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The BioZorb SP 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 SP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb SP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb SP Marker is provided sterile for single use and is implantable.

The provided text is a 510(k) summary for the BioZorb SP Marker and a letter from the FDA determining substantial equivalence. It does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop performance study.

Here's what can be extracted and what is missing:

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

The document states:

• Acceptance Criteria (Implied): "The BioZorb SP Marker met all specified input criteria and did not raise new safety or performance questions." (This is a general statement, not specific criteria points).
• Reported Device Performance: "Performance data with regards to imaging assessment and MR compatibility are provided in support of the substantial equivalence."

A specific table cannot be created from the given text as the detailed acceptance criteria and performance metrics are not listed. The document broadly indicates that the device met its intended performance based on imaging assessment and MR compatibility, which are considered sufficient to establish substantial equivalence to predicate devices.

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

This information is not provided in the document. The text mentions "performance data with regards to imaging assessment and MR compatibility," but gives no details about the studies' design, sample sizes, or data provenance.

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)

This information is not provided in the document. The document refers to "imaging assessment" but does not detail how ground truth was established or who assessed it.

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

This information is not provided in the document.

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

An MRMC study, particularly one involving AI, is not mentioned or implied in this document. The device is an implantable radiographic marker, not an AI diagnostic algorithm. Therefore, "human readers improve with AI vs without AI assistance" is not applicable in this context.

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

This is not applicable as the device is a physical implantable marker, not an AI algorithm.

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

This information is not explicitly stated. Given the device's nature (radiographic marker), the "imaging assessment" likely relied on visual confirmation by experts, but the exact method (e.g., expert consensus on image quality, visibility, or MR safety) is not detailed.

8. The sample size for the training set

This information is not provided and is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.

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

This information is not provided and is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.

In summary, the provided FDA document is for an implantable radiographic marker and focuses on demonstrating substantial equivalence to predicate devices based on its physical characteristics, indications for use, and general performance (imaging assessment and MR compatibility). It does not contain the detailed clinical study data, AI performance metrics, or reader study information typically associated with evaluating AI-powered diagnostic devices per your request.

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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 LP 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 LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.

The information provided is a 510(k) premarket notification for the BioZorb LP Marker. This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing a specific clinical study with acceptance criteria for device performance. Medical devices cleared via 510(k) often rely on non-clinical data (e.g., bench testing) to demonstrate equivalence if their technology and intended use are similar to existing devices.

Based on the provided text, here's what can be extracted and what information is not available:

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

The document states that "The modified BioZorb Marker met all specified criteria and did not raise new safety or performance questions" for the listed tests. However, the specific acceptance criteria (e.g., quantitative thresholds for mechanical integrity) are not detailed in this summary. The performance is generally stated as meeting criteria.

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

This information is not provided in the document. The tests listed (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility) are typically non-clinical bench or lab tests, not clinical studies involving human patients. Therefore, terms like "test set" in the context of patient data, data provenance, or retrospective/prospective would not apply here.

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)

This information is not provided or applicable to the type of testing described. The tests are non-clinical, and thus do not involve expert interpretation of images or other data for ground truth establishment.

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

This information is not provided or applicable. Adjudication methods are typically used in clinical trials involving expert review of patient data, which is not described here.

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

There is no mention of an MRMC study or AI assistance. This device is a physical implantable marker, not an AI-powered diagnostic tool.

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

This is not applicable as the device is a physical marker, not an algorithm.

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

For the non-clinical tests (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility), the "ground truth" would be established by engineering specifications, material properties, and objective measurements during the testing process, not by expert consensus, pathology, or outcomes data in the clinical sense. The specific details of how ground truth was established for each test are not provided.

8. The sample size for the training set

This is not applicable as the device is a physical marker and there is no mention of a training set in the context of machine learning or AI.

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

This is not applicable for the same reasons as above.

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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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The BioZorb™ Tissue Marker is indicated for radiographic marking of sites in soft tissue.

The BioZorb Tissue Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb Tissue Marker is comprised of a bioabsorbable component and a permanent component. The BioZorb Tissue Marker is provided sterile for single use and is disposable.

This submission describes a medical device, the BioZorb™ Tissue Marker, and its application for 510(k) clearance based on substantial equivalence to predicate devices. It does not present a study proving the device meets specific acceptance criteria in the manner described by the request. Instead, it focuses on demonstrating that the new device has similar characteristics and performs comparably to already approved devices.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be fully answered from the provided text.

Here's a breakdown based on the available information:

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

The provided text does not explicitly state specific quantitative acceptance criteria or detailed reported device performance for the BioZorb™ Tissue Marker. The submission's basis for clearance is "substantial equivalence" to predicate devices, meaning it aims to show it is as safe and effective as existing, legally marketed devices.

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a test set or data provenance related to a clinical study. The submission describes image-based verification and validation testing, but no details on the scope or nature of this testing are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts or the establishment of ground truth for any specific test set, as no detailed study is presented.

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

The document does not describe any adjudication method for a test set.

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

The document does not mention an MRMC comparative effectiveness study, nor does it describe an AI component. The device is an implantable radiographic marker, not an AI-powered diagnostic tool.

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

This question is not applicable as the device is a physical implantable marker, not an algorithm.

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

The document does not specify any type of ground truth used, as no detailed clinical study is described in the context of device performance. The submission relies on demonstrating substantial equivalence to predicate devices.

8. The sample size for the training set

The document does not mention a training set sample size, as it does not describe a machine learning or AI algorithm development process.

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

The document does not describe how ground truth for a training set was established, as it does not involve machine learning or AI.

Summary of what the document does provide:

• Device Name: BioZorb™ Tissue Marker
• Intended Use: Radiographic marking of sites in soft tissue.
• Classification: Class II device, Implantable Clip (21 CFR 878.4300), Product Code NEU.
• Predicate Devices: Hologic/Suros Tissue Site Marking System (K062528, K072913), Bard/SenoRx GelMark Ultra (K011402), Devicor/Artemis CorMARK Marker (K032217).
• Demonstration of Substantial Equivalence: The submission asserts that the BioZorb™ Tissue Marker is substantially equivalent to predicate devices in intended use, principal of operation, and technological characteristics. It specifically mentions "similar physical and technical characteristics" and "substantially equivalent" component materials.
• Performance Data Mention: "All necessary verification and validation testing has been performed for the BioZorb Tissue Marker to assure substantial equivalence to the predicate devices, including image based verification." However, no details of this testing (like sample size, specific outcomes, or acceptance criteria) are provided.

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