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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 BiomarC Gold Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

The BiomarC Gold Fiducial Marker is a sterile, pyrogen free, single patient use, gold discrete marker that is visible on standard radiographs, ultrasound and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.

The provided document is a 510(k) summary for the BiomarC Gold Fiducial Marker, which is a device intended for use in stereotactic radiosurgery and radiotherapy. This summary focuses on demonstrating equivalence to predicate devices and does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would typically be found in a clinical study report for an AI/ML-driven diagnostic device.

Therefore, I cannot provide the information requested in your prompt based on the input provided.

The document states:

• "The technological characteristics are equivalent to the predicate devices."
• "A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced."
• "A biocompatibility, visibility, and sterilization and packaging / shelf life adoption evaluation confirmed that the modified device, BiomarC Gold Fiducial Marker, was substantially equivalent to the predicate devices."

These statements indicate that the evaluation focused on device characteristics and equivalence, not on a detailed performance study with specific metrics as if it were an AI diagnostic tool.

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The Ball Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. Specifically, they can be used in intracranial diseases such as gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas. Additionally, they can be used in the body for treating hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, prostatic and breast tumors.

The Cosman Ball Fiducial Markers have similar physical and technical characteristics to the predicate devices.

The provided document is a 510(k) summary for the Cosman Ball Fiducial Markers. It states that the device is "substantially equivalent" to a predicate device (CIVCO MEDICAL SOLUTIONS, Fiducial Markers) and is "safe and effective for indicated intended use." However, it does not contain the specific information requested regarding acceptance criteria and a study proving those criteria are met.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, training sets, or data provenance.
• Information on the number or qualifications of experts used for ground truth.
• Adjudication methods.
• Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or their effect sizes.
• Information on standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for any training set was established.

The document is a regulatory submission focused on demonstrating substantial equivalence to a previously cleared device, not a detailed performance study report. The core of its argument for safety and effectiveness is simply that it has similar physical and technical characteristics to the predicate device.

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