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InterSeed™ implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. InterSeed™ implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.

InterSeed™ is an hermetically sealed radiotherapeutic source indicated for interstitial implantation. The radionuclide used in InterSeed™ is Palladium 103 (Pd-103). InterSeed™ is constructed by placing a platinum radiopaque marker and Pd-103 on the surface of a medical grade titanium inner tube. The device is sealed by sliding an outer tube, also medical grade titanium, over the inner tube and laser welding both ends. The resulting device has a hollow center with an inner diameter of 0.35 mm with all body tissue contacting surfaces made from medical grade titanium.

The provided text describes the InterSeed™ device, a radiotherapeutic source for interstitial implantation, and compares it to a predicate device, the Modified Palladium Seed Model 100, to demonstrate substantial equivalence for regulatory clearance. This is not a study proving device performance against acceptance criteria in the typical sense of a clinical trial or algorithm performance study. Instead, it's a regulatory submission demonstrating equivalence to an already approved device.

However, I can extract the information and frame it as acceptance criteria and reported device performance based on the provided document's structure for the purpose of your request.

Here's the breakdown of the information you requested, based on the provided document:

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

Since this is a substantial equivalence submission, the "acceptance criteria" are the features and performance of the predicate device, and the "reported device performance" is the InterSeed™ device's corresponding features and performance. The goal is to show they are "substantially equivalent."

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

• Sample Size: Not applicable. This document describes a comparison between a new device and a predicate device's specifications and performance characteristics, not a test set of data. The "comparison" is based on documented specifications and published data for the predicate device.
• Data Provenance: The new device (InterSeed™) is being manufactured by IBt SA in Seneffe, Belgium. The predicate device (Modified Palladium Seed Model 100) was cleared in 1987 in the US (K874787). The radiation dose data for the predicate device references a publication: Meigooni, Ph.D., A.S., et al, "Dosimetry of Palladium 103 Brachytherapy Sources for Permanent Implants." Endocurietherapy / Hypothermia Oncology, Vol. 6, pp. 107-117, April 1990. This indicates retrospective analysis of existing data or published research.

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. There is no "ground truth" in the sense of expert-labeled test data for this type of submission. The comparison relies on established technical specifications, physical measurements (for InterSeed™), and published dosimetry data (for the predicate).

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

Not applicable. There is no adjudication process involving multiple reviewers for a test set of cases. The substantial equivalence determination is made by the FDA based on the presented evidence.

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 document is about a brachytherapy seed, not an AI-assisted diagnostic device.

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

Not applicable. This is a medical device (brachytherapy seed), not an algorithm.

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

Not applicable. The "truth" in this context is the objective physical and radiological properties of the devices, as well as their intended use (indications). This is established through engineering specifications, scientific measurements, and prior regulatory clearances.

8. The sample size for the training set

Not applicable. This is not a machine learning model; therefore, there is no training set.

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

Not applicable. As there is no training set, this does not apply.

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