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Found 11 results
510(k) Data Aggregation
(227 days)
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.
Powder-Free Green Polychloroprene Examination Gloves, Powder-Free Blue Polychloroprene Examination Gloves, Powder-Free Brown Polychloroprene Examination Gloves
This document is a 510(k) premarket notification from the FDA regarding "Powder-Free Green Polychloroprene Examination Gloves," "Powder-Free Blue Polychloroprene Examination Gloves," and "Powder-Free Brown Polychloroprene Examination Gloves." It is a regulatory approval letter, not a study describing the acceptance criteria and performance of a device, especially not an AI/ML-based medical device.
Therefore, I cannot provide the requested information because the document does not contain details about:
- A table of acceptance criteria and reported device performance (in the context of AI/ML or clinical efficacy)
- Sample sizes for test sets or data provenance
- Number of experts or their qualifications for establishing ground truth
- Adjudication methods
- Multi-reader multi-case (MRMC) studies or effect sizes
- Standalone algorithm performance
- Types of ground truth used
- Sample size for training sets
- How ground truth for training sets was established
This document is solely an FDA clearance letter for a medical device (examination gloves), confirming its substantial equivalence to previously marketed devices based on its intended use as a barrier to prevent contamination. It does not describe a performance study for complex diagnostic or AI-driven devices.
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(89 days)
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 device also provides protection against exposure to certain chemotherapy drugs.
Powder Free Nitrile Examination Gloves (6Mil), Tested For Use With Chemotherapy Drugs (Blue); Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue)
This document describes the 510(k) premarket notification for Powder Free Nitrile Examination Gloves (6Mil) and Sterile, Powder Free Nitrile Examination Gloves, both tested for use with chemotherapy drugs (Blue). The key information revolves around the gloves' resistance to permeation by specific chemotherapy drugs.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a single numerical threshold for each drug, but rather presents the average breakthrough detection time for each chemotherapy drug. The implication is that a longer breakthrough time is better, with "> 240 minutes" being the best reported performance for many drugs, suggesting that a 240-minute duration without breakthrough is considered acceptable for practical use. The specific performance for some drugs which are noted as having "extremely low permeation time" for the Sterile glove indicates they do not meet a high standard of protection for those particular drugs.
| Chemo Drug (Concentration) | Acceptance Criteria (Implied) | Powder Free Nitrile (6mil) Performance (Average Breakthrough Time in Minutes) | Sterile, Powder Free Nitrile Performance (Average Breakthrough Time in Minutes) |
|---|---|---|---|
| Carmustine (BCNU) (3.3 mg / ml) | Longer breakthrough time desired; >240 likely ideal | 111.9 | 0.51 (Noted as "extremely low") |
| Thiotepa (10.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | 162.3 | 36.5 (Noted as "extremely low") |
| Fluorouracil (50.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Etoposide (Toposar) (20.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Mitomycin C (0.5 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Methotrexate (25.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Paclitaxel (Taxol) (6.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Doxorubicin Hydrochloride (2.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Dacarbazine (DTIC) (10.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Cisplatin (1.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Mitoxantrone (2.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Ifosfamide (50.0 mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
| Vincristine Sulfate (1.0mg / ml) | Longer breakthrough time desired; >240 likely ideal | > 240 | > 240 |
The acceptance criteria for glove performance against chemotherapy drugs generally follow standards like ASTM D6978, which specifies a minimum breakthrough time. While not explicitly stated as "acceptance criteria," the consistent reporting of "> 240 minutes" for many drugs suggests that 240 minutes is the target threshold for extended protection. The note concerning Carmustine and Thiotepa for the Sterile gloves indicates that their performance of
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(52 days)
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 device also provides protection against exposure to certain chemotherapy drugs.
Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue)
The provided document describes the FDA clearance (K101293) for "Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue)". This document is a 510(k) clearance letter and an accompanying "Indications for Use" form. It is not a study report for an AI device.
Therefore, most of the requested information regarding acceptance criteria and studies for an "AI device" cannot be extracted from this document, as it pertains to a physical medical device (examination gloves) and not software or an AI algorithm.
However, I can extract the "performance" data that was submitted to support the claim that the gloves provide "protection against exposure to certain chemotherapy drugs." This is presented as "Breakthrough detection time in minutes" for various chemotherapy drugs.
Here's the closest representation of the requested information based on the provided document:
Acceptance Criteria and Device Performance (for Nitrile Examination Gloves)
This document does not specify "acceptance criteria" in a typical numerical threshold format as would be expected for an AI algorithm. Instead, it presents the "Breakthrough detection time" as the performance metric for each listed chemotherapy drug. While the specific acceptance criterion is not explicitly stated as a minimal breakthrough time, the implication is that longer breakthrough times are better, and certain drugs exceeded 240 minutes, indicating strong protection. The critical warning for Carmustine indicates that its breakthrough time of 1.21 minutes is unacceptable for protection against that specific drug.
| Acceptance Criterion (Implicit) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|
| Sufficient protection against chemotherapy drugs (longer time is better, > 240 min appears desirable, 240 | |
| Etoposide (Toposar) (20.0 mg / ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg / ml) | > 240 |
| Mitomycin C (0.5 mg / ml) | > 240 |
| Methotrexate (25.0 mg / ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg / ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg / ml) | > 240 |
| Dacarbazine (DTIC) (10.0 mg / ml) | > 240 |
| Cisplatin (1.0 mg / ml) | > 240 |
| Mitoxantrone (2.0 mg / ml) | > 240 |
| Ifosfamide (50.0 mg / ml) | > 240 |
| Vincristine Sulfate (1.0mg / ml) | > 240 |
| Warning: Do Not Use with Carmustine | Indicates failure to meet protective needs |
Information Not Applicable or Not Provided in the Document (as it's not an AI device study):
- Sample sized used for the test set and the data provenance: Not applicable to a physical glove. The testing methodology for chemotherapy drug permeation is not detailed beyond the results.
- 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 permeation is established through laboratory testing (e.g., using a permeation cell, as per ASTM standards).
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. For the gloves, the "ground truth" is the empirically measured breakthrough time of the drug through the glove material in a controlled laboratory setting.
- The sample size for the training set: Not applicable (no AI training set).
- How the ground truth for the training set was established: Not applicable (no AI training set).
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(105 days)
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, Black
The provided document is a 510(k) premarket notification letter from the FDA for "Powder Free Nitrile Examination Gloves, Black." This document does not contain information about acceptance criteria or a study proving a device meets those criteria, as it pertains to AI/medical imaging devices.
Instead, this document is a regulatory letter, indicating that the device has been deemed "substantially equivalent" to legally marketed predicate devices. It outlines the regulatory classification, product code, and relevant FDA regulations for the device (patient examination gloves).
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as none of this information is present in the provided text.
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(43 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Not Found
The provided text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is a 510(k) premarket notification letter from the FDA to PT. Smart Glove Indonesia regarding their Polymer Coated Powder Free Nitrile Examination Gloves.
This document indicates that the FDA has reviewed the company's application and has determined the gloves are substantially equivalent to legally marketed predicate devices. This means the device can proceed to market, subject to general controls.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment, as this type of information is not present in the provided document.
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(136 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Polymer Coated, Powder Free, Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less), White Color.
The provided text describes a 510(k) premarket notification for "Polymer Coated, Powder Free, Latex Examination Gloves White Color" by PT. Smart Glove Indonesia. It is a communication from the FDA to the manufacturer, indicating that the device has been found substantially equivalent to legally marketed predicate devices.
However, the document is a regulatory letter and an "Indication for Use Statement" page. It does not contain any information about acceptance criteria, a study proving the device meets these criteria, sample sizes, expert qualifications, ground truth, or any specifics of device performance testing beyond the FDA's substantial equivalence determination.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other details of a study based on the provided text. The document focuses on regulatory approval rather than technical study results.
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(66 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Polymer Coated, Powder Free, Nitrile Examination Gloves, Blue Color
This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document only confirms that the specified polymer-coated, powder-free, nitrile examination gloves from PT. Smart Glove Indonesia are substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the given text.
The provided text focuses on the regulatory clearance process for a medical device (examination gloves) by the FDA. It does not contain the technical details of device performance, acceptance criteria, or study methodologies that would be needed to answer your specific questions.
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(45 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Latex Examination Gloves with protein labeling claim less than of 50 microgram or less of total water extractable protein per gram of gloves. with creamy (white) and blue colors.
I am sorry. I cannot provide the answer based on the context. The document is about a 510(k) premarket notification for examination gloves, which does not contain information about acceptance criteria and study data for a medical device's performance.
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(20 days)
This glove is disposable and intended for medical purpose that is hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves with Peppermint Flavor
This document is an FDA 510(k) clearance letter for "Powder Free Nitrile Examination Gloves with Peppermint Flavor." It explicitly states that the device is "intended for medical purpose that is hand to prevent contamination between patient and examiner."
The provided text does not contain any information about acceptance criteria, device performance metrics, study design, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies as typically found in a clinical or performance study report for an AI/ML device.
Therefore, I cannot answer your specific questions in the table format requested, nor can I elaborate on the various study design elements because this document does not describe such studies. This is a regulatory clearance letter based on substantial equivalence, not a detailed technical or clinical performance study report.
The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices, implying that its safety and effectiveness for its stated indication are comparable to existing products, without necessarily requiring new clinical performance studies for this type of device (examination gloves).
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(177 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Examination Gloves (Powdered) Blue Pur white colors
This document is a 510(k) premarket notification letter from the FDA regarding "Multiple Nitrile Examination Gloves, Powdered with Purple Blue, White Colors." It is not a study report that includes acceptance criteria and performance data for a device.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. This information is typically found in study reports, clinical trial summaries, or detailed technical documentation, not a 510(k) clearance letter.
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