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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 needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy.

The CP Medical Pre-waxed Needles with Gold Fiduciary Markers are designed for use in conjunction with conventional radiation therapy methods. The product consists of one (1) solid gold seed marker, loaded into a standard 17 or 18 gauge brachytherapy needle that has been preplugged with bone wax (CP Medical, K024372). The loaded needles are packaged individually or in groups of three. The packaged needles are sterilized via ethylene oxide.

The provided document K071550 describes the CP Medical Pre-waxed Needles with Gold Fiduciary Markers. This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through a clinical trial or extensive standalone performance evaluation.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert contributions, adjudication methods, and MRMC studies, which are typical for AI/CAD device submissions, is not applicable or available in this document. The submission relies on design verification and a comparison of materials and packaging to a predicate device.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly defined in terms of specific performance metrics with acceptance criteria. The submission focuses on substantial equivalence to the predicate device (Best Radiopaque Marker, K043117) rather than setting and meeting de novo performance targets. The "acceptance criteria" here implicitly relate to demonstrating equivalent materials, packaging, and the intended function through design verification.

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

Not applicable in the context of a typical AI/CAD performance study. The submission for this type of device (implantable marker/needle) focuses on engineering design verification rather than clinical test set performance. No "test set" of patient data (images, pathology, etc.) was used for evaluating algorithm performance. The "testing and verification activities" refer to engineering and manufacturing tests (sterilization, packaging, product integrity).

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

Not applicable. There was no test set requiring expert ground truth establishment for this device submission.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for an implantable radiographic marker and needle device, which does not involve human readers interpreting imaging with or without AI assistance.

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

No. This device is a physical medical instrument, not an algorithm, so standalone performance in the context of AI is not applicable.

7. The Type of Ground Truth Used

Not applicable in the context of AI/CAD ground truth. The "ground truth" for this submission is whether the physical device meets engineering specifications and is equivalent to the predicate device in materials, packaging, and intended use. This is established through design verification rather than expert consensus on clinical data or pathology reports.

8. The Sample Size for the Training Set

Not applicable. This device submission does not involve a "training set" as it's not an AI/CAD system.

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

Not applicable. There was no training set for this device.

Summary of Approach:

The K071550 submission for the CP Medical Pre-waxed Needles with Gold Fiduciary Markers followed a substantial equivalence pathway to a legally marketed predicate device (Best Radiopaque Marker, K043117). The primary evidence presented involved:

• Comparison of materials and packaging: Stating that they are equivalent to the predicate device.
• Design Verification: Confirming that engineering design inputs were achieved through activities like sterilization validation and package validation. Product integrity for the needle component was referenced as previously performed (K024372).

This type of submission does not involve the detailed performance studies or data sets typically associated with AI/CAD devices, as the product is a conventional medical instrument.

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The Oscera7™ Synthetic Absorbable Bone Wax is indicated in the control of bleeding from cut or damaged bones by acting as a pressure tamponade, or mechanical barrier .

The Oscera7™ Synthetic Absorbable Bone Wax is a kneadable, biocompatible, synthetic absorbable material indicated for control of bleeding from bone surfaces. Hemostasis is accomplished by the physical mechanism of tamponade as it is pressed into the pores of the cut or damaged bone surface.

Post-application, the component materials, which include a fatty acid salt, isopropyl hexadecanoate, an alkylene oxide copolymer and ß-tricalcium phosphate, are dispersed and absorbed within the body.

The provided text describes a 510(k) submission for the Oscera7TM Synthetic Absorbable Bone Wax. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and studies in the format requested for AI/software devices.

Therefore, many of the requested fields cannot be directly extracted or are not applicable to this type of medical device submission. However, I can infer some information based on the context of a 510(k) and the provided text.

Here's a breakdown of the available and inferred information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Inference:

• Acceptance Criteria: These are inferred from the "Intended Use," "Device Description," and "Design Verification" sections. For a 510(k), compliance with these functional requirements and demonstrating substantial equivalence to legally marketed predicate devices are the primary "acceptance criteria."
• Reported Device Performance: The document states that "Verification testing of Oscera7™ included both bench and animal testing. The testing demonstrated the hemostatic capability, bioresorbability, and biocompatibility, thereby establishing compliance to the functional requirements of the device." It also concludes that "the cumulative test results demonstrated the functionality, safety and effectiveness of Oscera7™, as well as its substantial equivalence to the predicate devices."

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

This information is not provided in the document. The text only mentions "bench and animal testing" but does not specify sample sizes or data provenance (e.g., country, retrospective/prospective). This level of detail is typically not included in a 510(k) summary.

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

This information is not provided and is not applicable to a non-AI/software medical device like bone wax. "Ground truth" in this context would likely refer to direct measurements or observations from animal models or bench tests, not expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation, especially for diagnostic or screening devices.

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

This is not applicable as the Oscera7TM Synthetic Absorbable Bone Wax is a physical medical device, not an AI or software device.

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

This is not applicable as the Oscera7TM Synthetic Absorbable Bone Wax is a physical medical device, not an AI or software device.

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

Based on the type of device and testing mentioned ("bench and animal testing"), the "ground truth" would likely be established through:

• Direct measurement/observation in bench tests: For properties like mechanical integrity, absorption rates, or material composition.
• Histopathology or physiological measurements in animal models: To assess hemostasis, bioresorption, and biocompatibility (e.g., inflammation, tissue integration, presence/absence of material).
• Clinical observation in animal models: For immediate hemostatic effect.

The document does not explicitly state the specific ground truth methods but implies these through the types of tests mentioned.

8. The Sample Size for the Training Set

This information is not provided and is not applicable to this type of device. "Training set" is a term used in machine learning; this device undergoes traditional design verification and validation testing.

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

This information is not provided and is not applicable to this type of device for the same reasons as #8.

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