Search Results

The Indigo Prostate Seeding Needle Cartridge System is a single use, disposable system which is intended as a convenience and radiation safety device for the purpose of loading a radionuclide brachytherapy source into the Índigo Prostate Seeding Needles for prostate brachytherapy.

The Indigo Prostate Seeding Needle Cartridge System is indicated for use in conjunction with the Indigo Prostate Seeding Needle to deliver a radionuclide brachytherapy source for permanent interstitial implantation in the prostate gland for the treatment of localized tumors which are of low to moderate radiosensitivity.

The Indigo Prostate Seeding Needle Cartridge System consists of two main components, a single use, disposable seed magazine with a stainless steel shield and a Polyglactin 910 (PG910) absorbable spacer, which is a small cylindrical pellet utilized to provide space between the radionuclide seeds as they are implanted into the body. Both devices are intended to be used only in conjunction with Indigo Prostate Seeding Needles.

The provided text, K992262, is a 510(k) summary for the Indigo Prostate Seeding Needle Cartridge System. This document describes a medical device and its predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance studies.

The "Nonclinical Tests" section mentions functional testing and a time study, but these are engineering/design validation tests and not a clinical study proving performance against predefined acceptance criteria for diagnostic accuracy or clinical efficacy. The device is an accessory for brachytherapy source delivery, not a diagnostic or AI-powered device that would typically have the requested types of performance studies.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the provided document.

Here's a breakdown of what can be extracted from the document, though it doesn't align with the requested format:

1. A table of acceptance criteria and the reported device performance

• Not available in the provided document. The document describes non-clinical tests (functional testing of cartridge material, compression testing of spacers, time study, and radiation scanning) but does not provide specific acceptance criteria or an aggregated "reported device performance" table in the context of clinical outcomes or diagnostic accuracy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available in the provided document. The document describes non-clinical tests, not clinical studies with test sets.

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 and not available. This device is an accessory for delivering brachytherapy sources, not an AI or diagnostic device requiring expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable and not available.

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 and not available. This is not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable and not available. This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable and not available. The "Nonclinical Tests" relate to device durability, functionality, time efficiency, and radiation exposure, not clinical ground truth for diagnosis/prognosis.

8. The sample size for the training set

• Not applicable and not available. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Not applicable and not available.

Summary of available non-clinical test information from the document:

• Nonclinical Tests Performed:

  • Functional testing of the cartridge material (post-autoclaving)
  • Compression testing of the spacers (post-autoclaving)
  • Time study (to ensure reduction in physicist's barriers for preloaded seed delivery)
  • Radiation scanning (to ensure reduction in physicist's barriers for preloaded seed delivery)

• Purpose of these tests: To ensure the durability and functionality of the devices and to demonstrate that the cartridge system reduces the physicist's barriers (time and radiation exposure) for the preloaded seed delivery technique.

Therefore, while non-clinical tests were performed to support the 510(k) clearance, the provided document does not contain the specific type of clinical performance study data requested for AI or diagnostic devices.

Ask a specific question about this device

For the manual application of a radionuclide source into the body for radiation therapy.

Prostate Seeding Needle

This document is a 510(k) premarket notification letter from the FDA for a Prostate Seeding Needle. It's a regulatory approval document and does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot answer your request based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.

Ask a specific question about this device