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The Craniofacial Anchors are indicated for use with resorbable suture in open and endoscopic brow lift procedures. The device is placed into a preditiled, tapped bone hole and assists the suture in anchoring soft tissue. These devices are not designed for use in the mandible and/or full load bearing procedures.

The devices are made of LactoSorb® material, which based on animal studies, completely resorbs by 12 months In Vivo. The devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs In Vivo by hydrolysis to lactic and glycolic acids which are then metabolized by the body.

This document is a 510(k) summary for the Craniofacial Anchors, focusing on establishing substantial equivalence to previously marketed devices. It does not contain information about specific acceptance criteria or a dedicated study proving device performance against those criteria in the way a clinical trial for a new drug or a novel AI diagnostic device would.

Here's an analysis based on the provided text, addressing your questions where possible:

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

This information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence, primarily through the material composition (LactoSorb®) and its historical use, rather than presenting a performance study with specific acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided document. As this is a 510(k) for a medical device (craniofacial anchors) made from a well-established resorbable material (LactoSorb®), the "test set" and "data provenance" as you might expect for an AI or diagnostic device study are not directly applicable or reported here. The safety and effectiveness are primarily supported by the long history of the material.

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)

This information is not present in the provided document. Ground truth as typically defined for diagnostic device studies is not relevant to this 510(k) submission.

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

This information is not present in the provided document. Adjudication methods are typically used in clinical trials or diagnostic accuracy studies, which are not detailed here.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and not mentioned in this document. This type of study is relevant for AI-powered diagnostic devices, not for a resorbable craniofacial anchor.

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

A "standalone algorithm performance" study is not applicable and not mentioned in this document. This is a medical device, not an algorithm.

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

"Ground truth" as a concept is not directly applicable to this 510(k) submission in the way it is for diagnostic devices. The safety and effectiveness are established based on:

• Material properties: LactoSorb® material's history of biocompatibility and resorption.
• Prior clinical use of material: "[T]he exact same LactoSorb® material has been implanted in humans for over 10 years in the form of a ligating clip and safety and effectiveness has been studied in two different clinical trials." This implies clinical outcomes data from previous uses of the material serve as the "ground truth" for the material's safety and bioresorption characteristics.
• Animal studies: "based on animal studies, completely resborbs by 12 months In Vivo."

8. The sample size for the training set

This information is not present in the provided document. "Training set" is a concept for machine learning, which is not relevant here.

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

This information is not present in the provided document. "Ground truth for a training set" is a concept for machine learning, which is not relevant here.

Summary of Device Acceptance (as per 510(k) process):

The acceptance of this device by the FDA for market clearance (as granted in the letter) is based on the determination of substantial equivalence to existing legally marketed predicate devices, not on meeting specific, de novo acceptance criteria from a new clinical study.

The primary evidence presented to support substantial equivalence revolves around:

• Material Safety and Effectiveness: The Craniofacial Anchors are made from LactoSorb® material. The document highlights:
  • It's a bioresorbable and biocompatible polymer (PLA/PGA).
  • Its safety is "well documented since the early 1970's" with FDA-approved resorbable sutures.
  • The "exact same LactoSorb® material has been implanted in humans for over 10 years in the form of a ligating clip" and its "safety and effectiveness has been studied in two different clinical trials."
  • It maintains strength for soft tissue reattachment and fracture healing.
  • Animal studies show complete resorption by 12 months in vivo.
• Indications for Use: The anchors are intended for use with resorbable suture in open and endoscopic brow lift procedures, where they assist in anchoring soft tissue. The document explicitly states they are not for use in the mandible or full load-bearing procedures.

The "study" referenced in the 510(k) is the long history and established safety and effectiveness of the LactoSorb® material itself, as demonstrated in prior animal studies and human clinical trials (for a ligating clip use). The FDA's letter confirms that based on this information, the device is considered substantially equivalent to pre-amendments devices and can be marketed.

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