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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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