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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, NoO) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The iovera8 System may be used in conjunction with standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired.

The device is comprised of four main components:

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

The provided text describes the iovera® System, a cryogenic surgical device cleared by the FDA (K243677). The document focuses on demonstrating substantial equivalence to predicate devices (K220656 and K211334) for a new Smart Tip configuration (STT21180STIM) that also facilitates nerve location.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily relies on adherence to recognized standards and satisfactory completion of design verification testing. Specific quantitative acceptance criteria for each test (e.g., specific thresholds for biocompatibility, precise tolerances for mechanical tests) are not explicitly detailed in this summary, but the general outcome of "meets all ISO10993-1 and USP acceptance criteria" or "complied with standards" is stated.

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

The document summarizes design verification testing rather than a clinical study with a "test set" of patient data. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this regulatory summary. The testing focuses on engineering verification (e.g., number of units tested for mechanical properties, number of samples for biocompatibility, etc.), not patient data.

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

Again, this pertains to a clinical study with patient data and does not apply to the design verification testing described. The "ground truth" for the engineering tests would be the compliance with recognized standards and specified performance parameters.

4. Adjudication Method for the Test Set:

Not applicable, as this is design verification testing rather than a clinical study requiring consensus from experts on case interpretation.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicate devices, not on evaluating human reader performance with or without AI assistance. The device in question is a physical cryogenic surgical device, not an AI diagnostic tool that assists human readers with interpretations.

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

Not applicable. The iovera® System is a physical medical device, not an algorithm. Performance is assessed through engineering tests of the device itself. While it facilitates nerve location, its primary function is direct tissue destruction via freezing, with a human operator always in the loop.

7. The Type of Ground Truth Used:

For the design verification testing, the "ground truth" used is:

• Compliance with recognized international and national standards (e.g., ISO 10993-1, IEC 60601-1, IEC 62366-1, ISO 11135, ASTM standards).
• Pre-defined product specifications and design input requirements for physical, electrical, mechanical, software, and biological properties.
• Laboratory test results (e.g., chemical analysis for extractables, temperature measurements for cooling performance, force measurements for bond strength).

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set of data.

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

Not applicable, as there is no training set for this type of medical device submission.

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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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