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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.

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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.

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Smith & Nephew RF Cannulae are intended to facilitate placement of Smith & Nephew RF Denervation Probes. The Smith & Nephew RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

Smith & Nephew RF Cannulae are intended to facilitate the placement of Smith & Nephew RF Denervation Probes for the use in RF heat lesion procedures. The RF Cannulae are offered in a variety of lengths, gauges and tip configurations to accommodate various anatomical locations and differences in patient anatomy.

I am sorry, but the provided text, while being a 510(k) summary, does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a submission for a medical device (Smith & Nephew RF Cannulae) for the purpose of demonstrating substantial equivalence to a previously cleared device (K063467). It focuses on:

• Device Description: What the cannulae are and their purpose.
• Intended Use: How they are meant to be used (facilitating placement of RF Denervation Probes for RF heat lesion procedures for pain relief).
• Technological Characteristics: Stating they are similar to the predicate device with minor improvements for insertion performance.
• Substantial Equivalence Information: Explicitly stating equivalence based on design, indications for use, and material composition to the predicate device.
• List of Models: Various gauges, lengths, and tip configurations.
• FDA Clearance Letter: Confirming the 510(k) clearance based on substantial equivalence.

There is no mention of any performance studies, clinical trials, or validation data that would include acceptance criteria or reported device performance metrics. The approval appears to be based on the similarity to an already cleared device, implying that the safety and effectiveness are established through that predicate.

Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement as that information is not present in the provided text.

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Smith & Nephew RF Denervation Probes and RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

The Smith & Nephew RF Denervation Probe is a temperature sensing electrode designed for use in radiofrequency lesion procedures. The RF Denervation Probe is used with a disposable Smith & Nephew RF Cannulae. The Smith & Nephew Denervation Probe is packaged non-sterile for reuse. The Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations, and are packaged sterile for single use.

Based on the provided text, the device in question is the Smith & Nephew RF Denervation Probes & RF Cannulae. The document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed clinical performance data against specific acceptance criteria for a new device.

Therefore, the information for many of your requested points is not present in this document. The existing information primarily relates to electrical safety standards.

Here's what can be extracted:

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

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

This information is not provided in the document. The document refers to "Summary Performance Data" which only states compliance with electrical safety standards, not a clinical test set.

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 information is not provided in the document, as no clinical test set requiring expert ground truth is described.

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

This information is not provided in the document, as no clinical test set requiring adjudication is described.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done (or at least, not reported in this document). The device is a medical instrument (probe and cannula), not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a medical instrument, not an algorithm or AI.

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

This information is not provided as no clinical performance study with a defined ground truth is described. The performance data presented relates to engineering standards (electrical safety).

8. The sample size for the training set

This information is not provided. The document describes a medical device, not a machine learning model, so there is no "training set" in the context of AI.

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

This information is not applicable, as there is no training set for an AI model.

Summary of the Study and Device Proof:

The "study" described in this 510(k) summary is not a clinical performance study in the traditional sense, but rather a demonstration of substantial equivalence to a previously cleared predicate device (Smith & Nephew RF Denervation Probes & RF Cannulae, K034012) and compliance with electrical safety standards.

• The device meets the requirements of UL 60601-1 and IEC 60601-1 electrical safety standards when used with a specific generator (Smith & Nephew Electrothermal® 20S Spine System Generator). This compliance serves as the "proof" for these specific acceptance criteria.
• The primary "proof" for regulatory clearance is the argument that the new device is substantially equivalent in design, materials, function, and intended use to the predicate device. This argument itself is the "study" for 510(k) purposes, rather than a clinical trial with performance metrics.

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Smith & Nephew RF Cannulae are intended to facilitate placement of Smith & Nephew RF Denervation Probes. The Smith & Nephew RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

The Smith & Nephew RF Denervation Probe is a temperature sensing electrode designed for use in radiofrequency lesion procedures. The RF Denervation Probe is used with a disposable Smith & Nephew RF Cannula. Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations. The RF Cannulae are packaged sterile for single use.

The provided text describes the regulatory clearance for the Smith & Nephew RF Cannulae. It does not contain information about a study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or improvement with AI assistance. Instead, it focuses on the device's substantial equivalence to a predicate device and its compliance with electrical safety standards.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. The document describes a regulatory submission based on substantial equivalence and compliance with safety standards, not a performance study on a test set of patient data.

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

• Not applicable. No such test set or ground truth establishment by experts is mentioned in the provided text.

4. Adjudication method for the test set:

• Not applicable. No adjudication method is described as there is no performance study or test set using patient data.

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:

• No. An MRMC study was not done, and the device is a medical cannulae, not an AI-assisted diagnostic tool. Therefore, there's no mention of human reader improvement with or without AI.

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

• No. The device is a physical medical instrument, not an algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The type of ground truth used:

• Not applicable. The "ground truth" in this context is the existing predicate device and established electrical safety standards, not clinical outcomes data or pathology from a study. The device's "performance" is primarily assessed against these regulatory and technical benchmarks.

8. The sample size for the training set:

• Not applicable. This device is hardware, not a machine learning model, so there is no concept of a "training set."

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

• Not applicable. As there is no training set for a machine learning model, this question is not relevant.

In summary: The provided document is a 510(k) summary for a medical device (RF Cannulae) seeking regulatory clearance. It focuses on demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant electrical safety standards. It does not describe a clinical study with performance metrics, patient data, or expert-established ground truth in the way one would expect for an AI-enabled diagnostic or prognostic device. The "study" mentioned is the evaluation of the device against standards and comparison to an existing device, rather than a prospective clinical performance trial.

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The Cosman RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain.

The Cosman RF Cannula is used in conjunction with the commercially available Cosman RF Generator (K050084) to create radiofrequency (RF) lesions for the treatment of pain. The Cosman RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip to deliver the RF energy to the tissue. The Cosman RF Cannula is provided as a sterile, single use, disposable device. The Cosman RF Cannula will be available in a variety of lengths and gauges. The Cosman RF Cannula is provided sterile packed, and is labeled for Single Use Only.

Here's an analysis of the provided text regarding the Cosman RF Cannula, focusing on acceptance criteria and supporting studies:

Based on the provided 510(k) summary, the device is not an AI/ML powered device. This document describes a medical device, a radiofrequency cannula, and its substantial equivalence to predicate devices, focusing on physical and technical characteristics and bench testing. Therefore, many of the typical acceptance criteria and study components relevant to AI/ML devices, such as performance metrics like accuracy, sensitivity, specificity, and detailed study designs with ground truth establishment, are not applicable or not present in this type of submission.

The document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving novel performance against predefined acceptance criteria for an AI algorithm.

Here's a breakdown based on your requested information, highlighting what is (and isn't) present in this particular 510(k) summary for a non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The primary "acceptance criteria" here is substantial equivalence to predicate devices. This isn't quantified with specific performance metrics in the same way an AI/ML device would be, but rather through comparison of characteristics and functional testing.
  • Functional Equivalence: The device must perform the same intended use as the predicate (RF heat lesion procedures for pain relief).
  • Technical Equivalence: The device must have similar physical and technical characteristics (e.g., stainless steel cannula, insulated shaft, exposed tip, sterile, single-use, disposable, available in various lengths and gauges).
• Reported Device Performance:

  Performance Characteristic	Acceptance Criteria / Predicate Equivalence	Reported Device Performance (Cosman RF Cannula)
  Intended Use	RF heat lesion procedures for pain relief	Indicated for use in RF heat lesion procedures for the relief of pain.
  Physical Characteristics	Similar to predicate devices: Material (stainless steel), construction (insulated shaft, exposed tip), sterility (sterile, single-use, disposable), dimensions (various lengths and gauges).	"The Cosman RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip... provided as a sterile, single use, disposable device. will be available in a variety of lengths and gauges."
  Technical Characteristics	Similar to predicate devices (e.g., ability to deliver RF energy for lesion creation).	Used in conjunction with the Cosman RF Generator (K050084) to create RF lesions.
  Safety & Effectiveness	Demonstrated by substantial equivalence to predicate devices and confirmed by non-clinical (bench) testing.	"Cosman Medical has done bench testing on the Cosman RF Cannula to confirm performance characteristics of this device." "The comparison to the predicate device demonstrates that the Cosman RF Cannula is safe and effective and is substantially equivalent to the predicate device."

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

• Not Applicable / Not Provided: For this type of device (RF cannula), there isn't a "test set" of patient data in the way there would be for an AI/ML diagnostic or prognostic device. The testing mentioned is "bench testing" to confirm performance characteristics, which would involve physical samples of the device undergoing various engineering tests. The sample size for this bench testing is not specified. Data provenance (country of origin, retrospective/prospective) is also not applicable here.

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

• Not Applicable: Given this is a physical medical device and not an AI/ML algorithm, there is no "ground truth" to be established by experts in the context of diagnostic performance. "Ground truth" for this device would relate to its physical properties and functional capability, confirmed through engineering tests.

4. Adjudication method for the test set

• Not Applicable: No adjudication method is described because there is no "test set" of clinical cases requiring expert review or consensus for this device type. Adjudication methods like 2+1 or 3+1 are specific to AI diagnostic performance studies.

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

• No, Not Applicable: An MRMC study is designed to evaluate AI assistance for human readers in diagnostic tasks. This device is an instrument used in a surgical/procedural context, not a diagnostic aid with an AI component.

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

• Not Applicable: This device is a physical instrument, not an algorithm. Therefore, "standalone algorithm" performance is not relevant.

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

• Not Applicable / Engineering Specifications: For this device, the "ground truth" is its adherence to engineering specifications and its ability to function as intended (e.g., generate a specific RF lesion profile) as demonstrated through bench testing. It's not a clinical "ground truth" derived from patient data.

8. The sample size for the training set

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set."

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

• Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary: The provided 510(k) pertains to a traditional, non-AI medical device (an RF cannula). The "study" referenced is "bench testing" to confirm performance characteristics and establish substantial equivalence to predicate devices, rather than a clinical trial or AI/ML performance study with specific acceptance criteria related to accuracy, sensitivity, etc. Therefore, most of your detailed questions regarding AI/ML study design are not applicable to this document.

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The LesionPoint RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain.

The LesionPoint RF Cannula is used in conjunction with the commercially available Cosman RFG-1A Lesion Generator (K050084) to create radiofrequency (RF) heat lesions for the treatment of pain. The LesionPoint RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip to deliver the RF energy to the tissue. The LesionPoint RF Cannula is provided as a sterile, single use, disposable device. The LesionPoint RF Cannula will be available in a variety of lengths and gauges. The LesionPoint RF Cannula is provided sterile packed, and is labeled for Single Use Only.

The provided 510(k) summary for the LesionPoint RF Cannula does not contain acceptance criteria or detailed study information.

The summary states:

1. Non-Clinical Data: "Cosman Medical has done bench testing on the LesionPoint RF Cannula to confirm performance characteristics of this device."
2. Conclusion: "The comparison to the predicate device demonstrates that the LesionPoint RF Cannula is safe and effective and is substantially equivalent to the predicate devices."

This document is a marketing application for a medical device seeking substantial equivalence to existing predicate devices. For such applications, detailed performance metrics, acceptance criteria, and comprehensive study results like those requested are typically not included in this summary document. The FDA determines substantial equivalence based on the device's intended use, technological characteristics, and safety and effectiveness information compared to predicates, often relying on a combination of bench testing, comparisons to predicate devices, and sometimes (but not always for 510(k)s) clinical data.

Therefore, for the specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document only mentions "bench testing...to confirm performance characteristics." No specific metrics or acceptance criteria are reported.
2. Sample size used for the test set and the data provenance: Not provided. The document only mentions "bench testing." No details on sample size or data provenance (e.g., country, retrospective/prospective) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. The document doesn't describe a test set requiring expert ground truth for performance evaluation of classification or diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
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 device is a radiofrequency cannula, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided. The device undergoes "bench testing," which typically involves engineering and physical property measurements rather than ground truth based on clinical or expert consensus.
8. The sample size for the training set: Not applicable/not provided. The document doesn't mention a training set, as it's not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable/not provided.

In summary, the provided 510(k) documentation focuses on demonstrating substantial equivalence to predicate devices through physical and technical characteristic comparisons and general bench testing, rather than detailed performance studies with specific acceptance criteria as might be seen for novel diagnostic or AI-powered devices.

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The Smith & Nephew RF Denervation Probes and Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

The Smith & Nephew RF Denervation Probe is a temperature sensing electrode designed for use in radiofrequency lesion procedures. The RF Denervation Probe is used with a disposable Smith & Nephew RF Cannula. The Smith & Nephew RF Denervation Probe is packaged non-sterile for reuse. Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations. The RF Cannulae are packaged sterile for single use.

The provided text describes a 510(k) summary for the Smith & Nephew RF Denervation Probes & RF Cannulae. For devices cleared through the 510(k) process, the primary "study" that proves the device meets acceptance criteria is a demonstration of substantial equivalence to legally marketed predicate devices. This typically involves performance data showing the new device functions similarly and safely to the predicate, rather than an extensive clinical trial designed to prove clinical efficacy.

Therefore, the requested information focusing on AI-specific metrics (like MRMC studies, standalone algorithm performance, training/test set sizes, expert adjudication for ground truth) is not applicable to this type of device and submission. The document explicitly states: "The Smith & Nephew RF Denervation Probes & RF Cannulae are substantially equivalent in design, materials, function and intended use to the following devices cleared for commercial distribution: Radionics Racz-Finch Electrode K870028 and Radionics Disposable RF Cannulae K980430."

However, the document does contain information about performance data related to electrical safety standards.

Here's the breakdown based on the available information:

Acceptance Criteria and Device Performance

Study Details (Based on available 510(k) summary)

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

   • Sample Size: Not explicitly stated as a separate "test set" in the context of a clinical performance study. The 510(k) process relies on demonstrating equivalence through technical characteristics and a summary of performance data (like electrical safety testing).
   • Data Provenance: Not applicable in the context of a clinical trial for substantial equivalence based on technical standards and comparisons. The performance data relates to general electrical safety testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for algorithm performance (e.g., in AI/ML studies) is not part of this 510(k) submission. The "ground truth" for substantial equivalence is the established performance and safety of the predicate devices and compliance with recognized standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There was no clinical study requiring adjudication of expert interpretations as described.

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 not an AI-assisted diagnostic or imaging device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a medical instrument (probe and cannula), not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this submission are the established safety and performance requirements of electrical safety standards (UL 60601-1, IEC 60601-1) and the characteristics of the legally marketed predicate devices.

7. The sample size for the training set: Not applicable. This device is not an AI-based system that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

Summary Rationale:

The provided document is a 510(k) summary for medical devices (RF Denervation Probes and Cannulae). The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving independent clinical effectiveness through extensive clinical trials as would be required for a novel device or an AI/ML product. The "study" here is primarily a technical comparison and confirmation of compliance with relevant industry standards (electrical safety), rather than a clinical trial with human subjects, ground truth panels, or AI performance metrics.

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