(49 days)
The Reprocessed 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, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are a sterile, single patient use 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 has a curved blade and clamp arm with Teflon pad. The instrument is 9 cm in length with a 16 mm active blade length. The Reprocessed HARMONIC FOCUS®+ Shears instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. Each Reprocessed HARMONIC FOCUS®+ Shears instrument is packaged with one sterile, single patient use, disposable Torque Wrench.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, the "Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the de novo effectiveness of a novel device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI/ML or diagnostic devices with quantifiable performance metrics (like sensitivity, specificity, AUC) is not directly applicable in the same way.
However, we can interpret acceptance criteria in the context of this 510(k) as demonstrating that the reprocessed device performs as well as the original predicate device, and that the reprocessing itself does not introduce new safety or effectiveness concerns.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided document for each specific point:
Acceptance Criteria and Study for Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
In the context of this 510(k) submission for a reprocessed device, the "acceptance criteria" are implicitly tied to demonstrating that the reprocessed device is substantially equivalent to the original predicate device and that the reprocessing process does not compromise safety or effectiveness. The "study" refers to the performance data submitted to the FDA to support this claim.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a reprocessed device, the acceptance criteria are not explicitly defined as numerical thresholds for specific performance metrics like those for a diagnostic AI. Instead, they are comparative, aiming to show that the reprocessed device performs equivalently to the new, original device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Device | "The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended." This generally means that the reprocessed device should not introduce new safety risks and should achieve the same clinical outcomes as the original device. Specific tests contributing to this include: |
- Electrical Safety: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
- Electromagnetic Compatibility: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
- Functional Performance (Comparative): Evaluation of ability to seal and divide vessels up to 5mm, including:
- Thermal spread
- Transection time
- Burst pressure
- Device functionality
- Device reliability
- Preclinical Laboratory Evaluations (Animal Model): Acute and chronic survival studies to evaluate thermal spread and ability to achieve hemostasis. |
| Biocompatibility | Testing was conducted. (Assumed acceptance: demonstrates no new biocompatibility risks after reprocessing). |
| Validation of Reprocessing | Testing was conducted. (Assumed acceptance: demonstrates the reprocessing method effectively cleans, restores, and prepares the device for reuse without degradation or contamination). The description mentions "removal of adherent visible soil and decontamination." |
| Sterilization Validation | Testing was conducted. (Assumed acceptance: demonstrates the reprocessed device is sterile). |
| Packaging Validation | Testing was conducted. (Assumed acceptance: demonstrates packaging maintains sterility and device integrity). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for the "bench and laboratory testing" or the "preclinical laboratory evaluations." It mentions "animal model" but not the number of animals or trials. The data provenance is internal to the manufacturer's testing, presumably conducted at their facilities or certified labs. No indication of country of origin of data beyond where Stryker Sustainability Solutions operates (Tempe, Arizona). The studies are inherently prospective in nature, as they involve testing the reprocessed devices under controlled conditions.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided in the document. For a reprocessed surgical instrument, "ground truth" is not established by expert consensus on image interpretation, but rather by objective physical, chemical, and biological testing as outlined above (e.g., burst pressure measurements, bacterial counts, visual inspection criteria, etc.). There would be engineers, microbiologists, and other technical experts involved in conducting and interpreting these tests, but they are not "experts establishing ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert interpretation of data (e.g., medical images) to establish a consensus ground truth. For instrument performance testing, the results are typically quantitative measurements or pass/fail criteria based on defined specifications, not subjective interpretation requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are conducted for diagnostic devices (often AI-assisted) to assess how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. This document is for a physical surgical instrument, not a diagnostic tool where human interpretation is involved.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. There is no AI algorithm being evaluated for its standalone performance in a diagnostic capacity. The "Adaptive Tissue Technology" refers to algorithms within the generator that communicate with the device to optimize energy delivery, but this is an integrated system functionality, not a standalone diagnostic algorithm. The functional performance tests implicitly evaluate the device's performance, which includes the integrated technology, without specific focus on "algorithm-only" performance as a separate entity.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Physical and Mechanical Measurements: Such as thermal spread, transection time, burst pressure, device functionality, and reliability, measured against predetermined specifications or compared to the predicate device's performance.
- Biological/Chemical Testing: Biocompatibility, sterilization validation (e.g., sterility assurance level), and validation of cleaning (e.g., residual protein levels, visual cleanliness).
- Preclinical (Animal Model) Outcomes: Evaluation of hemostasis and thermal spread in vivo.
This is distinct from "expert consensus," "pathology," or "outcomes data" in the context of diagnostic performance.
8. Sample Size for the Training Set
Not applicable. This is a reprocessed physical device, not an AI/ML algorithm that learns from a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm in this submission.
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