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The OsteoCool® V-3 RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Device Description

The OsteoCool V-3 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 Footswitch
OsteoCool Cart

The OsteoCool V-3 RF Ablation System represents an upgrade to the predicate OsteoCool V-2 RF Ablation System (K142480). Modifications have been made to the predicate generator and pump unit for aesthetic changes and to provide increased user flexibility and convenience. Minor changes have also been made to other system components for increased user flexibility and convenience and to optimize existing features.

The OsteoCool V-3 RF Ablation System delivers controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism to facilitate RF lesions in the vertebral body. The OsteoCool Radiofrequency (RF) Generator operates together with the OsteoCool RF Ablation Probe to deliver the RF enerqy 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 OsteoCool RF Generator can be used with the optional OsteoCool Footswitch. The OsteoCool RF Generator and Peristaltic Pump are mounted on the OsteoCool Cart during use.

AI/ML Overview

The provided text describes the OsteoCool V-3 RF Ablation System and its substantial equivalence to its predicate device, the OsteoCool V-2 RF Ablation System. This is a 510(k) summary, which focuses on demonstrating equivalence to a legally marketed device rather than proving absolute safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "device performance" are primarily framed around meeting established standards and demonstrating similar or improved performance compared to the predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table for a clinical study comparing the device against a benchmark. Instead, the acceptance criteria are implicitly defined by compliance with various industry standards and demonstration of comparable performance to the predicate device through verification and validation testing. The "reported device performance" refers to the successful outcomes of these tests.

Acceptance Criteria (Implied by Compliance Needs)	Reported Device Performance (as stated in the document)
Compliance with mechanical safety standards (e.g., IEC 60601-1, -2-2)	Mechanical verification testing conducted; compliance with IEC 60601-1: 2005, IEC 60601-2-2: 2009, and Baylis self-enforced requirements ensured.
Compliance with electrical safety standards	Electrical verification testing conducted; compliance with current electrical standard requirements ensured for relevant components.
Compliance with electromagnetic compatibility (EMC) standards	EMC testing completed; results demonstrated compliance of the proposed system to current IEC 60601-1-2 standard requirements.
Biocompatibility in accordance with ISO 10993-1 and FDA guidelines	Biocompatibility verification performed in accordance with requirements of ISO 10993-1 and FDA's modified ISO guidelines in accordance with FDA's blue book memorandum #G95-1 on biocompatibility.
Accuracy of thermocouple temperature measurements	Verification testing demonstrated that relevant components achieve accurate temperature measurements as per specified test requirements.
Usability requirements met	Testing performed to verify and validate the usability requirements.
Software level of concern addressed per FDA guidance	FDA's "Guidance for the content of premarket submissions for software contained in Medical Devices" (May-2005) used to determine the Level of Concern for the software. (Implicitly, the software was deemed acceptable for its intended use.)
Comparable ablation probe response curves to predicate device	Ex-vivo Bovine Liver Testing: Ablation probe response curves demonstrated and compared.
Comparable lesion sizes to predicate device	Ex-vivo Bovine Liver Testing: Comparison of lesion sizes demonstrated.
Acceptable thermal profile and lesion boundaries	Ex-vivo Bovine Liver Testing: Thermal profile and lesion boundaries demonstrated.
Comparable ablation volume in human cadaver vertebrae to predicate device	Human Cadaver Vertebrae Testing: Ablation volume and thermal imaging demonstrated; comparison of ablation volumes with predicate device performed.
Overall substantial equivalence to predicate device	All test requirements were met as specified by applicable standards and test protocols. Differences in design and technological characteristics between the proposed and predicate devices do not raise any new types of questions of safety and effectiveness. 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.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for the "test set" in terms of number of cases or patients. The studies described are primarily bench-top validation testing and ex-vivo/human cadaver testing.

Ex-vivo Bovine Liver Testing: No sample size (number of livers or tests) is provided.
Human Cadaver Vertebrae Testing: No sample size (number of cadavers or vertebrae) is provided.
The provenance of the data is from laboratory testing (bench-top, ex-vivo bovine liver, human cadaver vertebrae), not clinical data from specific countries or retrospective/prospective patient studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of experts to establish "ground truth" for the test set in the context of diagnostic performance or clinical outcomes. The studies described are engineering and preclinical performance evaluations (e.g., measuring lesion size, temperature accuracy). For these types of tests, the "ground truth" would be objective measurements obtained through calibrated instruments and established protocols, rather than expert consensus on medical findings.

4. Adjudication Method for the Test Set

Given that the studies are bench-top and ex-vivo performance evaluations focusing on objective measurements (e.g., lesion size, temperature), an "adjudication method" in the sense of resolving discrepancies in expert opinion (like 2+1 or 3+1 for medical image interpretation) is not applicable or described. The results would be based on direct physical measurements and observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. The document describes a 510(k) submission for a radiofrequency ablation system, not an AI-powered diagnostic or assistive tool for human readers/clinicians, nor does it involve a MRMC study. Therefore, this question is not applicable to the provided context.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This device is an RF ablation system, which is a therapeutic medical device used by clinicians. It does not operate as a standalone algorithm without human intervention. The software component mentioned is for device control and data display, not for autonomous diagnostic or therapeutic decisions.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described here is based on objective physical measurements and verified standards compliance.

For mechanical, electrical, EMC, and biocompatibility, the ground truth is defined by the requirements of the relevant international and self-imposed standards (e.g., IEC 60601, ISO 10993) and the successful demonstration of meeting those requirements.
For thermocouple temperature accuracy, the ground truth is established by calibrated temperature references.
For ex-vivo and cadaver testing, the ground truth related to ablation probe response, lesion sizes, thermal profiles, and ablation volumes would be derived from direct measurements using imaging (e.g., thermal imaging, gross pathology sectioning) and measuring instruments.

8. The Sample Size for the Training Set

The document does not describe any "training set" in the context of machine learning or AI. The tests performed are engineering and preclinical performance evaluations rather than the development or validation of an algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of an AI model or a "training set," this question is not applicable.

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