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The intended use of Implant Sciences Corp. Seed Link is for the treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

Implant Sciences Seed Link, containing Implant Sciences 125Iodine Brachytherapy Seeds with individual activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment, such as for prostate cancer or for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors. Seed Link may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.

Seed Link is a radionuclide brachytherapy source designed to incorporate a number of individual brachytherapy "seeds" into an integral assembly, and to maintain the specified spacing between the seeds during treatment. Seed Link incorporates the I-Plant Model 3500 interstitial brachytherapy seed, which has been previously cleared for marketing under 510(k) number K994317. Seed Link is an assembly of I-Plant 3500 interstitial brachvtherapy seeds, sleeves and spacers designed to pass freely through an 18 Gauge thin-walled implant needle (which has an inside diameter of 0.041 inch (1.04 mm)). The length of the assembly is determined by the number of seeds to be joined and the spacing required between seeds. As a minimum, an assembly would contain two seeds and a spacing of 5.5 mm, resulting in an overall length of 14.5 mm. As many as six seeds may be incorporated into an assembly, and the spacing between seeds may be as large as 50 millimeters. The Seed Link shell and sleeve subassembly may also be supplied without attached spacers as individual "seeds".

Implant Sciences' Seed Link 1231odine Brachytherapy Seed Assembly is a radionuclide brachytherapy source designed to incorporate a number of individual brachytherapy "seeds" into an integral assembly, and to maintain the specified spacing between the seeds during treatment. Seed Link incorporates the I-Plant Model 3500 interstitial brachytherapy seed into a titanium sleeve, which is coupled to other seeds by means of a bioresorbable polymer spacer. Seed Link is provided sterile.

The provided document is a 510(k) summary for the Seed Link brachytherapy source. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not present in this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria and reported device performance in the context of a dedicated performance study. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device(s).

The key "performance" aspect mentioned is that the Seed Link "is designed to pass freely through an 18 Gauge thin-walled implant needle (which has an inside diameter of 0.041 inch (1.04 mm))." However, no specific acceptance criteria (e.g., success rate, force required) or detailed study results demonstrating this ability are provided in this summary.

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

Not applicable. The document does not describe a performance study with a test set. This is a 510(k) submission, which focuses on substantial equivalence rather than a clinical trial or a standalone performance study with a test set.

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

Not applicable. There is no mention of a test set or ground truth established by experts in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a brachytherapy source, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This device is a physical medical device (brachytherapy source) and not an algorithm.

7. The Type of Ground Truth Used

Not applicable. The document does not describe a study involving ground truth in the context requested (e.g., expert consensus, pathology, outcomes data). The "ground truth" for a 510(k) is typically the performance and characteristics of the legally marketed predicate device(s).

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/algorithm-based device, there is no training set in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set.

Summary of Device and its Claimed Equivalence:

• Device Name: Seed Link
• Manufacturer: Implant Sciences Corp.
• Intended Use: Treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal, intraoperative, or surface irradiation.
• Technological Characteristics: An assembly of I-Plant Model 3500 interstitial brachytherapy seeds, titanium sleeves, and bioresorbable polymer spacers. Designed to maintain specified spacing between seeds and pass through an 18 Gauge thin-walled implant needle.
• Predicate Devices:
  • Nycomed Amersham I-125 Rapid Strand (K940632)
  • IBT, Inc. Interstrand 125 (K011155)
  • I-Plant Model 3500 interstitial brachytherapy seed (K994317) - this is a component of Seed Link.

The 510(k) submission asserts that Seed Link is substantially equivalent to these predicate devices based on its intended use and technological characteristics. The provided text details the device's design and mechanism but does not present a formal study with acceptance criteria and results as typically found for diagnostic or screening devices.

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