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510(k) Data Aggregation
(448 days)
The AveCure BT Microwave Ablation System is intended for:
- Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
- · Coagulation and ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
The MedWaves' AveCure BT Microwave Ablation System is comprised of a microwave (915MHz ±13MHz) generator-controller, two antenna sizes mounted on the distal end of probes or catheters of various lengths, and flexibility, and a set of extension cables, one for microwave (MW) transmission and another for information communication between the antenna and the generator. The accessories (probes, catheters and extension-cable set) are supplied sterile and the generator-controller is the durable component of the system and is supplied non-sterile.
The MedWaves AveCure BT Microwave Ablation System is intended for palliative treatment of metastatic malignant lesions in a vertebral body and coagulation/ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
Here's an analysis of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct "criteria" with pass/fail thresholds in the provided document. Instead, the study aims to demonstrate substantial equivalence to a predicate device. The performance metrics for this equivalence are the ablation range characteristics (volume, length, and width) and the treatment duration.
| Metric | Predicate OsteoCool V-3 RFA Performance | Subject AveCure BT MWA Performance | Difference | Equivalence Status |
|---|---|---|---|---|
| Ablation Volume | ||||
| Max Volume | 7018 mm³ (15 minutes cycle time) | 7260 mm³ (7.5 minutes cycle time) | 3.4% | Substantially Equivalent |
| Min Volume | 320 mm³ | 320 mm³ | 0% | Identical |
| Ablation Length (Z) | ||||
| Max Length | 31 mm | 30 mm | -3% | Substantially Equivalent |
| Min Length | 10 mm | 10 mm | 0% | Identical |
| Ablation Width (X & Y) | ||||
| Max Width | 22 mm | 22 mm | 0% | Identical |
| Min Width | 8 mm | 8 mm | 0% | Identical |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size used for the bench testing. It refers to "Data from experimental protocols" and "Bench testing in bone."
- Data Provenance: The study was a bench test conducted in-vitro (in bone). The country of origin of the data is not specified, but given the company's location in San Diego, California, it is presumably United States data. The study is implicitly prospective in its design, as it's a testing conducted to support a 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Bench testing typically relies on objective measurements rather than expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth for ablation performance in a bench test is typically based on direct physical measurements, not human expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focuses on the physical ablation capabilities of the device in a bench setting, not on physician performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is a physical device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The study evaluates the device's physical performance in creating ablations.
7. The Type of Ground Truth Used
The ground truth used for the bench testing was based on direct physical measurements of the ablation dimensions (volume, length, and width) created by the device in bone. The document states "Volumes are estimates based on the calculation of volume for an ellipsoid," indicating a quantitative measurement approach to define the ablation zones.
8. The Sample Size for the Training Set
This device is not an AI/ML algorithm that requires a training set. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML algorithm, the concept of a training set and its ground truth is not applicable.
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