 mg/ml > 240 minutes > 240 minutes Melphalan 5.0 mg/ml > 240 minutes > 240 minutes Mesna 50.0 mg/ml > 240 minutes > 240 minutes Methotrexate 25.0 mg/ml > 240 minutes > 240 minutes Mitomycin C 0.5 mg/ml > 240 minutes > 240 minutes Mitoxantrone 2.0 mg/ml > 240 minutes > 240 minutes Oxaliplatin 2.0 mg/ml > 240 minutes > 240 minutes Paclitaxel 6.0 mg/ml > 240 minutes > 240 minutes Paraplatin 10.0 mg/ml > 240 minutes > 240 minutes Pemetrexed 25.0 mg/ml > 240 minutes > 240 minutes Pertuzumab 30.0 mg/ml > 240 minutes > 240 minutes Raltitrexed 0.5 mg/ml > 240 minutes > 240 minutes Retrovir 10.0 mg/ml > 240 minutes > 240 minutes Temsirolimus 25.0 mg/ml > 240 minutes > 240 minutes Thiotepa 10.0 mg/ml > 240 minutes > 240 minutes Topotecan HCI 1.0 mg/ml > 240 minutes > 240 minutes Trisenox (Arsenic Trioxide) 1.0 mg/ml > 240 minutes > 240 minutes Velcade (Bortezomib) 1.0 mg/ml > 240 minutes > 240 minutes Vinblastine 1.0 mg/ml > 240 minutes > 240 minutes Vincristine Sulfate 1.0 mg/ml > 240 minutes > 240 minutes Vinorelbine 10.0 mg/ml > 240 minutes > 240 minutes Non-Chemotherapy Drug Concentration Acceptance Criteria (Implicit) Reported Device Performance (Breakthrough Detection Time in Minutes) Cetuximab 2.0 mg/ml > 240 minutes > 240 minutes Chloroquine 50.0 mg/ml > 240 minutes > 240 minutes Cyclosporin A 100.0 mg/ml > 240 minutes > 240 minutes Cytovene (Ganciclovir) 10.0 mg/ml > 240 minutes > 240 minutes Fulvestrant 50.0 mg/ml > 240 minutes > 240 minutes Propofol 10.0 mg/ml > 240 minutes > 240 minutes Rituximab 10.0 mg/ml > 240 minutes > 240 minutes Trastuzumab 21.0 mg/ml > 240 minutes > 240 minutes Triclosan 2.0 mg/ml > 240 minutes > 240 minutes Zoledronic Acid 0.8 mg/ml > 240 minutes > 240 minutes Fentanyl Citrate Injection 100mcg/2mL No breakthrough up to 240 minutes No breakthrough detected up to 240 minutes Gastric Acid Not specified No breakthrough up to 240 minutes No breakthrough detected up to 240 minutes Note: For Carmustine, the device did not meet the implied acceptance criteria of >240 minutes, and this is highlighted with a caution and warning in the document ("CAUTION: Testing showed an average breakthrough time of 77.6 minutes with Carmustine. WARNING: Do not use with Carmustine.").
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size (e.g., number of gloves tested) for each drug. It states "Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05." ASTM D6978-05 is a standard test method, which would specify the number of specimens to be tested, but this detail is not provided in the FDA letter.
The provenance of the data (country of origin, retrospective/prospective) is not specified in the provided text.
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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 product is a medical device (examination gloves) that is physically tested for permeation resistance. The "ground truth" is established through laboratory testing according to a recognized standard (ASTM D6978-05), not through expert consensus or interpretation of medical images. Therefore, the concept of "experts" in the context of clinical interpretation/diagnosis is not applicable here. The experts would be the laboratory personnel performing the tests according to the ASTM standard. Their qualifications are not specified but would typically involve training in chemical permeation testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 typically refer to reaching a consensus among multiple human readers for diagnostic tasks. This is not applicable to the physical permeation testing of gloves. The results are obtained directly from chemical analysis and measurement equipment according to a standardized protocol, so no human adjudication in that sense is necessary.
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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 MRMC comparative effectiveness study was conducted or is relevant for this type of device (medical examination gloves). This document pertains to the physical performance of gloves, not diagnostic AI software that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI-enabled device or algorithm. It is a physical product (gloves). Therefore, no "standalone" algorithm performance study was done.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth is established through objective laboratory testing against a recognized standard (ASTM D6978-05), which measures the breakthrough detection time of specific chemicals through the glove material. It is not based on expert consensus, pathology, or outcomes data.
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The sample size for the training set
This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The gloves are physically manufactured and then tested.
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How the ground truth for the training set was established
As explained above, there is no training set for this type of device.
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(171 days)
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentaryl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
The following drugs and concentrations have been tested the minimum breakthrough result of >240 minutes: Arsenic Trioxide 1.0 Azacitidine (Vidaza) 25.0 Bendamustine HCl 5.0 Bleomycin Sulfate 15.0 Busulfan 6.0 Carboplatin 10.0 Carfilzomib 2.0 Cetuximab 2.0 Chloroquine 50.0 Cisplatin 1.0 Cladribine 1.0 Cyclophosphamide (Cytoxan) 20.0 Cyclosporin A 100.0 Cytarabine 100.0 Cytovene (Ganciclovir) 10.0 Dacarbazine 10.0 Daunorubicin 5.0 Decitibine 5.0 Docetaxel 10.0 Doxorubicin Hydrochloride 2.0 Epirubicin (Ellence) 2.0 Etoposide (Toposar) 20.0 Fludarabine 25.0 Fluorouracil 50.0 Fulvestrant 50.0 Gemcitabine (Gemzar) 38.0 Idarubicin 1.0 Ifosfamide 50.0 Irinotecan 20.0 Mechlorethamine HCl 1.0 Melphalan 5.0 Mesna 50.0 Methotrexate 25.0 Mitomycin C 0.5 Mitoxantrone 2.0 Oxaliplatin 2.0 Paclitaxel 6.0 Paraplatin 10.0 Pemetrexed 25.0 Pertuzumab 30.0 Propofol 10.0 Raltitrexed 0.5 Retrovir 10.0 Rituximab 10.0 Temsirolimus 25.0 Topotecan HCl 1.0 Trastuzumab 21.0 Triclosan 2.0 Trisenox (Arsenic Trioxide) 1.0 Velcade (Bortezomib) 1.0 Vinblastine 1.0 Vincristine Sulfate 1.0 Vinorelbine 10.0 Zoledronic Acid 0.8
The following drugs have permeation times lower than 240 minutes: Carnustine: 55.1 minutes and Thiotepa: 199.2 minutes.
Fentaryl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Gastric Acid Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentaryl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This document is a 510(k) clearance letter for Blue Non Sterile Powder Free Nitrile Examination Gloves. It details the device's intended use and claims about its resistance to chemotherapy drugs, gastric acid, and fentanyl permeation. It does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/machine learning device.
The questions in the prompt are specific to the performance evaluation of an AI/machine learning-based medical device. This document describes the device performance claims for a physical medical device (gloves) based on physical permeation testing against various chemical agents, not an AI algorithm.
Therefore, I cannot provide answers to the requested information based on the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance: While drug permeation times are listed, these are performance metrics for a physical glove, not an AI device. There are no "acceptance criteria" in the AI sense (e.g., target precision, recall, AUC).
- Sample size for test set and data provenance: Not applicable to a physical glove's chemical resistance testing.
- Number of experts for ground truth and qualifications: Not applicable; ground truth for chemical resistance is determined by laboratory measurements, not expert consensus.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for human reader performance with/without AI assistance.
- Standalone (algorithm only) performance: Not applicable; there is no algorithm.
- Type of ground truth used: For these gloves, the "ground truth" is laboratory measurement of chemical permeation according to ASTM D6978-05.
- Sample size for the training set: Not applicable; there's no training set for an AI algorithm.
- How ground truth for the training set was established: Not applicable.
The document describes the testing methodology for the gloves' chemical resistance, which is analogous to how device performance is evaluated, but it's for a physical product, not an AI system. Specifically:
- Acceptance Criteria/Performance: The device "acceptably" resists permeation by various chemotherapy drugs, gastric acid, and fentanyl.
- For most listed chemotherapy drugs, the minimum breakthrough result was ">240 minutes" when tested according to ASTM D6978-05.
- For BCNU (Carmustine) and Thiotepa, permeation times were lower (55.1 minutes and 199.2 minutes, respectively).
- For Fentanyl Citrate Injection and Gastric Acid, no breakthrough was detected up to 240 minutes.
- Study Proving Acceptance: The device was tested for use with chemotherapy drugs, gastric acid, and fentanyl permeation resistance claims using ASTM D6978-05. This standard dictates the testing methodology for assessing the resistance of medical gloves to permeation by chemotherapy drugs. The results obtained from this standard testing are what "prove" the device meets its claims.
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(261 days)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows: Arsenic Trioxide 1.0 mg/ml >>240 mins
Azacitidine (Vidaza) 25.0 mg/ml > 240 mins Bendamustine HC1 5.0 mg/ml >>240 mins Bleomycin Sulfate 15.0 mg/ml >>240 mins Busulfan 6.0 mg/ml > 240 mins Carboplatin 10.0 mg/ml > 240 mins Carmustine (BCNU) 3.3 mg/ml 12.7 mins Carfilzomib 2.0 mg/ml > 240 mins Cetuximab 2.0 mg/ml >>240 mins Chloroquine 50.0 mg/ml >>240 mins Cisplatin 1.0 mg/ml > 240 mins Cladribine 1.0 mg/ml >>240 mins Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 mins Cyclosporin A 100.0 mg/ml >> 240 mins Cytarabine 100.0 mg/ml > 240 mins Cytovene (Ganciclovir) 10.0 mg/ml > 240 mins Dacarbazine 10.0 mg/ml > 240 mins Daunorubicin 5.0 mg/ml >>240 mins Decitibine 5.0 mg/ml >>240 mins Docetaxel 10.0 mg/ml >>240 mins Doxorubicin Hydrochloride 2.0 mg/ml >>240 mins Epirubicin (Ellence) 2.0 mg/ml >> 240 mins Etoposide (Toposar) 20.0 mg/ml >>240 mins Fludarabine 25.0 mg/ml >>240 mins Fluorouracil 50.0 mg/ml > 240 mins Fulvestrant 50.0 mg/ml > 240 mins Gemcitabine (Gemzar) 38.0 mg/ml >> 240 mins Idarubicin 1.0 mg/ml > 240 mins Ifosfamide 50.0 mg/ml >>240 mins Irinotecan 20.0 mg/ml >>240 mins Mechlorethamine HCl 1.0 mg/ml > 240 mins Melphalan 5.0 mg/ml >>240 mins Mesna 50.0 mg/ml >240 mins Methotrexate 25.0 mg/ml >>240 mins Mitomycin C 0.5 mg/ml >>240 mins
Mitoxantrone 2.0 mg/ml > 240 mins Oxaliplatin 2.0 mg/ml > 240 mins Paclitaxel 6.0 mg/ml >>240 mins Paraplatin 10.0 mg/ml >>240 mins Pemetrexed 25.0 mg/ml >>240 mins Pertuzumab 30.0 mg/ml >>240 mins Propofol 10.0 mg/ml > 240 mins Raltitrexed 0.5 mg/ml >>240 mins Retrovir 10.0 mg/ml > 240 mins Rituximab 10.0 mg/ml > 240 mins Temsirolimus 25.0 mg/ml >240 mins Thiotepa 10 mg/ml 35.8 mins Topotecan HCl 1.0 mg/ml > 240 mins Trastuzumab 21.0 mg/ml >240 mins Triclosan 2.0 mg/ml >>240 mins Trisenox (Arsenic Trioxide) 1.0 mg/ml >> 240 mins Velcade (Bortezomib) 1.0 mg/ml > 240 mins Vinblastine 1.0 mg/ml >>240 mins Vincristine Sulfate 1.0 mg/ml > 240 mins Vinorelbine 10.0 mg/ml >>240 mins Zoledronic Acid 0.8 mg/ml > 240 mins
CAUTION: Testing showed an average breakthrough time of 35.8 minutes with Thiotepa and 12.7 minutes with Carmustine.
WARNING: Do not use with Carmustine and Thiotepa.
Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes. Gastric Acid Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The provided document is a 510(k) premarket notification letter from the FDA for examination gloves. It does not describe an AI/ML powered medical device, nor does it contain information about acceptance criteria, study data, ground truth, or other aspects related to the evaluation of such devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from this document. The questions about AI/ML device performance, human readers, training/test sets, and ground truth are not applicable to the content provided.
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(69 days)
Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05, as guide lined by the FDA Medical Glove Guidance Manual.
The provided text describes testing and acceptance criteria for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K173942), focusing on their resistance to chemotherapy drug permeation. This is a medical device, not an AI/ML-based diagnostic or prognostic tool, therefore, many of the typical questions regarding AI model evaluation (like sample size for training set, number of experts for ground truth, MRMC studies, etc.) are not applicable to this submission.
The study proves the device's substantial equivalence to a predicate device (K172525) and its performance according to established industry standards.
Here's an analysis of the acceptance criteria and the study performance for the chemotherapy drug permeation aspect, as that's where specific performance data is provided:
Acceptance Criteria and Reported Device Performance
The key performance criterion for these gloves regarding chemotherapy drugs is the "Minimum Breakthrough Detection Time" as per ASTM D6978-05. While specific "acceptance criteria" (e.g., "must be >X minutes") are not explicitly stated as numerical thresholds for all drugs, the implicit acceptance criterion is to demonstrate a breakthrough time for each tested chemotherapy drug, and for certain drugs, specifically those known to have low permeation times (Carmustine and Thiotepa), to explicitly state their observed values, even if low. For the majority of drugs, the goal is often to demonstrate a breakthrough time exceeding a common testing duration (e.g., >240 minutes, which is 4 hours).
Table of Acceptance Criteria (Implicit) and Reported Device Performance:
| Tested Chemotherapy Drug | Implicit Acceptance Criteria (based on common medical glove standards and the data presented) | Reported Device Performance (Minimum Breakthrough Detection Time in minutes) |
|---|---|---|
| Bleomycin Sulfate | Demonstrate permeation data; ideally >240 min | >240 |
| Busulfan | Demonstrate permeation data; ideally >240 min | >240 |
| Carboplatin | Demonstrate permeation data; ideally >240 min | >240 |
| Carmustine | Demonstrate permeation data; acknowledge low time if applicable | 12.4 |
| Cisplatin | Demonstrate permeation data; ideally >240 min | >240 |
| Chloroquine | Demonstrate permeation data; ideally >240 min | >240 |
| Cyclophosphamide | Demonstrate permeation data; ideally >240 min | >240 |
| Cyclosporin | Demonstrate permeation data; ideally >240 min | >240 |
| Cytarabine HCI | Demonstrate permeation data; ideally >240 min | >240 |
| Dacarbazine | Demonstrate permeation data; ideally >240 min | >240 |
| Daunorubicin HCI | Demonstrate permeation data; ideally >240 min | >240 |
| Docetaxel | Demonstrate permeation data; ideally >240 min | >240 |
| Doxorubicin Hydrochloride | Demonstrate permeation data; ideally >240 min | >240 |
| Epirubicin (Ellence) | Demonstrate permeation data; ideally >240 min | >240 |
| Etoposide | Demonstrate permeation data; ideally >240 min | >240 |
| Fludarabine | Demonstrate permeation data; ideally >240 min | >240 |
| Fluorouracil | Demonstrate permeation data; ideally >240 min | >240 |
| Gemcitabine | Demonstrate permeation data; ideally >240 min | >240 |
| Idarubicin | Demonstrate permeation data; ideally >240 min | >240 |
| Ifosfamide | Demonstrate permeation data; ideally >240 min | >240 |
| Irinotecan | Demonstrate permeation data; ideally >240 min | >240 |
| Mechlorethamine HCI | Demonstrate permeation data; ideally >240 min | >240 |
| Melphalan | Demonstrate permeation data; ideally >240 min | >240 |
| Methotrexate | Demonstrate permeation data; ideally >240 min | >240 |
| Mitomycin | Demonstrate permeation data; ideally >240 min | >240 |
| Mitoxantrone | Demonstrate permeation data; ideally >240 min | >240 |
| Oxaliplatin | Demonstrate permeation data; ideally >240 min | >240 |
| Paclitaxel | Demonstrate permeation data; ideally >240 min | >240 |
| Paraplatin | Demonstrate permeation data; ideally >240 min | >240 |
| Retrovir | Demonstrate permeation data; ideally >240 min | >240 |
| Rituximab | Demonstrate permeation data; ideally >240 min | >240 |
| Thiotepa | Demonstrate permeation data; acknowledge low time if applicable | 24.4 |
| Topotecane | Demonstrate permeation data; ideally >240 min | >240 |
| Trisonex | Demonstrate permeation data; ideally >240 min | >240 |
| Velcade | Demonstrate permeation data; ideally >240 min | >240 |
| Vincristine Sulfate | Demonstrate permeation data; ideally >240 min | >240 |
The manufacturer clearly states the two drugs with "extremely low permeation times" (Carmustine and Thiotepa), indicating transparency and adherence to relevant standards (ASTM D6978-05).
Study Details:
This submission is for a medical device (gloves), not an AI/ML diagnostic. Therefore, the following points typical for AI/ML device evaluations are not applicable (N/A):
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Sample Size used for the Test Set and the Data Provenance:
- Test Set Sample Size: The document does not specify a "sample size" in terms of number of gloves tested for each drug, but rather the performance against a list of chemicals. ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) outlines the methodology for such testing. Typically, this would involve a statistically significant number of specimens to ensure reproducibility and reliability, but the exact number isn't in this summary.
- Data Provenance: The testing was done on the "Proposed Device" manufactured by Central Medicare Sdn. Bhd., located in Teluk Intan, Perak, Malaysia. The data is prospective, a result of new testing on the device.
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Number of Experts used to establish the ground truth for the test set and the qualifications of those experts: N/A for this type of device. The "ground truth" is established by physical/chemical testing as per recognized ASTM standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Physical/chemical testing does not involve human adjudication in this context.
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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: N/A. This is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a physical product, not an algorithm.
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The type of ground truth used:
- The ground truth for chemotherapy drug permeation is established through laboratory testing using standardized methods (ASTM D6978-05), which measures the time it takes for a chemical to permeate through a material. This is an objective, quantitative measurement, not based on expert consensus, pathology, or outcomes data in the traditional medical sense.
- Other ground truths for the gloves' properties (tensile strength, elongation, freedom from holes, powder content) are established via their respective ASTM standards (e.g., ASTM D6319-10, ASTM D5151-06, ASTM D6124-06).
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The sample size for the training set: N/A. This is not an AI/ML device.
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How the ground truth for the training set was established: N/A. This is not an AI/ML device.
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(84 days)
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large.
Gloves meet the specification of ASTM D6319-10 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05, as guide lined by the FDA Medical Glove Guidance Manual.
This document describes the premarket notification for "Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs" (K172525). The primary purpose of the submission is to demonstrate substantial equivalence to a predicate device (K163146) based on technological characteristics and performance data, particularly regarding resistance to chemotherapy drug permeation.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to ASTM standards and comparative performance against the predicate device.
| Acceptance Criteria/Standard | Reported Device Performance |
|---|---|
| ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application): | Device "meets the specification of ASTM D6319-10" and demonstrates "the standard specifications and performance are appropriate for the requirements of powder free nitrile examination gloves and specialty chemotherapy gloves." |
| * Physical Properties (Before Aging): | |
| * Tensile Strength | 15 Mpa min |
| * Ultimate Elongation | 500% min |
| * Physical Properties (After Aging): | |
| * Tensile Strength | 14 Mpa min |
| * Ultimate Elongation | 400% min |
| * Freedom from Holes (ASTM D5151-06) | In accordance with ASTM D5151-06, following ASTM D6319 AQL 2.5/Inspection Level G-I |
| * Powder Content | Max. 0.52 mg per glove |
| ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs): | Gloves "have been tested for use with chemotherapy drugs using ASTM D6978-05" and "will be labeled with a statement of compliance and a summary of the testing results." |
| * Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in minutes) | |
| * Carmustine (3.3 mg/ml) | 12.4 minutes |
| * Cisplatin (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Cyclophosphamide (20 mg/ml) | No breakthrough for up to 240 minutes |
| * Doxorubicin HCl (2.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Etoposide (20.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Fluorouracil (50.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Mitoxantrone (2.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Paclitaxel (6.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Thiotepa (10.0 mg/ml) | 24.4 minutes |
| * Dacarbazine (10.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Ifosfamide (50.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Vincristine Sulfate (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| Biocompatibility Testing | "Under the conditions of the study, the proposed device is not a sensitizer, or an irritant." These studies were performed on the proposed device. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for permeation, holes, or physical properties). However, it implies that the testing was conducted "in accordance with ASTM D5151-06, following ASTM D6319 AQL 2.5/Inspection Level G-I" for freedom from holes, which dictates sample size based on lot size and AQL. For other tests like chemotherapy drug permeation (ASTM D6978-05), the standard itself would define the testing methodology and implied sample size per drug.
- Data Provenance: The manufacturer, Central Medicare Sdn. Bhd., is located in Teluk Intan, Perak, Malaysia. The tests were likely conducted in Malaysia or by a testing facility in adherence to the specified ASTM standards. The data is retrospective in the sense that it represents characterization of the manufactured gloves to support the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
This device is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for glove performance is established through standardized physical and chemical tests (e.g., ASTM D6319-10, ASTM D6978-05). The "experts" are the qualified laboratory personnel performing these tests according to the standard operating procedures of the testing facilities. Their qualifications typically involve training and certification in laboratory testing methodologies relevant to material science and medical device performance standards.
4. Adjudication Method for Test Set
Not applicable for this type of device and testing. Test results are objective measurements from standardized protocols rather than subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical medical device (examination glove), not an imaging or diagnostic AI system.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This is a physical medical device. The performance evaluated is the physical and chemical properties of the glove itself.
7. Type of Ground Truth Used
The ground truth used is based on:
- Performance Standards: Adherence to established industry standards such as ASTM D6319-10 (for general glove properties) and ASTM D6978-05 (for chemotherapy drug permeation).
- Objective Laboratory Measurements: Direct measurements of tensile strength, elongation, freedom from holes, powder content, and breakthrough times for chemotherapy drugs. These are quantifiable results obtained through controlled experimental procedures.
- Biocompatibility Studies: In vitro or in vivo tests to assess sensitization and irritation, which also yield objective results based on established protocols.
8. Sample Size for Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The "device" is a physical product.
9. How Ground Truth for Training Set Was Established
Not applicable, as no training set is relevant for this device.
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