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The OIC Small / Mini Fragment Plate System is indicated for the fixation of fractures, mal-unions, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

The OIC Small / Mini Fragment Plate System consists of titanium plates including the Distal Radius, Clavicle, Proximal Humerus, Tibia and Distal Fibula, 1/3 tubular, Hook, Olecranon and Mini Fragment, bone screws and instruments for implantation. The plates come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 2.5mm and 3.5mm bone screws are available in three diameters (2.0mm, 2.5mm and 3.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads. The OIC Small / Mini Fragment Plate System is made of titanium alloy in compliance with ASTM F1472 or ASTM F67. The OIC Small / Mini Fragment Plate System is provided non-sterilized by the medical facility prior to implantation.

The provided text is a 510(k) premarket notification letter and summary for the "OIC Small / Mini Fragment Plate System," which is a metallic bone fixation appliance. This document is a regulatory submission for a physical medical device, not a software-based AI/ML device.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML device (e.g., acceptance criteria for AI performance metrics like diagnostic accuracy, sensitivity, specificity, AUC; sample sizes for test sets in AI studies; number of experts for ground truth establishment; MRMC studies; standalone algorithm performance; training set details) is not applicable to this submission.

The "Performance Testing" section in the document describes mechanical testing of the plates and screws (bend testing, torsional strength, driver torque, axial pullout strength) according to ASTM standards (F382 and F543). These tests are designed to demonstrate the physical and mechanical integrity and equivalence of the device to predicate devices, which is standard for orthopedic implants.

In summary, this document does not contain the type of information requested for a study proving an AI/ML device meets acceptance criteria.

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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 Emerge Medical Large Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, olecranon, ulna, humerus, femur, tibia, fibula, calcaneus, tarsals, and pelvis, including in osetopenic bone.

The Emerge Medical Small Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, scapula, olecranon, humerus, radius, ulna, tibia, fibula, tarsals, metatarsals, phalanges, and calcaneus, including in osetopenic bone.

The Emerge Medical Small and Large Non-Locking Fragment Plate System consists of stainless steel components. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The plates are provided non-sterile.

Here's a breakdown of the acceptance criteria and the study details for the Emerge Medical Small and Large Non-Locking Fragment Plate System, 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:

The provided text describes non-clinical mechanical testing and does not refer to human subject data or a "test set" in the context of clinical trials or AI/algorithm performance. Therefore, details about sample size (patients/cases) or data provenance (country, retrospective/prospective) are not applicable here. The testing was performed on the device itself.

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

Ground truth, in this context, would relate to the established standards or methods for evaluating the mechanical properties of bone plates. The text does not mention human experts involved in establishing a "ground truth" for the mechanical tests. The testing was performed according to a modification of a recognized standard (ASTM F382-99 (2008)).

4. Adjudication Method for the Test Set:

Not applicable, as this was mechanical testing, not a clinical study involving human assessment or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted. This is a medical device (bone plate) and the performance data consists of mechanical strength testing, not an assessment of human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical bone plate, not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant.

7. Type of Ground Truth Used:

The ground truth used for evaluating the device's performance was the modified ASTM F382-99 (2008) standard for dynamic four-point bending. This standard provides a recognized methodology for assessing the mechanical strength of bone fixation devices.

8. Sample Size for the Training Set:

Not applicable. This device is a physical bone plate, not an algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of medical device.

In summary, the provided document focuses on the mechanical performance of a bone plating system, demonstrating its equivalence to existing predicate devices through non-clinical laboratory testing. The evaluation does not involve clinical studies with human participants, AI algorithms, or the associated concepts of test sets, training sets, or expert ground truth as typically applied in AI/clinical performance assessments.

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The proposed Mini Fragment Plates are intended for essentially non load bearing 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, pelvis, and craniomax, illofacial skeleton.

The proposed Mini Fragment Plates are a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: Fragment Plates that are provided in the following design configurations: Straight, Y, Right Hockey Stick, and Left Hockey Stick. Pegs; Screws; and K-Wires. Included in the sterilization tray are the following re-useable instruments: Peg drivers, Other standard surgical tools. In addition, the following are non-reusable instruments included in the sterilization tray: F.A.S.T. Guide Technology™ Drill Guide, Drill bits.

The provided text is for a 510(k) premarket notification for "Mini Fragment Plates", a type of orthopedic implant. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the context of device performance metrics like sensitivity, specificity, or reader studies.

Therefore, the requested information, such as acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment, are not present in the provided document.

Instead, the document details:

• Device Name: Mini Fragment Plates
• Manufacturer: Hand Innovations, LLC
• Predicate Device: Fragment Plate System (K041081)
• Classification: Class II
• Indications for Use: 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, pelvis, and craniomaxillofacial skeleton.
• Device Description: Orthopedic plates and fasteners (Straight, Y, Right Hockey Stick, Left Hockey Stick), pegs, screws, K-wires, reusable instruments (peg drivers, standard surgical tools), and non-reusable instruments (F.A.S.T. Guide Technology™ Drill Guide, drill bits).
• Biocompatibility: Not required as the material (Ti-6Al-4V ELI per ASTM F 136-00) is the same as the previously approved predicate device and has a long history of safe use.
• Summary of Substantial Equivalence: The proposed Mini Fragment Plates have the same indications for use, intended use, basic shape/design, operating principle, and materials as the predicate device. The changes do not alter the fundamental scientific technology.

This document is a regulatory submission focused on confirming that the new device is "substantially equivalent" to an already approved device, meaning it doesn't raise new questions of safety and effectiveness. It does not involve performance testing against specific clinical or system-level acceptance criteria in the way a novel diagnostic or AI-driven device would.

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The Fragment Plate System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.

The Fragment Plate System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The set also includes screws, pins, and k-wires. The screws and pins are have a center drive head and are 2.5 mm in diameter. The plates will include "Y," straight, right, and left configurations. Manual surgical instruments are supplied with the system to facilitate implantation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fragment Plate System:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a premarket notification (510(k)) where substantial equivalence is claimed. It does not present clinical study data with a "test set" in the traditional sense for evaluating device performance in patients.

Instead, the "test set" equivalent primarily involves:

• Bench Testing: Used for the 13-point technological comparison to demonstrate substantial equivalence to the predicate device. The specific sample sizes for these bench tests are not provided in the document.
• Compliance with Standards: The document states compliance with ASTM material and fixation standards. These standards themselves define sample sizes and testing methodologies, but the report doesn't detail the specific number of samples tested by Hand Innovations to meet these standards.

Data Provenance: Not applicable in the context of a clinical test set. The data presented is from internal bench testing and compliance assessments, not patient data.

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

Not applicable. This device's clearance is based on substantial equivalence to a predicate device and compliance with material standards, not on a clinical ground truth established by medical experts for a test set of patient data.

4. Adjudication Method for the Test Set

Not applicable. No clinical ground truth requiring adjudication by experts was established for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a medical device (fragment plate system) for surgical fixation, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists). Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.

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

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

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Predicate Device: The performance and safety profile of the "Distal Volar Fracture Repair System" by Hand Innovations, Inc. is the primary ground truth for comparison.
• Industry Standards: The specifications and performance requirements outlined in ASTM F366 and ASTM F136 serve as a ground truth for material properties and fixation characteristics.
• Historical Biocompatibility: The "long history of safe usage" of the implantable materials establishes a form of historical ground truth for biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. No training set for an algorithm was used.

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