(29 days)
Titanium needles are intended for interstitial Brachytherapy procedures involving Nucletron mHDR remote afterloading equipment.
The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures.
Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. More and more brachytherapy treatments are carried out where CT and MR based imaging is used for volume and target delineation. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images.
The Titanium Needle is inserted into the treatment area, using standard interstitional insertion techniques. CT markers are inserted into the Titanium Needles for visualisation. Radiographic images are obtained to determine the precise location within the body. This information is then used for Brachytherapy treatment planning purposes.
The Titanium Needle Set is used as an accessory to the Nucletron microSelectron remote afterloaders.
This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance. Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The provided document (K080871) is a 510(k) summary for "Titanium Needle Sets." In a 510(k) submission for this type of device, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device, particularly for devices like interstitial needles which are accessories to a larger system. Performance is generally assessed through design specifications, material compatibility, and intended use alignment rather than through new clinical outcome studies with predefined statistical acceptance criteria typical of novel therapies or diagnostics.
The document states:
- "The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures."
- "The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images."
- "The modified device has the same intended use as the legally marketed predicate device cited."
- "The Titanium Needle Set is substantially equivalent to the cleared predicate device, Interstitial Needle Set, 510(k)#: K953946."
Based on the available text, specific quantitative acceptance criteria and reported device performance metrics (e.g., sensitivity, specificity, accuracy, or a specific range of artifact reduction) are not detailed. The "performance" is implicitly demonstrated through the claim of CT/MR compatibility with minimal artifacts and the overall substantial equivalence to the predicate.
2. Sample size 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 clinical study with a "test set" in the context of diagnostic or interventional performance. The "test" in this submission would likely refer to engineering verification and validation testing (e.g., material compatibility, dimensional accuracy, sterilization efficacy, imaging compatibility) rather than a clinical trial. Therefore, sample sizes for a clinical test set are not applicable here.
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, as no clinical "test set" requiring ground truth established by experts is described for this type of 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical "test set" requiring adjudication for ground truth 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 device is an interstitial needle for brachytherapy, not an AI-powered diagnostic or decision support tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical "test set" requiring ground truth is described. For a device like this, the "ground truth" would relate to its physical properties and performance (e.g., actual dimensions matching specifications, material composition, artifact presence in imaging under controlled conditions).
8. The sample size for the training set
Not applicable. This document is not describing a machine learning or AI algorithm development.
9. How the ground truth for the training set was established
Not applicable. This document is not describing a machine learning or AI algorithm development.
In summary:
The provided 510(k) document is for a medical device accessory (Titanium Needle Set) and aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission typically relies on comparing design, materials, and intended use, along with non-clinical performance data (e.g., imaging compatibility, mechanical robustness, biocompatibility), rather than extensive human-in-the-loop clinical studies with statistical acceptance criteria. Therefore, most of your requested information related to comprehensive clinical study design and performance metrics is not present in this regulatory submission.
§ 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.