ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141

• K Number: K993054
• Device Name: ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141
• Manufacturer: ETHICON ENDO-SURGERY, INC.
• Date Cleared: 1999-12-09 ( 87 days)
• Product Code: LFL
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K980099 , K925699

Intended Use

The Ultracision Harmonic Scalpel Curved LCS and CS 5 mm instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and scalpels in abdominal, pediatric, gynecologic and other endoscopic procedures.

Device Description

The UltraCision instruments are hand-held instruments which cut and coagulate tissue when attached to the ultrasonic hand piece and generator.

AI/ML Overview

This document pertains to a 510(k) premarket notification for the UltraCision® Harmonic Scalpel® LCS and CS Curved Shears. It describes the device, its intended use, and states that preclinical testing was performed. However, it does not contain specific acceptance criteria, detailed study designs, or reported performance data in a quantitative format that would allow for a direct comparison against acceptance criteria.

The information provided is typical for a 510(k) summary, which generally focuses on substantial equivalence to predicate devices rather than detailed performance against specific acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information as requested. The document explicitly states:

• "Preclinical testing was performed to ensure that the devices perform as intended. All bench and animal studies demonstrated satisfactory performance in cutting and coagulation." (Page 1)

This is a high-level summary and does not include the detailed breakdown required for your request.

Summary of unavailable information from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document only offers a general statement that performance was "satisfactory."
2. Sample sizes used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed ground truth establishment is not mentioned for preclinical studies of this nature.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not performed, as this is a surgical instrument and not an AI-assisted diagnostic device. The context of MRMC studies is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a surgical instrument, not an algorithm.
7. The type of ground truth used: Not explicitly stated beyond "bench and animal studies."
8. The sample size for the training set: Not applicable, as this is a surgical instrument, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Regulation Number and Section

N/A