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The Stryker OptaBlate BVN Intraosseous Nerve Ablation System is intended for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

The subject device Stryker Optablate® BVN Intraosseous Nerve Ablation System is a bipolar, high frequency electrosurgical system comprising the BVN probe, Microinfuser, syringe, introducer handpiece, introducer conduit, 10 G access cannula with diamond tip stylet, and 10 G bevel tip stylet. The subject device is intended to be used in conjunction with the existing Optablate radiofrequency (RF) generator (K221074), MultiGen2 Splitter Cable (K170242), and Optablate Microinfuser (K221074) to produce lesions by the direct application of radiofrequency currents for the relief of chronic low back pain. The subject 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 conduit that is within an access cannula. The application of RF energy causes a thermal reaction at the targeted tissue site to ablate the basivertebral nerve. It is indicated for the L3 through S1 vertebrae. When used, the subject OptaBlate BVN probes are connected to the splitter cable, which is connected to the generator, to deliver RF energy to the target tissue. The Optablate Microinfuser is connected to the probe to deliver a small amount of saline to the ablation site. The saline exits the probe between the emitters and helps ensure there is good electrical connection between the emitters and the tissue. The quality of the connection is measured in units called impedance. Impedance goes up if the connection is poor. If the impedance goes to high, the generator will trigger an error and stop the ablation. The Microinfuser slowly introduces saline to prevent impedance rises.

The provided FDA 510(k) clearance letter and summary for the OptaBlate BVN Intraosseous Nerve Ablation System focuses on the **device's safety and effectiveness **through comparison with a predicate device and non-clinical performance testing. It explicitly states "No clinical testing was required to support this submission." This means there was no study proving the device's performance in a clinical setting against acceptance criteria that would typically involve human or AI reader performance metrics, effect sizes, or ground truth established by experts.

Therefore, I cannot fulfill the request for information related to:

• Table of acceptance criteria and reported device performance based on clinical outcomes.
• Sample size for a test set (as no clinical test set was used for effectiveness).
• Number of experts and their qualifications used to establish ground truth.
• Adjudication method for a test set.
• MRMC comparative effectiveness study, effect size of human reader improvement.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for training set (as no AI/machine learning component is described).
• How ground truth for training set was established.

However, I can extract information related to the non-clinical acceptance criteria and proof of mechanism/performance.

Non-Clinical Acceptance Criteria and Device Performance (Summary):

The device's acceptance criteria primarily revolve around its ability to perform its intended function safely and effectively in a technical/mechanical/biological sense, rather than a diagnostic or AI-assisted clinical performance sense.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

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

• Test Set Sample Size: Not applicable in the context of clinical performance; the testing described is non-clinical (e.g., in-vitro biocompatibility tests, mechanical tests of device components, ex vivo tissue models for lesion formation).
• Data Provenance: The data comes from the manufacturer's internal testing (Stryker Instruments) as part of their 510(k) submission. No specific country of origin for test data is mentioned beyond "Stryker Instruments" (headquartered in Portage, MI, USA). The studies are "non-clinical" performance evaluations rather than retrospective or prospective human subject studies.

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

• Not applicable. The ground truth for this device's non-clinical performance is established by engineering specifications, international and national standards (e.g., ISO, IEC, ASTM), and the physical/chemical properties measured via established test methods. No human experts were used to establish "ground truth" in the diagnostic sense for this submission.

4. Adjudication Method for the Test Set:

• Not applicable. This concept applies primarily to clinical studies where human or AI interpretations are adjudicated. For non-clinical testing, results are typically binary (pass/fail) based on pre-defined quantitative or qualitative acceptance criteria.

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

• No. The submission explicitly states, "No clinical testing was required to support this submission." Therefore, no MRMC study to compare human reader performance with or without AI assistance was conducted or reported.

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

• Not applicable. This device is an ablation system, not a diagnostic algorithm. Its performance is related to its mechanical, electrical, and biological safety and its ability to create a lesion, not to interpret medical images or data.

7. The Type of Ground Truth Used:

• For Biocompatibility: Established by standardized biological response measurements against control samples, as per ISO 10993 series.
• For Electrical Safety/EMC: Established by conformance to specified IEC standards for medical electrical equipment.
• For Mechanical and Functional Testing: Established by engineering specifications and measurements in controlled laboratory settings (e.g., ex vivo tissue models for lesion size) and validated against ASTM standards where applicable. This is not "expert consensus, pathology, or outcomes data" in the clinical sense.

8. The Sample Size for the Training Set:

• Not applicable. This device does not involve an AI/machine learning component that would require a "training set."

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

• Not applicable, as no training set was relevant for this device submission.

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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.

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.

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