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The IsoAid Brachytherapy Kit is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, or have low to moderate radiosensitivity.

The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapy needle and a custom-loaded strand (K013975 or K103449 or Secure Strand) of seeds spaced at a precise distance within absorbable suture. The strand is optional, when no strand is requested the seeds and spacers are custom-loaded directly into the needle. A maximum total of 20 seeds and spacers can be loaded into a needle. The spacers (K010621 or K103449) are made from the same material as the sutures. The stranded Pd-103 (K033770) and I-125 (K011205) implants are placed inside the needle. Bone Wax (K024372 or Ethicon, Inc. Bone Wax) is used at the tip of the need to keep the implants from falling out. The needle is made from 18-gauge stainless steel.

This submission, K113210, for the IsoAid Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit, primarily focuses on demonstrating substantial equivalence to predicate devices through material and design comparisons, and biological safety testing. It does not present a study with specific performance acceptance criteria for the device's clinical effectiveness (e.g., accuracy, sensitivity, specificity) in tumor treatment.

The "Conclusions" section states: "Based on the results of the bench and animal tests performed it is concluded that these tests demonstrate that the Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit is as safe, as effective, and performs as well as or better than the predicate devices." This implies that the device is deemed to meet acceptance criteria through comparison to existing, cleared devices and adherence to established standards for safety and material integrity, rather than a clinical performance study with predefined metrics.

Here's a breakdown based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the submission does not define specific performance acceptance criteria in terms of clinical effectiveness (e.g., tumor response rates, survival). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices in terms of:

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

The document does not describe a clinical "test set" in the context of device performance on patients. The "tests" mentioned are bench and animal tests focused on material properties, biocompatibility, and degradation. No sample sizes for these specific bench or animal tests are provided in this summary, nor is data provenance in terms of country of origin or retrospective/prospective study design, as these are typically not relevant for material and biocompatibility testing as presented.

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

Not applicable. This type of information is relevant for studies involving human interpretation or clinical outcomes, which are not described here.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or clinical endpoint data requiring adjudication in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study would compare human reader performance with and without AI assistance for tasks like image interpretation or diagnosis. The device described is a physical medical implant, not an AI-driven diagnostic or assistive tool.

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

No. This also pertains to AI algorithm performance.

7. The Type of Ground Truth Used

For the bench and animal tests:

• Biological Ground Truth: Established through adherence to recognized international standards (ISO 10993 series and ASTM F1635-11) for biocompatibility, material properties, and degradation. Passing these standard tests serves as the "ground truth" for the device's safety and material performance.
• Design/Functional Ground Truth: Established by direct comparison to the physical and functional characteristics of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no training set involved, as this is not an AI/ML device.

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

Not applicable. There is no training set.

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The IsoAid Brachytherapy Kit is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy. The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, or have low to moderate radiosensitivity.

The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapy needle and a custom-loaded strand (K013975) of seeds spaced at a precise distance within absorbable suture. The strand is optional, when no strand is requested the seeds and spacers are custom-loaded directly into the needle. A maximum total of 20 seeds and spacers can be loaded into a needle. The spacers (K010621) are made from the same material as the sutures. The stranded Pd-103 (K033770) and I-125 (K011205) implants are placed inside the needle. Bone Wax (K024372) is used at the tip of the need to keep the implants from falling out. The needle is made from 18-gauge stainless steel.

The provided document is a 510(k) Summary for the IsoAid Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit. This type of regulatory submission establishes substantial equivalence to a predicate device and typically does not include detailed studies with acceptance criteria, sample sizes for test/training sets, expert consensus, or specific performance metrics in the way a clinical trial or device validation study might.

Instead, substantial equivalence is determined by comparing the new device's technological characteristics and indications for use to a legally marketed predicate device. The information provided heavily focuses on this comparison rather than presenting a performance study with acceptance criteria.

However, based on the provided text, I can infer the "acceptance criteria" through the comparison to the predicate device, as the primary goal of this submission is to show that the new device is as safe and effective as the predicate.

Here's an attempt to structure the information based on your request, understanding that the "study" here is essentially the substantial equivalence discussion, and not a traditional performance study as you might expect for AI/software devices.

Acceptance Criteria and Device Performance Study for IsoAid Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are implicitly met if the new device demonstrates substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and safety/effectiveness. The performance evaluation is primarily a comparison.

Note: For devices like this, "performance" is often related to manufacturing specifications, radiation characteristics (which are standardized for isotopes), and mechanical properties, not typically evaluated with metrics like sensitivity/specificity or human reader improvement. The document does not detail these specific engineering tests, but they would have been part of the underlying design controls.

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

This document does not describe a clinical "test set" in the context of diagnostic accuracy or AI performance as you might expect. The "testing" for a device like this in a 510(k) submission primarily involves:

• Bench testing to ensure manufacturing specifications, sterility, and mechanical integrity are met.
• Comparison of technical specifications and intended use to a legally marketed predicate device.

Therefore, there is no mention of a "sample size for a test set" or "data provenance" from clinical cases here. The evaluation is largely based on technical specifications and regulatory comparison.

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

Not applicable. This is not a study requiring expert-established ground truth for a test set of clinical data. The "ground truth" for a medical device's performance in a 510(k) context is often established by adherence to recognized standards, established material properties, and the known safety/efficacy profile of its predicate device and active components (radioisotopes).

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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 device is a brachytherapy kit, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc)

The "ground truth" for this regulatory submission is established through:

• Predicate device's safety and effectiveness: The Bebig Brachytherapy Strand Device (K040339) is a legally marketed device whose safety and efficacy have been previously established.
• Material specifications and established medical use: Components like Pd-103 and I-125 brachytherapy seeds have well-understood radiation characteristics and are standard in clinical practice. The materials used (e.g., absorbable suture, stainless steel) have established biocompatibility and properties.
  The submission essentially argues that because the new device is substantially equivalent in design, materials, and intended use to the predicate, its safety and effectiveness are also equivalent.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm or "training set" for this type of device.

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

Not applicable. There is no AI algorithm or "training set" for this type of device.

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