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The Synthes OrthoMesh Resorbable Graft Containment system is indicated for use in maintaining the relative position of weak bony tissue such as bone grafts, bone graft substitutes or bone fragments from comminuted fractures.

OrthoMesh implants may be used alone (without traditional rigid fixation) to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in non-load-bearing reconstructive procedures involving areas where bone stability has not been compromised, such as tumor resections and iliac crest graft harvest sites.

OrthoMesh implants must be used in conjunction with traditional rigid fixation in load bearing applications to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in reconstructive procedures involving long bones, flat bones, short bones, irregular bones, appendicular skeleton and thorax. These devices are not intended for use in the spine. The devices are not intended for load bearing indications unless used in conjunction with traditional rigid fixation

The Synthes OrthoMesh Resorbable Graft Containment System is comprised of meshes of 0.5mm, 0.8mm and 1.2mm thickness, and lengths and widths ranging from 48mm to 125mm. The Synthes OrthoMesh Resorbable Graft Containment System is also comprised of screws with a diameter ranging from 1.5mm to 2.5mm, and a length ranging from 4mm to 8mm. These implants are made from the resorbable copolymer poly (L-lactide-co-glycolide) that resorbs in vivo by hydrolysis into lactic and glycolic acids, and that are then metabolized by the body. Synthes OrthoMesh implants are resorbed completely within approximately 12 months. The implants are provided sterile and are intended for single patient use. OrthoMesh may be held in place with screws.

The provided text does not contain information about acceptance criteria or a study that proves a device meets those criteria.

The document is a 510(k) summary and an FDA clearance letter for the Synthes OrthoMesh Resorbable Graft Containment System. It describes the device, its intended use, contraindications, and declares its substantial equivalence to predicate devices. However, it does not include performance data, clinical study results, or specific acceptance criteria for device performance.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, data provenance, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

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The MARGRON™ Hip Replacement System is intended for primary or revision restruction, without bone cement, of the femoral portion of a severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. The patient should be skeletally mature. The patient's condition should be due to one or more of the following: Osteoarthritis, Rheumatoid arthritis, Tumor conditions involving the upper third of the femur or the acetablym, Ankylosing spondylitis, Psoriatic arthritis, Old osteomyelitis - with a long infection-free period and a normal WBC. ESR and C-reactive protein, Non union of femoral neck fracture or avascular necrosis of the femoral head, Post-traumatic fracture/dislocation of the hip, Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling, Revision of an unsuccessful cemented or un-cemented hip replacement stem, providing sufficient bone stock is present, Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The MARGRON 100 hip replacement stem has been designed to be used in an uncemented mode in bone which is of good quality physiologically and which will heal quickly. The MARGRON TM Femoral Stem is a modular prosthesis consisting of - A tapering stem cone with two different speed external threads and longitudinal . derotation columns. - A neck component which allows the optimum angle of anteversion to be selected ● after stem insertion. - . Precision milling and tapping is used to prepare the femur and stem insertion is by "screw home" rotation. - . A unique set of instruments have been designed to insert and extract the prosthesis.

The provided document is limited to a Special 510(k) Notification for the MARGRON™ Hip Replacement System, asserting substantial equivalence to an existing predicate device (K992158). This type of submission generally relies on demonstrating that changes to a previously cleared device do not introduce new questions of safety or effectiveness.

Therefore, the document does not contain the detailed information typically found in a study demonstrating performance against specific acceptance criteria for a novel device. It refers to the testing of the original design of the predicate device.

Based on the provided text, here's what can be extracted and what cannot:

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

This information is not provided in the document. The document states: "All materials used in the fabrication of this MARGRON™ Hip Replacement System were evaluated with the original design through physical testing (fatigue, torque and corrosion testing) and biocompatibility testing. It has been shown to be substantially equivalent to the predicate device."

This implies that the original device underwent testing, and the current device's materials are equivalent to those used in the original. However, specific acceptance criteria for these tests and the detailed results are not presented.

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

This information is not provided. The document makes generic statements about "physical testing" and "biocompatibility testing" of the "original design," but no details about sample sizes or data provenance are given.

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 applicable/provided. Since this is a physical medical device (hip replacement system) and not a diagnostic AI/software, the concept of "ground truth" established by human experts in the context of a test set (e.g., for image interpretation) does not apply. The testing mentioned (fatigue, torque, corrosion, biocompatibility) are laboratory-based physical and chemical tests, not clinical evaluations requiring expert interpretation of results in the same way.

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

This information is not applicable/provided for the same reasons as point 3.

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

This information is not applicable/provided. This is a physical hip replacement implant, not an AI or diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this device.

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

This information is not applicable/provided. This is a physical hip replacement implant, not an algorithm or software.

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

This information is not applicable/provided. As explained in point 3, the testing involves physical and chemical property assessments, not diagnostic evaluations requiring a "ground truth" derived from expert consensus, pathology, or outcomes data. The "ground truth" for material properties would be established by validated scientific methodologies and standards.

8. The sample size for the training set

This information is not applicable/provided. The concept of a "training set" applies to machine learning and AI, which is not relevant to this physical implant device.

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

This information is not applicable/provided for the same reasons as point 8.

In summary:

The provided document is a regulatory submission for a hip replacement system, focusing on demonstrating substantial equivalence to a predicate device based on similar design and materials. It does not provide details about specific acceptance criteria or performance studies in the format requested, as these are typically part of a full Premarket Approval (PMA) application or a more extensive 510(k) for a novel device, especially for AI/software products. The testing mentioned pertains to the physical and biocompatible properties of the materials used in the original design of the predicate device.

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The Lactosorb® Tap Free Screw is indicated for use in the following midface and 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, II) 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, II) 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 device is a screw having a non-threaded pin portion and a head portion. The Lactosorb® Tap Free Screw is designed with a slight helical groove that is cut into the major diameter. The head geometry, drive mechanism, major diameter, and tip geometry of the 1.5 x 4 mm Tap Free Screw is identical to that of the 1.5 x 4 mm Direct Drive Screw (K971870). The only difference between the two screws is the "thread" form.
Although the tap free screws are similar in design to the standard Lactosorb® direct drive screws (K971870), they function more like the Lactosorb® Push Screws (K002423). The push screws are designed with barbs that are pushed into a drilled hole that is slightly smaller than the diameter around the barbs. This press fit holds the push screw is place and provides adequate fixation. The tap-free screws are implanted by rotating the screws into a hole that is slightly smaller than the major diameter of the screws. The press fit between the implant and the hole provides the fixation.
Material: Lactosorb® (resorbable copolymer) - a polyester derivative of lactic and glycolic acids
Lactosorb® is made of 82% L-Lactide/18% Glycolide copolymer that degrades by hydrolysis into L-Lactic and glycolic acids. These hydrolytic products are then further degraded into carbon dioxide and water via the cellular Krebs cycle. Lactosorb® has been previously cleared by 510(k) notifications for use in bone plates (K992355, K992158, K971870, K960988, K955729) and bone screws (K002423, K981666, K960988) for cranial and maxillofacial use.
The modifications made to this device are not anticipated to significantly affect its safety and effectiveness.

The provided document is a 510(k) premarket notification for a medical device, the Lorenz Lactosorb® 1.5 mm x 4 mm Tap Free Screw. It details the device's indications for use, description, and the materials it's made from. It also includes the FDA's letter of substantial equivalence.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with predefined acceptance criteria. The document explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

Therefore, I cannot provide the requested information from the given text. A robust study proving the device meets acceptance criteria and detailed performance metrics are typically part of a Premarket Approval (PMA) application or a more extensive clinical trial, neither of which appears to be documented here.

If this were a typical AI/ML device approval, such information would be mandatory. However, for this type of mechanical medical device, the focus of a 510(k) is heavily on demonstrating similarity to already approved devices.

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