(224 days)
The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, gynecologic, ENT (Ears, Nose, Throat), thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Ultracision Harmonic Scalpel is a cutting and coagulating surgical instrument. The device system has three essential parts: the generator/foot-switch, the hand piece, and the blades. The blades are offered in a variety of configurations, shapes and sizes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ultracision Harmonic Scalpel:
It's important to note that the provided text is a summary of safety and effectiveness for a 510(k) submission to the FDA in 1999. It focuses on demonstrating substantial equivalence to predicate devices. As such, the level of detail regarding specific acceptance criteria and detailed study breakdowns (especially for AI/ML-related aspects) is not present because this device predates the widespread use of such methodologies in medical device clearances.
Missing Information: Many of the requested details (especially surrounding AI/ML, clinical study design, and detailed performance metrics) are not applicable or provided in this type of 510(k) summary for a surgical instrument from 1999.
Acceptance Criteria and Device Performance
The "acceptance criteria" for a 510(k) submission like this are generally demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. Specific quantitative performance metrics with defined acceptance thresholds are not explicitly listed in the provided summary as they might be for a novel diagnostic algorithm.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):
| Acceptance Criteria (Inferred for 510(k) Substantial Equivalence to Predicate Devices) | Reported Device Performance |
|---|---|
| Intended Use: Cut and coagulate soft tissues for specific surgical fields. | The device is intended for the same use as predicates. (The clearance implies this was accepted). |
| Bleeding Control: Achieve desired bleeding control. | "All bench and animal studies demonstrated satisfactory performance in cutting and coagulation." (This implies adequate bleeding control was observed.) |
| Minimal Thermal Injury: Minimize thermal injury. | "All bench and animal studies demonstrated satisfactory performance in cutting and coagulation." (This implies minimal thermal injury was achieved, as it's a key benefit of ultrasonic devices over electrosurgery). |
| Technological Characteristics: Be similar to predicate devices. | "The technological characteristics of the Ultracision Harmonic Scalpel are the same as the predicate devices. Ultrasonic technology is the method of activation." |
| Biocompatibility: Meet ISO 10993-1 for patient contact. | "The Harmonic Scalpel is constructed wholly of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile." |
| Safety and Effectiveness: Demonstrate satisfactory cutting and coagulation. | "All bench and animal studies demonstrated satisfactory performance in cutting and coagulation." (This is a general statement rather than specific quantitative data, but it satisfied the FDA for substantial equivalence). |
Study Details
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Sample size used for the test set and the data provenance:
- The document mentions "bench and animal studies."
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Animal studies typically refer to non-human animal models.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not specified. The studies were likely performed by engineers, veterinarians, and/or surgeons associated with the manufacturer, rather than independent experts establishing a "ground truth" in the way it's done for diagnostic AI/ML algorithms.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not specified. This concept is typically relevant for expert-consensus ground truth in diagnostic studies, which is not described here.
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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. This is a surgical instrument from 1999, not an AI/ML diagnostic or assistive device. MRMC studies or AI assistance were not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a manually operated surgical instrument. The concept of "standalone algorithm performance" is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench studies, ground truth would be based on engineering measurements (e.g., cut speed, temperature profiles, dissection depths, tissue adherence).
- For the animal studies, ground truth would be based on direct observation of surgical outcomes by trained personnel (e.g., completeness of cut, quality of coagulation, absence of excessive thermal damage to surrounding tissue, healing response in long-term animal models if included). No specific ground truth methodology is detailed in this summary.
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The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.