(132 days)
The myoscience ioveral device 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 selected site for the blocking of pain. The iovera® device is not indicated for treatment of central nervous system tissue.
The myoscience iovera® device 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 has the added functionality of having the treatment parameters being preprogrammed into its secure processor. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The iovera® device 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:
- A reusable Handpiece 1.
- A Charging Dock 2.
- A single-patient use Smart Tip 3.
- A Cartridge (Nitrous Oxide)
The provided text describes a 510(k) submission for the myoscience iovera® cryogenic surgical device. This document focuses on the substantial equivalence of the new device to a predicate device based on non-clinical performance testing. It does not include information about acceptance criteria and clinical study results in the format typically used for AI/ML device submissions, such as detailed performance metrics, ground truth establishment, or human reader studies.
Here's a breakdown of the requested information based only on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance
For this device, the "acceptance criteria" are implicitly meeting the design requirements and demonstrating substantial equivalence to the predicate device through non-clinical testing. The "reported device performance" is a simple pass/fail for each test, indicating it met the criteria for substantial equivalence.
| Acceptance Criteria (Test Performed) | Reported Device Performance (Result) |
|---|---|
| Temperature reproducibility | PASS, Substantially equivalent to predicate |
| Mechanical Integrity for System | PASS, Substantially equivalent to predicate |
| Nitrous Exposure | PASS, Substantially equivalent to predicate |
| Cryozone Size | PASS, Substantially equivalent to predicate |
| Needle Integrity | PASS, Substantially equivalent to predicate |
| Sterilization and Shelf Life Testing | PASS, Substantially equivalent to predicate |
| Electrical Safety Testing | PASS, Substantially equivalent to predicate |
| Software Testing | PASS, Substantially equivalent to predicate |
| Safety Testing | PASS, Substantially equivalent to predicate |
| Biocompatibility Testing | PASS, Substantially equivalent to predicate |
Study Details:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document states "Verification testing was performed on the Nonclinical myoscience iovera® device to demonstrate that the product met the design requirements for system performance." It does not specify sample sizes for these non-clinical tests (e.g., number of devices tested, number of cycles performed).
- Data provenance is not explicitly mentioned but would be from internal lab testing at myoscience, Inc. The nature of the tests (e.g., temperature reproducibility, cryozone size) implies prospective testing in a lab setting.
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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/Not provided. The "ground truth" for non-clinical performance tests like temperature reproducibility or mechanical integrity is typically established by engineering specifications and objective measurements, not by expert human reviewers.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are relevant for subjective human interpretations, often in clinical or image-based studies. These non-clinical tests rely on objective measurements against predefined engineering specifications.
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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. The document explicitly states: "Clinical Testing Submitted: None." This is a non-clinical submission, and therefore, no MRMC study or AI-related effectiveness study was performed or required for this 510(k). The device is a surgical tool, not an AI diagnostic/interpretive tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical, cryogenic surgical device, not a software algorithm. Therefore, "standalone algorithm performance" is not applicable. The device's "performance" is its ability to meet specified engineering parameters (e.g., temperature, mechanical integrity) during its operation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is based on engineering specifications and objective measurements (e.g., specific temperatures, physical dimensions, material properties, electrical safety standards). It is not dependent on expert consensus, pathology, or outcomes data, as these are not clinical tests.
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The sample size for the training set:
- Not applicable/Not provided. As this is not an AI/ML device, there is no "training set" in the machine learning sense. The device's design and functionality are based on established physical principles (Joule-Thomson Effect, Latent Heat of Vaporization) and engineering.
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How the ground truth for the training set was established:
- Not applicable/Not provided, as there is no training set for an AI/ML device.
§ 882.4250 Cryogenic surgical device.
(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).