(36 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, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.
The Harmonic FOCUS™ Curved Shears is 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 FOCUS Shears are designed for use with a generator capable of providing electrical energy to the FOCUS device and with a handpiece that converts the electrical energy to mechanical energy.
This document is a 510(k) premarket notification for the Harmonic FOCUSTM shears, specifically requesting a modification to the Indications for Use statement to include otorhinolaryngology procedures. It is not a study proving device performance against acceptance criteria in the manner requested (e.g., in terms of sensitivity, specificity, or other quantitative performance metrics usually associated with AI/software devices).
The device is a surgical instrument, and its performance evaluation for this 510(k) relies on showing substantial equivalence to previously cleared predicate devices, rather than a de novo clinical study with specific acceptance criteria and performance reporting as one might see for diagnostic AI.
Therefore, much of the requested information cannot be directly extracted from the provided text. I will address what can be inferred and explicitly state what is not available.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the form of quantitative performance metrics (e.g., a specific success rate, accuracy, etc.) for the device itself or for its application in otorhinolaryngology. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices.
The key performance claim related to the device's function is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to seal vessels | "The Harmonic FOCUS shears device will seal vessels up to and including 5mm in diameter." |
| Safety and effectiveness in otorhinolaryngology (ENT) procedures | "An assessment of published clinical literature demonstrates that there is a considerable body of knowledge and experience that show the use of ultrasonic Harmonic technology in otorhinolaryngological (ENT) procedures is as safe and effective as predicate technology for use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The submission relies on prior performance data (K063192) and clinical literature assessment for the safety and effectiveness in ENT procedures, rather than a new test set for this specific 510(k) modification.
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 applicable/provided. There was no new "test set" in the context of diagnostic performance that would require expert adjudication. The "ground truth" for the device's performance (e.g., vessel sealing capability) would have been established through engineering tests or animal/cadaver studies during the predicate device's clearance. For the literature review, the "experts" are the authors of the published clinical literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided for the reasons stated above.
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
This information is not applicable. This device is a surgical instrument, not an AI or diagnostic software that would involve human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the claims in this submission is implicit:
- Vessel sealing capability: Likely established through pre-clinical (e.g., in vitro, cadaver, or animal) studies, along with standard engineering and functional testing.
- Safety and effectiveness in ENT: Established through published clinical literature on ultrasonic Harmonic technology, comparing it to predicate technologies. This would primarily rely on outcomes data reported in those studies (e.g., bleeding control, thermal injury, surgical efficacy, patient safety).
8. The sample size for the training set
This information is not applicable/provided. This is not an AI/ML device that uses a "training set."
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated above.
Summary of Approach for This 510(k):
The manufacturer's strategy for this 510(k) was to demonstrate substantial equivalence to existing, legally marketed predicate devices. This involves showing that the modified device has the "same intended use, the indications for use, the technological characteristics and the energy requirements of the systems." For the specific inclusion of otorhinolaryngology, they relied on existing "clinical literature" to show that ultrasonic Harmonic technology (the core technology) is already proven safe and effective in this field. They explicitly state, "The design of the Harmonic FOCUS Shears is essentially unchanged and the performance data provided in K063192 is still applicable to the device."
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