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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 CP Medical Polydioxanone Synthetic Absorbable Seeding Spacers are single-use, absorbable seeds comprised of spacer material used to provide a predetermined space between radionuclide seeds for brachytherapy procedures. CP Medical's synthetic absorbable seeding spacers, made of polydioxanone material, are indicated for use in brachytherapy, soft tissue, or organ tissue but should not be used during cardiovascular or neurological procedures.

The CP Medical Polydioxanone Synthetic Absorbable Seeding Spacer consists of absorbable spacer material, which is cut into a small cylindrical seed spacer utilized to provide space between the radionuclide seeds as they are implanted into the body.

The provided text describes a 510(k) premarket notification for a medical device (Polydioxanone Synthetic Absorbable Seeding Spacers) and its substantial equivalence determination. It does not contain information about acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, or specific study details relating to proving the device meets acceptance criteria.

The document is a regulatory approval notice, not a study report. Therefore, I cannot extract the requested information from the provided text.

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