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General surgical fluid irrigation and infiltration.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Wells Johnson Infusion System, Model 20-6000-00." This type of letter addresses substantial equivalence to a predicate device and allows the device to be marketed. It does not typically contain detailed information about specific performance acceptance criteria or detailed study results like those found in a clinical study report or a premarket approval (PMA) application.

Therefore, for the information requested in your prompt:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on meeting specific performance acceptance criteria in the same way a clinical trial for a novel device would.
2. Sample sized used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in this document.
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 an "Infusion System," which is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available in this document, as it pertains to performance studies not detailed here. The primary "ground truth" for a 510(k) is the performance of the predicate device to which it is compared for substantial equivalence.
8. The sample size for the training set: Not applicable/available.
9. How the ground truth for the training set was established: Not applicable/available.

In summary, the provided document is an FDA clearance letter based on substantial equivalence for a physical medical device (an infusion system). It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods that would be typically found in a clinical study report for a diagnostic device or AI algorithm.

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BREAST RECONSTRUCTION, LIMB RECONSTRUCTION, CORRECTION OF CONGENITAL DEFORMITIES, COSMETIC DEFECTS, SCAR REVISION

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I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance data for the "Bircoll Balloon Dissector." The documents are FDA 510(k) letters for an administrative change and the original clearance, which primarily discuss regulatory classification, substantial equivalence, and general controls. They do not include the specific technical details of the device's performance or the studies conducted to establish its effectiveness.

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The UAS is designed for use in the fragmentation, emilsification and aspiration of soft tissue in the following surgical specialties: Neurosurgery, Gastrointestinal and affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Gynecology, Orthopedic Surgery.

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This document is an FDA 510(k) clearance letter for the UAS Ultrasonic Aspirator System, dated December 9, 1997. It explicitly states that the device is determined to be "substantially equivalent" to predicate devices marketed before May 28, 1976.

Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter is a regulatory approval document confirming substantial equivalence, not a detailed technical report of a clinical study or performance evaluation. The typical information requested in your prompt (e.g., acceptance criteria, test set details, ground truth, MRMC studies) is usually found in the 510(k) submission itself or related study reports, which are not part of this clearance letter.

Therefore, I cannot populate the table or answer the specific questions about studies, sample sizes, or ground truth based solely on the provided text. The letter only indicates the device is cleared for marketing based on substantial equivalence, and lists the intended uses.

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