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510(k) Data Aggregation
(89 days)
OsteoCool 2.0 RF Ablation System
The OsteoCool™ 2.0 RF Ablation System is indicated 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 subject OsteoCool™ 2.0 RF Ablation System includes the following hardware components:
- OsteoCool™ 2.0 Radiofrequency Generator
- OsteoCool™ 2.0 Peristaltic Pump & Pump Cable
- OsteoCool™ 2.0 Connector Hub
- OsteoCool™ 2.0 Cart
The OsteoCool™ 2.0 RF Ablation System line extension includes the following commercially available sterile disposables that remain unchanged from the OsteoCool™ RF Ablation System K182497 (S.E. 12/17/2018): - OsteoCool™ RF Ablation Probe with Tube Kit
- OsteoCool™ Independent Thermocouple with Introducer Kit:
The OsteoCool™ 2.0 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™ 2.0 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™ 2.0 Peristaltic Pump to circulate water internally through the OsteoCool™ RF Ablation Probe(s) during RF energy delivery. The OsteoCool™ 2.0 Pump Cable connects the OsteoCool™ 2.0 Peristaltic Pump to the OsteoCool™ 2.0 RF Generator, which controls the pump flowrate.
The OsteoCool™ 2.0 Connector Hub connects the OsteoCool RF Ablation Probe(s) and OsteoCool™ Thermocouple (s) to the OsteoCool™ 2.0 RF Generator. The OsteoCool™ Thermocouple Monitor is used with the OsteoCool™ Thermocouple Introducer and enables temperature monitoring around the thermal ablation zones during procedures.
This document describes the OsteoCool™ 2.0 RF Ablation System and its substantial equivalence to a predicate device (OsteoCool™ RF Ablation System, K182497 S.E. 12/17/2018). The information provided focuses on the device's characteristics and the testing performed, rather than a study proving the device meets acceptance criteria in the context of an AI/ML model for medical imaging, as might be implied by the prompt's structured questions.
However, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence for a medical device and "device performance" as the data presented to support this claim, I will attempt to answer the questions based on the provided text.
The provided text does NOT describe an AI/ML device or a study involving human readers and AI assistance for an imaging application. Therefore, many of the questions regarding AI/ML specific criteria, ground truth establishment, expert adjudication, MRMC studies, and training/test set details are not applicable (N/A) to this document.
The document details the physical device's technical specifications and bench-top testing to demonstrate substantial equivalence to a prior version.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the "acceptance criteria" are implied by the substantial equivalence demonstration, which relies on showing that the new device has "the same fundamental scientific technology, including principles of operation and mechanism of action" and performs comparably to the predicate device through various tests.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate Device) | Reported Device Performance (Summary from "Performance Data") |
|---|---|
| Functional Equivalence: Device delivers controlled RF energy for ablation. | The OsteoCool™ 2.0 RF Ablation System delivers controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism to facilitate RF lesions in target tissue. The generator, pump, and probes work together to deliver RF energy and circulate cooling water, consistent with the principle of operation. |
| Safety and Performance Compliance: Meets mechanical, electrical, biocompatibility, data integrity, temperature accuracy, cleaning, connectivity, and usability requirements. | Bench top testing was performed to demonstrate substantial equivalence. System components were subjected to the following verification and validation tests, as applicable: mechanical, electrical, biocompatibility, data integrity, temperature accuracy, cleaning, connectivity, and usability. The document states these tests were performed and implies successful completion to support substantial equivalence. |
| Comparative Ablation Characteristics: Produces comparable lesion size and thermal effects to the predicate device. | Bench-top validation testing was performed for the OsteoCool™ 2.0 RF Ablation System using ex-vivo tissue and product usage in cadaveric bone as per the guidance. Lesion size (length and width) was measured during ex-vivo testing at the 50 degree C isotherm. Color change due to blood coagulation at elevated temperatures between thermally affected tissue and raw tissue was evaluated. (The document states these measurements were taken but does not provide the specific numerical results of the lesion sizes or a direct comparison to the predicate's performance, only that it "demonstrated substantial equivalence" through these tests). |
The product being reviewed is an RF ablation system, a physical medical device, not a software/AI system for diagnostics from imaging data. Therefore, the following AI/ML-specific questions are largely not applicable.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "ex-vivo tissue" and "cadaveric bone" were used for bench-top validation testing. It does not specify the number of samples (e.g., number of tissue blocks, cadaveric segments) used.
- Data Provenance: The testing was "bench-top testing" performed by the manufacturer (Medtronic Sofamor Danek USA Inc.). It is laboratory testing; thus, it is not "country of origin of the data" in the sense of patient data, nor is it retrospective or prospective in the clinical study sense. It is laboratory product validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a physical device being tested for its functional performance (e.g., lesion creation, electrical safety), not an AI/ML system requiring expert-annotated ground truth from medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not applicable to physical device bench testing.
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:
- N/A. This is a physical RF ablation device, not an AI/ML software for image interpretation or diagnosis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical device designed for human use in a medical procedure. It is not an algorithm that functions in a "standalone" capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance would be the physical measurements of the lesions created (length, width, temperature isotherm), electrical parameters, and material biocompatibility, as determined by standard laboratory techniques and instruments, not expert consensus on medical images or pathology from human subjects.
8. The sample size for the training set:
- N/A. This device is not an AI/ML model that undergoes "training." Its performance is based on its engineered design and physical properties.
9. How the ground truth for the training set was established:
- N/A. Not applicable as there is no "training set" for this physical device.
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