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The A.L.P.S Proximal Humerus Plating System is indicated for fixation of fractures and fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.

The A.L.P.S. Proximal Humeral Plating System is made from a titanium alloy and is available in configurations for both the left and right sides, as well as in various lengths. This system includes both locking and non-locking screws/pegs, along with multidirectional screws crafted from titanium alloy and cobalt chromium. It comes complete with general orthopedic instrumentation and system-specific instruments designed for use during implant installation.

Implants are available in both gamma-sterilized and non-sterile options. The disposable instruments are provided only in a sterile condition, while the reusable instruments are offered non-sterile, allowing users to perform steam sterilization before use.

This FDA 510(k) clearance letter is for a medical device called the "A.L.P.S. Proximal Humerus Plating System," which is a metallic bone fixation appliance. As such, it is not an AI/ML (Artificial Intelligence/Machine Learning) device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI device is not applicable to this submission.

The FDA clearance for this device is based on comparing its technological characteristics and intended use to a legally marketed predicate device (K143697 - Biomet Proximal Humerus Plating System) and demonstrating substantial equivalence through non-clinical mechanical testing, rather than an AI performance study.

Summary of available information relevant to device performance and clearance (not AI-related):

• Acceptance Criteria & Reported Performance: The document states that the subject device's performance was evaluated through non-clinical testing. These tests include:

  • Implant Construct Axial Load Static Testing (for plates)
  • Implant Construct Axial Load Fatigue Testing (for plates)
  • Screw and Peg Performance Testing
  • The conclusion is that "any differences do not raise any different questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices." Specific numerical acceptance criteria and reported performance values from these mechanical tests are not provided in this clearance letter.

• Study Type: Non-clinical (mechanical) testing, not a clinical or AI performance study.

• Sample Size (Test Set): Not applicable in the context of an AI device's test set. For mechanical testing, the number of implants/constructs tested would be used, but this is not specified.

• Data Provenance (Test Set): Not applicable for an AI device. The "data" here refers to the results from mechanical testing of the device components.

• Number of Experts & Qualifications (Ground Truth for Test Set): Not applicable, as no expert-derived ground truth for an AI model's output is relevant here.

• Adjudication Method (Test Set): Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not conducted, as this is not an AI-assisted device.

• Standalone Performance (Algorithm Only): Not applicable, as there is no algorithm.

• Type of Ground Truth Used: Not applicable in the AI sense. The "ground truth" for this device would be established engineering standards and physical measurements from the mechanical tests.

• Sample Size for Training Set: Not applicable, as there is no AI model.

• How Ground Truth for Training Set was Established: Not applicable.

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The Pantheon Proximal Femur Reconstruction (PFR) System is a modular system intended to be used for the reconstruction of the proximal femur in the case of severe proximal femoral bone loss in hip revision surgery (due to infection, fracture, failed THA) or in the case of a bone tumor.

The FIXA Ti-Por cup is intended for cementless use.

The Pantheon PFR System is manufactured of Ti6A14V (except for femoral heads which are made of CoCrMo or ceramic and acetabular inserts made of cross-linked UHMWPE) and includes various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The Pantheon PFR System consists of:

• Pantheon Proximal Bodies made of Ti6Al4V Alloy additively manufactured.
• CoCrMo Alloy Femoral Heads Taper 12/14
• Biolox Delta Ceramic Femoral Heads Taper 12/14
• Pantheon Shaft made of Ti6Al4V Alloy
• Pantheon Bridging Collars made of Ti6Al4V Alloy additively manufactured
• Pantheon Cylindrical Bridging Collars made of Ti6A14V Alloy additively manufactured
• Pantheon Salvage Stem (Cemented) made of Ti6Al4V Alloy
• Pantheon Salvage Stem (Uncemented) made of Ti6A14V alloy
• Pantheon Proximal Body Locking Screw made of Ti6A14V Alloy
• Pantheon Salvage Plate Compression Screws made of Ti6Al4V Alloy
• Pantheon Salvage Plate with Spikes made of Ti6A14V Alloy
• Fixa Ti-Por Cup Acetabular Shells made of Ti6Al4V Alloy additively manufactured.
• Titanium Acetabular Screws made of Ti6A14V Alloy.
• Acetabular Inserts Flat made of Cross-Linked PE.
• Acetabular Inserts 15° Lipped made of Cross-Linked PE.

I am sorry, but the provided text describes a medical device called "Pantheon Proximal Femur Reconstruction (PFR) System" and its regulatory approval (510(k) submission) by the FDA. It does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.

The document is a standard FDA 510(k) summary for a physical orthopedic implant. It details:

• The device name and manufacturer.
• Its intended use.
• The materials it's made from.
• Its components and sizes.
• The predicate devices it claims substantial equivalence to.
• The performance testing conducted on the physical device (e.g., fatigue testing, corrosion testing, ceramic head burst testing) against physical device standards, not AI/ML performance metrics.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth related to an AI/ML device, as this information is not present in the given text.

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The Proximal Humerus Fixtion System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The Skeletal Dynamics Proximal Humerus Fixation System is a set of medical-grade Titanium Alloy (Ti-6Al-4V ELI) bone plates and Titanium and Cobalt Chrome (CoCr) screws and pegs designed for the stabilization and repair of fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus in conjunction with general and specialized instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

This document is a 510(k) K242436 FDA clearance letter for the Skeletal Dynamics Proximal Humerus Fixation System. It primarily focuses on demonstrating substantial equivalence to existing devices through performance testing, rather than reporting on a study with acceptance criteria and device performance as typically seen for AI/ML-based devices. Therefore, a direct response to some of the requested categories (like number of experts, adjudication method, MRMC study, training set details) will not be available in this document.

Here's the information extracted from the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This device is a mechanical fixation system, not a software or AI/ML device that uses a "test set" of data in the common sense. The "testing" refers to mechanical performance testing of the hardware components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the context of expert consensus, is not relevant for the mechanical testing of this hardware device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for evaluating human or AI interpretations of medical images or data, not for the mechanical testing of orthopedic implants.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This document does not mention any MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a medical device (orthopedic implant), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this mechanical device is based on established engineering standards and measurements as defined by ASTM F382-17 for plates and ASTM F543-23 for screws. The comparison is made against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (orthopedic implant), not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a medical device (orthopedic implant), not an AI/ML algorithm that requires a training set.

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The indications for the I.T.S. Intramedullary Nailing System (INS) - Proximal Femur include intramedullary treatment of fractures and stabilization after tumor resection in the area of the proximal femur, as well as combinations that additionally affect the shaft area using the long nails.

The indications for use of the I.T.S. INS Proximal Femur include:

All Nails:

• · Stable and unstable pertrochanteric fractures
• · Intertrochanteric fractures
• · Combinations of fractures listed above

Additionally for Long Nails:

• Subtrochanteric fractures
• · Proximal fractures as listed above associated with shaft fractures
• · Pathological fractures in regions as listed above
• · Nonunions and malunions in regions as listed above

The I.T.S. INS Proximal Femur Nail consists of the following implants:

1. Nails:
   The Proximal Femur Nails are designed for the treatment of femoral fractures. The Femur Nails are available in distal diameters ranging from 9 to 14mm and lengths of 180mm (short nail), 240mm (intermediate nail), and 260 to 480mm in 20mm increments (long nail). 180mm and 240mm nails have a single, oblong hole distally, while all nails with a length over 260 have a round hole, an oblong hole and another round hole for distal fixation. The oblong hole allows for both static and dynamic locking configurations. All Trochanteric Nails are locked proximally with a Lag Screw. The set screw engages with the lag screw and allows translation while preventing rotation. Endcaps close the top of the nail and are available in 0mm, 5mm, 10mm, 15mm and 20mm lengths.

2. Lag Screw
   Lag screws are cannulated with a major diameter of 10.5mm and lengths ranging from 70mm to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

3. Set Screw
   There are two types of set screws available. Inferior short and standard with a diameter of 6.6mm. The Length of the inferior short version is 45mm and the standard lengths are 70 to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

4. Distal Cortical Locking Screw
   Distal locking screws are fully threaded, with a diameter of 5.0mm and lengths ranging from 25mm to 120mm in 5mm increments (2.5mm increments available from 25-70mm). Thev are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

5. Instrumentation
   I.T.S. INS Proximal Femoral Nail Instrumentation consists of implant-specific targeting devices which help facilitate insertion of the nails, lag screws, and distal locking screws. Targeting devices are manufactured from stainless steel and carbon fibre reinforced PEEK. Other instrumentation includes drills, drill guides, k-wires and screwdrivers.

All nails and screws are provided Sterile for single-use.

The provided text describes a 510(k) submission for the I.T.S. INS Proximal Femur Nail. This is a medical device for intramedullary fixation, and the FDA has determined it to be substantially equivalent to previously marketed predicate devices.

However, the text does not include information about AI/ML device performance, acceptance criteria normally associated with diagnostic algorithms (like sensitivity, specificity), or details about studies involving human readers or ground truth establishment relevant to AI. The nature of this submission is for a physical medical device (an intramedullary nail), not an AI-powered diagnostic tool.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the provided document.

Here's a breakdown of what can be extracted from the text, focusing on the mechanical evaluation of the physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format typically used for AI/ML performance (e.g., minimum sensitivity). Instead, the performance is evaluated against consensus standards and compared to predicate devices for substantial equivalence.

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

Not applicable. This is a physical medical device, and the testing involved mechanical performance, not a test set of data for an AI algorithm.

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

Not applicable. Ground truth establishment by experts is relevant to AI/ML diagnostic performance, not the mechanical testing of an intramedullary nail.

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

Not applicable. Adjudication methods are relevant to expert consensus for AI/ML ground truth, not mechanical device testing.

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 device is a physical implant, not an AI-assisted diagnostic tool.

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

Not applicable. There is no AI algorithm being evaluated.

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

For the mechanical testing, the "ground truth" or standard for comparison was defined by consensus standards (ASTM F543 & ASTM F1264) and the mechanical performance of predicate devices.

8. The sample size for the training set

Not applicable. There is no AI algorithm with a training set.

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

Not applicable. There is no AI algorithm with a training set or ground truth in this context.

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TAMINA 3.5mm Proximal Humerus System
The TAMINA, TAMINA Long and TAMINA-TF Proximal Humerus System is indicated for
· Dislocated two-, three-, and four fragment fractures of the proximal humerus including osteopenic bone

• · Pseudarthroses (non-unions) of the proximal humerus
• · Osteotomies of the proximal humerus

POYA 3.5mm Lateral Proximal Tibia System
The POYA 3.5mm Lateral Proximal Tibia System is internal fixation of fractures of the proximal tibia in adults and skeletally mature adolescents including:

• · simple fractures
• · comminuted fractures
• · lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures
• · depression fractures
• · periprosthetic fractures
• · nonunions, malunions, tibial osteotomies and osteopenic bone
• · fractures with associated shaft fractures

LORRAINE 3.5mm Distal Humerus System
The LORRAINE 3.5mm Distal Humerus System is indicated for intra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture.

Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surqical use. Non-clinical testing has demonstrated the devices are MR Conditional.

The provided text describes a 510(k) premarket notification for the Bonebridge Osteosynthesis Plating System, which includes TAMINA 3.5mm Proximal Humerus System, POYA 3.5MM Lateral Proximal Tibia System, and LORRAINE 3.5mm Distal Humerus System. The submission aims to establish substantial equivalence to previously cleared predicate devices.

However, the document does not describe a study involving an algorithm or artificial intelligence (AI). Instead, it focuses on the non-clinical testing performed to demonstrate the substantial equivalence of the Bonebridge Osteosynthesis Plating System (a medical device for bone fixation) to established predicate devices. The acceptance criteria and "device performance" described relate to the physical and material properties of the bone plates and screws, rather than the performance of a diagnostic or assistive AI system.

Therefore, many of the requested points, which are relevant to AI/algorithm studies (such as sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, and training set details), are not applicable to this document.

Here's the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/Algorithm specific questions:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document is not about an AI/algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is not about an AI/algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This document is not about an AI/algorithm.
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 document is not about an AI/algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. This document is not about an AI/algorithm.
8. The sample size for the training set: Not applicable. This document is not about an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable. This document is not about an AI/algorithm.

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The XIA® 4.5 Spinal System is interior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: • Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - · Spondylolisthesis - · Trauma (i.e. fracture of dislocation) - · Spinal Stenosis - · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudarthrosis - · Failed Previous Fusion The Stryker Spine DIAPASON® Spinal System, Opus® Spinal System, and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat petients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The subject devices consist of a variety of multiple component spinal fixation systems intended for use as an adjunct to fusion. These devices have been previously cleared by FDA. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.

The Stryker Spine Sierra Mertz family of spinal implant systems (referred to as "the subject devices" in the document) is seeking an MR Conditional labeling claim.

Here's an analysis of the acceptance criteria and study proving device conformance, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The document refers to "the subject devices" which is a family of 20 different spinal systems. It's implied that various components within these systems were subjected to testing.
• Data Provenance: The document does not specify the country of origin of the data. The study was a prospective test conducted to establish MR Conditional labeling for the devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is not applicable as the study involved physical testing for MR compatibility according to a standard (ASTM F2503), not human expert evaluation of medical images or data.

4. Adjudication Method for the Test Set

This is not applicable for this type of physical device testing. The results are based on adherence to the parameters set by the ASTM F2503 standard.

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 is not applicable. The submission is for spinal implants and their MR compatibility, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable, as the device is a physical spinal implant system, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the test was compliance with the ASTM F2503 standard for MR compatibility. This standard defines specific parameters and limits for evaluating the safety and performance of medical devices in an MRI environment, such as magnetic field interactions, RF-induced heating, and image artifact.

8. The Sample Size for the Training Set

This is not applicable. This is a medical device clearance for physical implants, not a machine learning or AI model that requires a training set.

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

This is not applicable. As stated in point 8, there is no training set for this type of device submission.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study performed was a MR Compatibility testing per ASTM F2503. The FDA document states: "The test results demonstrate that the subject devices performance met the prescribed acceptance criteria and are substantially equivalent to the predicate devices." This indicates that the physical and electrical properties of the spinal implant systems, when subjected to MRI conditions outlined in the ASTM F2503 standard, did not pose unacceptable risks (e.g., excessive heating, dangerous magnetic force, or significant image artifacts) and thus were deemed MR Conditional. The purpose of this testing was to establish the MR Conditional labeling claim for the devices.

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The Proxima is intended for prescription use only, to be used for adult patients that require supplemental oxygen in a hospital setting.

The Proxima Model-100 is an electronic oxygen conserving device designed for use in a hospital environment. It incorporates a sensitive pressure sensor to detect inhalation, an electronic valve to deliver precise volume of oxygen and a graphical touch screen interface. In pulsed mode the Proxima delivers flows equivalent to 1 to 15 liters per minute of continuous oxygen flow. The volume of each bolus is calculated such that the patient receives the equivalent of the set volume regardless of how slow their breath rate is. To make sure the patient receives oxygen, even if inhalation is not detected, the Proxima automatically changes from pulsed to continuous oxygen flow at the set flow rate if inhalation is not detected for 15 seconds. Proxima displays a warning message to indicate low battery, low oxygen supply pressure, dislodged cannula, lack of inhalation and low nasal airflow. The Proxima is powered using an external 9-volt DC power supply and includes an internal back-up battery. The Proxima is for use with a customer supplied, dual lumen demand nasal cannula, for example the Salter Labs 4807 or similar, to ensure proper patient usage.

The provided text is a U.S. FDA 510(k) summary for a medical device called "Proxima". It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence for regulatory clearance.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical or algorithmic performance study, as typically seen for AI/ML-enabled devices.

The "acceptance criteria" section you're asking for typically refers to the pre-defined performance thresholds (e.g., minimum accuracy, sensitivity, specificity, or clinically relevant metrics) that an AI/ML algorithm must meet on a test set to be considered acceptable. The "study that proves the device meets the acceptance criteria" would detail the methodology of that study, including test set characteristics, ground truth establishment, expert involvement, and the actual performance metrics achieved by the device.

The provided document focuses on bench testing for the Proxima device, which is an oxygen conserving device, not an AI/ML diagnostic or prognostic tool. The performance testing mentioned (ISO 80601-2-67) evaluates physical parameters like pulse volume, breath rate, oxygen delivery, continuous flow, leak compensation, and breath trigger pressure. These are engineering and functional performance tests for a hardware device, not a performance study for an AI/ML algorithm.

Therefore, based solely on the provided text, I cannot extract the information required to populate your requested table and answer questions 1-9 about AI/ML device performance studies. The document describes a traditional medical device clearance, not an AI/ML device.

If the "Proxima" device were an AI/ML product, the information would typically be found in sections detailing clinical performance studies, often in the "Performance Data" or "Clinical Data" sections of a 510(k) summary, which are absent or not relevant in this document for the type of device described.

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The Artemis Proximal Femoral Nail System is indicated for fixation of stable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.

Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch.

The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur. The system includes single-use, sterile implants (Proximal Femoral Nail Kit Short, Proximal Femoral Nail Kit Long, Locking Screw, Lag Screw, and optional anti-rotational locking pins) as well as non-sterile, reusable, Class I and II surgical instruments.

The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK).

The Artemis Nails are available in short or long lengths from 180mm to 440mm and are cylindrical rods with preassembled Set Screws. The Nail is designed with holes, at the proximal and distal sections, for the insertion of a Lag Screw and Locking Screw, respectively. The Lag Screw has a diameter of 11mm and is available in various lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm and is available in various lengths ranging from 25mm to 110mm. Optional Anti-rotational Locking Pins are also available to aid in rotational stability.

The provided document describes the FDA 510(k) clearance for the Artemis Proximal Femoral Nail System. This document is a regulatory submission for a medical device that does not involve AI/ML components for diagnostic purposes, and therefore, the acceptance criteria and study proving device performance are based on mechanical and physical properties rather than algorithmic performance on image data.

Therefore, I cannot provide information on the following points:

• 1. A table of acceptance criteria and the reported device performance (in terms of AI/ML metrics): The document reports mechanical testing results, not AI/ML performance metrics.
• 2. Sample size used for the test set and the data provenance: There is no "test set" in the context of AI/ML for this device. The testing refers to mechanical and physical properties.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant for this type of device submission.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

However, based on the provided text, I can infer the "acceptance criteria" and "study proving device meets acceptance criteria" in the context of a non-AI medical device submission:

Acceptance Criteria and Study for the Artemis Proximal Femoral Nail System:

The acceptance criteria for the Artemis Proximal Femoral Nail System are based on its mechanical performance and material characteristics, demonstrating that the device is substantially equivalent to a predicate device. This is a common pathway for Class II medical devices where performance can be validated through engineering and physical testing, rather than clinical studies or AI algorithm performance.

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical/Material Focus):

Study Proving the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is primarily non-clinical performance testing, specifically mechanical testing.

• Type of Study: Mechanical Testing
• Specific Tests Conducted:
  • ASTM F1264: Standard Specification for Extramedullary Splints and Bone Plates (likely referenced for general principles or associated components, though the primary device is intramedullary).
  • ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws.
  • ISO 7206-4: Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components. (This standard refers to hip prostheses, but its principles for static and dynamic bending of constructs are applied to the femoral nail system).
• Data Provenance: The nature of mechanical testing means the "data provenance" is derived from laboratory tests conducted on samples of the device itself. This is typically done in a controlled, prospective manner. Country of origin of the data is not specified but would be the location of the GLW Medical Innovation's testing facilities or contracted labs.
• Sample Size Used for the Test Set: While not explicitly stated for each test, mechanical testing typically involves a sufficient number of samples (e.g., typically 3-6 or more samples per test condition, depending on the standard and variability) to ensure statistical significance and reproducibility of results for the physical properties being evaluated.
• Ground Truth: For mechanical testing, the "ground truth" is defined by the acceptance criteria established within the referenced ASTM and ISO standards. The device 'passes' if its performance (e.g., strength, fatigue life) meets or exceeds the minimum requirements specified in these industry standards for similar devices. There are no human experts establishing ground truth in terms of diagnostic interpretation or clinical outcomes for this specific submission.
• Clinical Data: The submission explicitly states: "No clinical data was necessary." This reinforces that the substantial equivalence determination was based entirely on non-clinical performance data (mechanical testing and comparison to the predicate).

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