(157 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.
The Reprocessed 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.
The provided text describes the regulatory clearance for a reprocessed medical device, specifically the "Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology." It details the device's indications for use, its characteristics, and the non-clinical tests performed to demonstrate its substantial equivalence to an original predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with quantitative targets and reported performance in the format typically seen for AI device studies (e.g., sensitivity, specificity thresholds). Instead, for this reprocessed surgical instrument, the acceptance criteria are implicitly defined by demonstrating that the reprocessed device performs as "originally intended" and is "substantially equivalent" to the original predicate device through a series of functional, safety, and sterilization tests.
From the "Summary of Non-Clinical Tests Conducted" section, the performance tests conducted include:
| Test Performed | Reported Device Performance |
|---|---|
| Grasping Force | Performed and found to be equivalent |
| Artery Seal Burst and Tissue Adhesion | Performed and found to be equivalent |
| Vein Seal Burst and Tissue Adhesion | Performed and found to be equivalent |
| Electrical and Thermal Safety IEC 60601 | Performed and found to be equivalent |
| Tissue (Jaw) Pad Life | Performed and found to be equivalent |
| Tissue (Jaw) Pad Removal Force | Performed and found to be equivalent |
| Thermal Spread and Transection Time | Performed and found to be equivalent |
| Cleaning Validation | Validated |
| Sterilization Verification | Verified |
| Ethylene Oxide Residual Testing (ISO 10993-7) | Performed and found to be compliant |
| Packaging Validation (ASTM D4169, ASTM F88, ASTM F2096) | Validated |
| Shelf-Life Validation (ASTM 1980-07) | Validated |
| Biocompatibility Testing (ISO 10993-1) | Compliant (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity) |
The overall conclusion states: "Performance testing shows the Harmonic FOCUS Shears + Adaptive Tissue Technology performs as originally intended." and "Results demonstrated substantial equivalence to the predicate devices with respect to safety and effectiveness."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each performance test. It mentions "Reprocessed devices were tested" and "Each device and accessory are marked and tracked through the reprocessing cycle." The testing appears to be conducted on samples of the reprocessed devices. The provenance is not explicitly stated in terms of country of origin of data or whether it was retrospective or prospective. It is implied to be prospective testing of reprocessed devices manufactured by SterilMed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a physical medical device, not an AI or imaging device that requires expert interpretation for ground truth. Therefore, the concept of "experts" establishing ground truth in this context is not applicable. The performance is assessed through objective engineering and biological tests, not human interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is objective performance testing of a physical device, not an interpretative task requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI or imaging device, and there is no human reader component. The study compares the performance of the reprocessed device against its original predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical surgical instrument, not an algorithm. The "standalone performance" in this context refers to the device's functional integrity and safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's reprocessed performance is established by:
- Predicate Device Performance: The original HARMONIC FOCUS® Shears + Adaptive Tissue Technology (Ethicon K133314) serves as the benchmark for expected performance.
- Accepted Standards: Compliance with various international and national standards (e.g., ISO 10993-7, ISO 10993-1, IEC 60601, ASTM D4169, ASTM F88, ASTM F2096, ASTM 1980-07) for sterilization, biocompatibility, packaging, and electrical safety.
- Engineering Specifications: The device's original design specifications for grasping force, seal burst, tissue adhesion, jaw pad life, removal force, thermal spread, and transection time.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device 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 this type of device.
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