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The Skeletal Dynamics Geminus Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius

The Skeletal Dynamics Geminus Volar Distal Radius Plate System contains bone plates for the repair of distal volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. Also included are a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.

The Geminus Volar Distal Radius Plates are available in various sizes and are made of medical grade titanium alloy. Cortical screws affix the plate to the diaphysis and fixed angle pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility.

The Geminus Volar Distal Radius Plate System is comprised of:

• Titanium alloy plates, washers and screws
• CoCr Cannulated Polyaxial Locking Screw (PLS)
• Stainless steel K-wires (for provisional fixation; not for implantation)
• System specific instrumentation

The provided text describes the regulatory clearance of a medical device, the "Geminus Volar Distal Radius Plate System," through a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo clinical studies to prove safety and efficacy against predefined acceptance criteria.

Therefore, the document does not contain information about:

• Acceptance criteria and reported device performance in the context of a clinical study.
• Sample size used for a test set, data provenance, or the number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI assistance (as this is not an AI/software device).
• Standalone (algorithm only) performance.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a training set or how ground truth for a training set was established.

Instead, the performance testing for this device focused on demonstrating equivalence to the predicate device through engineering analysis and testing.

Key information from the text regarding performance:

• Performance Testing: "Engineering analysis and testing demonstrated that the Geminus Volar Distal Radius Plate System is substantially equivalent to predicate devices currently marketed. Therefore, the subject device is as safe and effective as legally marketed predicate devices."
• Technological Characteristics: "The substantial equivalence of the Geminus Volar Distal Radius Plate System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness."

In summary, the provided text describes a 510(k) clearance based on substantial equivalence, not a study evaluating a device against specific clinical acceptance criteria. The "performance testing" mentioned refers to non-clinical engineering and bench testing to show that the new device performs similarly to predicate devices.

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The Stablyx CMC Arthroplasty Implant System is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis or post fracture deformation or bone loss which present as either painful, unstable thumb or a thumb with limited range of motion. The implant is intended for uncemented, press fit use.

The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) ioint. The single piece prosthesis has a highly polished. saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal. The saddle surface of the Stablyx CMC prosthesis articulates aqainst the saddle surface of the trapezium, allowing for flexion-extension, abduction-adduction and opposition motions. The prosthesis is available in fixe sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile. The Stablyx CMC Arthroplasty System is comprised of: Multiple sized hemi joint prosthesis System specific instrumentation

The provided text is a Fragment of a 510(k) Pre-market Notification for a medical device called the "Stablyx CMC Arthroplasty Implant System". This document is primarily focused on demonstrating substantial equivalence to a predicate device, as required by the FDA.

Based on the information provided, it is not possible to answer the detailed questions regarding acceptance criteria and a study proving the device meets those criteria. The document states:

1. "Engineering analysis and testing demonstrated that the Stablyx CMC Arthroplasty System is substantially equivalent to the predicate device currently marketed."
2. "Characterization testing, including gravimetric testing and analysis established equivalency."
3. "Therefore, the subject device is as safe and effective as legally marketed predicate devices."

This indicates that comparisons were made to a predicate device (Stablyx CMC Arthroplasty Implant System (K111068)) to establish substantial equivalence. However, the document does not provide:

• A table of acceptance criteria with reported device performance.
• Details about a sample size used for a test set or data provenance in a clinical study.
• Information about experts establishing ground truth.
• An adjudication method.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• Details of a standalone performance study.
• The type of ground truth used.
• Sample size for a training set or how its ground truth was established, as these are typically associated with machine learning or AI device development, which is not indicated here.

The "Performance Testing" section vaguely refers to "Engineering analysis and testing" and "Characterization testing, including gravimetric testing and analysis" to establish equivalency. This likely refers to bench testing (e.g., mechanical properties, wear resistance, dimensional analysis) to ensure the new device performs similarly to the predicate device and meets relevant performance standards for orthopedic implants.

In summary, the provided FDA 510(k) document is a regulatory submission focused on substantial equivalence based on engineering and characterization testing, not on clinical study data with acceptance criteria as typically defined for performance studies of AI/ML-driven devices or devices requiring extensive human reader involvement.

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The Align Radial Head System and accessories are designed specifically for
· Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

• o Joint destruction and/or subluxation,
• o Resistance to conservative treatment.
• · Primary replacement after fracture of the radial head.
• · Symptomatic sequelae after radial head resection.
• · Revision following failed radial head arthroplasty.

The system is intended for press fit use.

The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit. Combined with its unique instrumentation, the Align Radial Head System offer the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved.

The Align Radial Head System is comprised of:

• · Multiple sized CoCr Radial Heads with Locking Screw
• Multiple sized titanium alloy Stems, titanium plasma spray coated
• · System specific instrumentation.

This document is a 510(k) premarket notification for the "Align Radial Head System," a medical device. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device meets specific acceptance criteria with quantifiable metrics. Therefore, many of the requested categories for device performance studies cannot be directly extracted or are not applicable.

Here's an attempt to answer based on the provided text, highlighting where information is unavailable or not directly relevant to the request as phrased for AI/software-centric device studies:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Preclinical analysis and testing demonstrated that the Align Radial Head System is substantially equivalent to the predicate device currently marketed. Mechanical and characterization testing which established equivalency included static, shear and abrasion testing." However, specific quantitative acceptance criteria (e.g., "shear strength must be > X MPa") and the exact numerical results are not provided.

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

This information is not provided in the document. The testing mentioned (mechanical and characterization) would involve physical samples of the device, not a "test set" of data in the context of an AI/software study. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of device testing described.

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

This information is not applicable/provided. The ground truth for this device (an implantable prosthesis) would be established through engineering specifications, material science, and pre-clinical mechanical testing, not by expert consensus on a test set in the way AI/software studies use "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for human review of data or images to establish ground truth, which is not the type of testing described for this physical medical device.

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. This document describes an orthopedic implant, not an AI or software device that assists human readers.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established through engineering specifications, material properties, and physical mechanical testing results (static, shear, and abrasion tests) designed to confirm the device's functional integrity and safety. It's not expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI devices.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable/provided. As above, this device does not use a "training set" in the computational sense.

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The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.

The Skeletal Dynamics Distal Elbow Plating System is comprised of:

• Titanium alloy plates and screws in various configurations
• Cobalt chrome polyaxial screws
• Stainless steel K-wires (for provisional fixation not for implantation)
• System specific instrumentation

The current Skeletal Dynamics Distal Elbow Plating System (K140892) includes the radial head and proximal ulna plates. Plates in double hockey stick, Y and coronoid shape configurations with the same node and inter-node features as the radial head plate are being added for use in the proximal radius and ulna in this submission. All plates are made of medical grade titanium alloy. The radial head, proximal ulna and coronoid plates are offered in left and right applications, the proximal ulna plate is provided in various lengths, and the double hockey stick and Y plates are in single size and have bilateral application. Additional screws length as well as new threaded pegs, washers, polyaxial locking screws, and instruments have been added in the subject system in this submission. The system is provided non-sterile and is sterilized in the user facility.

This document is a 510(k) premarket notification for a medical device called the "Skeletal Dynamics Distal Elbow Plating System." It is not about an AI/ML medical device. Therefore, the information requested about acceptance criteria and study design for an AI/ML device, such as sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment, cannot be found in this document.

The document describes a traditional orthopaedic medical device (bone plates and screws) and demonstrates its substantial equivalence to previously cleared predicate devices through engineering analysis and preclinical mechanical testing, adhering to ASTM standards. There is no mention of algorithms, artificial intelligence, or machine learning.

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The Internal Joint Stabilizer – Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

The Skeletal Dynamics Internal Joint Stabilizer – Elbow is an internal elbow fixator, with three principal components:

• A Base Plate assembly consisting of a low profile Base Plate, contoured to fit within . the flat surface of ulna at the olecranon process; a Connecting Rod, a Boom and two Locking Joints designed to bridge over the anconeous muscle. The Connecting Rod and Boom are adjustable by means of the Locking Joints to accommodate different patient anatomies. The Base Plate assembly is made of titanium alloy and cobalt chrome.
• A cobalt chrome Axis Pin threads through the Boom of the Base Plate assembly and ● is inserted in the axis of rotation of the humerus, and
• . Titanium compression screws to attach the Base Plate Assembly to the ulna.
  Specialized instrumentation includes Axis Trajectory Guides (available in 3 sizes), K- Wire Guide, K-Wires, Depth Gauges, Drills, a Counter-torque tool, and a T-10 driver and quick connect handle.
  The Internal Joint Stabilizer - Elbow is intended to be removed once the elbow ligaments have healed, usually within 6 - 8 weeks after implantation.
  The system is provided non-sterile and is sterilized in the user facility.

The provided document describes the FDA 510(k) premarket notification for the "Internal Joint Stabilizer - Elbow" device. The acceptance criteria and the study proving the device meets them are detailed under "Performance Data" and "Clinical Study" sections.

Here’s a breakdown of the requested information based on the provided text:

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

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

• Test Set (Clinical Study):
  • Sample Size: 26 subjects enrolled (26 consented and screened). 24 subjects completed the study.
  • Data Provenance: Prospective, multi-center, non-randomized, cohort study conducted at 6 sites in the US.
• Comparator Data (for outcomes comparison):
  • Sample Size: Not explicitly stated for the retrospective cohort, but referred to as "a retrospective cohort of subjects who underwent external hinged fixation."
  • Data Provenance: Retrospective data from a major metropolitan hospital in the US.

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)

The document does not explicitly mention "experts" establishing ground truth in the context of radiologists or specific medical professionals rating images. Instead, the "ground truth" for the clinical study's efficacy was based on:

• Broberg Morrey Functional Rating: This is a standardized outcome measure for elbow function, typically assessed by clinicians as part of patient follow-up.
• Recurrent Dislocation: An objective clinical event, which would be determined by treating physicians.
• Device-related Adverse Events: Reported by treating physicians and/or study investigators.

The qualifications of the individuals who assessed these outcomes (e.g., the clinicians using the Broberg Morrey score or reporting adverse events) are not specified beyond their role in conducting a clinical study at "6 sites in the US."

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

The document does not describe any specific adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes or adverse events in the clinical study.

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

No, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" was not conducted. This study is for an internal joint stabilizer device, not an AI-powered diagnostic tool. The comparison was between the device's clinical outcomes and those of a predicate external hinged fixator.

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

Not applicable. This is a medical device, an internal joint stabilizer, not a software algorithm.

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

The ground truth for the clinical study was based on clinical outcomes data (Broberg Morrey Functional Rating, incidence of recurrent dislocation) and safety data (device-related adverse events).

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning algorithm that requires a "training set." The study evaluated the device performance in human subjects, which serves as the "test set" for its clinical effectiveness and safety.

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

Not applicable, as there is no "training set" in the context of an AI/algorithm.

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The Skeletal Dynamics Dorsal Spanning Plate is intended for fixation of fractures involving the distal radius and for wrist arthrodesis.

The Skeletal Dynamics Dorsal Spanning Plate consists of a bone plate designed for fracture fixation of the distal radius and wrist arthrodesis. Included in the system are titanium bone screws, k-wires, and specialized instrumentation. The system is provided non-sterile and is sterilized in the user facility. The Skeletal Dynamics Dorsal Spanning Plate is comprised of: Titanium alloy plate and screws; Stainless steel K-wires (for provisional fixation not for implantation); System specific instrumentation.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets those criteria. The document is a 510(k) premarket notification for a medical device (Dorsal Spanning Plate) and primarily focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the text mentions:

• Performance Testing: "Mechanical testing which established equivalency included static and dynamic testing." This indicates testing was performed but does not provide specific acceptance criteria or detailed results.
• Conclusion: "The Skeletal Dynamics Dorsal Spanning Plate is substantially equivalent to the predicate device identified in this premarket notification." This is the overall conclusion of the 510(k) submission, based on the comparison to the predicate.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts, ground truth establishment, or adjudication methods.
4. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
5. Details on training set sample size or ground truth establishment for a training set.

Therefore, I cannot extract the requested information from the provided text.

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The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include: Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titanium screws and specialized instrumentation. The screws are available in 11 length configurations between 10mm - 30mm, with increments of 2mm. The system is provided non-sterile and is sterilized in the user facility.

This document describes the Skeletal Dynamics Headless Compression Screw System, a device for bone fixation. However, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.

Instead, the document is a 510(k) premarket notification to the FDA for a medical device. The "performance testing" mentioned refers to mechanical testing of the hardware itself (compression and ASTM F543 testing), not the performance of an AI/ML algorithm or system.

Therefore, I cannot provide the requested information for an AI/ML device. The document explicitly states:

• "Compression testing and ASTM F543 testing were performed to demonstrate conformance to the requirements."
• "The substantial equivalence of the Skeletal Dynamics Headless Compression Screw System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness."

This indicates a traditional medical device submission based on substantial equivalence for physical properties and intended use, not an AI/ML diagnostic or assistive device.

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The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.

The Skeletal Dynamics Distal Elbow System consists of various bone plates designed for fracture fixation, fusions, osteotomies and non-unions of the radius and ulna. Included in the system are titanium bone screws and pegs, cobalt chrome cannulated polyaxial screws, k-wires, and specialized instrumentation.

The Radial Head and the Proximal Ulna plates are made of medical grade titanium alloy. They are offered in left and right applications. The Proximal Ulna plate is provided in various lengths. The system is provided non-sterile and is sterilized in the user facility.

The Skeletal Dynamics Fragment Plate System is comprised of:

• · Titanium alloy plates and screws
• Cobalt chrome polyaxial screws
• · Stainless steel K-wires (for provisional fixation not for implantation)
• · System specific instrumentation.

This document is a 510(k) premarket notification for the "Skeletal Dynamics Distal Elbow Plating System." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on performance testing. However, it does not contain the level of detail requested for acceptance criteria and a study proving those criteria are met for an AI-powered diagnostic device.

Here's why and what information is missing:

• This document describes a medical device (bone plating system), not an AI diagnostic device. The questions regarding ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and data provenance are highly specific to AI/ML diagnostic tools. These concepts are not applicable to the mechanical bone plating system described here.
• The "Performance Testing" section states mechanical testing was performed, including static and dynamic testing on plates, and pullout strength and torque testing on screws. This is typical for orthopedic implants to demonstrate structural integrity and mechanical equivalence.
• The "Acceptance Criteria" for this type of device would generally involve meeting certain mechanical performance thresholds (e.g., strength, fatigue life, screw retention) set by recognized standards (like ASTM or ISO) relevant to orthopedic implants. These specific criteria and the detailed results showing compliance are summarized but not explicitly listed in this FDA letter, which instead focuses on the determination of substantial equivalence.

Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text because it pertains to a different type of medical device (a mechanical implant) than what your questions are designed for (an AI diagnostic tool).

If this document were about an AI diagnostic device, the necessary information would typically include sections detailing clinical study design, endpoints, statistical analysis, and comparisons to human performance or ground truth.

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The Skeletal Dynamics Protean Fragment Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis, particularly in osteopenic bone.

The Skeletal Dynamics Protean Fragment Plate System is a set of titanium bone plates designed for stabilization and repair of small bone fragments. Included in the set are titanium bone screws, fixation pegs, cobalt chrome cannulated polyaxial screws, and specialized instrumentation. The Fragment Plates are available in 3 configurations and are made of medical grade titanium alloy. The system is provided non-sterilized in the user facility. The Skeletal Dynamics Protean Fragment Plate System is comprised of: Titanium alloy plates and screws, Cobalt chrome polyaxial screws, Stainless steel K-wires (for provisional fixation not for implantation), System specific instrumentation.

The provided text describes a 510(k) premarket notification for a medical device called the "Skeletal Dynamics Protean Fragment Plate System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies with detailed acceptance criteria as one might find for new drug applications or high-risk medical devices requiring PMA.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The primary "study" is a preclinical mechanical testing study to show equivalence, not a clinical trial evaluating human performance or AI capabilities.

Here’s a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. For mechanical testing of medical devices, "samples" typically refer to the number of devices or components subjected to a particular test. The document only states "Preclinical analysis and testing."
• Data Provenance: Not applicable in the context of clinical data. This refers to in-vitro mechanical testing conducted by the manufacturer.

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

• Not Applicable. This is a mechanical device evaluation, not a clinical study involving expert interpretation of data or images. "Ground truth" would relate to precisely measured mechanical properties or failure points, not expert consensus on diagnoses.

4. Adjudication method for the test set

• Not Applicable. There is no adjudication method described because there's no clinical data or expert interpretation involved in determining a "ground truth" through consensus.

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 bone plate system, not an AI or imaging diagnostic tool. No MRMC study was conducted.

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

• Not Applicable. This is a hardware medical device, not an algorithm or AI.

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

• For mechanical testing, the "ground truth" would be established by the physical testing parameters and measurements (e.g., force applied, displacement, cycles to failure, yield strength) as per recognized engineering standards (e.g., ASTM, ISO). The document does not specify which standards were followed, but these would define how performance is "measured."

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not an AI system that requires a "training set" of data.

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

• Not Applicable. No training set exists for this type of device submission.

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The Skeletal Dynamics GEMINUS Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.

The Geminus Volar Distal Radius Plate System contains bone plates for the repair of distal volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. Also included are a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.

The Geminus Volar Distal Radius Plate is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis, fixed angle pegs are used for distal bone fragments. The titanium Hook Plate Extension locks to the plate by a means of titanium screw. The system is provided non-sterile and is sterilized in the user facility.

The Geminus Volar Distal Radius Plate System is comprised of:

• · Titanium alloy plates, washers and screws
• · Cannulated cobalt chrome polyaxial locking screws
• · Titanium alloy hook plate extension
• · Stainless steel k-wires (for provisional fixation not for implantation)
• · System specific instrumentation.

The provided text describes a medical device, the Skeletal Dynamics GEMINUS Volar Distal Radius Plate System, and its clearance through the 510(k) pathway. This pathway relies on demonstrating substantial equivalence to predicate devices, rather than performing clinical studies to establish specific acceptance criteria and performance metrics for the device itself in terms of diagnostic accuracy or clinical outcomes.

Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them are not applicable in this context. The 510(k) summary focuses on preclinical performance testing to demonstrate equivalence, not clinical performance.

Here's an analysis based on the provided text, addressing elements that are applicable and explaining why others are not:

Acceptance Criteria and Reported Device Performance

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

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 / Not Provided: The text describes preclinical mechanical testing rather than testing on a clinical "test set" of patients or data. Mechanical tests typically involve a specific number of manufactured units or samples for laboratory testing. The sample size for these mechanical tests is not specified, nor is data provenance in the clinical sense (country, retrospective/prospective).

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)

• Not Applicable: This device is a bone fixation plate, not a diagnostic imaging device or AI algorithm that requires expert ground truth for interpretation. Mechanical testing typically involves engineers and quality assurance personnel, but "ground truth" in the clinical imaging sense is not relevant here.

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

• Not Applicable: Adjudication methods are used for resolving disagreements in expert interpretations, primarily in clinical studies or evaluations of diagnostic performance. This is irrelevant for mechanical testing of a medical implant.

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: An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic tasks. This device is a surgical implant and does not involve AI or human reading tasks.

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

• Not Applicable: This device is a metallic bone fixation system, not an algorithm.

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

• Not Applicable: For mechanical testing, the "ground truth" would be established engineering principles, material specifications, and regulatory standards for device performance, against which the device's mechanical behavior is measured. No clinical "ground truth" type (like pathology or outcomes data) is identified as this is not a clinical study.

8. The sample size for the training set

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set."

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

• Not Applicable: As stated above, there is no training set for this device.

Summary of the 510(k) for the GEMINUS Volar Distal Radius Plate System:

The 510(k) clearance for the Skeletal Dynamics GEMINUS Volar Distal Radius Plate System relies on demonstrating substantial equivalence to existing predicate devices already on the market. This means the device met acceptance criteria related to having the same intended use, indications for use, materials, fundamental scientific design, performance characteristics (including preclinical mechanical testing), sterility, and packaging as its predicates. The key finding is that the device does not present any new issues of safety or effectiveness compared to the predicate devices. The performance testing conducted was preclinical mechanical testing (static and dynamic), which was deemed sufficient to establish this equivalency. No clinical studies involving human subjects, diagnostic performance evaluation, or AI algorithms were part of this 510(k) submission.

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