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510(k) Data Aggregation
(48 days)
HARMONIC 10CM COMBINATION HOOK BLADE
The Harmonic™ 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 in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space), ENT (Ears, Nose, Throat), and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Harmonic TM 10 cm Combination Hook Blade is a sterile, single patient use instrument consisting of a titanium blade with a non-removable sheath. The working instrument length is 10 cm and the outer shaft diameter tapers from 8.5 mm proximally to 5.5 mm distally. The Harmonic™ 10 cm Combination Hook Blade must be used with the 5 mm Adaptor or Hand Switching Adaptor and connected to the Harmonic Hand Piece and Generator prior to use. The Harmonic™ 10 cm Combination Hook Blade is designed for use exclusively with the Harmonic™ Generator 300 (GEN04) and Harmonic™ Hand Piece (HP054), packaged separately. The Harmonic™ Generator 300 System User Manual should be referenced before using these instruments. The Harmonic™ 10 cm Combination Hook Blade allows for the coagulation of vessels up to and including 2 mm in diameter.
The provided 510(k) summary describes a surgical instrument, the HARMONIC™ 10 cm Combination Hook Blade, not an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria, study methodologies, ground truth establishment, expert adjudication, and comparative effectiveness studies for AI/ML-based devices is not applicable to this submission.
This document focuses on demonstrating substantial equivalence to predicate devices through bench and animal testing for physical and functional characteristics, and biocompatibility.
Here's a breakdown of the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria with corresponding performance data in the typical sense for an AI/ML device. Instead, it describes performance through qualitative statements and refers to testing demonstrating intended use and substantial equivalence.
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Design Parameters | Function as intended and be substantially equivalent to predicate devices. | Bench testing was performed to evaluate design parameters and demonstrate substantial equivalence to the HARMONIC™ Dissecting Hook and HARMONIC™ Sharp Curved Blade. |
| Hemostasis | Adequately achieve hemostasis for vessels up to and including 2mm in diameter. | Animal (porcine acute) study used to evaluate the device for hemostasis of vessels up to and including 2mm in diameter. The animal studies support the transection of vessels up to and including 2mm in diameter. |
| Transection | Adequately achieve transection for vessels up to and including 2mm in diameter. | Animal (porcine acute) study used to evaluate the device for transection of vessels up to and including 2mm in diameter. The animal studies support the transection of vessels up to and including 2mm in diameter. |
| Biocompatibility | Meet ISO10993-1: Biological Evaluation of Medical Device requirements for the appropriate level of tissue contact. | Manufactured with materials that meet ISO10993-1. Biocompatibility for limited patient contacting materials established through history of use in other marketed Ethicon Endo-Surgery medical devices. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Bench Test: Not specified.
- Animal Testing: Not specified, other than it was a "porcine acute study."
- Data Provenance:
- Animal Testing: Porcine (pig) model.
- Biocompatibility: Based on material certification (ISO10993-1) and history of use in other Ethicon Endo-Surgery devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a surgical instrument. "Ground truth" in the context of AI/ML diagnostic devices (e.g., expert consensus on images) is not relevant here. The evaluation involves physical performance and biological safety.
4. Adjudication method for the test set
N/A. Adjudication methods like "2+1" are for AI/ML diagnostic output interpretation. For this device, the evaluation would likely involve objective measurements and observations during bench and animal testing, performed by qualified personnel, consistent with Good Laboratory Practice (GLP).
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
N/A. This is not an AI/ML device, so MRMC studies where human "readers" interact with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical surgical instrument, not an algorithm.
7. The type of ground truth used
- Bench Testing: Engineering measurements, functional tests to compare against predicate device performance specifications.
- Animal Testing: Direct observation of hemostasis and transection in a biological model (porcine tissue).
- Biocompatibility: Conformance to ISO standards and established material safety profiles.
8. The sample size for the training set
N/A. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
N/A. Not an AI/ML device.
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