(79 days)
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:
- A reusable Handpiece
- A Charging Dock
- An assortment of single-patient use Smart Tips
- 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.
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | PASS |
| Sensitization | PASS | |
| Intracutaneous Reactivity | PASS | |
| Acute System Toxicity | PASS | |
| Material-Mediated Pyrogenicity | PASS | |
| Software Functionality | Software verification for new Smart Tip descriptor | PASS |
| Bench/Hardware Performance | Electrical Safety Testing per IEC 60601-1 | PASS |
| EMC/Immunity Testing per IEC 60601-1-2 | PASS | |
| Visual and Dimensional Inspection of Smart Tip needle | PASS | |
| Verification of temperature reproducibility | PASS | |
| Cryozone Testing | PASS | |
| Needle Integrity | PASS | |
| Tip Descriptor verification to confirm treatment parameters | PASS |
Study Details
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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.
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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.
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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.
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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, 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.
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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.
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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.
- For the performance data provided, the "ground truth" is based on:
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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.
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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.
§ 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).