(54 days)
The Mick Radio-Nuclear Instruments, Inc. CT Compatible Intrauterine Sleeve is intended for use as an accessory to the cervical applicators used in High Dose Rate (HDR) Brachytherapy as described for the predicate device. The intended use and design of this system is the similar to that of the predicate device (Varian Medical Systems, Inc. Cervical Sleeve, K955844). Fractionated HDR Brachytherapy of the Cervix requires repeated insertion of the applicator during treatment. Use of the CT Compatible Intrauterine Sleeves allows the user to repeatedly insert non-curved tandems without repeated delivery of anesthesia to the patient and helps prevent the possibility of uterine penetration by the tandems.
The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modern era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities for this are Low Dose Rate and High Dose Rate remote afterloading (Brachytherapy). One common application of Brachytherapy is in the treatment of cancer of the cervix. This accessory for cervical applicators is designed as an accessory for any Cervical Applicator that has a non-curved tandem. Use of the Intrauterine Sleeve aids in repeated insertion of the cervical applicator during fractionated treatments, eliminating repeated use of anesthesia and prevents the possibility of uterine perforation.
The Mick Radio-Nuclear Instruments, Inc. CT Compatible Intrauterine Sleeve is intended for use as an accessory to the cervical applicators used in High Dose Rate (HDR) Brachytherapy as described for the predicate device. The intended use and design of this system is the similar to that of the predicate device (Varian Medical Systems, Inc. Cervical Sleeve, K955844). Fractionated HDR Brachytherapy of the Cervix requires repeated insertion of the applicator during treatment. Use of the CT Compatible Intrauterine Sleeves allows the user to repeatedly insert non-curved tandems without repeated delivery of anesthesia to the patient and helps prevent the possibility of uterine penetration by the tandems.
The provided document is a 510(k) summary for a medical device called the "CT Compatible Intrauterine Sleeve." This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed performance studies with acceptance criteria and ground truth for a novel AI device.
Therefore, much of the requested information (e.g., sample sizes for training/test sets, number of experts for ground truth, MRMC studies, standalone performance, training set ground truth establishment) is not applicable or available within this document, as it describes a conventional accessory device, not an AI/ML-based diagnostic system.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is deemed acceptable because it is "similar in design and construction, and has the same intended use and performance characteristics to the predicate device."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar design & construction | Similar to predicate device (Varian Medical Systems, Inc.; Cervical Sleeve, K955844) |
| Same intended use | Same as predicate device (accessory to cervical applicators in HDR Brachytherapy, allows repeated insertion of non-curved tandems without repeated anesthesia, helps prevent uterine penetration) |
| Same performance characteristics | Same as predicate device |
| No new issues of biocompatibility | No new issues raised |
| No new issues of safety or effectiveness | No new issues introduced |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a conventional medical device, not an AI model requiring a test set of data. The submission relies on design, materials, and intended use comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for a test set is not relevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. The device is a physical accessory, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, the "ground truth" for its safety and effectiveness is established by its similarity to a legally marketed predicate device, which itself would have demonstrated safety and effectiveness through its own regulatory pathway (pre-amendments or clinical data).
8. The sample size for the training set
Not applicable. This is a conventional medical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable.
§ 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.