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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 Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

The Intracept System is comprised of two basic, sterile, single use components, both of which are currently cleared for marketing via 510(k).

• The Intracept Easy Access Instrument Set (Instrument Set) is an instrument kit containing trocars, cannulas and guides that provide access to the intended site of radiofrequency (RF) ablation.
• The Intracept Flexible Bi-Polar RF Probe (RF Probe) conducts RF energy to the target location.
  Additionally, a commercially available, legally marketed RF Generator provides RF energy to the RF Probe. An Interconnect Cable is provided to connect the RF Generator. The only RF Generator currently recommended for use with the Intracept System is the Stockert Neuro N50 (K070336).
  The Intracept System technique uses RF ablation of the basivertebral nerve for relief of chronic low back pain and involves a two-step process. First, utilizing the Instrument Set, a minimally invasive, "transpedicular approach" is used to allow the placement of a cannula into the vertebral body, and a path or channel is created to the terminus of the basivertebral foramen. An RF Probe is then placed into this channel at the terminus of the basivertebral foramen, and controlled RF energy is delivered to destroy the basivertebral nerve where it enters the vertebral body. This nerve has been identified as a proprioceptive sensory nerve with innervation of the vertebral endplates.

This document describes the Intracept Intraosseous Nerve Ablation System, which is used for the relief of chronic low back pain. The acceptance criteria and supporting studies are presented, though not in the format of a typical AI device study.

Here's an analysis of the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table format alongside specific numerical performance targets for an AI device. Instead, it describes performance in terms of "PASS" for various tests and clinical efficacy for the medical device itself.

Since this is not an AI device, but a physical medical device, the acceptance criteria are related to safety, biocompatibility, electrical safety, mechanical integrity, sterilization, and clinical effectiveness. The performance is reported as meeting these criteria.

Table of Acceptance Criteria and Reported Device Performance (Non-AI Device)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Clinical Study - Test Set):
  • Pilot Study: Seventeen patients.
  • Pivotal Randomized, Double-Blind, Sham Controlled Clinical Study: 225 patients.
    • Intention-To-Treat (ITT) population: 144 in Intracept arm, 77 in Sham arm.
    • Per Protocol (PP) population: 128 in Intracept arm, 77 in Sham arm.
• Data Provenance: The document does not specify the country of origin of the data. The clinical studies were prospective, as indicated by the description of a randomized, double-blind, sham-controlled clinical study with follow-up.

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 as the document describes a physical medical device (Intracept Intraosseous Nerve Ablation System) and its clinical efficacy, not an AI device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" here is the patient's self-reported pain and disability scores (ODI), which are clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the document describes a clinical trial evaluating the efficacy of a medical device based on patient-reported outcomes (ODI scores) and not an AI device that requires adjudication of algorithmic outputs against expert opinions. The clinical trial was randomized and double-blind, with data analysis determining the efficacy.

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 is not applicable as the document describes a physical medical device and its direct clinical effectiveness study, not an AI device or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the document describes a physical medical device and its clinical effectiveness, not a standalone AI algorithm. The Intracept System is a medical procedure performed by a clinician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the clinical performance testing, the "ground truth" or primary measure of effectiveness was the patient's self-reported outcomes data, specifically the Oswestry Disability Index (ODI) Total Score. This index measures disability due to low back pain. The improvement in this score over time, compared to a sham control, served as the primary clinical ground truth.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device and its clinical efficacy, not an AI device that requires a training set. The device itself (RF Probe, Instrument Set) undergoes engineering and performance testing, but there's no "training set" in the machine learning sense.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

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