(75 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or prevent contamination between patient and finger to examiner.
Nitrile Powder-Free Examination Gloves
Based on the provided text, this document is a 510(k) clearance letter for "Nitrile Powder-Free Examination Gloves." This type of document does not contain information about acceptance criteria or a study proving that an AI/device meets acceptance criteria in the way you've described for medical AI.
This 510(k) clearance signifies that the device is substantially equivalent to a predicate device, meaning it has similar indications for use, technological characteristics, and safety and effectiveness. The FDA's review for such a device typically focuses on performance data (e.g., strength, durability, biocompatibility for gloves) in comparison to a predicate, rather than the complex clinical study designs often associated with AI software.
Therefore, I cannot extract the requested information points because they are not present in this type of regulatory document.
However, if this were a document about a medical AI device, here's what each section of your request generally refers to:
- A table of acceptance criteria and the reported device performance: This would typically list metrics like sensitivity, specificity, AUC, F1-score, accuracy, or other relevant performance indicators, alongside the predefined thresholds the device needed to meet.
- Sample size used for the test set and the data provenance: This would specify the number of cases/patients in the independent test set, and details about where the data originated (e.g., anonymized patient data from multiple hospitals in the US, Europe), and whether it was collected historically (retrospective) or specifically for the study (prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would detail how many highly qualified specialists (e.g., board-certified radiologists, pathologists) independently reviewed the test cases to determine the true diagnosis or finding.
- Adjudication method for the test set: This explains how discrepancies among expert opinions for ground truth were resolved (e.g., 2+1 means two experts agree, or a third experienced expert acts as tie-breaker).
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This would assess if human clinical performance improved when using the AI device as an aid compared to reading without it. An effect size (e.g., increase in AUC, sensitivity) would be reported.
- If a standalone performance study was done: This measures the algorithm's performance without any human intervention.
- The type of ground truth used: This specifies the gold standard against which the device's performance was measured (e.g., confirmed by pathology, long-term clinical outcome follow-up, consensus of multiple experts).
- The sample size for the training set: The number of cases/patients used to train the AI model.
- How the ground truth for the training set was established: Similar to the test set, but specifically for the data used to teach the AI.
Again, this type of information is not present in the provided 510(k) clearance letter for examination gloves.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG | | 1998
Mr. Lee Aik Lim Managing Director Besglove Medicare Sdn. Bhd. Lot 6, Jalan P/2A, Bangi Industrial Estate, 43650 Bandar Baru Bangi, Selangor Darul Ehsan, MALAYSIA
Re : K981877 Trade Name: Nitrile Powder-Free Examination Gloves Requlatory Class: I Product Code: LZA Dated: May 8, 1998 :" Received: May 28, 1998
Dear Mr. Lee Aik Lim:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Dutram for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) number(if known): 981877
Device Name: Nitrile Powderfree Examination Gloves
Indications For Use:
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or prevent contamination between patient and finger to examiner.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Qur S. Lz
(Division Sign Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Pormat 1-2-96)
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.