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A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:

1. Comminuted fractures of the naso-ethmoidal infraorbital areas
2. Comminuted fractures of the frontal sinus wall
3. Pediatric midface or craniofacial trauma
4. LeFort (I,II,III) fractures
5. Orbital floor fractures
6. Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones
7. Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
   B. General Indication: reconstructive procedures of the midface or craniofacial skeleton Specific Indications:
8. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
9. LeFort (I,II,III) osteotomies
10. Tumor reconstruction in midface or craniofacial procedures
11. Bone graft procedures in the midface or craniofacial skeleton
12. Pediatric reconstructive procedures
13. Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
14. Craniotomy flap fixation

The devices are made of LactoSorb®, which is comprised of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. The LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs In Vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue. Additional designs have been added to the system which pose no new risks regarding safety and effectiveness.

The provided text describes the LactoSorb® Trauma Plating System and its indications for use, along with an FDA 510(k) clearance letter. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document is a summary of safety and effectiveness submitted for 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to a predicate device already on the market. It states the device materials are bioresorbable and biocompatible, having been used in surgical procedures for years, and that the material "has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue." The FDA letter confirms the 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide details on the requested information regarding acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.

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The LactoSorb® Trauma Plating System is indicated for use in the following midface or craniofacial procedures.
A. General Indication: trauma procedures of the midface or craniofacial skeleton
Specific Indications:

1. comminuted fractures of the naso-ethmoidal infraorbital areas
2. comminuted fractures of the frontal sinus wall
3. pediatric midface or craniofacial trauma
4. LeFort (I,II,III) fractures
5. orbital floor fractures
6. fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones
7. trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
   B. General Indication: reconstructive procedures of the midface or craniofacial skeleton
   Specific Indications:
8. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
9. LeFort (I,II,III) osteotomies
10. tumor reconstruction in midface or craniofacial procedures
11. bone graft procedures in the midface or craniofacial skeleton
12. pediatric reconstructive procedures
13. reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
14. craniotomy flap fixation
    This system is not designed for use in the mandible and/or full load bearing procedures.

The LactoSorb® plates/mesh/screws are made of bioresorbable and biocompatible polymer 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.

Here's an analysis of the provided text regarding the LactoSorb® Trauma Plating System, structured to address your specific points.

The provided document is a 510(k) summary for the LactoSorb® Trauma Plating System, submitted in 1997. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through extensive clinical trials with pre-defined acceptance criteria in the way a PMA submission would. Therefore, much of the information you've requested regarding acceptance criteria, specific performance metrics, and clinical study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) is not present or explicitly defined in this summary document. The summary primarily focuses on material biocompatibility and general effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not explicitly stated in the provided text. The document mentions an "FDA approved clinical study" and "mechanical testing," but does not provide details on the sample size of patients or data sets used in these studies.
• Data Provenance: Not specified.

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/Not stated. This information is generally not part of a 510(k) summary, especially for a device like a trauma plating system where the "truth" is typically evaluated via clinical outcomes and imaging rather than expert assessment of AI output. The clinical study mentioned would have involved surgeons and possibly other medical professionals, but their role in "ground truth establishment" for a test set (in the context of an AI device) is not relevant here.

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

• Not applicable/Not stated. Adjudication methods are typically relevant for studies validating diagnostic or AI tools where there might be disagreement in expert interpretation. This is a physical implant device.

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

• No. This is not an AI device, therefore MRMC studies (which are designed to evaluate human reader performance with and without AI assistance) are not applicable.

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

• No. Not an AI device.

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

• For the "effectiveness" of the device, the implied "ground truth" or evidence appears to be:
  • Clinical Outcomes/Observation: "adequate fixation in the craniomaxillofacial region with no device related complications reported." This suggests direct observation of patient outcomes.
  • Resorption Data: "completely resorbs by 12 months IN VIVO." This would be verified through follow-up imaging or possibly histological studies.
  • Biocompatibility Data: Established through "years" of use of the base material (PLA/PGA sutures since early 1970s) and "over 10 years" in the Poly Surgiclip device. This would likely involve historical clinical data, pathology, and toxicology studies.
  • Mechanical Testing: This would use engineering performance metrics as ground truth.

8. The sample size for the training set

• Not applicable/Not stated. This is not an AI/algorithm-based device requiring a training set. The "training data" for the safety component implicitly comes from decades of biological use for PLA/PGA.

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

• Not applicable/Not stated. As it's not an AI device, there's no "training set" in the context of an algorithm. The safety and biocompatibility of the material (PLA/PGA) were established over many years through widespread clinical use in other FDA-approved devices (sutures, Surgiclip), historical data, and likely pre-clinical testing, forming the basis for its known biological behavior and "ground truth" regarding its safety profile.

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The LactoSorb® Trauma Plating System is indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton.

• Comminuted fractures of the naso-ethmoidal and l. infraorbital areas.
• 2. Comminuted fractures of the frontal sinus wall.
• 3. Trauma of the midface or craniofacial skeleton.
• 4 . Reconstructive procedures of the midface or craniofacial skeleton.
  This system is not designed for use in the mandible and/or full load bearing procedures.

The LactoSorb® implants are made of bioresorbable and biocompatible polymer that have been used in surqical 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. The safety of PLA/PGA material has been well documented since the early 1970's when the FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in for over 10 years in Poly humans Surqiclip® device manufactured by United States Surgical Corporation. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue.

This document is a "Summary of Safety and Effectiveness" for the LactoSorb® Trauma Plating System, dated April 8, 1996. It describes the device, its intended use, material composition, and general claims about its safety and effectiveness.

However, the provided text does not contain the specific information requested in the prompt's numbered points regarding acceptance criteria and a study that proves the device meets them.

The document states: "The effectiveness of this resorbable system was determined by mechanical testing and an FDA approved clinical study. The LactoSorb® system was found to provide adequate fixation in the craniomaxillofacial region. This system is as effective as similar metal micro fixation systems on the market."

While it mentions a "clinical study" and "mechanical testing," it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone (algorithm only) performance. (This is not applicable as it's a physical device, not an AI algorithm)
7. Type of ground truth used.
8. Training set sample size. (This is not applicable as it's a physical device, not an AI algorithm)
9. How ground truth for the training set was established. (This is not applicable as it's a physical device, not an AI algorithm)

Therefore, based only on the provided text, I cannot fulfill the request for information beyond reiterating that a clinical study and mechanical testing were performed, and the system was found to provide adequate fixation. The specific details, metrics, and acceptance criteria are not present in this summary document.

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