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The iovera? system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera" system is not indicated for treatment of central nervous system tissue.

The ioveraº system's "1x90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

The iovera system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue creating a nerve block through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N2O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The iovera® system may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.

The device is comprised of four main components:

1. A reusable Handpiece
2. A Charging Dock
3. An assortment of single-patient use Smart Tips
4. A Cartridge (Nitrous Oxide)

Based on the provided text, the document is a 510(k) Premarket Notification for the Myoscience iovera® system, primarily focused on an extended Smart Tip configuration. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance data submitted to demonstrate substantial equivalence to predicate devices, rather than a clinical outcome study in the traditional sense of proving clinical efficacy for a new indication.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this submission are primarily focused on demonstrating the safety and performance of the new Smart Tip configuration (1x90mm) as being substantially equivalent to existing predicate devices, particularly regarding its physical characteristics and operational performance within the iovera® system. The acceptance criteria are essentially implied by the "PASS" results for various tests.

Study Details

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

   • The document does not specify numerical sample sizes for each of the performance tests (e.g., number of Smart Tips tested for dimensional inspection, or number of cycles for temperature reproducibility).
   • Data Provenance: The tests were conducted by Myoscience, Inc. as part of their premarket notification for the device. The document does not specify a country of origin for the data or whether it was retrospective or prospective, but given it's a premarket submission, it would be prospective testing conducted for the purpose of the submission.

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

   • For this type of device and submission (a 510(k) for a modification to an existing device, emphasizing engineering and material performance), "ground truth" is established through standardized engineering tests, material testing protocols (like ISO-10993), and software verification, rather than clinical expert consensus on complex diagnostic images. Therefore, the concept of "experts establishing ground truth" in the clinical sense is not directly applicable. The "experts" would be qualified engineers, test technicians, and quality assurance personnel performing the described tests according to recognized standards.

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

   • Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving multiple human readers assessing medical images or outcomes. This document details engineering and biocompatibility testing, not a clinical reader study. Therefore, no such adjudication method was used or is relevant to the data presented.

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:

   • No, an MRMC comparative effectiveness study was not performed. This device is a cryogenic surgical system, not an AI-powered diagnostic or assistive tool for human readers. The concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.

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

   • No, this term typically applies to AI algorithms. The "software testing" mentioned is for the device's embedded software (e.g., for controlling treatment parameters), not a standalone AI algorithm for medical image analysis or diagnosis.

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

   • For the performance data provided, the "ground truth" is based on:
     • Standardized Test Specifications: For electrical safety, EMC, dimensional accuracy, temperature reproducibility, cryozone formation, and needle integrity, the ground truth is defined by pre-established engineering specifications and international standards (e.g., IEC 60601-1, ISO-10993).
     • Chemical/Biological Standards: For biocompatibility, the ground truth is determined by the results of specific standardized biological tests (Cytotoxicity, Sensitization, etc.) against accepted pass/fail criteria from ISO-10993.
     • Software Design Requirements: For software verification, the ground truth is the confirmed meeting of the software design requirements for the new Smart Tip descriptor.

7. The sample size for the training set:

   • This document describes performance testing for a 510(k) submission, not an AI model development. Therefore, there is no "training set" as understood in machine learning. The device itself (the iovera® system) has undergone extensive development and testing, but the term "training set" is not applicable here.

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

   • As there is no "training set" in the context of this 510(k) submission, this question is not applicable.

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The iovera? system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera" system is not indicated for treatment of central nervous system tissue.

The ioveras system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue creating a nerve block through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N2O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The ioveraº system may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.

The device is comprised of four main components:

1. A reusable Handpiece
2. A Charging Dock
3. An assortment of single-patient use Smart Tips
4. A Cartridge (Nitrous Oxide)

The iovera Handpiece is battery powered and provides feedback to the user during device preparation and use. The Handpiece connects to both the Cartridge and to the Smart Tip. The user activates a treatment cycle through a control on the Handpiece, which starts and stops the treatment. The Handpiece also contains LEDs for providing feedback to the user when the device is ready to use. The Charging Dock stores the Handpiece between uses and provides power for charging the battery.

An assortment of Smart Tips is available for the iovera system. All Smart Tip needles are made of stainless steel and have a closed-end that fully contains the cryogen so that it does not enter the target tissue. The Smart Tip is the only patient contacting component of the iovera° system. The user removes the Smart Tip from the sterile packaging and attaches it to the Handpiece.

The ioveras system uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N2O.

This document describes the FDA 510(k) clearance for the ioveraº system, a cryogenic surgical device, for an expanded indication related to the relief of pain and symptoms associated with osteoarthritis of the knee.

1. Table of Acceptance Criteria (Primary and Secondary Endpoints) and Reported Device Performance

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

• Sample Size: 180 subjects were enrolled and analyzed.
  • ioveraº system treatment group: 121 subjects
  • Sham device control group: 59 subjects
• Data Provenance: The study was a multi-center, prospective, randomized, double-blind, sham-treatment controlled trial. The specific country of origin is not explicitly stated in the provided text, but the FDA submission implies a US-based or FDA-regulated study. Being a prospective, randomized, double-blind trial suggests high-quality clinical data.

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

This type of study does not rely on "experts establishing ground truth" in the same way an imaging AI study would. Instead, the "ground truth" for efficacy is established by the participants' self-reported pain and symptom scores using validated instruments (WOMAC scale) and comparison against a sham control. Eligibility criteria included a diagnostic block by a local anesthetic, which would have been assessed by a clinician (likely a physician or pain specialist). The study design (randomized, double-blind, sham-controlled) is a robust method for establishing efficacy.

4. Adjudication Method for the Test Set

Not applicable in the context of this clinical trial for the stated endpoints. The outcome measures are quantitative scores (WOMAC) and percentages of responders, directly recorded from treatment and control groups. Blinding of both the treating investigator and the subject to the study treatment serves as the primary method to prevent bias in assessment.

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 a clinical trial evaluating a medical device (cryogenic surgical system) for pain relief, not an AI software evaluating medical images. Therefore, the concept of "human readers improving with AI" does not apply.

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

Not applicable. The ioveraº system is a physical device used by a clinician, not an algorithm. Its performance is determined by its physiological effect (tissue destruction/nerve lesioning) and resulting clinical outcomes. This study evaluates the device in use by humans.

7. The Type of Ground Truth Used

The ground truth for the efficacy endpoints was based on patient-reported outcomes (PROs) using the validated Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale, specifically measuring changes from baseline in pain, stiffness, and physical function. The diagnostic block of the infrapatellar branch of the saphenous nerve with a local anesthetic served as a pre-screening "ground truth" to confirm a subject was a candidate for treatment before randomization.

8. The Sample Size for the Training Set

Not applicable. This is a clinical trial for a medical device and does not involve an AI algorithm with 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 algorithm in this context.

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The myoscience ioveraº system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the blocking of pain. The ioveraº system is not indicated for treatment of central nervous system tissue.

The iovera° system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N₂O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. iovera° may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.

The device is comprised of four main components:

1. A reusable Handpiece
2. A Charging Dock
3. An assortment of single-patient use Smart Tips
4. A Cartridge (Nitrous Oxide)

The provided text is a 510(k) Summary for the Myoscience iovera® system, a cryogenic surgical device. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study data for a novel device or AI algorithm.

Therefore, much of the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance is not present in this document.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several bench tests and software tests with a pass/fail outcome. It doesn't explicitly state quantitative acceptance criteria beyond "PASS," but it implies meeting design requirements and pertinent standards.

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

• Test Set Sample Size: Not specified in the document. The tests performed are described but not the number of units or instances tested for each.
• Data Provenance: Not applicable in the context of this device's testing. The tests are primarily bench and software 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:

• Not applicable as this is not an AI/diagnostic device requiring expert ground truth for image interpretation or diagnosis. The ground truth for device performance is based on direct measurement and adherence to engineering specifications and standards.

4. Adjudication method for the test set:

• Not applicable. The tests are objective measurements or functional verifications, not subjective expert reviews.

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 diagnostic device.

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

• Not applicable. This is not an AI algorithm. The device performance tests mentioned are standalone tests of the physical device and its software.

7. The type of ground truth used:

• The ground truth for the device's performance tests appears to be based on:
  • Engineering specifications and design requirements: For dimensional integrity, temperature reproducibility, cryozone size, and needle integrity.
  • International standards: Such as ISO 11135-1 for sterility and ISO-10993 for biocompatibility.
  • FDA guidance documents: For software verification testing.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model that requires a training set.

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

• Not applicable. No training set for an AI model.

Summary based on the Provided Text:

The provided document is a 510(k) summary for a medical device (Myoscience iovera® system) seeking substantial equivalence to a predicate device. It focuses on the safety and effectiveness of the device itself through bench testing, software verification, and biocompatibility evaluations, especially for the modified "Smart Tip" component. It explicitly states that "No preclinical testing was deemed necessary for this modification" and "No clinical testing was deemed necessary for this modification," indicating that the decision for substantial equivalence was based on non-clinical data. The document does not describe the evaluation of an AI algorithm or diagnostic performance.

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