(84 days)
Tennis Racquet inserts are intended for use in Radiation Therapy to facilitate treatment of the patient when laying prone or supine on the treatment couch. Tennis Racquets provide a beam path that is considered attenuation free while supplying firm support for the patient.
The AKTINA Medical Physics Corporation Tennis Racquet Insert is intended for use in Radiation Therapy as an aid in suporting the patient during external beam irradiation.
This appears to be a 510(k) submission for a non-diagnostic device (a 'Tennis Racquet Insert' for radiation therapy patient support), not a diagnostic AI device. Therefore, the provided documents do not contain the information required to answer the questions about acceptance criteria, study details, ground truth, or AI performance that are typically associated with diagnostic AI systems.
The submission focuses on establishing substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating performance of a diagnostic algorithm.
Here's a breakdown of why this information is missing:
- Acceptance Criteria/Reported Performance: These are typically for diagnostic accuracy (sensitivity, specificity, AUC) or other quantifiable performance metrics. This device doesn't have such metrics. Its "performance" is about supporting a patient without introducing new safety/effectiveness issues compared to similar devices.
- Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size, Training Set Ground Truth: All these points relate specifically to studies designed to evaluate the accuracy and reliability of a diagnostic algorithm, often against a human gold standard or pathology. This device is a physical support apparatus, not a diagnostic tool, so these types of studies were not applicable or performed.
What the document does state regarding "performance":
- Performance Standards: "The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for Tennis Racquet Inserts." This indicates there are no specific, pre-defined quantitative performance metrics for this type of device from the FDA.
- Summary of Substantial Equivalence: "This device is similar in design and construction, and identical in materials, intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device." This is the core "performance" claim – that it performs identically to existing, legally marketed devices.
In summary, because this device is a physical medical device for patient support during radiation therapy, and not an AI-powered diagnostic tool, the typical criteria and study design questions you've asked are not applicable to the provided documentation.
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.