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This winged needle holder is indicated for use in securing and positioning a hypodermic needle during the administration of a peribulbar nerve block.

The winged needle holder is fabricated from polyethylene.

This document describes a 510(k) submission for a "Removable Wings" device, also referred to as a "Winged needle holder." The submission focuses on demonstrating substantial equivalence to a predicate device already on the market. Consequently, the study described does not involve performance criteria and a study to prove they are met in the manner of a typical medical device with measurable outcomes (e.g., accuracy, sensitivity, specificity for a diagnostic device, or efficacy for a therapeutic device).

Instead, the "acceptance criteria" here are based on the comparison of attributes to a legally marketed predicate device. The "study" is a comparison table rather than a clinical trial or performance study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the traditional sense for this type of submission. There is no "test set" of patient data or clinical samples. The "test" is a direct comparison of physical and functional attributes of the submitted device against a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The "ground truth" for this substantial equivalence submission is the attributes of the legally marketed predicate device. No expert consensus on a test set was required.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication.

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 is not an AI-assisted device, nor is it a diagnostic imaging device that would typically undergo an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is the characteristics and functionality of a legally marketed predicate device (Becton Dickinson and Company's removable winged needle holder). This is a regulatory "ground truth" for substantial equivalence rather than a clinical one.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an algorithm or AI-powered device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set. The "ground truth" for the comparison was established by the existence and characteristics of the predicate device, presumably through manufacturer specifications and its established market use.

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Indications: This instrument is indicated for use with a compatible trumpet valve during endoscopic surgery for facilitating the removal of gallstones.

The stone extractor has a nominal diameter of 0.392", a tube length of 13.0" and has a scoop 0.6" long. The surface of the stone extractor is polished on the proximal 3.0" and matte finished on the remaining 10.0". The stone extractor is fabricated from 304 stainless steel.

The provided text is a 510(k) summary for a medical device (Stone Extractor) submitted in 1997. This type of submission relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting new clinical studies with defined acceptance criteria and performance metrics typically associated with AI/software devices today.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, or AI performance metrics. The text focuses on comparing the new device's physical attributes and intended use to a legally marketed predicate device.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission is a comparison of attributes to a predicate device, not a performance study against predefined criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or clinical study is described.
3. 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): Not applicable. No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process is described.
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 a physical stone extractor, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical stone extractor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established as there is no performance study.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

The 510(k) summary explicitly states its purpose is to demonstrate "Substantial Equivalence" based on a comparison of device attributes and intended use. The provided table compares specific attributes of the submitted device to a predicate device, showing identical or similar specifications (e.g., material, dimensions, reusability, sterility). This comparison is the "study" for a 510(k) of this nature. The FDA's letter (K971123) confirms substantial equivalence, which allows the device to be marketed.

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