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The Medline ReNewal Harmonic ACE+7 Shears 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 steel scalpels in general, plastic, pediatric, gyneoologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.

Device Description

The Medline ReNewal Reprocessed Harmonic ACE+7 Shears (models HARH23, HARH36, and HARH45) are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch.

AI/ML Overview

This document is a 510(k) summary for the Medline ReNewal Reprocessed Harmonic ACE+7 Shears, which is a reprocessed medical device. It aims to demonstrate substantial equivalence to a legally marketed predicate device.

Acceptance Criteria and Device Performance (Based on the document):

The document primarily focuses on demonstrating substantial equivalence to the predicate device (Ethicon Harmonic ACE+7 Shears, K132612) through comparisons of various characteristics and performance testing. The "acceptance criteria" here implicitly refer to meeting the performance and safety profiles of the original device after reprocessing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance testing conducted to ensure equivalency after reprocessing. The acceptance criteria are implied to be achieving results comparable to or within acceptable ranges of the original, new device.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Summary from "Performance Testing" section)
Electrical Safety & EMC	Compliance with IEC 60601-1 and 60601-1-2	"Evaluated and found to be equivalent to the predicate devices in accordance with IEC 60601-1 and 60601-1-2"
Simulated Use	Equivalent performance during simulated surgical use	"Evaluated and found to be equivalent to the predicate devices"
Device Integrity	Maintenance of structural and functional integrity	"Evaluated and found to be equivalent to the predicate devices"
Handle Operation	Proper and equivalent handle functionality	"Evaluated and found to be equivalent to the predicate devices"
Shaft Knob Rotation	Smooth and effective shaft rotation	"Evaluated and found to be equivalent to the predicate devices"
Device Recognition	Proper recognition by the associated generator (Ethicon GEN11)	"Evaluated and found to be equivalent to the predicate devices" (Specifically, the ReNewal Key-integrated flex circuitry enables additional use, implying successful recognition for subsequent use).
Cutting Time	Comparable cutting efficiency/speed	"Evaluated and found to be equivalent to the predicate devices"
Thermal Analysis Characterization	Comparable thermal profiles to minimize thermal injury	"Evaluated and found to be equivalent to the predicate devices"
Tissue Sticking	Comparable minimal tissue sticking properties	"Evaluated and found to be equivalent to the predicate devices"
Burst Pressure	Maintenance of vessel sealing integrity/strength	"Evaluated and found to be equivalent to the predicate devices"
Histopathology	Comparable tissue effects related to coagulation and transection	"Evaluated and found to be equivalent to the predicate devices"
Seal Quality	Effective and consistent tissue sealing	"Evaluated and found to be equivalent to the predicate devices"
Cleaning (Protein, Carbohydrates, Endotoxin)	Demonstration of effective decontamination/sterilization from biological residue	All tests passed; specific levels not provided but implied to meet acceptable limits for reprocessing.
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Materials-mediated Pyrogen, Acute Systemic Toxicity)	No unacceptable biological reactions from reprocessed materials	All tests passed; implied to meet acceptable standards for patient contact.
Performance Qualification	Overall device performance consistently meeting specifications	"Evaluated and found to be equivalent to the predicate devices"
Sterilization Validation	Device can be effectively sterilized for patient safety	Passed and achieved required sterility assurance levels.

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

The document broadly states that the functional characteristics were "evaluated." It does not specify the exact sample sizes (N) for each of the performance tests listed. The data provenance is implied to be from prospective testing conducted by Medline ReNewal as part of their 510(k) submission process for the reprocessed device. There is no indication of country of origin for the testing, other than the submitting company being based in the USA.

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

This document describes technical and functional performance testing of a physical medical device, not an AI/algorithm-based diagnostic device. Therefore, the concept of "experts used to establish ground truth" (e.g., radiologists, pathologists) for interpreting test results is not applicable in the same way as for diagnostic AI. The "ground truth" for the device's performance is established by the direct measurements and results of the physical and biological tests against established engineering and safety standards. The individuals conducting and analyzing these tests would be qualified engineers, technicians, and potentially toxicologists/biologists. The document doesn't specify how many or their exact qualifications.

4. Adjudication Method for the Test Set:

Not applicable in the context of this device's performance testing. Adjudication methods like 2+1 or 3+1 are typical for human interpretation of medical images or data, not for direct physical performance measurements. The results of the tests would be objectively measured and compared to predefined criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of an AI system on human reader performance in diagnostic tasks, which is not the subject of this 510(k) submission for a reprocessed surgical instrument.

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

This is not applicable as the device is a physical surgical instrument (Harmonic ACE+7 Shears), not an AI algorithm. Its performance is inherent to the reprocessed device itself.

7. The type of ground truth used:

The "ground truth" for this reprocessed device is established through various physical, electrical, mechanical, and biological measurements against established engineering specifications and safety standards for the original device and similar devices. This includes:

Direct measurements of cutting time, burst pressure, and other functional parameters.
Results from standardized cleaning and sterilization validation protocols.
Outcomes of biocompatibility testing.
Comparisons against the performance data of the original predicate device (implicitly serving as a benchmark for acceptable "ground truth" performance).

8. The sample size for the training set:

Not applicable. This device is a physical reprocessed medical instrument and does not involve AI or machine learning models that require training sets.

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

Not applicable, as there is no training set for this device.

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