(102 days)
The HARMONIC FOCUS™ 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, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
The HARMONIC Blue Hand Piece, when used in conjunction with the HARMONIC Scalpel Instrument, is 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.
The HARMONIC FOCUS™ Curved Shears 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 instruments working length is 9cm with a 16mm active blade length. The FOCUS instrument allows for the cutting and coagulation of vessels up to and including 5mm in diameter.
The HARMONIC Blue Hand Piece is designed to convert electrical energy from the HARMONIC Generator to mechanical motion for the instrument blade. The Blue Hand Piece is intended for use exclusively with the HARMONIC Scalpel Generator 300 (Model GEN04). The Blue Hand Piece is permanently attached to a blue cord, which connects to the front of the Generator.
The provided 510(k) summary for the HARMONIC FOCUS™ Curved Shears and Blue Hand Piece does not contain detailed acceptance criteria or the specific results of a study proving the device meets these criteria in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device.
However, based on the information provided, here's a summary of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated | "Bench and preclinical testing was performed to evaluate the performance of the intended use of the new device. The testing shows that the HARMONIC FOCUS™ Curved Shears and the HARMONIC Blue Hand Piece is equivalent to the predicate device." |
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 mentions "Bench and preclinical testing" but does not specify the sample size used for these tests. Data provenance (country of origin, retrospective/prospective) is also not provided.
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 information is not provided. The study mentioned is "Bench and preclinical testing," which typically does not involve human expert consensus for ground truth as it relates to evaluating device performance against pre-defined engineering or biological parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to bench and preclinical testing of a surgical instrument.
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
No such study was mentioned or performed. This type of study (MRMC, AI assistance) is not relevant to the evaluation of a surgical instrument like the HARMONIC FOCUS™.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a surgical instrument. The HARMONIC FOCUS™ is a physical device used by a human surgeon, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the bench and preclinical testing would likely be based on established engineering standards for device function (e.g., cutting efficacy, coagulation effectiveness, thermal spread, mechanical integrity) and biological tissue responses in preclinical models. Specific details are not provided.
8. The sample size for the training set
This is not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device requiring a training set.
Summary of what the submission does indicate regarding performance:
The submission states that "Bench and preclinical testing was performed to evaluate the performance of the intended use of the new device." The conclusion drawn from this testing is that "the HARMONIC FOCUS™ Curved Shears and the HARMONIC Blue Hand Piece is equivalent to the predicate device." This implies that the device met performance standards comparable to, or as good as, the predicate device in relevant testing scenarios, but the specific acceptance criteria and the detailed results are not disclosed in this summary. The focus is on demonstrating "substantial equivalence" to legally marketed predicate devices rather than providing a detailed performance study against explicit acceptance criteria in the requested format.
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