(130 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 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. 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 provided document K211334 is a 510(k) Premarket Notification for the Iovera System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving significant clinical efficacy or performing novel clinical trials to establish acceptance criteria for a new device's performance.
Therefore, the document does not contain the detailed information necessary to answer all parts of your request, especially regarding acceptance criteria for a new device's analytical performance, a groundbreaking study proving its independent performance, reader study details (MRMC), or specifics about training and test sets.
Here's an analysis of what can and cannot be extracted from the provided text:
Key Takeaway from the Document:
The Iovera System (subject device) is being cleared as substantially equivalent to a previously cleared Iovera System (predicate device, K161835). This means the focus of the submission is to show that any modifications to the device since its last clearance do not raise new questions of safety or effectiveness and that the core performance remains the same as the already approved predicate. It does not describe a new study to establish performance metrics against a novel set of acceptance criteria for a first-of-its-kind device.
Information Extracted/Deduced from the Document:
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A table of acceptance criteria and the reported device performance:
The document states:
"Design Verification testing was performed for the iovera° system to demonstrate that the device meets product specifications."
"The subject ioveraº system device met the design verification and validation inputs, passing all predetermined acceptance criteria."However, the document does not provide a specific table of acceptance criteria with numerical targets or the reported device performance outcomes for these criteria. It lists the categories of testing performed:
- Functional Testing
- Product Performance (Handpiece and Cartridge)
- Smart Tip Testing
- User Interface Testing
- Electrical /EMC safety Testing
Given this is a 510(k) for substantial equivalence based on modifications, the "acceptance criteria" likely refer to internal engineering and design verification specifications for the modified components to ensure they perform as intended and don't negatively impact the device's established safety and effectiveness. These are typically pass/fail for specific tests rather than statistical performance metrics like sensitivity/specificity for an AI or diagnostic algorithm.
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Sample sizes used for the test set and the data provenance:
The document does not provide information on sample sizes for any "test sets" in the context of clinical performance or algorithm evaluation. The testing described is design verification and validation, which often involves engineering tests on a defined number of units, but these are not typically referred to as "test sets" in the context of clinical data for performance evaluation.
Data provenance (country of origin, retrospective/prospective) is also not mentioned as this type of clinical data is not the focus of this submission. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The device is a cryogenic surgical device, not a diagnostic or AI device that relies on expert interpretation to establish ground truth for performance evaluation. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided for the same reasons as point 3. -
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:
This information is not applicable and not provided. The Iovera System is a therapeutic device (cryogenic surgical device), not a diagnostic device or AI software that assists human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. The Iovera System is a physical device used by a clinician, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As this is a physical therapeutic device, the concept of "ground truth" for performance evaluation in the context of diagnostic accuracy does not apply in the way it would for an AI or diagnostic device. The performance is assessed through meeting engineering specifications and demonstrating safe and effective tissue destruction/lesion creation as intended. -
The sample size for the training set:
This information is not applicable and not provided. The device is not an AI model that requires a "training set." -
How the ground truth for the training set was established:
This information is not applicable and not provided for the same reasons as point 8.
In summary, the provided document relates to a 510(k) submission for a physical medical device (cryogenic surgical device) that is being cleared based on substantial equivalence to a predicate device after modifications. It does not contain the type of performance evaluation study details (e.g., test sets, ground truth methodology, reader studies) that would be relevant for an AI/diagnostic 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).