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The Needlecatcher is designed for grasping suture needles during suturing and holding them during transport throughout the operating theatre.

The Needle Catcher ™ is a stainless steel needle grasping instrument for use in suturing tissue to allow both tissue retaining and needle grasping in the same instrument. The Needle Catcher ™ uses a piston and cylinder assembly to grasp and hold the needle safely during knot tying.

The provided document, K051281, is a 510(k) premarket notification for the "Needlecatcher™" device. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices. However, the document does not contain explicit acceptance criteria or detailed study results that would typically be found in a comprehensive clinical or performance study report.

Instead, the document states: "Using the instrument on artificial skin and animal tissue with a variety of surgeons, nurse operators and medical students its indicated that it is safe and easy to use and that it achieves its indicated functions of needle grasping and needle shielding." This statement summarizes the findings of a performance evaluation but lacks the structured detail required to populate the requested table and provide specific answers to many of the questions.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's the information that can be inferred or directly stated from the document, along with explanations for what cannot be provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document mentions "a variety of surgeons, nurse operators and medical students" and "artificial skin and animal tissue" but does not quantify the number of participants or the amount of tissue used.
• Data Provenance: The study appears to be a performance evaluation conducted as part of the 510(k) submission process. It involved "artificial skin and animal tissue," implying laboratory or simulated settings, not human clinical trials. The location of this testing is not specified, though the applicant is based in Northern Ireland. It is retrospective in the sense that the results are being reported as part of a submission, but the tests themselves would have been prospective for the purpose of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified. The document states "a variety of surgeons, nurse operators and medical students" were involved in "using the instrument," but it doesn't clarify if these individuals established a ground truth, or were simply users providing feedback.
• Qualifications of Experts: The broad categories "surgeons," "nurse operators," and "medical students" are mentioned. No specific experience levels (e.g., "radiologist with 10 years of experience") are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not described. The document only reports that the instrument was "indicated" to be safe and effective, suggesting an overall consensus or observation, but no formal adjudication process (like 2+1 majority voting) is detailed.

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 document describes a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to "human readers improve with AI vs without AI assistance" is not relevant to this device and was not conducted.

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

• Standalone Performance: Not applicable. The "Needlecatcher™" is a manual surgical instrument, not an algorithm. Its performance is inherently human-in-the-loop as it is operated by a healthcare professional.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The "ground truth" seems to have been based on observational feedback and assessment by users (surgeons, nurses, medical students) during the instrument's use on "artificial skin and animal tissue." This is a form of expert assessment of performance and ease of use, rather than a definitive "ground truth" established by pathology or strict outcomes data typically seen in diagnostic device studies.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a mechanical surgical instrument, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no training set for a mechanical device.

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Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).

Semkin Bipolar Forcep

This is a letter about the substantial equivalence of a medical device (Semkin Bipolar Forcep) filed under a 510(k) premarket notification. These documents typically don't include detailed information about acceptance criteria or specific studies that prove the device meets those criteria in the way a clinical trial report or specific performance testing report would. The purpose of a 510(k) is to demonstrate that a device is as safe and effective as a legally marketed predicate device, not necessarily to re-prove its safety and effectiveness from scratch with specific performance metrics and dedicated studies.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be found in the provided text.

Based on the provided document:

1. A table of acceptance criteria and the reported device performance:

   • The document does not explicitly state specific quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) or the reported performance of the Semkin Bipolar Forcep against such criteria.
   • The basis for acceptance in a 510(k) is "substantial equivalence" to a predicate device. This typically means demonstrating that the new device has the same intended use, technological characteristics, and performs as well as or better than the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. The document implies the device met the requirements for substantial equivalence.

2. Sample size used for the test set and the data provenance:

   • Not mentioned in the document. 510(k) submissions generally rely on existing predicate data, and if new testing is conducted, its details like sample size and provenance are often in supporting documentation not included here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not mentioned in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not mentioned in the 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:

   • This document is for a Bipolar Forcep, a surgical instrument. MRMC studies and AI assistance are not relevant to this type of device.

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

   • Not relevant for this type of device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not mentioned in the document. For a bipolar forcep, ground truth would likely relate to its ability to remove tissue and control bleeding, demonstrated through engineering tests or pre-clinical/clinical data if deemed necessary for substantial equivalence.

8. The sample size for the training set:

   • Not mentioned, and generally not applicable in the context of a 510(k) for a basic surgical instrument, which doesn't involve "training sets" in the AI sense.

9. How the ground truth for the training set was established:

   • Not mentioned, and not applicable for this type of device.

Summary of available information:

The document is a 510(k) clearance letter for the "Semkin Bipolar Forcep," indicating that the FDA determined it is substantially equivalent to a legally marketed predicate device. The intended use is "Intended to remove tissue and control bleeding by use of high frequency electrical current." The acceptance criterion, implicitly met, is "substantial equivalence" to a predicate device, meaning it is as safe and effective. Details on specific performance studies (like clinical trials, test set data, expert reviews, or AI-related metrics) are not provided in this regulatory letter itself, as they would typically be part of the larger 510(k) submission which this letter is a response to.

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Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).

Titan Cushing Bayonet Insulated Bipolar Forcep

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the "Titan Cushing Bayonet Insulated Bipolar Forcep." It is a regulatory approval letter and does not contain information about acceptance criteria, device performance studies, or any of the other specific details requested in the prompt related to evaluating AI/device performance.

Therefore, I cannot extract the requested information from the provided text.

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Intended to remove tissue and control bleeding by use of high frequency electrical current. (21 CFR §878.4400).

Semkin Insulated Bipolar Forcep

The provided document is a 510(k) clearance letter from the FDA for the Semkin Insulated Bipolar Forcep. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter only states that the device is substantially equivalent to legally marketed predicate devices for its intended use, which is "Intended to remove tissue and control bleeding by use of high frequency electrical current." It also mentions general controls provisions and compliance with Good Manufacturing Practice.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study from this document. This typically would be found in the 510(k) summary or a more detailed technical submission, which is not provided here.

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