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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.

· 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.

The OsteoCool V-3 RF Ablation System delivers controlled radiofrequency (RF) enerqy 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 enerqy 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.

The document describes the OsteoCool V-3 RF Ablation System and its substantial equivalence to predicate devices, particularly focusing on its indications for use. The submission is not for a new device but for a modification to the indications for use of an already cleared device (K152057). Therefore, the performance testing focuses on demonstrating that this modification does not introduce new safety or effectiveness concerns.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets for the device's performance in terms of diagnostic accuracy or clinical outcomes. Instead, it demonstrates "substantial equivalence" to predicate devices, meaning it performs similarly with no new safety or effectiveness concerns. The performance testing primarily addresses the physical and functional characteristics of the device and its safety.

However, based on the comparative effectiveness and performance testing, we can infer some "acceptance" in the context of substantial equivalence:

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

• Mechanical, Electrical, EMC, Biocompatibility, Thermocouple Accuracy, Usability, Software: The document states that "system components were subjected to the following verification and validation tests, as applicable." It does not specify the exact sample sizes for each of these engineering and safety tests (e.g., number of devices or components tested). The tests are typically performed on a statistically relevant sample size during product development and regulatory submission.
• Ablation Performance (Comparative Bench-top): The document mentions that for each test, "temperature response curves showing temperature and power over time were generated from procedural data obtained from each respective RF generator." It then states, "Following lesion formation, the tissue samples were cross-sectioned and lesion dimensions directly measured." The exact number of "tests" or "tissue samples" is not specified, but it implies multiple comparative tests ("For each test," "lesion dimensions achieved by the subject device... compared to those obtained with the predicate device under the same test setup and conditions").
• Data Provenance:
  • Bench-top testing: Prospective in-vitro testing conducted by the manufacturer with fresh bovine liver and bovine bone.
  • Clinical Efficacy (Literature Review): Retrospective analysis of published clinical articles (scientific literature review) from 2007 to present, focusing on RFA for metastatic bone tumors. This combines with a prior literature review for the K080451 predicate. The country of origin of the data might be global, depending on the scope of the literature search, but is not specified.

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

• Bench-top Testing: No "experts" were used to establish ground truth in the sense of clinical diagnoses. The ground truth for lesion dimensions was direct measurement from cross-sectioned tissue samples in a lab environment.
• Clinical Efficacy (Literature Review): The "ground truth" here is derived from the aggregated findings of published clinical studies, which is considered a form of outcome data or expert consensus within the scientific community. The individual studies would have had their own ground truth determination methods (e.g., pain assessment scales, imaging, clinical follow-up), but the document does not detail this for the literature review itself. No specific number or qualification of experts are mentioned for establishing the "ground truth" of the literature review itself, rather it's leveraging existing published clinical evidence.

4. Adjudication Method for the Test Set

• Bench-top Testing: Adjudication is not applicable in the sense of expert review of data. Lesion dimensions were directly measured.
• Clinical Efficacy (Literature Review): Not explicitly stated. Literature reviews typically involve a systematic process for inclusion/exclusion and synthesis of findings based on predetermined criteria, but a formal adjudication method by a specific panel of experts is not described for this regulatory submission. The document only mentions that articles not meeting "predetermined exclusion criteria were included."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not conducted. The submission is for a modification to an existing device's indications for use, and it primarily relies on demonstrating substantial equivalence through engineering, biocompatibility, and bench-top performance tests, complemented by a literature review for clinical efficacy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The OsteoCool V-3 RF Ablation System is a medical device for performing RF ablation; it is not an AI algorithm for diagnosis or image analysis. Therefore, the concept of "standalone (algorithm only)" performance is not applicable to this device. It is an operator-controlled device where the physician is always "in the loop." Its software ensures proper device function, not autonomous decision-making or diagnostic output.

7. The Type of Ground Truth Used

• Bench-top Testing: Direct physical measurement of lesion dimensions in ex-vivo tissue (fresh bovine liver in bovine bone).
• Clinical Efficacy (Literature Review): Published clinical outcomes data from peer-reviewed scientific literature, largely related to pain palliation and the established use of RFA.

8. The Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning algorithms. Since the OsteoCool V-3 RF Ablation System is a physical medical device and not an AI algorithm, there is no "training set" in this context. The device's design and operating parameters are developed through engineering principles, bench testing, and potentially pre-clinical studies, rather than machine learning training data.

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

As there is no "training set" for an AI algorithm in this submission, this question is not applicable. The device's functionality and performance are established through traditional engineering verification and validation methods and comparison to predicate devices, not through a "training set" with established ground truth.

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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.

The OsteoCool V-3 RF Ablation System includes the following components:

1. OsteoCool Radiofrequency Generator
2. OsteoCool RF Ablation Kit:
   i. OsteoCool RF Ablation Probe
   ii. OsteoCool Tube Kit
3. OsteoCool Thermocouple Kit:
   i. Osteocool Thermocouple Monitor
   ii. Osteocool Thermocouple Monitor Introducer
4. Osteocool Peristaltic Pump & OsteoCool Pump Cable
5. OsteoCool Connector Hub
6. OsteoCool Footswitch
7. 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.

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.

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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