(285 days)
The OsteoCool® V-2 RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
The OsteoCool V-2 RF Ablation System represents an upgrade to the cleared OsteoCool RF Ablation System (K111523) for the addition of a secondary system thermocouple to enable temperature monitoring around thermal ablation zones.
The OsteoCool V-2 RF Ablation System includes the following components:
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- OsteoCool RF Ablation Kit (OsteoCool Probe, OsteoCool Introducer, and Tube Kit)
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- Pain Management Pump Unit & Pump Connector Cable
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- Baylis Pain Management Generator-TD
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- DuoCool™ Y-Connector Cable With TC
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- Thermocouple Monitor
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- Thermocouple Monitor Box
The OsteoCool V-2 RF Ablation System is designed to deliver controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism. The Baylis Pain Management Generator-TD (PMG-TD) operates together with the OsteoCool Probe to deliver the RF energy to the target ablation site. The OsteoCool Introducer provides a path for the OsteoCool Probe to its target site. The Tube Kit is used with the Pain Management Pump Unit to circulate water internally through the OsteoCool Probe during RF energy delivery. The Pump Connector Cable connects the Pain Management Pump Unit to the PMG-TD, which powers and controls the pump speed. The DuoCool Y-Connector Cable With TC connects the OsteoCool Probe and Thermocouple Monitor to the PMG-TD. The Thermocouple Monitor Box is battery operated and connects to a port on the PMG-TD to display the temperature detected by the Thermocouple Monitor.
This document, a 510(k) Summary for the OsteoCool® V-2 RF Ablation System (K142480), focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for a new device's performance against clinical endpoints. Therefore, it does not contain the specific information requested in many of your points, such as detailed acceptance criteria, sample sizes for test sets, expert-driven ground truth, or MRMC studies.
However, I can extract information related to performance testing that was conducted to support the substantial equivalence claim.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative, pass/fail format for clinical performance. Instead, it relies on demonstrating that the OsteoCool® V-2 RF Ablation System performs comparably to the predicate device and meets safety and effectiveness requirements through various tests.
The comparison table provided focuses on design and technological characteristics. The performance data section describes the types of tests conducted rather than specific acceptance criteria for clinical outcomes.
Here's a table summarizing the areas of performance testing and the general intent, as acceptance criteria are not explicitly defined in the provided document:
| Performance Area | General Intent (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Device components (e.g., probe, introducer) should withstand typical forces encountered during use without failure that would compromise safety or effectiveness. | Pull test: Performed to assess mechanical integrity. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. |
| Impulse test: Performed to assess mechanical integrity. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. | ||
| Electrical Testing | The Thermocouple Monitor must meet relevant electrical safety standards (IEC 60601-1:2005 and IEC 60601-2-2:2009) at baseline and after simulated aging to ensure continued safe and accurate operation. | Electrical verification: Conducted to ensure the OsteoCool Thermocouple Monitor (OST) meets the electrical requirements of IEC 60601-1:2005 and IEC 60601-2-2:2009 after 0 and 4 years of aging. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. |
| Temperature Testing | The device should accurately measure and report temperature. | Temperature accuracy testing: Conducted. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. |
| Bench Top Validation | ||
| Ex-vivo Bovine Liver | Ablation parameters (probe and thermocouple response) should be consistent with expected device function. Lesion sizes and thermal profiles should be comparable to what is understood for RF ablation and potentially to the predicate device's expected performance. | Ablation probe response curves: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. |
| Thermocouple monitor response curves: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. | ||
| Comparison of lesion sizes: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. | ||
| Thermal profile and lesion boundaries: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. | ||
| Human Cadaver Vertebrae | Ablation volumes and thermal characteristics in human vertebral tissue should be consistent with the intended therapeutic effect and comparable to the predicate device, demonstrating effective palliative treatment of metastatic lesions in vertebral bodies. | Ablation volume: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. |
| Thermal imaging: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. | ||
| Comparison of ablation volumes with predicate: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. | ||
| Overall Scientific Basis | Differences in design/technological characteristics between the proposed and predicate devices should not raise new concerns of safety and effectiveness. The device should be safe and effective for its stated indications for use, and demonstrate substantial equivalence to the predicate. | The document concludes that "The results of verification and validation testing support the safe and effective use of the proposed device for its intended use and its substantial equivalence determination to the predicate device." And "Differences in design and technological characteristics between the proposed and predicate devices do not raise any new concerns of safety and effectiveness." |
For the remaining points, the provided 510(k) summary does not contain the detailed information typically found in a clinical study report. This document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and
non-clinical performance data, rather than a clinical trial with human subjects and specific endpoints for AI performance.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the performance tests. The testing described (Ex-vivo Bovine Liver, Human Cadaver Vertebrae) did not involve human subjects as a "test set" in the clinical sense.
- Data Provenance: Not specified for the benchtop tests. Ex-vivo bovine liver and human cadaver vertebrae are mentioned, indicating lab-based, non-clinical data. This type of data would be considered "prospective" in the sense that the experiments were set up and performed to generate the data for this submission, rather than re-analyzing existing data.
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)
This information is not applicable and not provided. The ground truth for the performance tests (e.g., lesion sizes, thermal profiles, electrical measurements) would be established by direct measurement from the conducted experiments, not by expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.
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
No. This document does not mention any MRMC study or AI assistance. The device is a physical ablation system, not a diagnostic imaging AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical electrosurgical system. There is no "algorithm only" performance for this type of medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests conducted would be:
- Measurements taken directly during mechanical and electrical testing.
- Physical measurements of lesion size and thermal profiles from ex-vivo bovine liver and human cadaver vertebrae experiments.
8. The sample size for the training set
Not applicable. This device is an RF ablation system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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.