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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.

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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The Beacon Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The proposed Beacon Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The proposed Beacon Tissue Marker is 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. The proposed Beacon Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

The proposed Beacon Tissue Marker is comprised of Oxford Performance Materials (OPM) OXPEKK-IG200 filled with Barium Sulfate (Polyetherketoneketone with 20% BaSO4 by wt%). OXPEKK-IG200 is a radiolucent material and serves as the carrier for the radiopaque BaSO4.

The proposed Beacon Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the Beacon Tissue Marker. The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. 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. The Beacon Tissue Marker delivery system is used to place the Beacon Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a beveled 12 cm / 14 gauge needle with 1 cm depth marks and a plunger.

The provided document is a 510(k) summary for the Beacon Tissue Marker, which describes a device modification. It states that the purpose of the submission is to seek clearance for a modification to an already cleared tissue marker to be inserted into an already cleared delivery system.

Therefore, this document does not describe a study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to pre-existing predicate devices based on the modification of components already cleared by the FDA. The submission largely relies on the prior clearance of its constituent parts and asserts that the combined device does not raise new questions of safety or efficacy.

As a result, I cannot provide the specific details requested in your prompt regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These types of studies would typically be conducted for novel devices or significant modifications, which is not the case described here.

The document indicates that the change is the combination of:

• KMD-Mark1 Tissue Marker (K093473) - already cleared
• BiomarC® Tissue Marker delivery system (K063193) - already cleared

The document states: "Scion Medical Technologies, LLC believes that the proposed Beacon Tissue Marker... does not raise any new or significant questions of safety and efficacy and is substantially equivalent to the predicate Kent Medical Devices, Inc. KMD-Mark1 Tissue Marker (K093473)... and the predicate Carbon Medical Technologies, Inc. BiomarC Tissue Marker (K063193)."

This type of submission often relies on a comparison of technical characteristics and existing performance data of the predicate devices rather than new, extensive clinical studies for the combined product.

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