(112 days)
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:
- A reusable Handpiece
- A Charging Dock
- An assortment of single-patient use Smart Tips
- 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.
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tip Descriptor verification to confirm treatment parameters (Software testing) | Treatment parameters confirmed correctly | PASS |
| Visual and dimensional inspection of Smart Tip needle (Bench testing) | Met design specifications | PASS |
| Verification of temperature reproducibility (Bench testing) | Consistent and reproducible temperature (within specified range) | PASS |
| Validation of cryozone size (Bench testing) | Cryozone formed within specified parameters | PASS |
| Validation of needle integrity in simulated use conditions (Bench testing) | Maintained integrity | PASS |
| After flexing, needle shall return to straight condition (Bench testing) | Needle returns to straight condition | PASS |
| Needle shall not leak after kink failure (Bench testing) | No leakage after kink failure | PASS |
| Sterility Testing (Bench testing) | Compliant with sterility standards (e.g., ISO 11135-1) | PASS |
| Transit/Shelf Life Testing (Bench testing) | Maintained performance over transit/shelf life | PASS |
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.
§ 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).