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Beacon Tissue Marker (SE) is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future procedures.

The Beacon Tissue Marker (SE) consists of a radiographic soft tissue marker and the delivery system. The Beacon Tissue Marker (SE) includes a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength.

This submission is for an additional offering of a delivery system with radiused tip and increased rod length corresponding to the new radius tip. The delivery system is sterile, single patient use, and is pre-loaded incorporating the tissue marker. The delivery system has a radius tip 12 cm /14 gauge needle with 1 cm depth marks. The delivery system consists of a cannula with a handle with integral tabs to retain the tissue marker, a push rod with a plunger, and a tip cover. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle.

This document is a 510(k) premarket notification for a medical device called the "Beacon Tissue Marker (SE)". It does not describe a study involving an AI algorithm or digital health product. Instead, it is a submission for a physical implantable clip used to mark soft tissue. Therefore, many of the requested elements for an AI/digital health product study are not applicable to this document.

However, I can extract information related to the device and its claimed "substantial equivalence" to predicate devices, which serves a similar purpose to acceptance criteria and a study for traditional medical devices.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a physical medical device submission like this, "acceptance criteria" are typically met by demonstrating substantial equivalence to a legally marketed predicate device, rather than specific performance metrics against pre-defined thresholds as would be common for an AI algorithm. The performance is assessed by comparing key characteristics to the predicate.

• Same basic design
• Same component materials
• Same sterilization method and sterility assurance level
• Same packaging materials|
  | Performance Characteristics and Results (Compared to Predicate) | The proposed device has the same performance characteristics and results as the predicate device. |
  | Radiographic Visibility (Same as predicate) | Visible on standard radiographs (x-ray, mammography), ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. |
  | Delivery System Cannula Tip (Compared to relevant predicate) | Radiused tip. This specific change is compared to the SenoRx, Inc. StarchMark® Breast Tissue Marker (K131654), which also has an applicator tip with a radius. |
  | Delivery System Rod Length | Increased rod length corresponding to the new radius tip. |

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

Not applicable. This document describes a physical medical device (tissue marker) and its delivery system. The "study" here is a demonstration of substantial equivalence through comparison of design, materials, and intended use to existing predicate devices, rather than a clinical study with a "test set" of data or patient samples in the context of an AI/digital health product.

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

Not applicable. See answer to #2.

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

Not applicable. See answer to #2.

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

Not applicable. This device is a physical tissue marker, not an AI or imaging diagnostic tool that would involve human readers.

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

Not applicable. This is not an algorithm or software device.

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

Not applicable. For this type of device, the "ground truth" for demonstrating substantial equivalence primarily relies on engineering specifications, material properties, manufacturing processes, and comparison to the established performance and safety profile of legally marketed predicate devices, rather than clinical outcomes or diagnostic accuracy measurements.

8. The sample size for the training set

Not applicable. See answer to #2.

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

Not applicable. See answer to #2.

Summary of the document's relevance to "proving acceptance criteria":

The provided document is a 510(k) "Special" submission for a modification to an already cleared device, the Beacon Tissue Marker. The "proof" that the device meets its "acceptance criteria" (which in this context means proving substantial equivalence to predicate devices) is provided through a comparison and discussion (Section G of the Special 510(k) Summary) and by demonstrating compliance with Design Controls and relevant standards (Section H).

The key argument for substantial equivalence is that the proposed Beacon Tissue Marker (SE) has the same indications for use and technological characteristics as its primary predicate (Beacon Tissue Marker K140835). The specific change is a radiused tip and increased rod length on the delivery system, which is deemed substantially equivalent to the delivery system of another predicate device (SenoRx, Inc. StarchMark® Breast Tissue Marker K131654).

This regulatory pathway relies on the existing safety and effectiveness profiles of the predicate devices, rather than entirely new studies for every aspect of the modified device.

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