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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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