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The LactoSorb® Panels and Fasteners are used in maintaining the position of bony of bony fragments or morselized bone graft in Iliac Crest autograft procedures. This product is not intended for use in the spine or joint space. This product is also not indicated for pelvic fracture fixation.

The LactoSorb® devices are made of bioresorbable and Ine backed activers that have been used in surgical procedures Brocompacible porymers chac have copolymer is synthetic polyester derived from lactic and glycolic acids. polylactic/polyglycolic acid copolymer degrades and resorbs IN vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found meconocible by the both soft tissue and bone tissue. Both co be brocomputible in lostudies have proven the safety and preciliadar and these devices in trauma and reconstructive procedures in the midface and craniofacial skeleton.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Biomet LactoSorb® Panels and Fasteners, focusing on their substantial equivalence to predicate devices and their intended use. It does not contain details about specific performance metrics, studies with sample sizes, expert involvement, or ground truth establishment.

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The LactoSorb® Panels and Fasteners are used to maintain the position of bony fragments in mandibular bone graft procedures and are used in conjunction with rigid internal fixation.

The LactoSorb® 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 acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in both soft tissue and bone tissue. Both preclinical and clinical studies have proven the safety and effectiveness of these devices, in trauma and reconstructive procedures in the midface and craniofacial skeleton .

The provided information does not describe acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for the LactoSorb® Panels and Fasteners, which is a regulatory submission to the FDA. It declares the device's substantial equivalence to existing predicate devices, rather than presenting a performance study with acceptance criteria.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria: The document describes the device, its material (bio-resorbable and biocompatible polymers), and its intended use. It states that "Both preclinical and clinical studies have proven the safety and effectiveness of these devices, in trauma and reconstructive procedures in the midface and craniofacial skeleton." However, it does not specify any quantitative acceptance criteria for performance (e.g., specific thresholds for tensile strength, degradation rates, or clinical success rates).
• No Detailed Study Description: While it mentions "preclinical and clinical studies," it does not provide details about these studies. It does not describe their methodology, sample sizes, data provenance, ground truth establishment, or any specific performance metrics measured against acceptance criteria.
• Focus on Substantial Equivalence: The core of the 510(k) submission is to demonstrate that the new device is "substantially equivalent" to an already legally marketed predicate device. This process typically involves showing that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety or effectiveness. It does not generally require presenting detailed performance data against specific, pre-defined acceptance criteria in the same way a de novo or PMA submission might.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document serves as an FDA notification of intent to market, asserting safety and effectiveness based on previous studies and equivalence, but does not contain the detailed study results or acceptance criteria themselves.

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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. Orbital floor fractures
5. 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:

1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma etc.)
2. Tumor reconstruction in midface or craniofacial procedures
3. Bone graft procedures in the midface or craniofacial skeleton
4. Pediatric reconstructive procedures
5. Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
6. Craniotomy flap fixation

The LactoSorb® Panels consist of sheets of LactoSorb® available in various sizes. The panels can be heated to malleable state and cut/shaped to conform to the bony anatomy. Heating is done using a sterile LactoSorb® Heat Pack. At the time of surgery, drill holes can be placed as needed to accept LactoSorb® screws and rivets. These devices are not for use in the mandible or other load bearing indications. The LactoSorb® Panels 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. The polycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in both soft tissue and bone tissue. The material retains its strength for at least 8 weeks and completely resorb by 9-15 months.

The provided text describes the LactoSorb® Panels, a medical device used for fixation in craniofacial and midface trauma and reconstructive procedures. However, the document does not contain any information about acceptance criteria, a specific study proving device performance against acceptance criteria, sample sizes, data provenance, expert qualifications, ground truth establishment, or clinical effectiveness studies (MRMC or standalone).

The text primarily focuses on:

• Indications for Use: Listing specific trauma and reconstructive procedures where the LactoSorb® Panels are intended to be used.
• Device Description: Explaining that the panels are made of bioresorbable and biocompatible polymers (lactic and glycolic acids) that degrade over time.
• Predicate Device Comparison: Stating that the LactoSorb® Panels are used similarly to LactoSorb® mesh and thin metal meshes, and that "Biomechanical testing has proven that the LactoSorb® Panels will be as effective as the predicate devices in midface and craniofacial procedures." There are no details provided about this biomechanical testing.
• FDA Clearance: The document includes an FDA 510(k) clearance letter, indicating the device was found substantially equivalent to predicate devices.

Therefore, I cannot populate the requested table and information as the source document does not contain the necessary details.

To answer your request, a different document that describes the specific studies, methodologies, and results used to demonstrate the device's performance against defined acceptance criteria would be needed.

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