(111 days)
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):
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization | ISO 11135:2014 & ISO 10993-7:2008/Amd 1:2019 (Ethylene Oxide - Kits); ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017 (Radiation - Microinfuser) | Conformance with standards for effective sterilization and acceptable residuals. | Pass (Compliance demonstrated) |
| Biocompatibility | ISO 10993-5:2009, ISO 10993-12:2021 (Cytotoxicity); ISO 10993-23:2021, ISO 10993-12:2021 (Irritation); ISO 10993-11:2017, ISO 10993-12:2021 (Acute Systemic Toxicity); ISO 10993-10:2010, ISO 10993-12:2021 (Sensitization) | Test articles to be non-cytotoxic, show no greater biological reaction than controls, and cause no sensitization reaction. | Pass (All tests met criteria) |
| Electrical Safety & EMC | IEC 60601-1 Ed. 3.2 (General Safety); IEC 60601-1-2 Ed. 4.1 (EMC); IEC 60601-1-8 Ed. 2.2 (Alarms); IEC 60601-2-2 Ed. 6.1 (HF Surgical Equipment) | Compliance with essential performance and safety requirements of specified electrical and electromagnetic compatibility standards. | Pass (All applicable clauses tested and conform) |
| Physical/Mechanical Performance | ASTM D4169 (Transit); ASTM F2096 (Bubble Test); ASTM F88 (Seal Peel Test); Internal Specs (Mechanical Testing, Dimensional, Visual Inspection) | Device and packaging integrity maintained during transit; no gross leaks; adequate seal strength; specified mechanical properties (insertion force, retraction force, flow rate, tensile strength, twist cycle, torsional stiffness, impact force); adherence to dimensional specifications; absence of surface defects. | Pass (All tests met criteria) |
| Functional Performance (BVN Probe Specific) | Internal Test Method (Temperature Accuracy); Internal Test Method (Lesion Size) | Accuracy verified across full functional use range; measured RF lesion size in ex vivo tissue model. | Pass (Accuracy verified; ex vivo lesion size measured and acceptable) |
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.
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).