(52 days)
The HARMONIC FOCUS® Long 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, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
The HARMONIC FOCUS+ Long 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. Measured from the blade tip to the MAX hand control power button, the instrument is 17 cm in length with a 16 mm active blade length. The HARMONIC FOCUS+ Long Shears instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.
This document is a 510(k) premarket notification for a medical device, the HARMONIC FOCUS® Long Shears + Adaptive Tissue Technology. It is primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report designed to "prove" the device meets these criteria in the way one might expect for a novel AI device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not directly applicable or available in this type of submission. The submission relies heavily on design verification and validation activities rather than clinical study-style performance metrics.
Here's an attempt to extract and interpret the information based on the provided text, while also noting where information is not present or not relevant to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "Design Specifications" and "Performs as Intended") | Reported Device Performance (From "Performance Data" and "Conclusion") |
|---|---|
| Performs cutting and coagulation of vessels. | Performs cutting and coagulation of vessels up to and including 5 mm in diameter. |
| Produces minimal thermal injury. | Produces minimal thermal injury. |
| Maintains bleeding control. | Maintains bleeding control. |
| Operates using ultrasonic technology. | Operates using ultrasonic technology (HPBLUE handpiece for ultrasonic vibration). |
| Does not have safety or effectiveness affected by design differences from predicate. | Design verification activities confirmed no effect on safety or effectiveness from ergonomic or subtle blade frequency differences. |
| Meets design specifications. | Device performance assessed against design requirements; included process verification, design verification, and design validation. |
| As safe and effective as predicate devices. | As safe and effective as identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter. |
Explanation: The "acceptance criteria" for this type of device are primarily implicit in its intended use, design specifications, and the demonstration of substantial equivalence to a predicate. The "reported device performance" are the general claims made about the device based on the verification and validation activities. Specific quantitative metrics are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as this was not a clinical trial. The "ex-vivo tests" and "design verification and validation" activities would have involved testing a certain number of devices or tissues, but the precise sample sizes for these internal engineering tests are not disclosed in this 510(k) summary.
- Data Provenance: Not applicable. The data comes from internal company testing (ex-vivo tests, design verification, design validation) rather than patient data from a specific country or retrospective/prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for this engineering-focused 510(k) submission is derived from engineering design specifications, performance standards, and comparison to the predicate device's known performance, rather than expert interpretation of medical images or case outcomes.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. There was no clinical test set requiring expert 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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a surgical instrument, not an AI-powered diagnostic tool, so such a study would not be relevant.
- Effect Size of Human Readers: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a surgical instrument that inherently requires human interaction for its function. It is not an AI algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" in this context is the design specifications and performance requirements established by the manufacturer, along with the known performance characteristics of the predicate device. The goal of the testing was to demonstrate that the subject device met these engineering and performance standards and was substantially equivalent to the predicate.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
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