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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.

When stimulation compatible components are used , the iovera System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.

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. The iovera" System may be used in conjunction with standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired.

The device comprises four main components:

• A reusable Handpiece
• A Charging Dock
• An assortment of single-patient-use Smart Tips
• A Cartridge containing nitrous oxide

The iovera® System 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 contains an LCD display 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 ioveraº system. All Smart Tip needles are made of stainless steel and have a closed-end design 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 its sterile packaging and attaches it to the Handpiece immediately before use. Certain Smart Tip designs provide a connection to an external nerve stimulator to facilitate nerve location prior to treatment.

The iovera System uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N20.

This document is a 510(k) premarket notification for the iovera® System, a cryogenic surgical device. The purpose of this notification is to demonstrate that the modified iovera® System is substantially equivalent to previously cleared iovera® Systems (K211334 and K173763).

Based on the provided text, the device is evaluated against its product specifications. The document describes a series of engineering and performance tests rather than a clinical study evaluating diagnostic or prognostic performance with human readers. Therefore, several of the specific questions related to clinical studies (e.g., sample size for training/test sets, expert ground truth, MRMC studies) are not directly applicable or are not detailed in this submission.

Here's a breakdown of the acceptance criteria and the study (design verification testing) that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The subject iovera® System device met the design verification and validation inputs, passing all predetermined acceptance criteria." However, it does not provide a specific table with numerical acceptance criteria and corresponding reported performance values for each parameter. Instead, it lists categories of testing performed to demonstrate compliance.

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

The document describes "Design Verification testing" and "Verification and validation testing." These are engineering and performance validation tests, not clinical efficacy or diagnostic performance studies involving patient data. Therefore, the concept of a "test set" in the context of a dataset with patient outcomes or images is not applicable here. The "samples" would be units of the device or its components tested in a lab setting. The document does not specify the number of device units or components tested for each category.

• Data Provenance: Not applicable in the context of patient data. The tests are likely conducted in-house or by accredited testing laboratories.
• Retrospective or Prospective: Not applicable as it's not a clinical study involving patient data. These are design verification tests.

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

Not applicable. The ground truth for these engineering performance tests is established by product specifications, recognized standards (e.g., ISO, IEC, ASTM), and internal design requirements, not by expert consensus on clinical data.

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

Not applicable. This is for performance testing against established engineering specifications, not for interpretation of clinical data requiring expert adjudication.

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 submission is for a medical device (cryogenic surgical system), not an AI/CADe or CADx device that assists human readers in interpreting medical images.

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

Not applicable. The iovera® system is a physical device used by a human practitioner. It's not a standalone algorithm.

7. The type of ground truth used:

The ground truth for this device's performance is based on:

• Engineering Specifications: Pre-defined design requirements and performance parameters for the device and its components (e.g., temperature range, timing, electrical properties).
• Recognized Standards: Compliance with international and national standards (IEC, ISO, ASTM) for medical devices, software, electrical safety, biocompatibility, and sterility.
• Predicate Device Equivalence: The claim of substantial equivalence to previously cleared iovera® Systems (K211334 and K173763) implies that their performance characteristics serve as a benchmark.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, this is not an AI/machine learning device, so there is no "training set." The performance verification relies on meeting established design specifications and adhering to relevant industry standards.

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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 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. The device comprises four main components: A reusable Handpiece, A Charging Dock, An assortment of single-patient-use Smart Tips, A Cartridge containing nitrous oxide.

The provided document K211334 is a 510(k) Premarket Notification for the Iovera System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving significant clinical efficacy or performing novel clinical trials to establish acceptance criteria for a new device's performance.

Therefore, the document does not contain the detailed information necessary to answer all parts of your request, especially regarding acceptance criteria for a new device's analytical performance, a groundbreaking study proving its independent performance, reader study details (MRMC), or specifics about training and test sets.

Here's an analysis of what can and cannot be extracted from the provided text:

Key Takeaway from the Document:
The Iovera System (subject device) is being cleared as substantially equivalent to a previously cleared Iovera System (predicate device, K161835). This means the focus of the submission is to show that any modifications to the device since its last clearance do not raise new questions of safety or effectiveness and that the core performance remains the same as the already approved predicate. It does not describe a new study to establish performance metrics against a novel set of acceptance criteria for a first-of-its-kind device.

Information Extracted/Deduced from the Document:

1. A table of acceptance criteria and the reported device performance:
   The document states:
   "Design Verification testing was performed for the iovera° system to demonstrate that the device meets product specifications."
   "The subject ioveraº system device met the design verification and validation inputs, passing all predetermined acceptance criteria."

   However, the document does not provide a specific table of acceptance criteria with numerical targets or the reported device performance outcomes for these criteria. It lists the categories of testing performed:

   • Functional Testing
   • Product Performance (Handpiece and Cartridge)
   • Smart Tip Testing
   • User Interface Testing
   • Electrical /EMC safety Testing

   Given this is a 510(k) for substantial equivalence based on modifications, the "acceptance criteria" likely refer to internal engineering and design verification specifications for the modified components to ensure they perform as intended and don't negatively impact the device's established safety and effectiveness. These are typically pass/fail for specific tests rather than statistical performance metrics like sensitivity/specificity for an AI or diagnostic algorithm.

2. Sample sizes used for the test set and the data provenance:
   The document does not provide information on sample sizes for any "test sets" in the context of clinical performance or algorithm evaluation. The testing described is design verification and validation, which often involves engineering tests on a defined number of units, but these are not typically referred to as "test sets" in the context of clinical data for performance evaluation.
   Data provenance (country of origin, retrospective/prospective) is also not mentioned as this type of clinical data is not the focus of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable and not provided. The device is a cryogenic surgical device, not a diagnostic or AI device that relies on expert interpretation to establish ground truth for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable and not provided for the same reasons as 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:
   This information is not applicable and not provided. The Iovera System is a therapeutic device (cryogenic surgical device), not a diagnostic device or AI software that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is not applicable and not provided. The Iovera System is a physical device used by a clinician, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As this is a physical therapeutic device, the concept of "ground truth" for performance evaluation in the context of diagnostic accuracy does not apply in the way it would for an AI or diagnostic device. The performance is assessed through meeting engineering specifications and demonstrating safe and effective tissue destruction/lesion creation as intended.

8. The sample size for the training set:
   This information is not applicable and not provided. The device is not an AI model that requires a "training set."

9. How the ground truth for the training set was established:
   This information is not applicable and not provided for the same reasons as point 8.

In summary, the provided document relates to a 510(k) submission for a physical medical device (cryogenic surgical device) that is being cleared based on substantial equivalence to a predicate device after modifications. It does not contain the type of performance evaluation study details (e.g., test sets, ground truth methodology, reader studies) that would be relevant for an AI/diagnostic device.

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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.

Ask a specific question about this device

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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