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510(k) Data Aggregation
(125 days)
The COOLIEF* Cooled Radiofrequency Probe is to be used in conjunction with a radiofrequency generator to create lesions in nervous tissue. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.
The COOLIEF* Cooled Radiofrequency (RF) Probe is a sterile, single-use device that delivers RF energy within the area of the active probe tip, while the probe tip is cooled by sterile water that circulates within the probe. Cooling the probe tip creates a larger. more homogenous RF heating area that results in a larger RF lesion in the target tissue. COOLIEF* Cooled RF Probe is used in conjunction with the Halyard RF Generator to create RF lesions in nervous tissue. The shaft of the probe is insulated with a polyimide sheath, and the distal tip consists of a medical grade stainless steel electrode. Sterile water circulates through a cavity in the electrode to cool the electrode tip during the cooled RF ablation procedure. The COOLIEF* Cooled Radiofrequency (RF) Probe is sterilized by ethylene oxide.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a singular section for clinical performance. Instead, it describes the effectiveness endpoint and provides the results.
| Characteristic / Test Type | Acceptance Criteria (Implied) | Reported Device Performance (COOLIEF* Cooled RF Probe) |
|---|---|---|
| Clinical Effectiveness (Primary Endpoint) | Superiority to corticosteroid injection in achieving ≥ 50% pain reduction at 6 months post-treatment in patients with moderate to severe knee pain due to radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block. | 67.2% of the COOLIEF* Cooled RF study group achieved ≥50% pain relief at 6 months, compared to 15.7% of the corticosteroid injection group (p-value for superiority not explicitly stated but implied by "superior to steroid injection").Mean NRS pain reduction: 4.9 points (from 7.3 to 2.5) at 6 months.Significant functional improvement: 39.7% reported "Satisfactory Joint Function" vs. 3% in comparison group.Global Perceived Effect: 91.4% reported "improved" knee condition vs. 23.9% in comparison group. |
| Cytotoxicity | Qualitative Grade = 0; Quantitative = cell death < 30% | Pass: No Cytotoxic effect |
| Sensitization | Challenge Phase = Less than Grade 1 and less than the controls | Pass: No signs of sensitization |
| Irritation or Intracutaneous Reactivity | Test sample score < 1.0 for Erythema and Edema grading | Pass: No signs of Irritation |
| Systemic Toxicity (acute) | No animal death | Pass: No signs of systemic toxicity |
| Electrical Safety | Conformance to IEC 60601-1:2005 | Passed |
| High Frequency Surgical Equipment | Conformance to IEC 60601-2-2: 2009 (Fifth Ed.) | Passed |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2:2007 / AC 2010 | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study Test Set Sample Size: The document indicates an Intent-to-Treat (ITT) population for the primary effectiveness endpoint.
- COOLIEF* Cooled RF (CRFA) group: 76 subjects
- Corticosteroid Injection (IAS) group: 75 subjects
- Data Provenance: The clinical study was a prospective, multicenter, randomized comparative human study. The document does not specify the country of origin, but given the FDA submission, it's typically a US-based or international study adhering to US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device and study. The "ground truth" for the clinical study was based on patient-reported outcomes (Numeric Rating Scale for pain, "Satisfactory Joint Function" report, Global Perceived Effect) and a diagnostic genicular nerve block response for patient selection, not expert consensus on images or pathology.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies where subjective assessments (e.g., image interpretation) need to be resolved. This clinical study focused on patient-reported outcomes and objective measures (like pain scale changes), so a formal adjudication method as commonly understood in imaging studies would not be directly applicable. The "ground truth" was directly from the patient or objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study was a randomized controlled trial comparing the device (COOLIEF Cooled RF Probe) to a control treatment (corticosteroid injection)* for pain management in patients, not a study evaluating human readers' performance with and without an AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not an AI/algorithm-based device. The COOLIEF* Cooled RF Probe is a medical device that physically delivers radiofrequency energy. Therefore, the concept of a "standalone algorithm performance" does not apply. The study evaluated the device's therapeutic effect.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The primary ground truth for the clinical effectiveness study was:
- Outcomes Data (Patient-Reported Outcomes): Numeric Rating Scale (NRS) for pain reduction, patient reports of "Satisfactory Joint Function," and Global Perceived Effect of knee condition.
- Diagnostic Response: Patients were selected based on a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block, serving as an inclusion criterion rather than a "ground truth" for the clinical outcome itself.
For the non-clinical tests, the ground truth was derived from established scientific and regulatory standards (e.g., ISO guidelines) and laboratory measurements (e.g., cell death percentage for cytotoxicity, animal responses for sensitization/irritation/toxicity).
8. The Sample Size for the Training Set
This is not an AI/machine learning device, so there is no "training set" in the conventional sense for an algorithm. The clinical study was a prospective comparative trial to evaluate the device's performance directly on human subjects.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" for an algorithm. The clinical data was collected from the prospective human study to directly assess the safety and effectiveness of the device.
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