(91 days)
To provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply a radionuclide source into the body or to the surface of the body for radiation therapy. Single Use Device. Do not re-clean, re-sterilize device. Any reprocessing may result in changes in the physical characteristics of the device. Do not counter accepted clinical practice or institution guidelines.
The AOS Universal Connecting Guide Tube coupling catheters are substantial equivalence to Varian Coupling catheter (K952913), and Omnitron International Coupling catheter (K881665). Construction and materials are the same for all referenced devices. All devices are listed as single use, provided as non sterile.
This document is a "Summary & Certification" for a medical device called the "AOS Universal Connecting Guide Tube." It appears to be a submission to a regulatory body (likely the FDA in the US, given the "K" numbers for predicate devices). It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel diagnostic or AI-powered device.
Therefore, many of the requested points cannot be directly addressed from the provided text. I will answer what is available and indicate where information is not present.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Varian Coupling Catheters (K952913) and Omnitron International System (K881665)) in safety and efficacy. | "The AOS Universal Connecting Guide Tube coupling catheters are substantial equivalence to Varian Coupling catheter (K952913), and Omnitron International Coupling catheter (K881665). Construction and materials are the same for all referenced devices. All devices are listed as single use, provided as non sterile. The conclusion drawn from the above is that the AOS Universal Connecting Guide Tube is equivalent in safety and efficacy to its predicate device." |
| Indication for Use: To provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply a radionuclide source into the body or to the surface of the body for radiation therapy. | The device's stated indications for use are met by virtue of its substantial equivalence to predicate devices which perform this function. |
| Contraindications: Single Use Device. Do not re-clean, re-sterilize device. Any reprocessing may result in changes in the physical characteristics of the device. Do not counter accepted clinical practice or institution guidelines. | The device adheres to these contraindications. |
| Classification: Class II, 90-JAQ, No Performance Standards for Brachytherapy Applicators in effect. | The device is classified as Class II, 90-JAQ, acknowledging no specific performance standards are in effect. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a study with a test set of data. It is a declaration of substantial equivalence based on comparison to existing predicate devices, primarily in terms of construction, materials, indications for use, and manufacturing. No sample size, data provenance, or study type (retrospective/prospective) for a performance test is mentioned.
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. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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. This is not a study of an AI or diagnostic device; it is a regulatory submission for a physical medical device (coupling tube) demonstrating substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is the established safety and efficacy of the predicate devices. The document asserts that the new device shares the same "construction and materials" and "indications" as these devices, leading to the conclusion of "equivalent in safety and efficacy." There is no other empirical ground truth established by a study within this document.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. No training set and thus no ground truth for a training set is mentioned.
§ 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.