(125 days)
The OsteoCool™ RF 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.
- Ablation of benign bone tumors such as osteoid osteoma.
The OsteoCool™ RF Ablation System includes the following components:
- OsteoCool Radiofrequency Generator
- OsteoCool RF Ablation Kit:
i. OsteoCool RF Ablation Probe
ii. OsteoCool Tube Kit - OsteoCool Thermocouple Kit:
i. Osteocool Thermocouple Monitor
ii. Osteocool Thermocouple Monitor Introducer - Osteocool Peristaltic Pump & OsteoCool Pump Cable
- OsteoCool Connector Hub
- OsteoCool Cart
The OsteoCool™ RF Ablation System delivers controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism to facilitate RF lesions in target tissue. The OsteoCool Radiofrequency (RF) Generator operates together with the OsteoCool RF Ablation Probe to deliver the RF energy to the target ablation site(s). The OsteoCool Tube Kit is used with the Osteocool Peristaltic Pump to circulate water internally through the OsteoCool RF Ablation Probe(s) during RF energy delivery. The OsteoCool Pump Cable connects the Osteocool Peristaltic Pump to the OsteoCool RF Generator, which controls the pump speed. The OsteoCool Connector Hub connects the OsteoCool RF Ablation Probe(s) and OsteoCool Thermocouple Monitor(s) to the OsteoCool RF Generator. The OsteoCool Thermocouple Monitor is used with the OsteoCool Thermocouple Monitor Introducer and enables temperature monitoring around the thermal ablation zones during procedures.
The provided document is a 510(k) premarket notification for the Medtronic OsteoCool™ RF Ablation System, specifically focusing on a modification to its indications for use to include the ablation of benign bone tumors such as osteoid osteoma.
Based on the provided text, the device itself is an RF ablation system. The study described focuses on demonstrating "substantial equivalence" of the modified device (with the new indication) to previously cleared predicate devices, rather than establishing direct acceptance criteria for a new, unproven device against specific performance metrics for that new indication.
Therefore, the "acceptance criteria" here are primarily about demonstrating that the expanded indication for use (ablation of osteoid osteoma) for the OsteoCool™ RF Ablation System does not raise new questions of safety and effectiveness compared to its predicate devices, especially the Uniblate Electrosurgical Device which already had an osteoid osteoma indication.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of quantitative acceptance criteria for the expanded indication. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is shown through various verification and validation tests and a comparative bench-top study to show the device performs similarly to the predicate devices and that the new indication is supported.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (General) | The manufacturer concludes that "The results of verification and validation testing support the substantial equivalence of the subject OsteoCool™ RF Ablation System to the predicate devices." |
| Mechanical Requirements (IEC 60601-1, IEC 60601-2-2) | "Mechanical verification testing was conducted... to ensure compliance." (Conclusion: Compliant) |
| Electrical Standards (Current electrical standard requirements) | "Electrical verification testing was conducted... to ensure compliance." (Conclusion: Compliant) |
| Electromagnetic Compatibility (IEC 60601-1-2) | "The results demonstrated compliance of the subject system to current IEC 60601-1-2 standard requirements." (Conclusion: Compliant) |
| Biocompatibility (ISO 10993-1) | "Biocompatibility verification was performed..." (Conclusion: Compliant) |
| Thermocouple Temperature Accuracy | "Verification testing demonstrated that the relevant components... achieves accurate temperature measurements as per specified test requirements." (Conclusion: Accurate) |
| Usability | "Testing was performed to verify and validate the usability requirements..." (Conclusion: Verified and Validated) |
| Software V&V (FDA Guidance on Software, Major Level of Concern) | "The applicable software verification and validation was completed... based on a Major Level of Concern classification." (Conclusion: V&V completed as per guidance) |
| Comparative Ablation Performance | "The results demonstrated that the lesion dimensions achieved by the subject device are substantially equivalent to those obtained with the predicate device under the same test setup and conditions." |
| Performance in Dry Bone (Osteoid Osteoma Environment) | "Impedance Testing with dry bovine bone verified that the OsteoCool™ RF Ablation Probe can be used to adequately perform ablations in dry bone, as often seen in Osteoid Osteoma." "Impedance tests in patients with osteoid osteoma confirmed that the patient data is similar to the bench testing result with dry bovine bone tissue and the subject device is safe and effective for the intended use." (Conclusion: Performs adequately in target environment, patient data supports bench test findings) |
| Non-Pyrogenic (FDA and USP pyrogen limit specifications) | "LAL testing... will be conducted on every lot to verify that devices are non-pyrogenic. The devices meet current FDA and USP pyrogen limit specifications." (Conclusion: Meets specifications) |
| New Risks for Osteoid Osteoma Indication | "Medtronic's examined both the published use of RFA in OO regardless of manufacturer and irrespective of patient demographic or tumor location and patient outcomes to determine if any new patient risks are created. Medtronic maintains that the potential benefits provided by these devices outweigh the potential risks." (Conclusion: No new risks identified that outweigh benefits; literature supports RFA for OO generally) |
| Overall Substantial Equivalence | "Based on the data provided... the intended use of the subject OsteoCool™ RF Ablation System is substantially equivalent to the predicate devices. The subject and predicate devices share the same fundamental scientific technology, including principles of operation and mechanism of action. Differences in design and technological characteristics... do not raise any new types of questions of safety and effectiveness." (Overall conclusion: Substantially Equivalent) |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Comparative bench-top validation testing: The sample size is not explicitly stated. It mentions "For each test, temperature response curves..." and "Following lesion formation, the tissue samples were cross-sectioned and lesion dimensions directly measured." This implies multiple tests were conducted, but a concrete number is missing. The data provenance is a "soft tissue model consisted of fresh bovine liver placed in shell of bovine bone." This is a lab/benchtop study, not a clinical study.
- Impedance Testing: Again, specific sample sizes are not given for the bench tests ("dry bovine bone"). For the patient data, it states "Impedance tests in patients with osteoid osteoma confirmed that the patient data is similar to the bench testing result..." The number of patients is not specified. This appears to be retrospective use of existing patient data (implied by "confirmed that the patient data is similar to the bench testing result"), but this is not explicitly stated as retrospective Vs. prospective. No country of origin is mentioned.
- Clinical Literature Review: This is a review of published literature on RFA for Osteoid Osteoma. This is not a direct study with a specific "test set" sample size for the device itself but rather a synthesis of existing clinical evidence on the therapy. Data provenance is "published use of RFA in OO regardless of manufacturer."
- Other tests (Mechanical, Electrical, EMC, Biocompatibility, Usability, Software, Pyrogen): These are lab-based verification/validation tests. Specific sample sizes for these engineering tests are not provided in this summary, but they would typically involve a specific number of units/components tested to defined protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a "ground truth" for the test sets in the typical sense of a human-AI study or a clinical trial. The "truth" for the performance tests (e.g., lesion dimensions, electrical parameters) is established by direct measurement against engineering specifications and comparison to the predicate device, not by expert consensus on clinical findings.
For the literature review, no specific experts are detailed beyond the general understanding that published literature (e.g., peer-reviewed studies) represents a form of accepted evidence within the medical community, likely generated by and reviewed by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study comparing interpretations or classifications that would require adjudication (e.g., imaging reads). The performance tests are objective measurements or comparisons to established standards/predicate devices.
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, an MRMC comparative effectiveness study was not done. This document is for an ablative device, not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an electrosurgical device, not a software algorithm for diagnosis. The "standalone" performance here refers to the device's ability to achieve its intended physical effect (ablation) as demonstrated through bench testing and its similarities to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is multi-faceted:
- Bench-top performance data: Direct physical measurements (e.g., lesion dimensions, temperature response curves) are the "ground truth" for comparing the device's functional performance to the predicate.
- Engineering Standards: Compliance with international and self-enforced standards (IEC, ISO) served as the "ground truth" for mechanical, electrical, EMC, biocompatibility, and pyrogenicity.
- Predicate Device Performance: The established, cleared performance of the OsteoCool V-3 RF Ablation System (K161949) and the Uniblate Electrosurgical Device (K080451) served as the "ground truth" for comparison to demonstrate substantial equivalence.
- Published Clinical Literature: For the new osteoid osteoma indication, the "ground truth" on safety and effectiveness was derived from a review of existing clinical literature on RFA for Osteoid Osteoma. This represents a form of pooled "outcomes data" and clinical experience.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI/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 above.
§ 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.