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The MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (1851). Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.

C4 Imaging's MRI Marker™ consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride:N-Acetylcysteine (CoCl2:NAC) solution. It is used as an accessory to radionuclide sources (seeds) during prostate brachytherapy procedures. The length of the capsule is 5.5 mm and the diameter is 0.8 mm.

Here's an analysis of the provided text regarding the MRI Marker, addressing your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the safety and effectiveness of the MRI Marker, rather than specific performance metrics against pre-defined acceptance criteria in the traditional sense of diagnostic accuracy or sensitivity/specificity. The criteria are largely related to established medical device standards and the device's intended function.

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

The document does not specify a distinct "test set" in the context of diagnostic performance (e.g., a specific number of images or patients for evaluation). The performance demonstrations are through:

• Sterilization Validation: No explicit sample size mentioned for this, as it's a validation of a process.
• Biocompatibility Testing: "In vivo and in vitro tests were performed." No specific numbers of samples or animals are provided.
• MRI Safety Testing: No specific sample size mentioned for the devices tested.
• Radiographic Visualization: "Phantom prostate imaging testing" (implies one or more phantoms) and "X-ray imaging of the seeds and MRI Markers loaded in strands and brachytherapy needles." No specific number of phantoms, strands, or needles are given.
• Animal Testing: "Animal testing indicates..." No specific number of animals or data provenance (e.g., country of origin, retrospective/prospective) is provided.

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

This information is not provided in the document. The studies described are technical performance tests (e.g., sterilization, biocompatibility, MRI compatibility) and visualization tests using phantoms or animal models, rather than clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided as there is no mention of a human-read test set requiring adjudication in the context of the described performance testing.

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

No, an MRMC comparative effectiveness study was not done. The device (MRI Marker) is a physical marker for brachytherapy seeds, not an AI or software algorithm itself that would assist human readers in interpretation.

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

No, a standalone performance study in the context of an algorithm or AI was not done, as the MRI Marker is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the various tests was primarily based on:

• Sterilization: Industry standards (ISO 11137) and laboratory verification (e.g., absence of microbial growth).
• Biocompatibility: Established biological endpoints (e.g., absence of irritation, toxicity) as defined by ISO 10993-1 and observed in in-vitro, in-vivo, and animal models.
• MRI Safety: Measurement of physical forces (displacement, torque) and temperature changes according to ASTM standards.
• Radiographic Visualization & Spacing: Direct observation of images (MRI and X-ray) to confirm the presence of a positive signal and appropriate spacing in phantoms and simulated setups.

8. The Sample Size for the Training Set

This information is not applicable/provided. The MRI Marker is a physical device and does not involve AI or machine learning algorithms that would require a training set.

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

This information is not applicable/provided. As above, there is no training set for this device.

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OptiStrand103 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, breast, cervix, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. OptiStrand103 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

OptiStrand 103 implants are OptiSource™ seeds (#K040766) linked together with a spacer or spacers to create a multi-seed sourcetrain.

This 510(k) pertains to OptiStrand™, an interstitial implant used in brachytherapy. The documentation provided does not include the level of detail requested for acceptance criteria, device performance, and study methodology typically found in a comprehensive clinical or performance study report.

Based on the provided information, the 510(k) submission is a traditional submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance study with detailed acceptance criteria and statistical analysis as would be done for novel devices or those requiring a PMA.

Here's a breakdown of the available information and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the given 510(k) summary and FDA clearance letter. A 510(k) submission for this type of device (radionuclide brachytherapy source) often relies on demonstrating technical and performance equivalence to a legally marketed predicate device rather than setting new, specific performance acceptance criteria for clinical outcomes. The performance characteristics would typically relate to source strength, radiation output, physical dimensions, and biocompatibility, which are assumed to be equivalent to the predicate.

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

This information is not provided. As this is a traditional 510(k) for a device like a brachytherapy source, a "test set" in the context of evaluating diagnostic accuracy (e.g., for AI) is not applicable. The evaluation would have focused on engineering and physical performance characteristics.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided. This concept of "ground truth" established by experts is relevant for diagnostic accuracy studies, which are not detailed here.

4. Adjudication Method:

This information is not provided. Adjudication methods are typically used in studies where multiple readers or experts provide assessments and a consensus is needed to establish ground truth or resolve discrepancies, which is not applicable in the context of this device's 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not provided. MRMC studies are used to evaluate the performance of diagnostic imaging devices or AI algorithms in comparison to human readers. This device is a therapeutic brachytherapy source, not a diagnostic tool, so such a study would not be relevant.

6. Standalone (Algorithm Only) Performance Study:

This information is not provided. A standalone algorithm performance study is relevant for AI-powered diagnostic devices. This device is a physical therapeutic implant, so this type of study is not applicable.

7. Type of Ground Truth Used:

This information is not provided. Ground truth (e.g., pathology, outcomes data) is typically established for diagnostic or prognostic devices. For a brachytherapy source, the "ground truth" relates to its physical and radioactive properties (e.g., accuracy of dose delivery, source strength, physical integrity), which are evaluated through engineering tests and quality control, not typically through clinical "ground truth" as might be understood for a diagnostic algorithm.

8. Sample Size for the Training Set:

This information is not provided. The concept of a "training set" is relevant for machine learning or AI algorithms. This device is a physical medical device, not an AI product.

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

This information is not provided for the same reasons as point 8.

Summary of what can be ascertained from the provided document regarding acceptance criteria and study:

The 510(k) filing for OptiStrand™ seeks market clearance based on substantial equivalence to a previously cleared predicate device. This means the manufacturer demonstrated that the new device is as safe and effective as a legally marketed device that is not subject to PMA.

The core of the "study" for a device like OptiStrand™ would involve demonstrating that:

• Materials: The materials used are equivalent to the predicate or are biocompatible.
• Design and Dimensions: The physical dimensions and design of the seeds and spacers are equivalent to the predicate or meet established standards.
• Radioactive Properties: The radionuclide and its activity levels are consistent with established standards for brachytherapy sources and equivalent to the predicate (OptiSource™ seeds #K040766). This would involve physical measurements and calculations.
• Sterility and Packaging: The device can be consistently sterilized and packaged to maintain sterility until use.
• Manufacturing Quality: The manufacturing process ensures consistent quality and adherence to specifications.

The FDA's clearance letter (K043336) states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced within to reviewed the device is substantially equivalent (for the indications for use stated in above und nave deegally marketed predicate devices marketed in interstate commerce prior to the cleasars) to regally that the Medical Device Amendments, or to devices that have been May 20, 1770, the classicans of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in accordantes approval application (PMA)." This confirms that the basis for approval was substantial equivalence, and therefore, a detailed clinical study with the specified metrics for AI devices was not performed or required. The "study" was a demonstration of equivalence in design, materials, and intended use as assessed through documentation and potentially bench testing.

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