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The IlluminOss Photodynamic Bone Stabilization System is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, ulna, clavicle, pelvis, fibula, metacarpals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDAcleared fracture fixation systems to provide supplemental fixation in these anatomic sites. The IlluminOss System may be used in the femur and tibia to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system.

The IlluminOss Photodynamic Bone Stabilization System provides an important treatment option in the fixation and stabilization of fractures through a minimally invasive procedure. The system uses a catheter to deploy an inflatable, noncompliant, thin wall PET balloon into the medullary canal of the bone across the fracture site. The balloon is infused using a syringe with a photodynamic (light cured) monomer that causes the balloon to slowly expand and fill the intramedullary canal of the fractured bone. Activation of the light system allows for visible spectrum light to be delivered through a radially emitting light fiber that is temporarily positioned into a central lumen of the catheter that runs the length of the balloon. With this design, the liquid monomer within the balloon is exposed to light along the entire length of the balloon during the curing process. The system is currently indicated for use in the humerus, radius, ulna, clavicle, metacarpal, metatarsal, phalanges, ulna, fibula, and anterior ring of the pelvis. The purpose of this Special 510(k) is to expand the indications of the IlluminOss Photodynamic Bone Stabilization System (PBSS) to include use in the femur and tibia in conjunction with FDA-cleared fracture fixation systems.

The provided text describes the IlluminOss Photodynamic Bone Stabilization System (PBSS) and its expanded indications for use. However, it does not contain the specific details about acceptance criteria, a comparative study with a test set, ground truth establishment, or human reader performance that would typically be found in a detailed study report.

Based on the information provided in the 510(k) summary:

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

   Acceptance Criteria	Reported Device Performance
   Improves pull-out strength	Device demonstrated statistically significantly higher screw pull-out loads compared to when the IlluminOss device is not used.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
   The document does not specify the sample size for the test set or data provenance (country of origin, retrospective/prospective). It generally refers to "samples" being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   This information is not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   This information is not provided in the document.

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 was not conducted, as this device is a physical medical device (bone stabilization system), not an AI algorithm for diagnostic imaging.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
   This question is not applicable as the device is a physical bone stabilization system, not an algorithm. However, performance testing of the device itself (standalone) was conducted, focusing on its mechanical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   The "ground truth" in this context is likely derived from mechanical testing data (e.g., direct measurements of pull-out strength in a laboratory setting) rather than clinical expert consensus or pathology, as the study focuses on the device's mechanical performance in supplemental fixation.

8. The sample size for the training set
   This information is not provided. It's important to note that for a physical device undergoing mechanical testing, the concept of a "training set" as understood in machine learning is generally not applicable. Instead, there would be samples used for initial design verification and validation testing.

9. How the ground truth for the training set was established
   Not applicable, as a "training set" in the machine learning sense is not relevant here. For the mechanical testing performed, the "ground truth" (i.e., the actual pull-out strength for a given construct) would have been established through direct experimental measurement in a controlled laboratory environment.

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The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.

The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant. The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.

The Synthes 4.5mm VA-LCP Curved Condylar Plate System consists of anatomically-contoured, stainless steel and titanium plates and screws featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur and system-specific instrumentation. The current 510(k) introduces OPTILINK™ Technology stainless steel screws, positioning pins for cerclage cable, and system-specific instrumentation as a line extension to the currently cleared Synthes 4.5mm VA-LCP Curved Condylar Plate System.

The provided text is a 510(k) summary for the "Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins". This document is a premarket notification for a medical device seeking substantial equivalence to existing devices. It focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the way one might for a novel AI device or a device requiring a PMA.

Therefore, the information typically requested in your prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of regulatory submission. This submission primarily relies on non-clinical performance data and material characterization to demonstrate substantial equivalence to predicate devices, and explicitly states that "Clinical data was not needed to demonstrate the safety and effectiveness of the proposed devices."

Since this is a Class II device and a line extension, the focus is on mechanical and material testing to ensure it performs comparably to the predicate.

Here's an attempt to answer your questions based only on the information available in the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" in this context:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not provided. The document refers to "testing" and "evaluations" but does not specify the number of samples or specimens used in these mechanical or material tests.
• Data Provenance: Not specified, but generally refers to laboratory testing. Not applicable for retrospective/prospective human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. Ground truth as typically understood for AI/clinical studies (e.g., expert consensus on image interpretation) is not relevant for mechanical and material testing of an orthopedic implant. Performance is evaluated against engineering standards and specifications.

4. Adjudication method for the test set

• Not applicable. Performance is measured against predetermined test specifications and standards for mechanical and material properties. There is no "adjudication" in the clinical sense.

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 is not an AI device or an imaging device requiring human-in-the-loop performance evaluation.

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)

• The "ground truth" equivalent in this context would be the established engineering standards and material specifications (e.g., ASTM standards, specified endotoxin limits) that the device must meet, and the performance characteristics of the predicate device for comparison.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable. This is not a machine learning or AI device.

Summary based on the document:

The device (Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins) demonstrates its performance and safety through non-clinical testing, material characterization, and comparison to a legally marketed predicate device (Synthes 4.5mm VA LCP Curved Condylar Plate System (K110354)) to establish "substantial equivalence." The evaluations included various mechanical tests (Dynamic Fatigue, Connection Strength, Torque, Torsional Properties, Insertion/Removal Torque, Pull-out Strength) and material tests including endotoxin and corrosion assessments. All performed tests indicated that the device met the required specifications and demonstrated substantial equivalence to the predicate device. No clinical data or human reader studies were deemed necessary for this 510(k) submission.

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