Search Results

Implant Sciences Model HDR 4454 Source Assembly, with individual activity up to 27Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy.

This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, hyperthermia or chemotherapy.

Implant Sciences Corp. Model HDR-4454 is a singly-encapsulated 160 Ytterbium Brachytherapy Source. It consists of a stainless steel capsule containing solid radioactive feer thium pellets. The pellets are sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.

This document describes a 510(k) premarket notification for a medical device (Implant Sciences Corp. Model HDR-4454 169Ytterbium Brachytherapy Source), which is a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device. It does not describe an AI/ML medical device, and therefore the concepts of acceptance criteria, study design, ground truth, and human-in-the-loop performance as they relate to AI/ML devices are not applicable.

The document states that the device is "substantially equivalent" to a predicate device (Implant Sciences Corp. Model HDR-4140, K042864). This means that the FDA determined that the new device is as safe and effective as a legally marketed device.

Here's how the information provided aligns with your request, even though it's not an AI/ML device:

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

• Acceptance Criteria (Implicit): For a 510(k), the primary acceptance criterion is "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This is not expressed in a quantitative table for this type of device.
• Reported Device Performance: The document highlights the technological characteristics of the new device (Model HDR-4454 169Ytterbium Brachytherapy Source) and compares them to the predicate (Model HDR-4140). The key performance aspect is that it utilizes photons from 169 Ytterbium, which is similar to the predicate. The FDA's letter states that they have determined the device is substantially equivalent, implying it met the regulatory performance requirements for this type of medical device submission.

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

• Not Applicable: For this type of device (a physical radioactive source), there isn't a "test set" in the sense of patient data or algorithm performance data. The evaluation for substantial equivalence relies on design specifications, material properties, manufacturing controls, and potentially non-clinical testing (e.g., radiation safety, dose uniformity, mechanical integrity), rather than empirical data from a "test set" of cases.

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: This device is not an AI/ML diagnostic tool, so there is no "ground truth" established by experts on a test set of medical images or patient data. The "ground truth" for a brachytherapy source relates to its physical and radio-pharmacological properties, which are verified through various physical and chemical tests, not clinical expert consensus.

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

• Not Applicable: As there is no "test set" in the context of clinical data for an AI/ML device, there is no adjudication method.

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 an AI/ML device, so no MRMC study looking at human reader performance with or without AI assistance would have been conducted or is relevant.

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

• Not Applicable: This is a physical medical device, not an algorithm.

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

• Engineering and Physical Standards: For a brachytherapy source, the "ground truth" would be established by validated engineering specifications, radiation physics principles, material science standards, and potentially preclinical testing results (e.g., dose distribution measurements, mechanical integrity tests).

8. The sample size for the training set

• Not Applicable: This device is not an AI/ML device, so there is no "training set."

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

• Not Applicable: This device is not an AI/ML device, so there is no "training set" or corresponding ground truth.

In summary, this document is a regulatory approval for a physical medical device (a brachytherapy source) based on substantial equivalence to a predicate, not an AI/ML device requiring clinical performance studies with acceptance criteria, ground truth, or human performance evaluations.

Ask a specific question about this device