FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The HARMONIC FOCUS® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Device Description

The Ethicon Endo-Surgery HARMONIC FOCUS Shears + Adaptive Tissue Technology is a sterile, single-patient use surgical instrument consisting of a soft grip scissor handle housing assembly with two hand controls (MIN for minimum power level and MAX for maximum power level). The instrument's working length is 9 cm in length with a 16 mm active blade length. The instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.

AI/ML Overview

Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria

The provided 510(k) summary for the HARMONIC FOCUS Shears + Adaptive Tissue Technology does not explicitly list acceptance criteria in a quantitative table format or a detailed study protocol for performance. However, based on the Performance Data section, the general acceptance criteria are:

Equivalence to the predicate device: The HARMONIC FOCUS Shears + Adaptive Tissue Technology device performance was equivalent to the predicate (HARMONIC FOCUS® Shears, K100597) in terms of safety and effectiveness.
Effective cutting and coagulation: The device effectively cuts and coagulates soft tissue and seals vessels up to 5 mm in diameter.
Biocompatibility: The device is biocompatible.
Electrical safety and EMC compliance: The device meets electrical safety and electromagnetic compatibility (EMC) standards.

The study that proves the device meets these acceptance criteria is described as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Performance Goal	Reported Device Performance
Equivalence to Predicate	Overall safety and effectiveness comparable to HARMONIC FOCUS® Shears (K100597).	"The results demonstrate the HARMONIC FOCUS Shears + Adaptive Tissue Technology device performance was equivalent to the predicate."
"The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology are as safe and effective and perform as well as the identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ."
Functional Performance	Effective cutting and coagulation of soft tissue and vessels up to 5 mm.	"The results of those evaluations demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology effectively cut and coagulated vessels 1 to 5mm in diameter."
"The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology are as safe and effective and perform as well as the identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ."
Material Safety	Biocompatibility	"Biocompatibility studies... were performed." (Implies positive outcome indicating compliance).
Electrical Safety	Electrical safety compliance	"electrical safety testing... were performed." (Implies positive outcome indicating compliance).
EMC Compliance	Electromagnetic compatibility (EMC) compliance	"EMC testing were performed." (Implies positive outcome indicating compliance).

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

Sample Size: Not explicitly stated for either bench testing or animal models. The document refers to "laboratory evaluations in an animal model" and "biocompatibility studies, electrical safety testing, and EMC testing" without specifying the number of samples or animals used.
Data Provenance: The studies were preclinical laboratory evaluations and non-clinical bench testing. The country of origin of the data is not specified but is typically internal to the company or contracted labs. The studies were prospective in nature, designed specifically to test the new device.

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

Not applicable. This submission does not involve human clinical data or expert visual/interpretive assessment of medical images/data. The "ground truth" for this device's performance relies on objective measurements from bench testing (e.g., power output, blade temperature, vessel sealing strength, cutting speed) and direct observation/assessment in animal models.

4. Adjudication Method for the Test Set

Not applicable. As the "ground truth" for performance was based on objective measurements and direct observation in controlled environments (bench and animal labs), there was no need for an adjudication method by human experts for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "This premarket notification does not rely on data from human clinical trials to demonstrate substantial equivalence. Clearance was based on non-clinical and preclinical testing." This type of study is typically used for diagnostic devices involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The performance studies described (biocompatibility, electrical safety, EMC, bench testing, and animal model evaluations) assess the device's inherent mechanical and electrical functionality, including its "Adaptive Tissue Technology" algorithm, in a standalone manner without human subjective input affecting the outcome of the performance metrics. The algorithm's function (reducing power, providing a secondary tone) is evaluated by observing its effect on the physical performance of the instrument.

7. Type of Ground Truth Used

Objective Measurements and Direct Observation/Assessment:
- Bench Testing: Mechanical properties, electrical characteristics, thermal profiles, cutting efficacy, coagulation performance (e.g., burst pressure for sealed vessels).
- Animal Models: In vivo assessment of cutting and coagulation effectiveness on vessels of specific diameters (1-5mm), observation of acute and 30-day chronic healing responses, and assessment of thermal injury.

8. Sample Size for the Training Set

Not applicable/Not specified. This device uses an "Adaptive Tissue Technology algorithm" but the 510(k) summary does not indicate that this algorithm was "trained" in the typical machine learning sense using a specific dataset. It refers to "power output algorithm that is utilized by the devices" and "algorithm parameters stored on the device EEPROM." It is more likely a rule-based or control algorithm designed based on engineering principles and validated through the performance studies rather than a machine learning model requiring a discrete "training set."

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

Not applicable. As described in section 8, a "training set" in the context of machine learning is not implied or specified for this device's algorithm. The "ground truth" for developing the algorithm's parameters would have been established through engineering design, material science, and possibly iterative prototyping and testing to optimize the power delivery for different tissue conditions.

Summary

Regulation Number and Section

N/A