(84 days)
The Intracavitary/Interstitial System is intended for cancer treatment of the uterus, cervix, and vagina using HDR or PDR brachytherapy.
The Intracavitary/Interstitial System is a device with two (2), hollow, open-ended catheters which connect to applicator sets with ovoids, ring caps or templates on the distal end.
The guide tubes extend outside of the patient. An interstitial needle is guided through the guide tube from outside the patient to an interstitial hole in the applicator. The proximal end of the guide tube contains a fixation mechanism for fixing the needle insertion depth between needle insertion and removal of the implant.
The Intracavitary/Interstitial System is intended to be used with the following required accessories: Plastic Needles (K120341) and Leak Stop Channel Markers (K152018).
I am sorry, but based on the provided FDA 510(k) clearance letter for the Intracavitary/Interstitial System (K250289), there is no information provided regarding acceptance criteria for device performance, nor is there a study described that proves the device meets such criteria in terms of clinical or algorithmic performance.
The document primarily focuses on:
- Administrative details of the 510(k) clearance: Device name, regulation number, product code, date of clearance, contact information.
- Device description and intended use: What the device is and what it's used for (brachytherapy for uterus, cervix, vagina).
- Comparison to a predicate device: Highlighting similarities in intended use, technological characteristics, materials, anatomical sites, MR compatibility, and use environment.
- Non-clinical performance testing: This section details engineering and safety tests like biocompatibility, cleaning/disinfection/sterilization, human factors, mechanical/acoustic, MR compatibility (physical properties under MR, not clinical performance), and electromagnetic compatibility (EMC). It also lists various consensus standards followed during design and evaluation.
Specifically, the document does NOT contain any of the following information requested in your prompt:
- A table of acceptance criteria and reported device performance related to a clinical outcome or algorithmic performance metric. The "performance data" mentioned is exclusively for non-clinical, engineering, and safety assessments.
- Sample size used for a test set or data provenance for any clinical performance evaluation. No clinical test set is described.
- Number of experts, qualifications, or adjudication methods for establishing ground truth. This is relevant for studies involving human interpretation or AI performance assessment, which are not detailed here.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study information or effect sizes.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical or AI performance study.
- Sample size for a training set or how ground truth was established for a training set. These are relevant for AI/ML device submissions, but this document describes a physical medical device, not an AI algorithm for diagnosis or treatment planning.
Conclusion:
The provided 510(k) letter demonstrates that the Intracavitary/Interstitial System (a physical medical device) has undergone various engineering, safety, and compatibility tests to show it is as safe and effective as its predicate. However, it does not detail any clinical performance study, nor does it refer to an AI/ML component where acceptance criteria for diagnostic/prognostic accuracy or human-in-the-loop performance would be relevant. The performance data presented are purely non-clinical validation steps for a hardware device.
Therefore, I cannot populate the requested tables or provide details on the study proving the device meets performance criteria in the way you've outlined, as that information is not present in the given text.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.