Search Results
Found 2 results
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.
Ask a specific question about this device
(292 days)
The MedWaves AveCure™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation-ablation of soft tissue.
The MedWaves AveCure™ Ablation System is not intended for use in cardiac procedures.
The MedWaves AveCure® Ablation System is designed to deliver ultrahigh radiofrequency (RF) through an antenna placed next to or embedded into soft-tissue for coagulating a volume of that tissue.
The MedWaves AveCure® Ablation System is composed of a durable generator-controller, and single-patient-use sterile accessories consisting of four antenna sizes and extension cable sets.
Each antenna-probe assembly is composed of one of the four antennas mounted at the distal end of one of many shaft configurations that are stiff, flexible or combination of both. The extension cable set is used to connect antennas to the generator controller. The material compositions of antennas and extension cables are nonmagnetic in nature and MRI safe. Therefore, the devices can be used in intraoperative, laparoscopic and percutaneous methods with CT, MR and Ultrasound imaging techniques to positions the antenna for ablation of softtissues.
The MedWaves AveCure® Ablation System is very efficient in transmitting RF power from the generator-controller to the antenna. With the low-power loss, the system does not need cooling pump, CO- or other mechanism to irrigate the antenna shaft and RF transmission lines for patient and user safety.
The provided document does not contain acceptance criteria for device performance based on a study, nor does it describe a study that proves the device meets specific performance criteria.
Instead, the document is a 510(k) summary for the MedWaves AveCure™ Ablation System, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. The "Performance Data" section primarily discusses compliance with design specifications, risk analysis, and medical device standards (electrical safety-EMC, biocompatibility, sterility, and packaging shelf-life). It makes a general statement about mechanical and coagulation-ablation performance:
"The mechanical and coagulation-ablation performance ex-vivo and in-vivo meets the intended design and shows to be similar to the predicated devices."
This statement does not provide specific acceptance criteria or detailed study results. Therefore, I cannot generate the requested table and information.
To answer your request, I would need a document that explicitly details:
- Specific, quantifiable acceptance criteria (e.g., minimum ablation zone diameter, maximum ablation time for a certain volume, specific temperature achieved).
- The methodology and results of a study designed to test these criteria.
Ask a specific question about this device
Page 1 of 1