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Internal Locking Plate and Screw Fixation System is intended for temporary fixation, correction or bones in various anatomical regions.
3.5mm LCP Clavicle Plate is indicated for fixation of fractures, malunions, and osteotomies of the clavice.
LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
3.5mm LCP Distal Humerus plate is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
2.4 mm LCP Volar Distal Radius Plate is indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
5.0 LCP Distal Femur Plate is indicated for buttressing multifragmentary distal femur fractures including; supracondylar, intra-articular and extra-aticular condylar, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur.
3.5mm LCP Medial Proximal Tibia Plate is indicated to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft.
3.5mm LCP Anterolateral Distal Tibia Plate is indicated for fractures, and non-unions of the distal tibia, especially in osteopenic bone.
2.7mm/3.5mm LCP Distal Fibula Plate is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
2.0mm LCP condylar Plate is indicated for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
The 3.5mm Round Hole Reconstruction Locking Plates is indicated for fixation of fractures, osteotomies and non-unions of the pelvis, particularly in osteopenic bone for adult patients.

Internal Locking Plate and Screw Fixation System consists of plates in various designs and size. Plates are provided in straight designs and various geometric configurations that are commonly used in traumatic and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws. They are named according to both anatomical positions and biomechanical functions of the plates. The Internal Locking Bone Plate and Screw Fixation System is divided into four types: large, small, mini, and reconstruction. The length of the plate varies from 45 to 316mm, and hole number from 3 to 22 holes.
Geasure Internal Locking Bone Screw System is used either to fasten plates or similar devices onto bones or to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. There are two styles: locking screw, cortex or cancellous screw. The screw recess is hexagon or star shaped to allow screw removal and insertion. The thread diameter of screw varies from 2.0 to 6.5mm, total length from 6 to 120mm.
Internal Locking Plate and Screw Fixation System is a construct in which the screws are locked in the plate. The heads of the locking screws contain male threads while the holes in the plates contain female thread, this allows the screw head to be threaded into the plate. Various plate designs are available depending on specific anatomic locations, these may be larger or smaller, thicker or thinner as appropriate to various anatomic sites and the loads to which they will be subjected. The holes in the plate are designed for locking screws, or locking and non-locking screws combination to facilitate dynamic compression. By combining locking screw holes with compression screw slots in the shaft, the plate can be used as both a locking device and a fracture compression device. Internal Locking plate and screw Fixation systems do not disrupt the underlying cortical bone perfusion as much as conventional plates, which compress the plate to the cortical bone.

This document primarily focuses on the K232394 Internal Locking Plate and Screw Fixation System, a medical device for bone fixation, and its substantial equivalence to predicate devices, as reviewed by the FDA. It outlines the regulatory classification, intended use, and technical characteristics.

Crucially, this document is a 510(k) Premarket Notification and does NOT contain information about an AI/ML-based device or a clinical study proving performance against specific acceptance criteria for such a device.

Therefore, I cannot fulfill your request for descriptions of:

1. A table of acceptance criteria and the reported device performance: This document refers to bench tests for mechanical properties (e.g., bend testing, torsional properties, pullout strength) and reprocessing and sterilization validation, which are standard for implantable devices. There are no acceptance criteria or performance metrics related to an AI/ML algorithm or its diagnostic/clinical performance.
2. Sample sizes used for the test set and data provenance: No test sets in the context of AI/ML are mentioned. The "tests" performed are mechanical and reprocessing validations.
3. Number of experts used to establish ground truth & qualifications: Not applicable as there's no diagnostic AI/ML component.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. The document explicitly states "No clinical study data is submitted in this 510(k)."
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

What the document does provide is information critical for a mechanical implant device:

• Device Name: Internal Locking Plate and Screw Fixation System
• Intended Use: Temporary fixation, correction, or stabilization of bones in various anatomical regions, with specific indications for different plates (e.g., clavicle, humerus, radius, femur, tibia, fibula, small bones, pelvis).
• Regulatory Class: Class II
• Product Codes: HRS (Plate Fixation, Bone), HWC (Screw, Fixation, Bone)
• Materials: Titanium alloy (Ti-6Al-4V) ELI
• Sterilization: Provided non-sterile; manual cleaning and steam sterilization instructions are provided for the end-user.
• Non-clinical tests performed (bench tests):
  • Single Cycle Bend Testing for bone plate (per ASTM F382-17)
  • Fatigue Property Testing for bone plate (per ASTM F382-17)
  • Torsional Properties Test for screws (per ASTM F543-17)
  • Driving Torque Test for screws (per ASTM F543-17)
  • Axial Pullout Strength Test for screws (per ASTM F543-17)
  • Self-Tapping Performance Test for screws (per ASTM F543-17)
  • Reprocessing and sterilization validation (following FDA guidance, AAMI TIRs, and ISO standards)
• Premarket Submission Type: 510(k) Premarket Notification – this means the device is seeking clearance based on substantial equivalence to predicate devices, not approval based on extensive clinical trials for a novel technology like AI.
• Lack of Clinical Data: The document explicitly states, "No clinical study data is submitted in this 510(k)." and "No animal study data is submitted in this 510(k)."

In summary, the provided text describes a conventional orthopedic implant, not an AI/ML diagnostic device, and therefore does not contain the information required to answer your specific questions related to AI acceptance criteria and study methodologies.

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SGM Femoral Nail System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, and combinations thereof. The long SGM Femoral Nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.

An intramedullary fixation nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. SGM Femoral Nail System consists of a series of metal rods, proximal helical blades, bone locking bolts and end caps. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations. The implantable devices are manufactured from titanium alloy and are provided non-sterile.

The provided document is a 510(k) summary for the SGM Femoral Nail System, a medical device for femoral fracture fixation. It is not a document about an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies, cannot be found in this document.

The document details the substantial equivalence of the SGM Femoral Nail System to a predicate device (Synthes (USA) Trochanteric Fixation Nail (TFN) System) based on similar intended use and technological characteristics. The performance data provided is related to bench testing for mechanical properties of the physical device, reprocessing, and sterilization, not AI/ML algorithm performance.

Here's what can be extracted from the provided text about the device's assessment:

Device: SGM Femoral Nail System (Intramedullary fixation rod)

Regulatory Class: Class II

Acceptance Criteria and Device Performance (Based on provided document):

The acceptance criteria for this medical device, being a mechanical implant, are related to its physical and mechanical properties, as well as its ability to be reprocessed (cleaned and sterilized). The document states that the non-clinical data demonstrates the SGM Femoral Nail System is substantially equivalent to the predicate device. This implies the device's performance met the standards of the predicate and relevant ASTM standards.

Since the device is a physical implant and not an AI/ML algorithm, the following points of your prompt are not applicable to the submitted 510(k) summary for K230456:

• Sample size used for the test set and the data provenance: Not an AI/ML test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no diagnostic ground truth to establish for AI/ML.
• Adjudication method for the test set: Not applicable for a physical device.
• 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 is for AI-assisted human performance, not applicable.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a physical implant's mechanical properties.
• The sample size for the training set: Not applicable; there is no AI/ML training set.
• How the ground truth for the training set was established: Not applicable.

In summary, this document is for a traditional medical device (femoral nail system) and its clearance is based on substantial equivalence to a predicate device through non-clinical (bench) testing, not on AI/ML performance studies.

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The PEEK Spinal Fusion Cage is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.These implants are to be used with autogenous bone graft.
The PEEK Spinal Fusion Cage may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an transforaminal approach.
These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The PEEK Spinal Fusion Cage consists of INVIBIO PEEK-OPTIMA LTI lumbar cages of various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.The cages contain radiographic tantalum markers used for both intra and post-operative positioning and visualization. The implants are single-use and non-sterile provided.

The provided document is a 510(k) premarket notification for a medical device called the "PEEK Spinal Fusion Cage." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving that the device meets specific performance criteria through a study involving AI or human readers evaluating imaging.

Therefore, many of the requested elements for describing AI/human reader performance studies (such as acceptance criteria for AI, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and training set details) are not applicable to this type of submission.

The document discusses bench performance testing to show the device's physical and mechanical properties are comparable to the predicate device.

Here's a breakdown of the relevant information provided, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present acceptance criteria and performance in a direct "table" format as one would for an AI model's diagnostic accuracy. Instead, it states that various standard tests were "utilized to complete bench performance testing" and that the non-clinical data demonstrates substantial equivalence to the predicate device. The underlying assumption is that the device performed comparably or better than the predicate in these tests.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable. This is not an AI/diagnostic study with a test set of images/patient data. It involves physical and chemical tests of the device itself.
• Data Provenance: Not applicable. The "data" refers to the results of bench testing of the physical medical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not applicable. Ground truth for a physical medical device (like a spinal fusion cage) is established through standardized engineering and biocompatibility testing, not expert review of images.
• Qualifications of Experts: Not applicable. While engineers and scientists with relevant expertise conducted the tests, this is not a study requiring medical expert consensus on diagnostic images.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No, an MRMC study was not done. This device is a physical implant, not a diagnostic AI tool that assists human readers.
• Effect Size of Human Readers Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used:

• Ground Truth Type: For this device, "ground truth" is established by adherence to recognized national and international standards for material properties, biocompatibility, and mechanical performance (e.g., ASTM F2077, ASTM F2267, ISO 10993 series, ISO 13782, ASTM F2026). The performance is compared to the predicate device.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is not an AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth for Training Set: Not applicable.

Summary of Relevant Information from the Document:

• Device Name: PEEK Spinal Fusion Cage
• Intended Use: Interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1 (with or without Grade 1 Spondylolisthesis/retrolisthesis).
• Predicate Device: CAPSTONE® Spinal System (K073291) manufactured by Medtronic Sofamor Danek USA, Inc.
• Studies Conducted (Non-Clinical):
  • Material Characterization Testing: Utilizing ISO 13782:2019 and ASTM F2026-17.
  • Biocompatibility Testing: Utilizing various ISO 10993 standards (Parts 1, 3, 5, 6, 10, 11, 12, 13, 18).
  • Bench Performance Testing: Utilizing ASTM F2077-18 (Test Methods for Intervertebral Body Fusion Devices) and ASTM F2267-04 (Reapproved 2018) (Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression). These tests included static and dynamic compression, static and dynamic compression-shear, and subsidence tests.
• Clinical/Animal Studies: No animal or clinical study data was submitted for this 510(k).
• Conclusion: The non-clinical data demonstrates that the PEEK Spinal Fusion Cage is substantially equivalent to the predicate device, with minor differences (device sterilization method, bench performance tests) that do not raise new questions of safety and effectiveness.

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Spinal Inner Fixation System is intended for posterior, non-cervical, pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft.

The Spinal Inner Fixation System is a medical device system for surgical fixation of the spine. It is made up of pedicle screws, set screw, rods and cross connecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implants are single-use. The surgical instruments may be reprocessed and re-used. The Spinal Inner Fixation System includes model GB1Z-I and GB1Z-II according to the rod diameter, and each model comprises of different length rods, various length and diameter screws, set screws and accessories. Both models are designed for internal posterior thoracolumbar fixation of the spine. Patient diagnosis and individual conditions should be taken into consideration when selecting the surgical option. Surgical instruments are provided with the device system.

I am sorry, but the provided text from the FDA 510(k) K222031 does not contain information about acceptance criteria or a study that proves a device meets such criteria in terms of AI/algorithm performance.

The document discusses a "Spinal Inner Fixation System," which is a medical device for surgical fixation of the spine, made up of mechanical components like pedicle screws, rods, and connectors.
The "Performance - Bench" section mentions bench performance testing completed according to ASTM F1717-18 standards, including static compression bending, dynamic compression bending, and static torsion. This information pertains to the mechanical properties of the physical device, not the performance of an AI or algorithmic medical device.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample sizes for test sets or data provenance for an AI/algorithm.
3. Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
4. Adjudication methods for an AI/algorithm test set.
5. MRMC comparative effectiveness studies or effect sizes for human readers with and without AI assistance.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for an AI algorithm.
8. Sample size for a training set for an AI algorithm.
9. How ground truth for a training set was established for an AI algorithm.

The K222031 document is a 510(k) summary for a mechanical orthopedic implant, not an AI-powered medical device.

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