(11 days)
The Arthroscopic Energy System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
The ConMed Arthroscopic Energy System consists of a radiofrequency (RF) generator, probes or electrodes, a dispersive pad (as needed), and wired or wireless foot controls. The probes or electrodes are single-use devices used with the Arthroscopic Energy System for the purpose of wet field arthroscopic and orthopedic soft tissue resection (dissection), ablation (removal) and coagulation (hemostasis). The generator is compatible with ConMed monopolar and bipolar probes or electrodes. The generator outputs are delivered to the probes or electrode handpieces within the specification ranges currently cleared and marketed by generators that have equivalent indications. The generator has a liquid crystal display (LCD) touch screen user interface. Power levels are assigned numeric values and are adjustable via the user interface. Control is accomplished via probe or electrode hand-piece controls, wired foot control or wireless foot control.
The provided document pertains to a 510(k) premarket notification for the ConMed Arthroscopic Energy System. The document focuses on establishing substantial equivalence to a predicate device (K140578) rather than presenting a detailed study proving the device meets specific acceptance criteria based on performance metrics.
Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-based devices or devices demonstrating novel performance, is not present in this regulatory submission.
Here's what can be extracted and inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance in terms of clinical or technical metrics (e.g., accuracy, precision, efficacy rates) for the Arthroscopic Energy System itself.
Instead, the performance data presented is focused on demonstrating the functionality and safety of a modification (Footswitch, Extension Cable) and adherence to regulatory standards:
Acceptance Criterion (Implicit) | Reported Device Performance |
---|---|
Footswitch, Extension Cable Functionality | Verification and Validation completed. (Details not provided) |
Electromagnetic Compatibility (EMC) | "Standards evaluation" completed. (Compliance implied) |
Electrical Safety | "Standards evaluation" completed. (Compliance implied) |
Substantial Equivalence to Predicate Device (K140578) | Demonstrated in design, manufacturing materials, intended use, principles of operation, and technical characteristics. Raises no new issues of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data or AI/ML performance. The "testing" mentioned refers to verification and validation of the footswitch/extension cable and standards evaluations. No sample sizes for devices or patients are provided for these types of tests. Data provenance (country, retrospective/prospective) is also not applicable or mentioned for these engineering-focused tests.
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)
Not applicable. The document does not describe a study involving expert-established ground truth for a test set, as it is not validating a diagnostic or AI-driven device with such requirements. The "ground truth" for the engineering and electrical safety tests would be the established engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described as there is no clinical test set requiring expert consensus.
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
Not applicable. This is not an AI-assisted device, and no MRMC study is mentioned or relevant to this type of device (electrosurgical system).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrosurgical system, not an algorithm, and therefore the concept of standalone algorithmic performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the conventional sense for clinical or AI/ML ground truth. The "ground truth" for the described testing would be adherence to:
* Engineering Specifications: For the footswitch and extension cable verification/validation.
* International Standards: For Electromagnetic Compatibility and Electrical Safety (e.g., IEC standards for medical electrical equipment).
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set" or corresponding ground truth establishment process.
§ 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.