(84 days)
The Fletcher Style Applicator Sets (defined geometry) are intended to treat cancer of the uterus, cervix, endometrium and vagina.
The GammaMed Titanium Fletcher-style Applicator Set with defined geometry was developed to treat cancer of the uterus, cervix, endometrium and vagina.
The Interstitial Plastic Needles are designed for interstitial brachytherapy treatments in areas such as the head and neck, gynecological, breast and prostate.
The GM11006200 Titanium Fletcher-Style Applicator Sets are designed for intracavitary radiotherapy treatments in the uterus, cervix, endometrium and vagina. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories.
Intrauterine Probe with stopper 30 °, length: 40mm, 60mm, 80mm (optional 30mm, 50mm, 70mm Colpostats: 20mm, 25mm, 30mm spread
The provided text is for a 510(k) Premarket Notification for the "Titanium Fletcher-Style Applicator Set" and "Interstitial Plastic Needles". It describes the device, its intended use, and a comparison to a predicate device.
However, the document does not describe a study involving an AI model or a device that uses AI. The "acceptance criteria" and "reported device performance" are related to biocompatibility, sterilization, bench testing (functionality, durability, material radiation resistance, positional accuracy), MRI compatibility, and usability for a physical medical device (an applicator set and needles) used in brachytherapy.
Therefore, many of the requested elements for describing an AI study, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth for training/test sets, cannot be answered from the provided text.
Below is the information that can be extracted or inferred from the provided document, but please note it is primarily focused on the physical device's non-clinical performance and a declaration of substantial equivalence, not an AI model.
Acceptance Criteria and Reported Device Performance (Non-AI Device)
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10933-1:2009 and 510(k) Memorandum - #G95-1. | |
| Specifically: No leachable cytotoxic materials, no sensitization reactions, no irritant/corrosive effect. | - Released no leachable cytotoxic materials |
- Caused no reactions identified as sensitization
- Showed no irritant/corrosive effect
- Requirements of BS EN ISO 10993-1:2003 and FDA#G95-1 have been met |
| Sterilization & Shelf Life | Verify effectiveness of proposed cleaning, disinfection, and sterilization cycles.
Verify suitability of design and material by inspecting for damage affecting safety or effectiveness after proposed number of cycles. | Tests verified effectiveness of cycles and suitability of design/materials, with no damage affecting safety/effectiveness. |
| Bench Testing | Demonstrate correct function with VariSource and GammaMedplus afterloaders.
Withstand lifetime use cycles.
Materials not significantly affected by radiation over lifetime.
Adequate positional accuracy.
Assess effects of MRI on the device.
Usability assessed to IEC 62366:2007. | - Functions correctly with both VariSource and GammaMedplus afterloaders. - Can withstand lifetime use cycles.
- Materials not significantly affected by radiation.
- Positional accuracy is adequate.
- Effects of MRI assessed (CT compatible, MR Conditional for 3 Tesla).
- Usability assessed to IEC 62366:2007 requirements. |
Information Relevant to AI Studies (Not Applicable / Not Provided)
Given that the provided document is a 510(k) for a physical medical device (applicator set and needles) and does not describe an AI/software as a medical device (SaMD), the following points cannot be addressed from the input.
- Sample size used for the test set and the data provenance: Not applicable, as no algorithm test set is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert-derived ground truth for an algorithm is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no algorithm ground truth is mentioned.
- The sample size for the training set: Not applicable, as no algorithm training set is mentioned.
- How the ground truth for the training set was established: Not applicable.
Summary based on document content:
The document describes premarket notification for a physical medical device (Titanium Fletcher-Style Applicator Set and Interstitial Plastic Needles). The acceptance criteria and performance data are entirely related to the physical and material properties, functionality, safety (biocompatibility, sterilization), and compatibility of this hardware device. There is no mention of any artificial intelligence, machine learning, or software algorithm, therefore, none of the questions pertinent to an AI-driven device can be answered. The study referenced is a series of non-clinical bench tests and biocompatibility evaluations confirming the device's safety and effectiveness compared to a predicate device.
§ 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.