Search Results

The NeuroOne OneRF® Trigeminal Nerve Ablation System is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

OneRF® Ablation System for Trigeminal Nerve (TN) Ablation uses radiofrequency (RF) ablation to create lesion(s) in an area of nerve tissue that the surgeon has identified for ablation. The ablation site may be identified by diagnostic stimulation of the trigeminal nerve using the Trigeminal Nerve Radiofrequency (TN-RF) Probe to accurately locate the target area for ablation.

The subject device is identical to the sEEG-RF Probe cleared after FDA review of K231675. In K231675, the FDA reviewed and cleared the sEEG-RF Probe when used with the NeuroOne OneRF® Generator to form the OneRF® Ablation System. The OneRF® Ablation System is indicated to create radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

In this new 510(k), we propose to market the identical sEEG-RF Probes to create lesion(s) in the trigeminal nerve "for the treatment of pain." This use for treatment of facial pain requires new accessories (Cannula and Tuohy Borst Adapter) for insertion/placement of the sEEG-RF Probe. When the sEEG-RF Probe is used to create lesion(s) in the trigeminal nerve, it will be marketed as the Trigeminal Nerve Radiofrequency (TN-RF) Probe. The TN-RF Probe and new accessories, when combined with the cleared (K231675) NeuroOne OneRF® Generator and accessories, will be referred to as the OneRF® Trigeminal Nerve Ablation System.

The OneRF® for TN Ablation System components/accessories consist of the following:

1. TN-RF Probe (with Stylet)
   • 16mm x 5 Contact TN-RF Probe Kit
   • 26.5mm x 8 Contact TN-RF Probe Kit
2. Insertion Components
   i. Insulated Cannula w/Stylet
   ii. Tuohy Borst Adapter (Adapter)
3. Stimulation Components
   i. Cable Assembly (5 or 8 connector pins) (CA)
4. Ablation Components
   i. Stylet
   ii. Temperature Accessory (TA)
   iii. Spacer Tubes
   iv. Radiofrequency Connector Box (RFCB)
   v. Equipment
   1. Generator
   2. Generator Interface Cable (GIC)
   3. Cart
   4. Foot Pedal (optional)
   5. Ground Pad

The provided document is a 510(k) Clearance Letter for a medical device. It does not describe a study that uses a test set, training set, or ground truth to evaluate algorithm performance. The clearance is based on the substantial equivalence of the "NeuroOne OneRF Trigeminal Nerve Radiofrequency Probes" to existing predicate devices, supported by non-clinical performance tests and biocompatibility assessments.

Therefore, I cannot provide the requested information in a table format as there are no relevant acceptance criteria or reported device performance metrics for an AI/algorithm-based study within the document.

Here's why each of your requested points cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document focuses on performance testing related to mechanical, dimensional, packaging integrity, and sterilization aspects of the physical device, not an AI algorithm's performance. The "Lesion Size Testing" states "Lesion sizes were proportional to time and temperature. Lesion size is comparable to predicate," but it doesn't provide specific quantitative acceptance criteria or detailed numerical results beyond this qualitative statement.
2. Sample size used for the test set and the data provenance: Not applicable. The studies are non-clinical, involving physical device testing, not data analysis on a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for a test set in these non-clinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information regarding performance testing:

The document outlines a series of non-clinical performance tests to support the substantial equivalence claim. These tests primarily verify the physical and functional integrity of the device and its components.

• Lesion Size Testing:
  • Overview: Measured lesion size as a function of temperature and time, for monopolar and bipolar configurations, and temperature control/manual modes.
  • Results: "Lesion sizes were proportional to time and temperature. Lesion size is comparable to predicate." (No specific numerical data or explicit acceptance criteria provided in the summary).
• Dimensional Verification of the Cannula:
  • Overview: Evaluated dimensional characteristics and compatibility between components.
  • Results: "Pass – The test results indicate that the Cannula meet the dimensional requirements."
• Mechanical Performance:
  • Overview: Verified specifications related to mechanical interaction between the TN-RF Probe, Cannula, and Tuohy Borst Adapter.
  • Results: "Pass – The test results indicate that the TN-RF Probe, Cannula, Tuohy Borst Adapter designs meet the mechanical performance requirements."
• Mechanical Integrity:
  • Overview: Evaluated mechanical integrity of the TN-RF Probe, Cannula, and Tuohy Borst Adapter.
  • Results: "Pass - The test results indicate that the TN-RF Probe, Cannula and Tuohy Borst Adapter designs meet the mechanical integrity requirements."
• TN-RF Probe Kit Package Integrity:
  • Overview: Tested the packaged device and labeling against conditions of packaging, shelf life, and distribution per ISO 11607-1, ISTA 3A, ASTM D4169, ASTM F1980, ASTM F2096, ASTM F88.
  • Results: "Pass - The test results indicate that the TN-RF Probe Kit (...) packaging designs meet the integrity requirements (i.e., seal strength, bubble leak, label inspection, and no damage that impacts device sterility)."
• Sterilization:
  • Overview: Validated ethylene oxide sterilization process to achieve a minimum SAL of 10⁻⁶ per ISO 11135.
  • Results: "Pass – All criteria passed and the new product/package configuration was adopted into the validated sterilization cycle."
• Usability – Summative Validation:
  • Overview: Performed in accordance with FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices," February 3, 2016.
  • Results: "Pass – The NeuroOne OneRF® TN-RF Ablation System has been found to be safe and effective for the intended users, uses, and use environments."
• Biocompatibility:
  • Overview: Tested sEEG-RF Probe for prolonged contact and Cannula w/stylet, Tuohy Borst Adapter for limited contact.
  • Results: "Passed" for all tested components. No testing for Temperature Accessory/Spacer Tubes/Stylet and Radio Frequency Connector Box as there is no direct or indirect patient contact.

The provided document specifically clarifies that the device is substantially equivalent, and the "conclusions drawn from the nonclinical testing demonstrate the device is as safe, as effective, and performs as well as the legally marketed device predicates, per 21 CFR 807.92(b)(3)." This is a traditional medical device clearance, not an AI/ML-driven software clearance.

Ask a specific question about this device

Ask a specific question about this device

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.

Ask a specific question about this device

Ask a specific question about this device

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 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 Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of sterile, singleuse components: The Intracept Access Instruments include cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation. The Intracept RF Probe conducts RF energy to the target location. To obtain the energy needed for tissue ablation, the Intracept RF Probe is used with the Relievant Radiofrequency Generator (RFG). The Relievant RFG is a universal AC powered, microcontroller controlled, bipolar RF generator intended to deliver RF energy to a targeted site. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. Currently, the Relievant RF Generator (reference device (K171143)) is the only compatible RF generator for use with the Intracept System. The Intracept System uses RF energy to ablate the basivertebral nerve for relief of chronic low back pain and involves a two-step process. First, utilizing the Access Instruments, based on a minimally invasive, transpedicular or extrapedicular approach, a cannula and stylets are placed into the vertebral body to create a path or channel to the terminus of the basivertebral foramen. The RF Probe is then placed into this channel and controlled RF energy is delivered to ablate the basivertebral nerve. This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

The Relievant Medsystems, Inc. Intracept Intraosseous Nerve Ablation System (K222281) did not undergo a clinical study as substantial equivalence was determined based on non-clinical performance testing. The device is a modification of a previously cleared device (K213836). Modifications were made to the Access Instruments component of the system to improve usability and performance, but the RF Probe remained unchanged.

Here's a summary of the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device

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 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 Intracept Intraosseous Nerve Ablation System is comprised of sterile, singleuse components:

• The Intracept Access Instruments include introducers, cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation.
• The Intracept RF Probe conducts RF energy to the target location.
  To obtain the energy needed for tissue ablation, the Intracept RF Probe is used with the Relievant Radiofrequency Generator (RFG).
  The Intracept System uses RF ablation of the basivertebral nerve for relief of chronic low back pain and involves a two-step process. First, utilizing the Access Instruments, based on a minimally invasive, transpedicular or extrapedicular approach, a cannula and stylets are placed into the vertebral body to create a path or channel to the terminus of the basivertebral foramen. The RF Probe is then placed into this channel at the terminus of the basivertebral foramen and controlled RF energy is delivered to ablate the basivertebral nerve (BVN). This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

The provided text describes the 510(k) premarket notification for the Intracept Intraosseous Nerve Ablation System. It focuses on demonstrating substantial equivalence to a predicate device, specifically regarding the introduction of an additional set of ablation parameters.

Based on the provided information, the device in question is a medical device for radiofrequency ablation, not an AI/ML powered device. Therefore, many of the requested elements for describing an AI/ML powered medical device, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth for training was established, are not applicable and not present in this document.

The document primarily focuses on demonstrating that the new version of the device, with additional ablation parameters, is substantially equivalent to a previously cleared version. The "acceptance criteria" here are effectively the criteria for establishing substantial equivalence, which is shown through non-clinical performance testing.

Here's an interpretation based on the provided text, recognizing its focus on a hardware device rather than an AI/ML algorithm:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a hardware device (RF ablation system) rather than an AI/ML diagnostic device, the "acceptance criteria" are not reported in terms of standard diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, they are framed around demonstrating safety and efficacy comparable to a predicate device, particularly with the introduction of new ablation parameters.

The key difference for the new device is the addition of ablation parameters:

• New Ablation Parameters: 75° C, 0.5°C/second ramp, 7 minutes (420 seconds) time. The predicate had only 85° C, 1°C/second ramp, 15 minutes (900 seconds).

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

This document does not describe a clinical study with a "test set" of patient data for evaluating an AI/ML algorithm. The "testing" mentioned is "Non-Clinical Performance Testing." This likely refers to in-vitro or bench testing, and potentially animal studies, to validate the device's physical performance, safety, and the effects of the new ablation parameters on tissue.

• Sample Size: Not explicitly stated, as it's non-clinical performance testing, not a clinical trial with a patient test set.
• Data Provenance: Not applicable as it refers to non-clinical testing, not patient data (e.g., retrospective/prospective).

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

Not applicable. The ground truth for a hardware device's performance is typically established through engineering specifications, physical measurements, and biological response studies, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" in the context of expert review of data for AI/ML performance.

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

Not applicable. This is a hardware device submission, not an AI/ML algorithm where MRMC studies are relevant for assessing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Not applicable. This is a standalone device in the sense that it performs a physical action (ablation), but not a standalone AI algorithm generating an output without human intervention for diagnostic or clinical decision-making purposes.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on non-clinical performance testing. This would involve:

• Engineering specifications and measurements: Ensuring the device delivers RF energy as expected.
• Pre-clinical (in-vitro/ex-vivo/animal) studies: Demonstrating the desired biological effect (ablation leading to cellular necrosis) and safety profile in relevant tissues using the specified parameters.
• Risk analysis: Evaluating potential increases in risk profile with the new ablation parameters.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML model that undergoes a "training set" process.

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

Not applicable, as it's not an AI/ML model with a training set.

Ask a specific question about this device

The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed ostecarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.

The COOLIEF® SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADV ANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVAN CED) to create RF lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site.

The COOLIEF* Cooled Radiofrequency Kit Advanced is a modification to the predicate COOLIEF* Cooled Radiofrequency Kit cleared under K163461. The subject device consists of the following:

• COOLIEF* Cooled Radiofrequency Probe Advanced
• COOLIEF* Cooled Radiofrequency Fluid Tubing Kit ●
• COOLIEF* Cooled Radiofrequency Fluid Delivery Introducer ●

The modifications to the subject device are specific to the probe and fluid tubing kit.

The subject probe and fluid tubing kit are also included in the COOLIEFSINERGY Cooled Radiofrequency Kit Advanced.

The subject device has several configurations based on the anatomic region of use, length of the introducer and probe, and the length of the active electrode. The COOLIEF* Cooled Radiofrequency Kit Advanced is composed of fluid delivery introducers, probes, and fluid tubing kit. The kit is sterile, non-pyrogenic, and single-use. The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue.

The COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVANCED) to create RF lesions in nervous tissue. This device includes the same components as the COOLIEF* Cooled RF Kit Advanced, but also includes an Epsilon The Epsilon Ruler is a circular stainless-steel ruler that may be used during the COOLIEF Ruler. SINERGY* procedure to assist the user in providing a 'template' around the foramen, which is specific to performing procedure around the sacroiliac (SI) nerve.

This document is a 510(k) summary for the COOLIEF® Cooled Radiofrequency Kit Advanced, a medical device for creating lesions in nervous tissue. It details the device's characteristics, comparison to predicate devices, and non-clinical testing results.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that clinical data was not applicable for the subject device and therefore was not provided. All testing mentioned is "non-clinical testing" or "bench performance testing." The sample sizes for these non-clinical tests are not specified in the provided text, nor is the provenance of the data beyond being "bench performance testing."

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

This information is not applicable as there was no clinical study described that involved establishing a ground truth with experts. The stated tests are non-clinical, focusing on device performance and safety parameters.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical study described. Adjudication methods are typically relevant for human-led assessments in clinical trials.

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 information is not applicable. The device described is a radiofrequency kit, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI or MRMC studies in the provided text.

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

This information is not applicable. The device is hardware (a radiofrequency kit) and not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable as no clinical studies with a ground truth were conducted or described. The "ground truth" for the non-clinical tests would be the established engineering and safety standards and specifications to which the device was tested.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable. As stated above, the device does not involve a training set or ground truth in the context of an algorithm.

Ask a specific question about this device

The Vesta RF Cannula, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.

The Vesta RF Cannula consists of an insulated cannula with an active tip for use in radiofrequency heat lesion procedures for the relief of pain. It is designed to be used with compatible pain management generators and probes that have a maximum voltage rating less than or equal to 280 V. The Vesta RF Cannula is sterilized and intended for single use only.

The information provided is about the Biomerics Vesta RF Cannula, cleared under K190259, which is a medical device and not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable.

However, I can provide the acceptance criteria and study information that was conducted for this device. The regulatory submission primarily relies on bench testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance (Not applicable for AI/ML device studies)

The device, the Vesta RF Cannula, is a non-AI medical device. Its performance is demonstrated through meeting various industry standards for physical characteristics, sterilization, and biocompatibility, rather than metrics like sensitivity, specificity, or AUC as would be seen in an AI study.

Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-AI/ML device, the following points are largely inapplicable or have no information provided in the given document.

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

   • Test Set Sample Size: Not applicable for an AI/ML test set. For bench and biocompatibility testing, the sample sizes are determined by the respective ISO or test standards. These typically involve a small number of samples for physical and chemical tests (e.g., a few units per test).
   • Data Provenance: Not applicable. The tests are bench and lab-based studies performed to evaluate device characteristics, not clinical data.

2. 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):

   • Not applicable as this is a non-AI/ML device. Ground truth is established by objective measurements against engineering specifications and industry standards for physical and chemical properties.

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

   • Not applicable as this is a non-AI/ML device. Performance is determined by objective measurements and standard compliance.

4. 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:

   • Not applicable. This device is an RF cannula, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • For this device, the "ground truth" for its safety and effectiveness is established by compliance with recognized international standards (ISO, IEC, ASTM) for material properties, sterilization, physical dimensions, and biocompatibility. This involves objective measurements and qualitative assessments (e.g., "non-irritant," "non-cytotoxic") based on established laboratory protocols.

7. The sample size for the training set:

   • Not applicable. This is a non-AI/ML device, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. This is a non-AI/ML device.

Ask a specific question about this device

The LCCS VC-S RF Cannula is intended for use in RF heat lesion procedures for the relief of pain.

The LCCS VC-S RF Cannula is used in conjunction with the RF electrode for the use in RF heat lesion procedures. The LCCS VC-S RF Cannulas are offered in a variety of lengths, gauges to accommodate various anatomical locations and differences in patients' anatomy. The LCCS VC-S RF Cannula is a stainless steel cannula with an insulated shaft having one exposed tip and one side port located at the end of the cannula to diffuse the anesthesia closer to the lesion site and deliver the RF energy to the tissue. When RF Electrode was inserted into LCCS VC-S RF Cannula and came out from the side port, both active tip and RF Electrode section stuck out of side port can deliver Radio Frequency energy. This RF cannula is provided as a sterile, single use, disposable device. This RF Cannula is offered in a variety of length and Needle outside Dimension to accommodate various anatomical locations and differences in patient anatomy. The LCCS VC-S RF Cannula is consisted of: Protection Sleeve, Needle Tube, Insulating layer, Needle hub, Stylet, Stylet Hub.

The provided text is a 510(k) summary for the LCCS VC-S RF Cannula, which is a medical device. This document focuses on demonstrating the substantial equivalence of the proposed device to existing predicate devices, primarily through a comparison of design features, intended use, technology, and non-clinical testing.

Crucially, this document does not contain information about a clinical study involving human patients or a study comparing the device's performance to specific acceptance criteria related to a machine learning or AI algorithm's performance (e.g., sensitivity, specificity, or AUC). The "acceptance criteria" discussed in this document refer to the device's design specifications and performance against established safety and engineering standards (e.g., sterilization, biocompatibility, mechanical safety), not diagnostic or predictive performance metrics of an AI system.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria for an AI algorithm's performance, a test set, ground truth establishment, MRMC studies, or training sets, as that information is not present in the provided context.

The document's "conclusion" (on page 8) states that the device is considered "as safe, as effective, and performance is substantially equivalent to the predicate devices." This substantial equivalence is based on the comparison table and non-clinical tests, not on a human-in-the-loop or standalone AI study.

To directly answer your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance:
   The document includes a "Comparison to Predicate Devices" table (pages 5-6) that lists features like intended use, material, needle gauge, needle tube length, structure, method of sterilization, and biocompatibility. The "reported device performance" is essentially that these features are "identical" or "equivalent" to the predicate devices and that the device complies with certain voluntary standards (e.g., AAMI/ANSI ES 60601-2-2, ISO 7864, ISO 10993-1). There is also a "Summary of Non-Clinical Tests" table (page 7-8) which shows test results for biocompatibility (Cytotoxicity, Acute Systemic Toxicity, Sensitization, Intracutaneous Reactivity, Pyrogen) and concludes "Non-Cytotoxic," "Non-Acute Systemic Toxicity," etc. This is the closest the document comes to defining acceptance criteria and performance, but it's for the physical device, not an AI.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set for an AI algorithm is mentioned. The testing refers to non-clinical, biocompatibility, and engineering tests of the device itself.

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): Not applicable. No ground truth for an AI algorithm is established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for an AI algorithm is mentioned.

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: Not applicable. No AI algorithm or MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI algorithm performance is discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for an AI algorithm is mentioned. The "ground truth" for this device's acceptance is its conformity to design specifications, material properties, and safety standards demonstrated through non-clinical testing.

8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set for an AI algorithm is mentioned.

Ask a specific question about this device

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 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 changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System 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 changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of sterile, single-use components:

• . The Intracept Access Instruments include introducers, cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation.
• The Intracept RF Probe conducts RF energy to the target location.
  To obtain the energy needed for tissue ablation, the Intracept RF Probe is used with the Relievant RFG.
  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 Access Instruments, based on a minimally invasive, transpedicular or extrapedicular approach, a cannula and stylets are placed into the vertebral body to create a path or channel to the terminus of the basivertebral foramen. The RF Probe is then placed into this channel at the terminus of the basivertebral foramen and controlled RF energy is delivered to ablate the basivertebral nerve. This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

This document is a 510(k) premarket notification for the Intracept Intraosseous Nerve Ablation System and its associated RF Generator. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, primarily by clarifying the Indications for Use related to Modic changes on MRI.

Based on the provided text, the device itself is an RF ablation system used to treat chronic low back pain. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission are not about the performance of a new or modified device against specific performance metrics for clinical efficacy or diagnostic accuracy. Instead, the focus is on demonstrating that the clarified indications for use do not alter the substantial equivalence to the previously cleared devices, meaning it does not introduce new questions of safety or effectiveness.

Therefore, the typical structure for describing an AI/ML device's acceptance criteria and proven performance doesn't directly apply here. The device itself is not an AI/ML system, nor is the 510(k) submission primarily presenting a study to prove its performance in a diagnostic or predictive sense. The "proof" in this context is the argument for substantial equivalence without new clinical or non-clinical testing.

Here's an attempt to answer your questions based on what is relevant and stated in the document, acknowledging that many of your specific questions about AI/ML acceptance criteria and testing are not addressed because this is a different type of medical device submission:

Summary of Acceptance Criteria and Device Performance (in the context of a 510(k) for modified Indications for Use):

The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating Substantial Equivalence to the predicate devices (Intracept Intraosseous Nerve Ablation System K180369, K170827 and Relievant RFG K171143), specifically concerning the modification of the Indications for Use statement. The key "performance" here is that the modified Indications for Use do not raise different questions of safety or effectiveness and do not describe a new disease condition or patient population.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Not applicable. This submission is not based on a new test set of data for performance evaluation in the way an AI/ML device would be. It relies on the substantial equivalence argument, stating no new clinical or non-clinical testing was performed because the device design remained unchanged and the IFU modification did not raise new questions of safety or effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No new test set data or formal independent ground truth establishment processes (as would be typical for diagnostic performance studies) are described in this 510(k) submission. The clarification of Modic changes in the IFU is based on existing medical understanding and classification, not a novel ground truth process for a test set.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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:

• Not applicable. This is not an AI-enabled device, and no MRMC study was conducted or presented in this 510(k) for the purpose of demonstrating comparative effectiveness with human readers.

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

• Not applicable. This is not an AI/ML algorithm or software device that performs a diagnostic function. It is a physical medical device (RF ablation system).

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

• Not applicable. No new ground truth derivation was required for this 510(k) submission. The modifications to the Indications for Use reflect an elaboration of existing, clinically recognized characteristics of Modic changes on MRI, which are established medical knowledge.

8. The sample size for the training set:

• Not applicable. There is no AI/ML model described in this submission that would require a training set.

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

• Not applicable. There is no AI/ML model described in this submission.

Ask a specific question about this device