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The Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

The BioZorb Marker GOLD / LP Marker GOLD is an implantable radiopaque marker comprised of a bioabsorbable component and a permanent component. The BioZorb Marker GOLD / LP Marker GOLD is provided sterile for single use and is implantable.

The provided text does not contain information about the acceptance criteria or a detailed study proving the device meets specific performance metrics. It primarily focuses on the FDA's regulatory approval process for the BioZorb Marker GOLD / LP Marker GOLD, establishing its substantial equivalence to predicate devices. Therefore, I cannot fulfill most of the requested table and answer many of the specific questions about studies and ground truth.

However, I can extract the general types of performance data that were reviewed and a very high-level statement about meeting criteria.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Missing Information for the table: Specific quantitative or qualitative acceptance criteria for "Simulated Use", "Device Integrity", "Imaging Assessment", and "MR Compatibility" are not provided. The document only states that the device "met all specified criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "Simulated Use," suggesting some lab-based or non-clinical testing, but no details are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The document does not describe the use of experts for establishing ground truth in a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

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 MRMC comparative effectiveness study is mentioned. This device is an implantable marker, not an AI-powered diagnostic tool, so such a study would not be relevant in this context.

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

• Not applicable. This is a physical medical device (an implantable marker), not an algorithm or AI system.

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

• Not specified. The document does not describe the establishment of "ground truth" as would be relevant for an AI or diagnostic device evaluation. Instead, it refers to performance testing of a physical marker.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for this type of device.

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The BioZorb Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

The BioZorb Marker is an implantable radiopaque marker comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 or more years and a permanent component (titanium). The BioZorb Marker is provided sterile for single use and is implantable.

The provided document is a 510(k) summary for the BioZorb Marker, which is an implantable radiographic marker. The document does not describe a study that establishes acceptance criteria and then proves the device meets those criteria in the way that an AI/ML device would be evaluated for clinical performance metrics like sensitivity, specificity, accuracy, etc.

Instead, this 510(k) pertains to a physical medical device (an implantable marker) and focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and certain performance tests related to safety and physical properties.

Therefore, many of the requested elements (like "acceptance criteria for clinical performance", "sample size for test set", "number of experts for ground truth", "MRMC study", "standalone performance", "training set sample size") are not applicable to the type of device and study described in this 510(k) summary.

However, I can extract the information that is present and indicate where information is not applicable or not provided.

Here's the closest representation of the requested information based on the provided text:

Acceptance Criteria and Device Performance for BioZorb Marker

Given that this is a 510(k) for an implantable radiographic marker (a physical device), the "acceptance criteria" and "device performance" are primarily focused on physical and material properties, sterilization, and biocompatibility, rather than clinical efficacy metrics associated with AI/ML devices. The "performance data" listed below serves as the basis for demonstrating that the device is safe and performs as intended, and crucially, is substantially equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Summary Statement: The document states, "The Focal BioZorb Marker performance is identical to the predicate device (K113202)." This is the primary "proof" of meeting performance expectations, by demonstrating substantial equivalence to an already marketed device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided: The document describes performance data related to physical and material testing (pyrogenicity, MR compatibility, shelf life) and states the device performance is "identical to the predicate device (K113202)". It does not discuss a "test set" in the context of clinical data or AI/ML model validation with a specific sample size of patients/cases, nor does it specify data provenance in terms of country or retrospective/prospective collection for clinical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: This information is relevant for studies validating diagnostic or predictive AI/ML models. For a physical implantable marker, ground truth for clinical performance in this context is not established by expert review of images, but rather by the physical and biological performance of the device itself (e.g., its visibility on imaging, biocompatibility, resorption rate).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: Adjudication methods are used to establish a consensus ground truth in reader variability studies, which is not described for this device.

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: This is a submission for a physical implantable marker, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or described.

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

• Not Applicable: This is not an algorithm or AI device.

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

• For the performance data listed (pyrogenicity, MR compatibility, shelf life), the "ground truth" implicitly relies on validated standard testing methodologies (e.g., USP Pharmacopeia, ASTM, ISO standards) that define acceptable parameters for these physical and biological characteristics. For the primary claim of substantial equivalence, the "ground truth" is the performance of the legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable: There is no AI/ML model for which a training set would be used.

9. How the ground truth for the training set was established

• Not Applicable: There is no AI/ML model for which a training set ground truth would be established.

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