(200 days)
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:
| Acceptance Criteria (Inferred from Substantial Equivalence and Testing) | Reported Device Performance (OsteoCool V-3 RF Ablation System) |
|---|---|
| Mechanical Requirements: Compliance with standards | Compliant: Verified to meet IEC 60601-1: 2005, IEC 60601-2-2: 2009, and Baylis self-enforced requirements. |
| Electrical Requirements: Compliance with standards | Compliant: Verified to meet current electrical standard requirements. |
| Electromagnetic Compatibility (EMC): Compliance with standards | Compliant: Verified to meet IEC 60601-1-2 standard requirements. |
| Biocompatibility: Absence of adverse biological reactions | Compliant: Verified in accordance with current ISO 10993-1 requirements for patient-contacting components. |
| Thermocouple Temperature Accuracy: Accurate temperature measurements | Accurate: Verification testing demonstrated accurate temperature measurements per specified test requirements. |
| Usability: Meeting usability requirements | Compliant: Testing performed to verify and validate usability requirements. |
| Software Verification & Validation: Meeting software requirements | Compliant: Applicable software V&V completed based on a Major Level of Concern classification using FDA's "Guidance for the content of premarket submissions for software contained in Medical Devices" (May-2005). |
| Ablation Performance: Substantial equivalence in lesion dimensions | Substantially Equivalent: Direct comparative bench-top validation testing demonstrated that lesion dimensions achieved by the subject device (OsteoCool V-3 RF Ablation System) were substantially equivalent to those obtained with the predicate device (Uniblate Electrosurgical Device K080451) under the same test setup and conditions. (Tested in a soft tissue model consisting of fresh bovine liver placed in a shell of bovine bone). |
| Pyrogenicity: Non-pyrogenic | Non-pyrogenic: OsteoCool RF Ablation Kit and OsteoCool Thermocouple Monitor Kit are supplied non-pyrogenic and meet current FDA and USP pyrogen limit specifications, with LAL testing conducted on every lot to verify. |
| Clinical Efficacy (Pain Palliation for Bone Metastasis): Evidence from literature | Supported: An updated scientific literature review (2007-present) of RFA for metastatic bone tumors for pain palliation, combined with the literature review from the predicate Uniblate device (K080451), supports the established clinical use of RFA in patients with bone metastases for pain palliation. The literature review did not include exclusion criteria, suggesting a broad review. |
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.
§ 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.