(253 days)
The Varian Cervical Sleeves are intended for use for treatment of any case where high dose irradiation with an intrauterine tandem is an acceptable clinical practice.
Varian Cervical Sleeves are brachytherapy applicator accessories. The cervical sleeves are used for insertion into the cervix prior to treatment and acts to guide the radioactive source to the correct locations for treatment. The sleeve can be sutured in place and left for a series of treatments. Presence of the sleeve helps to insure against perforation of the uterine wall by the distal end of the tandem.
The provided text describes a 510(k) premarket notification for the "Varian Cervical Sleeves." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific performance metrics and acceptance criteria for an AI/software device.
Therefore, many of the requested sections (e.g., specific acceptance criteria, reported device performance metrics, sample sizes for test and training sets, ground truth establishment methods, MRMC studies, standalone performance, expert qualifications, adjudication methods) are not applicable as this is a medical device clearance, not an AI/software performance study.
The document discusses the physical characteristics, intended use, and conducted verification and validation testing for the cervical sleeves, which are brachytherapy applicator accessories.
Here's an attempt to answer the relevant parts based on the provided text, while indicating where information is not available:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, AUC) are provided in the context of an AI/software study. The device is a physical accessory, and performance is demonstrated through conformance to standards and safety requirements.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Met testing requirements in conformance with ANSI/AAMI/ISO 10993-1 “Biological Evaluation of Medical Devices - Part 1” for irritation, sensitization, and acute systemic injection. |
| Cleaning Validation | Cleaning validation test requirements have been met. |
| Quality Management | Hardware verification and validation testing conducted according to FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard, and other FDA-recognized consensus standards. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. |
| Standards Conformance | Conforms in whole or in part with standards including: ISO 14971:2007, ISO 15223:2012, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2002, ISO 10993-12:2012, ISO 11138-1:2006, ISO 11737-2:2009, AAMI/ANSI ST79:2010 +A2:2011, AAMI/ANSI ST81:2004 +R2010, ISO 14161:2009, IEC 62366:2007. |
| Safety and Effectiveness | Conclusion: Based on the verification, validation and non-clinical 10993 standard testing, the Varian Cervical Sleeves are as safe, effective and performs as well as or better than the legally marketed predicate device (K955844). (This is a statement of substantial equivalence, not a specific performance metric). Additionally, MR safe compatibility is noted as a technological characteristic and difference from the predicate, implying this was also assessed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is not a study involving a "test set" of patient data for an algorithm. The testing described relates to the physical device's characteristics (biocompatibility, sterility, material properties).
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)
This information is not applicable. Ground truth in the context of an AI/software study is not relevant for the clearance of this physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is 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
This information is not applicable. No MRMC study is performed or discussed; the device is a physical accessory, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical accessory and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. For a physical device like cervical sleeves, the "ground truth" would relate to its physical properties, material compatibility, and adherence to manufacturing/safety standards. The text indicates that these were assessed through various ISO and AAMI/ANSI standards (e.g., biocompatibility standards like ISO 10993).
8. The sample size for the training set
This information is not applicable.
9. How the ground truth for the training set was established
This information is 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.