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510(k) Data Aggregation
(130 days)
The 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.
Nitrile Exam Glove, Pre-Powdered, Color White, Blue
The provided document is a 510(k) premarket notification letter from the FDA for Nitrile Exam Gloves. This type of document is for a Class I medical device (patient examination gloves) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a detailed study proving the device meets specific performance acceptance criteria through clinical trials or elaborate engineering studies typically associated with AI/ML or more complex medical devices.
The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not part of this type of regulatory submission for a simple Class I device like examination gloves. These details are much more relevant for software as a medical device (SaMD) or devices with complex algorithms, where performance metrics like sensitivity, specificity, AUC, and their associated studies are critical.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an attempt to address the prompt based only on the available information, noting where information is absent:
Acceptance Criteria and Device Performance for Nitrile Exam Glove
As this is a 510(k) submission for a Class I device (Nitrile Exam Glove), the "acceptance criteria" and "device performance" are primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical performance metrics. The core "acceptance criteria" for a 510(k) of this nature would revolve around meeting recognized standards and established physical properties for examination gloves, which are implicitly accepted by the FDA when a substantial equivalence determination is made. The document itself does not explicitly list a table of acceptance criteria or reported device performance in the way the prompt describes for more complex devices.
The "study that proves the device meets the acceptance criteria" for this type of device typically involves bench testing to demonstrate physical properties and biocompatibility, as well as an assessment against consensus standards. The 510(k) decision letter indicates that the FDA reviewed the submission, which would have included such data, but the letter itself does not contain the detailed study results.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Nitrile Exam Gloves) | Reported Device Performance (Implied as "Substantially Equivalent") |
|---|---|
| Sterility (if applicable) | Not explicitly stated in this letter, but reviewed in 510(k) |
| Biocompatibility | Not explicitly stated in this letter, but reviewed in 510(k) |
| Physical Properties (e.g., tensile strength, elongation, barrier integrity) | Not explicitly stated in this letter, but reviewed in 510(k) and assessed against predicate |
| Freedom from powder (if powder-free) | Pre-Powdered (as stated in product name) |
| Compliance with relevant ASTM/ISO standards | Assumed to have been demonstrated in the 510(k) submission. |
| Intended Use | "Disposal device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." |
| Material properties (e.g., Nitrile) | Nitrile (as stated in product name) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided FDA letter. For examination gloves, this would typically involve samples from manufacturing lots tested for physical properties (e.g., ASTM D412, D6319 for physical properties, ASTM F1671 for viral penetration, ISO 10993 for biocompatibility)
- Data Provenance: Not specified in the letter. The manufacturer is "Jiangsu Sunshine Plastic Products, Company, Limited" based in "China, Taiwan 251," suggesting the manufacturing and potentially some testing data may originate from these regions. The document is retrospective from the perspective of the FDA review, as it's a letter confirming a decision on a submission that has already occurred.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. For examination gloves, "ground truth" is typically established by objective physical and chemical testing against recognized standards, not by expert consensus on images or clinical assessments.
- Qualifications of Experts: Not applicable/not specified. Testing would be performed by qualified laboratory personnel following standard operating procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not specified. This method is used for resolving discrepancies in expert interpretations, common in image-based diagnostic studies. It is not relevant for the physical testing of examination gloves.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This type of study is completely irrelevant for an examination glove. These studies are used to assess the impact of AI/ML algorithms on human reader performance in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is irrelevant as the device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For examination gloves, the "ground truth" refers to the established technical specifications and performance requirements derived from international and national standards (e.g., ASTM, ISO) for physical properties (e.g., tensile strength, elongation, leak resistance) and biocompatibility. Compliance is verified through laboratory testing as opposed to expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not specified. This concept is relevant for AI/ML models, not for passive medical devices like gloves.
9. How the ground truth for the training set was established
- Establishing Ground Truth for Training Set: Not applicable/not specified. This is relevant for AI/ML models, not for passive medical devices like gloves.
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(126 days)
The 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.
Powder-Free Non-Sterile Vinyl Examination Glove
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Non-Sterile Vinyl Examination Gloves." This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The letter is an approval for marketing the device based on its substantial equivalence to a legally marketed predicate device. It confirms that the device falls under general controls and lists various regulatory requirements that the manufacturer must adhere to. The "Indications for Use" section briefly states the intended purpose of the glove.
Therefore, I cannot extract the requested information from the provided input:
- A table of acceptance criteria and the reported device performance: Not present. The document does not discuss performance metrics or acceptance criteria for the gloves.
- Sample size used for the test set and the data provenance: Not present. No test data or study details are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
- Adjudication method: Not present.
- 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 present. This document does not pertain to AI or reader studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
This document is purely an FDA clearance letter for a medical device, not a scientific study report or a detailed performance specification document.
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(126 days)
The 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.
Pre-Powdered Vinyl Patient Examination Glove
The provided document is a 510(k) premarket notification letter from the FDA for a Pre-Powdered Vinyl Patient Examination Glove. This product is a Medical Device Class I.
The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."
The determination of substantial equivalence for Class I devices like examination gloves typically involves demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different technological characteristics that do not raise different questions of safety and effectiveness. This often relies on performance standards rather than extensive clinical studies as would be required for higher-risk devices or novel technologies.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not applicable to this document because it pertains to a simple Class I medical device (patient examination glove) whose substantial equivalence is determined by fulfilling established performance standards for such products, not through clinical trials or complex AI model validation.
The "Indications for Use" section (page 3 of the document) describes the intended purpose of the glove: "The 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." This is a standard indication for such devices.
The 510(k) clearance process for this type of device typically involves demonstrating compliance with recognized standards for physical properties (e.g., tensile strength, elongation), barrier integrity (e.g., freedom from holes), and biocompatibility, rather than efficacy studies involving human subjects or AI model performance.
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(85 days)
The 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.
Nitrile Exam Glove, Powder-Free Model Color White, Blue
This document is a 510(k) clearance letter from the FDA for a Nitrile Exam Glove. It does not contain information about the acceptance criteria or a study that proves a device meets such criteria, as it is for a low-risk device (Class I) that typically does not require extensive clinical studies or performance acceptance criteria beyond established standards for gloves (e.g., integrity, barrier protection).
Therefore, I cannot extract the requested information from the provided text.
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