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510(k) Data Aggregation
(289 days)
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology is 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, otorhinolaryngolic (ear, nose and throat [ENT]), plastic, pediatic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected, packaged, and sterilized for an additional clinical use.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology. The focus of the acceptance criteria and study is on demonstrating substantial equivalence to a predicate device, rather than on a new AI/algorithm-driven device with standalone performance or human-in-the-loop studies.
Therefore, the requested information on AI-specific criteria (like effect size of AI assistance, standalone algorithm performance, training set details, and expert adjudication methods for a test set based on expert ground truth) is not applicable to this document. This document describes the testing for substantial equivalence of a reprocessed surgical instrument.
Here's the information that can be extracted from the provided text, tailored to the context of a reprocessed medical device:
Acceptance Criteria and Device Performance (for a Reprocessed Surgical Instrument)
The study focuses on demonstrating substantial equivalence of the reprocessed device to the predicate device. The acceptance criteria are implicit in the performance testing conducted to show that the reprocessed device maintains the functional characteristics and safety profile of the original device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Functional Performance | Simulated Use | Evaluated and found to be substantially equivalent to the predicate device (implies meeting intended functional parameters) |
| Grasping/Pulling Force | Evaluated and found to be substantially equivalent to the predicate device | |
| Cutting Effectiveness/Functionality | Evaluated and found to be substantially equivalent to the predicate device | |
| Drop Test | Evaluated and found to be substantially equivalent to the predicate device | |
| Device Integrity | Evaluated and found to be substantially equivalent to the predicate device | |
| Cutting/Coagulation Evaluation for a Prolonged Period of Time | Evaluated and found to be substantially equivalent to the predicate device | |
| Thermal Analysis Characterization | Evaluated and found to be substantially equivalent to the predicate device | |
| Tissue Sticking | Evaluated and found to be substantially equivalent to the predicate device | |
| Vessel Burst Pressure | Evaluated and found to be substantially equivalent to the predicate device | |
| Safety & Biocompatibility | Electrical Safety (in accordance with IEC 60601-1) | Evaluated and found to be substantially equivalent to the predicate device |
| Cleaning (Protein, Carbohydrates, Hemoglobin, and Endotoxins) | Evaluated and found to be substantially equivalent to the predicate device (implies residual levels within acceptable limits) | |
| Biocompatibility (Sensitization, Irritation, and Acute Systemic Toxicity) | Evaluated and found to be substantially equivalent to the predicate device (implies no unacceptable biological reactions) | |
| Sterility & Stability | Performance Qualification | Evaluated and found to be substantially equivalent to the predicate device |
| Sterilization Validation | Evaluated and found to be substantially equivalent to the predicate device (implies maintaining sterility assurance level) | |
| Product Stability | Evaluated and found to be substantially equivalent to the predicate device | |
| Overall Conclusion | The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device. Based on the information provided, the Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology are substantially equivalent to the predicate device. | The conclusion states that the device meets the criteria for substantial equivalence to the predicate device based on the comprehensive testing performed across functional, safety, and operational aspects. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test performed (e.g., number of reprocessed devices tested for "simulated use" or "tissue sticking"). The nature of these tests for a physical device would involve a defined number of units or test cycles, but these numerical details are not provided in the summary.
Data Provenance: The data provenance is from the manufacturer (Medline ReNewal) and is part of their submission to the FDA for a 510(k) premarket notification. It is derived from testing conducted specifically for this reprocessed device to demonstrate its equivalence. The document does not specify the country of origin of the data or explicitly state whether it's retrospective or prospective, but testing for a 510(k) submission is typically prospective for the purpose of the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. This is a submission for a reprocessed physical medical device, not an AI/software device that relies on expert interpretation to establish ground truth for a test set. The "ground truth" for this device would be its physical and functional specifications and performance against established standards and the predicate device, demonstrated through objective tests.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods like 2+1 or 3+1 are used when human interpretation of data (e.g., images for a diagnostic AI) is ambiguous and requires expert consensus to establish a definitive ground truth. For a physical device undergoing performance testing, the results are typically quantitative or directly observable and do not require this type of expert adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This document describes a reprocessed surgical instrument, which does not involve human readers interpreting cases with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical surgical instrument. The concept of "standalone algorithm performance" does not apply. The device's performance is inherently "standalone" in that it performs its physical function.
7. The Type of Ground Truth Used
The "ground truth" for this reprocessed device is established through:
- Predicate Device Specifications and Performance: The original manufacturer's specifications and the known performance characteristics of the legally marketed predicate devices (K133314, K124033, K100597) serve as the benchmark.
- Industry Standards: Compliance with relevant industry standards, such as IEC 60601-1 for electrical safety.
- Objective Performance Metrics: Direct measurement of physical and functional characteristics (e.g., grasping force, cutting effectiveness, residual levels after cleaning, sterility validation).
- Biocompatibility Testing: Ensuring that the reprocessed device does not pose new or increased biological risks.
8. The Sample Size for the Training Set
Not Applicable. This document describes a reprocessed physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.
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