(464 days)
The Ablation Generator System and Ablation Instrument are indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Ablation Generator System is a microprocessor controlled radiofrequency (RF) generator designed for use with the hand held, bipolar, sterile, single use Ablation Instrument for percutaneous delivery of low power bi-polar RF energy by the physician to the tissue site in contact with the Electrode of the Ablation Instrument.
The Ablation Instrument is a hand held, bi-polar, sterile, single use device designed specifically for use with the Ablation Generator System. The user connects the Ablation Instrument to the Ablation Generator System using the AE Cable (for delivery of RF energy). The user positions the distal tip of the device containing the active and return electrodes at the tissue site where the specific treatment is to be performed.
The provided text describes a 510(k) summary for the Ablation Generator System and Ablation Instrument. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing de novo performance criteria against specific numerical acceptance values. Therefore, much of the requested information regarding acceptance criteria and performance metrics (e.g., effect size, specific accuracy metrics, training set details) is not explicitly present in the provided document.
Here's an analysis based on the available information:
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the given text.
The filing relies on showing substantial equivalence to predicate devices. The "Performance" section within the "Test Results" states: "Results of in-vitro and in-vivo testing (performance, mechanical, electrical, software) demonstrate that the Ablation Generator System and the Ablation Instrument function as intended and the results of tests were as expected." This indicates that the device met internal performance benchmarks, but these specific benchmarks and their numerical acceptance criteria are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided.
The text mentions "in-vitro and in-vivo testing" but does not specify the sample sizes (e.g., number of patients, animals, or in-vitro samples) used for these tests, nor the provenance of any data (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided.
The submission does not describe a study involving expert-established ground truth in the way one would for diagnostic or AI-assisted devices. The "testing" appears to be focused on functional performance, mechanical safety, electrical safety, and software functionality.
4. Adjudication Method for the Test Set
This information is not applicable/provided.
As there's no mention of expert consensus-based ground truth establishment, no adjudication method would have been used in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described.
This type of study is typically performed to evaluate the impact of a device on human reader performance, often in AI-assisted diagnostic tools. The provided information relates to an ablation device, where the focus is on its functional safety and efficacy in delivering RF energy for palliative treatment.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable/provided.
The device described (Ablation Generator System and Ablation Instrument) is a physical medical device for delivering RF energy. It does not appear to involve an "algorithm" in the sense of a diagnostic or image analysis algorithm that would have standalone performance. Its "performance" refers to its mechanical, electrical, and functional operation.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation appears to be based on engineering specifications, safety standards (e.g., biocompatibility testing against ISO 10993-1), and expected functional outcomes during in-vitro and in-vivo performance tests. It's not about establishing a diagnostic "ground truth" for a condition.
8. The Sample Size for the Training Set
This information is not applicable/provided.
The device is not described as having a "training set" in the context of machine learning or AI. Performance testing was conducted on the physical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided.
As there is no mention of a training set, the method for establishing its ground truth is not relevant.
Summary of Device Evaluation in the Provided Document:
The 510(k) submission for the Ablation Generator System and Ablation Instrument primarily relies on demonstrating substantial equivalence to existing predicate devices (ArthroCare Cavity SpineWand and ArthroCare Orthopedic Electrosurgery System). The "Test Results" section indicates that:
- Performance: In-vitro and in-vivo tests showed the device "function[s] as intended and the results of tests were as expected." This implies the device met its internal design specifications and safety requirements.
- Biocompatibility: The materials met ISO 10993-1 requirements.
The core argument for clearance is that "The minor technological differences between the subject devices... and their predicate devices... raise no new issues of safety or effectiveness. Performance data demonstrate that Ablation Generator System and the Ablation Instrument are as safe and effective as the predicate devices for their intended use."
Therefore, the "acceptance criteria" were implicitly tied to meeting internal design specifications, safety standards, and demonstrating performance comparable to the predicate devices, rather than a specific numerical performance metric in a clinical study against a defined ground truth.
§ 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.