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Star Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical procedure or for future surgical procedures

The Star Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The Star Tissue Marker 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 a new cross sectional profile of the tissue marker. The delivery system is sterile, single patient use, and is pre-loaded incorporating the tissue marker. The delivery system has a 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 the "Star Tissue Marker," an implantable clip used to radiographically mark soft tissue. The submission claims substantial equivalence to a predicate device, the "Beacon Tissue Marker" (K140835).

Since this is a 510(k) premarket notification for a Class II device claiming substantial equivalence to a predicate device, it does not typically include a clinical study with detailed acceptance criteria and performance data like a PMA application would. The FDA's 510(k) pathway focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through non-clinical testing and comparison. Therefore, the requested information regarding acceptance criteria and a study proving performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, is generally not found in these types of submissions for this device.

The document states:

• The device is a "Star Tissue Marker" and the predicate device is the "Beacon Tissue Marker" cleared on May 20th, 2014 (K140835).
• The submission is for a "new cross sectional profile of the tissue marker."
• "The results of assessment of the change to the new tissue marker conducted under Design Controls, support that the new offering is substantially equivalent to the predicate tissue marker."

This implies that the "study" demonstrating equivalence would be a series of engineering and material assessments comparing the new tissue marker's design, materials (PEKK), and radiographic visibility (X-ray, mammography, ultrasound, MRI up to 3.0 Tesla) to the predicate device, rather than a clinical trial with human subjects. The acceptance criteria would likely be defined by these engineering and performance standards to match or exceed those of the predicate device.

Without more detailed information from the original submission (which is beyond this document), it's not possible to provide the specific data requested in the format of acceptance criteria and proven device performance from a clinical study. The FDA's review for a 510(k) largely relies on non-clinical data and comparisons to the predicate, as evidenced by the mention of "Compliance with Design Controls" and "Compliance with Standards" (ISO 15223-1:2012, ISO 14971:2007, EN 1041:2008).

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The Cassi Rotational Core Biopsy Device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. It is not intended for use in bone.

The Cassi Device is also indicated to provide breast tissue sampling of breast abnormalities. It is designed to provide breast tissue for histological examination with partial or complete removal of the imaged abnormality. The extent of a histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The proposed CASSI II Rotational Core Biopsy System consists of the following primary components: a fully integrated CASSI biopsy handle, a valve block, battery, cryogen, a Cassi biopsy needle (CASSI biopsy needle comprised of a sticking needle and cutting cannula/piston assembly), and a sample collection tray. The sticking needle is operated by CASSI biopsy handle and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula is available in two sizes (10 and 12 gauge).

The proposed CASSI biopsy handle are minor design evolution of the predicate CASSI II biopsy handle. The proposed CASSI II biopsy needle unit assembly remains unchanged from the predicate CASSI II biopsy needle unit assembly.

The proposed CASSI II system uses one control unit handle and allows for multiple, single patient use, biopsy needle units to operate with the handle, in the very same manner as the predicate CASSI II device. The principles of operation for the proposed CASSI™ II Rotational Core Biopsy System and the predicate CASSI II system remain unchanged.

The provided text is a 510(k) summary for the CASSI™ II Rotational Core Biopsy System, which focuses on changes to manufacturing and minor design evolutions rather than a study demonstrating clinical performance against acceptance criteria. Therefore, I cannot extract information related to clinical studies from this document.

However, based on the information provided, I can infer the following about the device's technical specifications and aspects addressed in the submission:

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

Since this submission is for manufacturing and minor design changes, it does not present a table of clinical acceptance criteria and device performance in that context. The "performance" discussed relates to maintaining equivalence to the predicate 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 to this 510(k) submission. This document describes manufacturing and minor design changes, not a clinical test set.

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 to this 510(k) submission. No clinical test set requiring expert ground truth establishment is described.

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

Not applicable to this 510(k) submission. No clinical test set is described.

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 to this 510(k) submission. This device is a biopsy system, not an AI-assisted diagnostic tool.

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

Not applicable to this 510(k) submission. This device is a biopsy system, not an algorithm.

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

Not applicable to this 510(k) submission. The document focuses on demonstrating that design and manufacturing changes do not alter fundamental performance or safety, rather than evaluating clinical accuracy against a ground truth.

8. The sample size for the training set:

Not applicable to this 510(k) submission. This device is not an AI/machine learning system.

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

Not applicable to this 510(k) submission. This device is not an AI/machine learning system.

In summary, this 510(k) submission (K161234) for the CASSI™ II Rotational Core Biopsy System focuses on demonstrating substantial equivalence to a previously cleared predicate device (K123606) following changes in contract manufacturers, sterilizer, and minor design evolutions to the biopsy handle, rather than presenting a clinical study and acceptance criteria for its diagnostic performance. The document confirms that the device's intended use and principles of operation remain unchanged and that the modifications do not raise new questions of safety or efficacy.

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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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