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Tayman Medical AccuGuide is used to mount disposable 18 gauge x 20 centimeter automated biopsy needles to the CLI 4900 Utrasound Probe manufactured by Capistrano Labs for the purpose of accurately guiding the needle to the site where the biopsy sample is to be taken.

Tayman Medical Inc., AccuGuide comprises a steel spring mounting clip, a stainless steel mounting tab and a stainless steel biopsy needle guide tube.

The Tayman Medical AccuGuide is comprised of three basic components: the probe clamp, the mounting tab, and the biopsy needle guide tube.

Probe Clamp - the probe clamp is made of medical grade hard chrome plated steel it provides a spring force to hold the Tayman Medical AccuGuide to the ultrasound probe. The probe clamp does not contact the patient.

Mounting Tab - the mounting tab is made of stainless steel. It provides a common joining point for the other components and acts as a stabilizer between the Tayman Medical AccuGuide and the ultrasound probe. The mounting tab does not contact the patient.

Biorsy Needle Guide Tube - the biopsy needle guide tube is made of stainless steel. It guides the needle along the predetermined path. This component contact intact tissue. This component is designed in a low profile with a smooth, rounded tip.

The provided text describes a 510(k) premarket notification for the Tayman Medical AccuGuide, a biopsy guide device. However, the submission does not contain information on acceptance criteria, a study proving device performance against those criteria, or details regarding clinical studies (like sample sizes, ground truth establishment, or expert involvement).

The document focuses on demonstrating substantial equivalence to a predicate device (Teknar, Inc. Biopsy Needle Guide Attachments, K881605) based on device description, intended use, and material similarities.

Therefore, I cannot provide the requested information from the given text. The relevant sections of your request are answered as "Not provided in the document."

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not provided in the document.
• Data provenance: Not provided in the document. The document describes the device's components and compares them to a predicate device, but no clinical or performance testing data is presented.

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

• Not provided in the document. No test set or ground truth establishment is described.

4. Adjudication method for the test set

• Not provided in the document. No test set 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 biopsy guide, not an AI-powered diagnostic tool for human readers. No MRMC study is mentioned.

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

• Not applicable. This device is a mechanical biopsy guide, not an algorithm. No standalone performance study is mentioned.

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

• Not provided in the document. No ground truth is mentioned as no performance studies are described.

8. The sample size for the training set

• Not applicable. This device is a mechanical biopsy guide, not an AI model requiring a training set.

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

• Not applicable. This device is a mechanical biopsy guide, not an AI model requiring a training set.

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The Tayman Medical, Inc. Stepping and Stabilization System is used to provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate cancer.

The seeding device is comprised of three basic components. The adjustable height base. The adjustable, multi-axis head. The ultrasound probe holder and needle guide.

The provided text is a summary of safety and effectiveness for a medical device (Tayman Medical, Inc. Stepping and Stabilization System). It describes the device, its intended use, and its similarities to a predicate device.

However, the document does not contain any information regarding acceptance criteria, study results, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in the prompt.

Therefore, I cannot fulfill the request using the provided input. The document focuses on regulatory equivalence rather than performance evaluation against specific criteria.

Ask a specific question about this device