Search Results

"Selecta-Tip" Laparoscopic scissors tips are intended for use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.

The Selecta-Tip" Laparoscopic Scissors are surgical blades used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of reusable tips. The tip assembly is designed with a proprietary single thread and ball system, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Scissors tip configurations include: Metzenbaum, Mini, Hook, Endocut, and Micro.

Here's an analysis of the provided text, focusing on the request for acceptance criteria and study details.

Based solely on the provided text for K970826, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a 510(k) premarket notification for a medical device. The purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific performance metrics through a clinical study.

Therefore, most of your requested information cannot be extracted from this text.

I will populate the table and answer the questions to the best of what the document offers, making it clear when the information is not present.

Acceptance Criteria and Device Performance Study Analysis (K970826)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/Not mentioned. No test set or study data is described.
• Data Provenance: Not applicable/Not mentioned. The document describes the device and its predicate.

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 mentioned. No ground truth establishment described.
• Qualifications of Experts: Not applicable/Not mentioned.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not mentioned. No test set or adjudication process 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

• MRMC Study: No. The device is a surgical instrument (scissors tips), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or described.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not applicable/Not mentioned. No ground truth is described as being established for this submission. The basis for clearance is "Substantial Equivalence" to the predicate, implying the predicate itself established sufficient safety and effectiveness.

8. The sample size for the training set

• Sample Size: Not applicable/Not mentioned. There is no training set described as this is a physical device, not a machine learning model.

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

• Ground Truth Establishment: Not applicable/Not mentioned. No training set or ground truth establishment for a training set is described.

Summary based on the provided text:

The document K970826 is a 510(k) summary focused on establishing substantial equivalence for the "Selecta-Tip" Laparoscopic Scissors to a predicate device, "Re-New (K962119)." It provides details on:

• Submittor information
• Device identification
• Identification of the predicate device
• Device description (reusable handles, detachable scissors tips for various abdominal tissues)
• A statement of substantial equivalence, noting that differences in technical specifications, materials, and physical appearance do not affect relative safety or effectiveness.

Crucially, this document does not contain information about explicit acceptance criteria or a dedicated study with performance metrics, sample sizes, expert adjudication, or ground truth relevant to your specific questions about device performance analysis (e.g., sensitivity, specificity, accuracy often associated with diagnostic tools or complex algorithms). These types of detailed studies are more common for novel devices or those seeking clinical claims beyond substantial equivalence to an already marketed device. For a 510(k) for a surgical instrument, the "proof" often lies in demonstrating that its design, materials, and intended use are similar enough to a device already deemed safe and effective by the FDA.

Ask a specific question about this device