(157 days)
The intended use of the OptaBlate™ Radiofrequency (RF) Generator System is as follows:
- 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 OptaBlate™ Radiofrequency (RF) Generator system is a bipolar, high frequency electrosurgical system. The OptaBlate™ RF Generator will be used in conjunction with OptaBlate™ Probes, OptaBlate™ Microinfuser™ Infusion Device, OptaBlate 150 mm Temperature Sensor, MultiGen 2 Splitter Cable, and other currently marketed Stryker compatible accessories to produce lesions by the direct application of radiofrequency currents. The generator applies temperature-controlled, radiofrequency (RF) energy into the probe. During lesion creation, targeted tissue is exposed to RF energy using an active probe inserted into a cannula. The application of RF energy causes a thermal reaction at the targeted tissue site to create a lesion. Each OptaBlate™ Radiofrequency (RF) Generator System is composed of a RF generator, a Splitter Cable, Temperature Sensor, and a choice of 4 disposable kit options. The kits contain disposable probes and infusion devices.
This submission is for a Radiofrequency Generator System, which is an electrosurgical cutting and coagulation device. This type of device does not typically involve AI/ML and therefore the concept of training and test sets, ground truth establishment by experts, and MRMC studies does not apply in the context of diagnostic AI/ML devices. Therefore, I will focus on the performance testing carried out to demonstrate substantial equivalence to the predicate device.
**1. A table of acceptance criteria and the reported device performance.
**
The document does not explicitly present a table of "acceptance criteria" against which "reported device performance" is measured in the classical sense of an AI/ML model's performance metrics (e.g., accuracy, sensitivity, specificity). Instead, substantial equivalence is demonstrated through comparative bench-top verification testing and a literature review. The performance testing focuses on demonstrating that the subject device produces similar ablation characteristics to the predicate device and that the technology is safe and effective for its intended uses.
| Acceptance Criteria (Implied by Comparison) | Reported Device Performance |
|---|---|
| Functional Equivalence | |
| - Similar energy type (Radiofrequency Energy) | Confirmed: Both subject and predicate use Radiofrequency Energy. |
| - Similar principle of operation (Operator controlled; RF delivered) | Confirmed: Both subject and predicate use operator-controlled RF delivery from a compatible generator. |
| - Similar mechanism of action (Cellular necrosis through thermal coagulation) | Confirmed: Both subject and predicate cause cellular necrosis through thermal coagulation. |
| - Similar control of temperature rise in tissues | Confirmed: Controlled by RF Generator for both. |
| - Similar feedback mechanism (Temperature Controlled) | Confirmed: Both use temperature-controlled feedback. |
| - Compatible with similar accessories | Confirmed: Subject device uses connecting cables, probes, and cannulae similar to the predicate. |
| Performance in Tissue Models (Bench-top) | |
| - Achieve substantially equivalent lesion dimensions (length and width) in chicken muscle to predicate device. | Result: "The results demonstrated that lesion dimensions achieved by the subject device are substantially equivalent to those obtained with the predicate device." (Page 18) |
| - Achieve substantially equivalent tissue temperature at ablation zone boundary in bovine bone compared to predicate device. | Result: "Bovine bone lesions were indirectly measured via tissue temperature at a given ablation zone boundary... The results demonstrated that lesion dimensions achieved by the subject device are substantially equivalent to those obtained with the predicate device." (Page 18) |
| - Accurate temperature measurements by relevant components. | Result: "Verification testing demonstrated that the relevant components of the subject OptaBlate RF Ablation system achieves accurate temperature measurements as per specified test requirements." (Page 18) |
| Safety and Efficacy (Through Literature Review) | |
| - Radiofrequency ablation devices are safe and effective for indicated uses. | Result: "Results from the literature search conclude that RF ablation devices are safe and effective. RF ablation consistently resulted in decreased patient pain post procedure regardless of indication. Furthermore, safety events were primarily due to underlying conditions or the use of cement post procedure." (Page 19) |
| - Potential benefits outweigh potential risks. | Result: Overall, this search supports that the potential benefits from this device / treatment outweigh the potential risks." (Page 19) |
| Electrode and Generator Specifications | |
| - Active Electrode Length: 15, 20 mm | Predicate: 7, 10, 15, 20 mm. Subject device has fewer options but still within the range, considered "Similar". (Page 12) |
| - Active Electrode Material: Stainless Steel (304 or 304L) | Predicate: Stainless Steel (304 or 304L). Considered "Similar". (Page 12) |
| - Electrode Insulation Material: Polyetheretherketone | Predicate: Polyimide. Considered "Similar" as both are high-performance plastics with high heat resistance. (Page 12) |
| - Electrode Diameter: 13 Gauge | Predicate: 17 Gauge. Considered "Similar" as both are percutaneous sizes. (Page 12) |
| - Electrode Length: 16 cm | Predicate: 16 cm. "Identical". (Page 12) |
| - Electrode Sterilization: EO, Single Use | Predicate: EO, Single Use. "Identical". (Page 12) |
| - Generator Power Output Channels: 4 | Predicate: 2. Considered "Similar" as OptaBlate allows flexible 1 to 4 channels. (Page 12) |
| - Generator Maximum Output Energy: System: 30W, Per Channel: 7.5W | Predicate: System: 40W, Per Channel: 20W. Considered "Similar" as OptaBlate requires less power output. (Page 12) |
| - Generator Maximum Voltage: System: 48.5 VRMS | Predicate: System: 130 VRMS. Considered "Different" but explained by OptaBlate requiring less power per channel. (Page 12) |
| - Generator Output Frequency: 500 kHz | Predicate: 465 kHz. Considered "Similar" as both frequencies are within the typical band for RF ablation and create equivalent lesion sizes. (Page 12) |
| - Default Ablation Temperature: 95°C | Predicate: 70°C. Considered "Similar" as both systems achieve up to 95°C in adjacent tissue, with predicate's lower setpoint due to active tip cooling. (Page 12) |
| Infusion Device Performance | |
| - Infusion Liquid: Saline | Predicate: Saline. "Identical". (Page 17) |
| - Flow Rate Range: 6 to 10 ml/hr | Reference: 3 to 42 ml/hr. Considered "Similar" as OptaBlate operates within a smaller window of the reference device infusion range. (Page 17) |
| - Disposable: Yes | Reference: Pump: No, Tubing Set: Yes. Considered "Similar" as OptaBlate Microinfuser is completely disposable versus reusable pump/disposable tubing. (Page 17) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Bench-top Verification Testing: The document states that "Tissue models consisted of fresh chicken muscle and bovine bone." However, the exact sample size (number of tissues/ablations) used for this testing is not specified in the provided text.
- Clinical Literature Review: For the clinical evaluation, Stryker identified 175 unique publications, which were screened based on predefined criteria. A "thorough full-text review of 41 manuscripts" was performed. This represents a retrospective analysis of existing published data. The provenance of this data (e.g., specific countries of origin of the studies) is not detailed, but peer-reviewed publications are generally global in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable in the traditional sense for this device as it is not an AI/ML diagnostic device requiring ground truth labeled by experts for a test set. The performance evaluation relies on physical measurements in bench-top models and a systematic review of existing clinical literature on RF ablation.
- For the bench-top testing, lesion dimensions and temperature measurements were the "ground truth", which are directly measurable physical quantities.
- For the literature review, the "ground truth" on safety and efficacy is derived from reported outcomes in peer-reviewed clinical studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable for this type of device and study design. Adjudication methods are typically used in AI/ML performance studies where multiple human readers assess cases and their interpretations need to be reconciled to establish a ground truth or resolve discrepancies.
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
This section is not applicable as the OptaBlate RF Generator System is not an AI-assisted diagnostic or treatment planning device, and therefore, no MRMC study was performed to assess human reader improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable as the OptaBlate RF Generator System is a medical device, not a standalone algorithm. Its function is to deliver RF energy for ablation, which is a clinician-performed procedure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench-top Verification Testing: For the in-vitro comparison study, the ground truth was direct physical measurement. For chicken muscle, lesion lengths and widths were directly measured. For bovine bone, tissue temperature at a given ablation zone boundary was indirectly measured as an indicator of lesion size.
- Clinical Efficacy/Safety: The "ground truth" for clinical efficacy and safety was established through a literature review of reported clinical outcomes and vigilance databases. This includes "clinical and technical success, improvements in pain through validated measures (VAS), and the need for repeat procedures" for efficacy, and "reported complications" for safety.
8. The sample size for the training set
This section is not applicable as the OptaBlate RF Generator System is a hardware device, not an AI/ML model that undergoes "training."
9. How the ground truth for the training set was established
This section is not applicable as there is no "training set" for this type of device.
§ 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.