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InterSource125 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. InterSource125 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.

InterSource125 is a hermetically sealed radiotherapeutic source indicated for interstitial implantation. The radionuclide used in InterSource125 is Iodine-125 (I-125). InterSource125 is constructed by placing a platinum / iridium radiopaque marker and I-125 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 0.37 mm with all body tissue contacting surfaces made from medical grade titanium.

The InterSource125 device, an Iodine-125 seed for brachytherapy, demonstrated substantial equivalence to its predicate device, the Amersham/Medi+Physics Model 6711 Therapeutic Seed Source, rather than a direct performance study against acceptance criteria from a standalone test. The assessment of substantial equivalence was based on a comparison of key characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, direct "acceptance criteria" as would be seen in a performance study with defined thresholds for metrics like sensitivity or specificity are not present. Instead, the "acceptance criteria" are implied by the similarity to the predicate device's characteristics. The "reported device performance" is the InterSource125's characteristics and its computed radiation distribution compared to the predicate's known characteristics and measured radiation distribution.

2. Sample Size Used for the Test Set and the Data Provenance

This submission is a comparison to a predicate device for substantial equivalence, not a standalone clinical performance study with a distinct "test set" of patients or cases. The "test set" in this context refers to the characteristics and properties of the InterSource125 device itself, which were compared against the known characteristics of the predicate device.

• Sample Size: Not applicable in the traditional sense of patient data. The "sample" is the InterSource125 device's design, materials, and its computed radiation characteristics.
• Data Provenance: The data for the InterSource125 is based on its design specifications, material compositions, and computational modeling (for radiation dose). The predicate device's data is based on its known characteristics as a legally marketed device and previously published measured values for radiation dose. The submission originated from the USA (IBt, Inc.) and Belgium (IBt SA) in 1998/1999.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth for device characteristics (like physical dimensions, materials, and radioisotope properties) is established through technical specifications, manufacturing processes, and validated measurement methods, not typically by expert consensus in this context. For the radiation dose comparison, the "ground truth" for the predicate device was based on previously published measured values, implying a scientific consensus or accepted measurement methodology, rather than specific expert adjudication for this submission.

4. Adjudication Method for the Test Set

Not applicable. This was a comparative analysis based on objective device specifications and published data for the predicate, not a subjective assessment requiring adjudication.

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 a submission for a brachytherapy seed, a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.

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

This is not applicable to a physical medical device like a brachytherapy seed. Performance is inherent to the device's physical and radioactive properties. The "device performance" relies on the accurate emission of radiation and reliable physical integrity, not an algorithm. The computation of radiation dose can be considered a "standalone" assessment of a device characteristic.

7. The Type of Ground Truth Used

The "ground truth" for the InterSource125 device and its comparison to the predicate device relied on:

• Device Specifications: Engineering drawings, material lists, and manufacturing process descriptions for both devices.
• Published Data/Measurements: For the predicate device's radiation dose distribution.
• Radioisotope Properties: Established physics data for Iodine-125 (e.g., half-life, principal energy levels).

8. The Sample Size for the Training Set

Not applicable. 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, as there is no "training set."

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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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