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TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

The subject TrueLok Elevate is an external fixation component system (including its accessories) to be used with the Orthofix TrueLok family, for which Orthofix identified as a predicate device TrueLok Hexapod System (TL-HEX) V2.0 (K170650). The subject device consists in a further series of elements for external fixation added to the Orthofix TrueLok family with the aim of supporting the Orthofix TrueLok external fixator systems family falling within the indications for use of the more extensive, cleared indications for use of the chosen predicate device, for the specific use in bone transport treatment.
The subject TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.
The subject device is constituted by an external fixator and related accessories (half pins, k-wires, drill positioning guide, template and template inserts and convenience kits).
The technique for the use of the subject device consists in fixing two half pins on the first cortical of the bone segment that the surgeon decided to transport, and two half pins on both cortexes of the bone.
The positioning of the half pins is driven by a template.
During the treatment, through the knob present on the device, the bone segment is gradually pulled outward by the patient/caregiver to laterally transport the bone segment.
The subject device, as the predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures (including application and removal), in the operating theatre only. The distraction of the limb will be activated in home by the patient/caregiver or in clinic theatre by the HCP. Treatment activation for pediatric patients in the home environment may require the assistance of a caregiver.

The Orthofix TrueLok™ Elevate is an external fixation component system intended for the treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities in adult and pediatric patients (greater than 2 through 21 years of age).

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific pass/fail acceptance criteria values for the mechanical tests conducted. Instead, it describes comparative testing against predicate or reference devices to demonstrate similarity in performance. The assessment for each technological characteristic indicates that "no different questions have been raised" or that the subject device's indications fall within the predicate's, suggesting that the goal was to demonstrate equivalence rather than meeting pre-defined numerical thresholds for acceptance.

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

The document does not explicitly state the sample sizes used for the mechanical tests (e.g., number of external fixators or half pins tested).
The provenance of the data is not specified regarding country of origin or whether it was retrospective or prospective, as these were bench tests performed on devices rather than patient data.

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

This information is not applicable to this type of submission. The ground truth for mechanical performance is established through standardized testing protocols (e.g., ASTM standards) and comparisons to previously cleared predicate devices, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to this type of submission as the mechanical tests are objectively measured, not subject to subjective interpretation requiring adjudication.

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

An MRMC study was not performed. This type of study is typically relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. The TrueLok™ Elevate is a physical external fixation system.

6. Standalone (Algorithm Only) Performance Study

A standalone study was not performed, as the device is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for demonstrating performance was based on objective mechanical measurements conducted in accordance with recognized industry standards (e.g., ASTM F1541-17) and comparisons to the established performance characteristics of legally marketed predicate devices. The "truth" is that the new device's mechanical properties fall within acceptable limits or are comparable to those of the predicate, as determined by these tests.

8. Sample Size for the Training Set

This information is not applicable. The TrueLok™ Elevate is a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

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FITBONE® Trochanteric is indicated for limb lengthening of the femur. FITBONE® Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

The FITBONE® Trochanteric is a fully implantable intramedullary lengthening nail and accessories. The subject FITBONE® Trochanteric consists of the implantable intramedullary lengthening nail and accessories (Locking screws, Trial nails, K-wire and Convenience kits). The Subject device is implanted into the medullary canal of the femur and connected to the primary predicate intracutaneous Receiver (K163368) by a bipolar feed line. The external FITBONE Control Set is the same as previously cleared for the primary predicate Fitbone TAA device (K203399) and consists of a control electronics station and transmitter. There are no changes to the previously cleared Control Sets and Receiver as a result of this submission. The power required for the distraction process is controlled by hermetically enclosed motor which draws the telescope apart. The electro-magnetic field sent from the Transmitter to the Receiver is converted in the Receiver into DC-Voltage to supply the motor of the subject Fitbone Trochanteric Nails with voltage, when actioned. The subject Fitbone Trochanteric Nails are available in two different diameter models (D09mm, D11mm), different lengths and lengthening capabilities. The subject nail is anchored to the bone by subject locking screws. The locking screws are available in two variants (standard locking screws and revision locking screws), in two diameters, D4.5mm and D4mm, and in multiple lengths. The energy needed for the distraction process is transmitted from the outside by placing the external transmitter over the implanted receiver, which is placed in the subcutaneous tissue during surgery. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body. The subject trial nails accessories are available for each variant of the Fitbone Trochanteric nails and are used to simulate the shape of the implant. The subject Fitbone Trochanteric nail and K-wire are provided in sterile conditions only. The trial nails are provided in non-sterile version only. The bone screws are available in both sterile and non-sterile versions. The subject Fitbone Trochanteric Nails and their accessories are made from, as follows: Nail: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)", and Silicone Nusilmed (NuSil MED-4870, NuSil MED-1511, Nusil MED 4750, NUSIL MED1-161, NUSIL MED2-4502). Trial nail: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" and ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments. Locking screws: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" K-wire: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" The Subject, as the primary predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures

The provided text describes the regulatory clearance for the Orthofix Fitbone Trochanteric, an intramedullary lengthening nail. However, this document does not contain information about acceptance criteria, device performance, ground truth establishment, sample sizes for training or testing sets, expert qualifications, adjudication methods, or MRMC studies for an AI/ML powered medical device.

The document is a 510(k) summary for a traditional medical device (an intramedullary lengthening nail), not an AI/ML-powered device. Therefore, the specific types of studies and criteria outlined in your request are not relevant to this submission.

The "Performance Analysis" section describes mechanical testing performed on the implantable nails and screws to demonstrate their safety and effectiveness, based on established ASTM and ISO standards for medical devices. This is a standard non-clinical performance evaluation for mechanical orthopedic implants.

In summary, none of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or study types (MRMC, standalone) for an AI/ML device is present in the provided text because the device is not an AI/ML product.

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The LINK™ External Fixator is indicated for 1) hand and foot bone fragment and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude LINK™ Bone Pin placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.

The LINK™ External Fixator is a single use External Fixator consisting of a stainless steel flat spring formed into a box shape so that when released it applies forces and moments to Bone Pins, K-wires or Steinmann pins embedded in bone to actively pull together and compress or distract bone.

In clinical use the LINK™ External Fixator is held with its holes aligned using surqical needle drivers while wires or pins are advanced through the LINK™ External Fixator, skin and into bone. Once pins are placed the needle drivers are released, the LINK™ External Fixator bridge shortens to apply forces and the LINK™'s side elements swing outward to create moments on the wires or pins.

The LINK™ External Fixator uses spring heat treated 17-7 stainless steel which is uniquely formed from a flat plate to create a shape changing spring. The Bone Pins in this kit are formed with 316 Stainless Steel. The LINK™ External Fixator has a separate removable silicon elastomer cover to protect the LINK™ External Fixator and the patient from the pin ends. Only the Bone Pins are in contact with the patient while the LINK™ External Fixator and its cover are external to the body and not intended for patient contact.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called the "LINK™ External Fixator." This document details the device, its intended use, comparison to a predicate device, and the basis for its substantial equivalence determination.

However, the information requested in your prompt (acceptance criteria, details of a study proving device meets criteria, sample sizes, expert involvement, ground truth establishment, etc.) is not present in this document.

The text focuses on mechanical bench testing to demonstrate the device's physical performance characteristics, such as:

• Construct pull out
• 4-point bending for bone pin
• 4-point bending for fixator construct in a bone analog
• Static ultimate strength in tension bending
• Fatigue in tension bending
• LINK™ force applied to bone

It explicitly states: "Performance Data: Bench testing included construct pull out, 4-point bending for bone pin, 4-point bending for fixator construct in a bone analog, static ultimate strength in tension bending, fatigue in tension bending and the LINK™ force applied to bone."

This is a physical medical device, not an AI or software-based diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sensitivity, specificity, clinical accuracy, MRMC studies, human reader improvement with AI assistance, independent algorithm performance) are not applicable here.

In summary, based only on the provided text, I cannot fill out the requested table or answer the questions related to clinical study performance, AI component validation, or expert-based ground truth because the document describes a traditional mechanical medical device cleared based on bench testing and comparison to a predicate device, not clinical validation of diagnostic performance.

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The RODEO Telescopic Nail is indicated for fractures, osteotomies, malunions and non-unions in femur and tibia in pediatric patients suffering from osteogenesis imperfecta.

The subject RODEO™ Telescopic Nail is a self-extending rod intended to provide bone fixation. The nail includes the telescopic rod, which consists of two parts (male and female) and bone anchors, which could be either a cap or an epiphyseal screw suitable to the anatomical application. The nail is provided in sterile and non-sterile version and is available in five diameters (3.5mm, 4.0mm, 4.5mm, 5.0mm and 6.0mm), identified by the outer diameter of the female part of the rod, and five lengths for each diameter model (from 100 mm up to 350 mm). Application and removal are performed with Orthofix general orthopedic instrumentation. The subject RODEO™ Telescopic Nail consists of three different components which are intended to be assembled to form the implant: Male component - A solid shaft with a built-in bone anchor for bone connection; the bone anchor has the same design as the cap (described below). Female component - A hollow shaft designed to host the male component. Bone anchors - Two options are available depending on the desired application: Cap - A self-locking screw to be connected with the female component at the opposite aspect of the extremity relative to the male component. Epiphyseal Pin - A threaded pin to be inserted into the distal extremity hole to hold the female component in position and prevent migration (see Figure 3) When the male and female components are assembled, the resulting implant is a telescopic rod. Male and female components are free to move both axially and rotationally; this allows the nail to extend axially as the patient growth occurs while allowing rotation around the bone anchors. The subject implants are made from AISI 316LVM stainless steel, conforming to ASTM F138 and ISO 5832-1.

This response describes the acceptance criteria and study proving the device meets criteria, derived from the provided text.

Based on the provided FDA 510(k) summary for the RODEO™ Telescopic Nail, the device's acceptance criteria and the study that proves it meets these criteria are primarily based on bench testing and demonstration of substantial equivalence to a predicate device, rather than clinical performance or AI algorithm validation. The documentation focuses on engineering and material properties.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device and relevant ASTM standards (ASTM F1264-16). The performance is shown by demonstrating that the subject device's mechanical properties are "equivalent or better" than the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details: Device Validation (Bench Testing)

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a number of units, but testing was performed on "both male and female components of the subject and predicate devices" for mechanical testing, and "the worst case (smallest diameter) fully-assembled subject and predicate devices" as well as "the largest diameter fully-assembled subject and predicate devices" for additional static and dynamic testing. This implies multiple samples of each configuration were tested to generate data for stiffness, yield strength, fatigue, etc.
   • Data Provenance: The data is from "bench testing" conducted by Orthofix SRL. It is not patient or clinical data, so country of origin isn't relevant in the same way, nor is it retrospective or prospective in the clinical sense. It's laboratory-generated data.

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

   • Not applicable. This is not a study involving human interpretation of data (e.g., medical images) to establish "ground truth." The ground truth for mechanical testing is established by the specified ASTM standards and the measured physical properties of the materials and devices.

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

   • Not applicable. This is not a study involving human readers or subjective assessments requiring adjudication. The results are objective measurements from mechanical tests.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is a medical device (intramedullary nail) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.

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

   • Not applicable for the same reason as above. It is not an AI algorithm.

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

   • The "ground truth" for this type of submission is based on engineering specifications, material science standards (e.g., ASTM F138, ISO 5832-1), and mechanical testing standards (e.g., ASTM F1264-16). The performance of the subject device is measured against these established engineering benchmarks and compared directly to a legally marketed predicate device.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning model, so there is no training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no training set for a machine learning model.

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The TrueLok™ EVO is intended to provide bone fixation.

The TrueLok™ EVO is indicated for fractures, pseudarthrosis / non-unions, joint arthrodesis and correction of bony or soft tissue deformities and defects (e.g. bone transport) in long bones and in the foot.

The TrueLok™ EVO system is a modular circular external fixation system based on Ilizarov fixation apparatus principles. The TrueLok™ consists of external supports (rings and footplates), variable length struts and a variety of connection elements that build the external frame. The TrueLok™ external frame is secured by using the Orthofix predicates pin and wires. The Subject external support components (rings, footplates and struts), are made from AISI 316LVM, AISI 630, Aluminum alloy (EN-AW 6082 T6) and Epoxy carbon fiber. Application and removal of the TL-EVO can be performed with Orthofix general orthopedic instrumentation. TrueLokTM EVO fixator components are provided in single-use sterile configuration and they are available as single component packaged in double pouches or in multiple components packaged in double rigid blister.

The provided text describes the 510(k) premarket notification for the TrueLok™ Evo, a bone fixation device. However, it does not contain information about acceptance criteria for a device's performance, a study proving it meets such criteria, or any details related to AI/algorithm performance.

The document focuses on demonstrating substantial equivalence to predicate devices, primarily through:

• Indications for Use: Comparing the intended use of the TrueLok™ Evo to predicate devices.
• Technological Characteristics: Highlighting similarities in materials, design, and general principles of operation.
• Performance Analysis (Non-Clinical): Detailing specific non-clinical tests conducted, such as MRI compatibility testing and mechanical testing according to ASTM standards.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria & Reported Performance: The document states that the performance data supports substantial equivalence and that the device performs "as well as or better than the predicate devices." It also lists the standards used for testing (ASTM F2052, F2213, F2182, F2119 for MRI, and ASTM F1541-17 for mechanical testing). However, it does not quantify specific acceptance criteria (e.g., "displacement must be less than X mm") nor does it report the specific measured performance values (e.g., "displacement was Y mm") that would allow for a direct comparison in a table as requested. The "Effectiveness" mentioned refers to the device's ability to achieve its intended function, not a quantifiable performance metric for an algorithm.

2. Sample Size & Data Provenance (Test Set): This document does not describe a "test set" in the context of an algorithm or AI. The performance analysis refers to physical testing of the device components.

3. Number of Experts & Qualifications / Adjudication Method (Test Set): This information is relevant for studies involving human interpretation or ground truth establishment for AI. It is not applicable to the non-clinical mechanical and MRI compatibility testing described here.

4. MRMC Comparative Effectiveness Study: There is no mention of an MRMC study or AI assistance for human readers as the device is a physical bone fixation system, not an AI diagnostic tool.

5. Standalone Performance Study: No standalone algorithm performance study is mentioned for the same reason as above.

6. Type of Ground Truth: The ground truth for the non-clinical tests described would be the physical measurements and observations during those tests, compared against the limits defined by the regulatory standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense used for AI.

7. Sample Size for Training Set: Not applicable as there is no AI/algorithm being trained.

8. How Ground Truth for Training Set was Established: Not applicable as there is no AI/algorithm being trained.

In summary, the provided document details a 510(k) submission for a physical medical device (bone fixation system) and its non-clinical testing to demonstrate substantial equivalence, not the performance of an AI or algorithm. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from this text.

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Pitkar External Fixation System- Rail Mechanism consist of Rail Fixation System and ALFA Fixator System. Their components are intended to be used on adult or pediatric patients as required.

A. Rail fixation System
1.Fracture fixation
2.For correcting diaphyseal deformities. metaphyseal deformities with or without shortenings
3.Correction of bony or soft tissue deformities
4.Limb Lengthening
5.For treating non-union and mal-union
6.Bone transport application

B. ALFA Fixator System
1.Open and closed fracture fixation
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction:
3.Pseudoarthrosis of long bones;
4.Limb lengthening;
5.Infected fractures or non-unions; and
6.Correction of long bone deformities.

Note: For Rail Fixation System and ALFA Fixator System

1. For Adult Assembly: Population to be adult males and females for given indications
2. For Pediatric Assembly: Population to be between age of 5 to 10 for given indications
3. It is recommended to avoid operating on children under the age of five, in case of pediatric application

Pitkar External Fixation System- Rail Mechanism. The subject application has two devices covered that fall under Rail fixation category. Both the systems have Adult & Pediatric apparatus. Both the systems have different Rail design & clamps design. They are designated as: 1. Rail Fixation System 2. Alfa Fixator System Thus, there will be two subject devices for approval under this heading as both these systems have same application, device description, Indications, material composition etc.

This document describes the 510(k) premarket notification for the "Pitkar External Fixation System - Rail Mechanism." This device is intended for orthopedic procedures such as fracture fixation, deformity correction, and limb lengthening.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each non-clinical test. It mentions that the device performance was "demonstrated against applicable standards ASTM F1541-02" for mechanical tests and "meets the ISO 10993-1 standard requirements" for biocompatibility.

The data provenance is retrospective, as the justification for biocompatibility relies on the device being comprised of "the same material and have the same manufacturing, body contact, and sterilization properties as other commercially available devices and materials with a long history of clinical use in orthopedic implants." The mechanical tests are also non-clinical and performed under controlled laboratory conditions rather than on patient data.

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

This information is not applicable as the described tests are non-clinical engineering and materials tests, not studies involving expert medical interpretation or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable as the described tests are non-clinical engineering and materials tests, not studies requiring adjudication of various expert opinions.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (external fixation system), and the performance evaluation is based on non-clinical mechanical and biocompatibility testing, not on human interpretation of images or data.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done. This submission is for a physical medical device, not an algorithm or AI software. All tests conducted were on the physical components of the device.

7. Type of Ground Truth Used

The ground truth used for the performance evaluation consists of established engineering standards and material science principles.

• For mechanical tests (Axial Load, Torsion, Fatigue, Cantilever Bending, 4-Point Bending), the ground truth is adherence to the specifications and performance requirements outlined in ASTM F1541-02.
• For biocompatibility, the ground truth is compliance with the requirements of ISO 10993-1 and the demonstrated safe use of similar materials in predicate devices.

8. Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set. The device's performance is not learned from data but inherent in its design, materials, and manufacturing.

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

This information is not applicable for the reasons stated in point 8.

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The PRECICE® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients.

The PRECICE Plating System includes the PRECICE plate, cortical screws, surgical instruments, and is compatible with an external remote controller (ERC). The PRECICE plate is supplied sterile by gamma radiation while the cortical screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE plate is implanted using cortical screws and reusable surgical instruments. The PRECICE plate contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the plate to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE Plate is available in various sizes, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The cortical screws are also available in a variety of lengths and thread styles. The ERC is available in several compatible models.

The provided text is a 510(k) summary for the PRECICE Plating System, a medical device for orthopedic indications. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical performance data.

However, the document does not contain information regarding acceptance criteria for device performance in the context of clinical studies, sample sizes for test sets or training sets, ground truth establishment methods (expert consensus, pathology, etc.), details about human expert involvement, adjudication methods, or MRMC comparative effectiveness studies.

The provided text details non-clinical performance verification, establishing substantial equivalence to existing predicate devices through mechanical testing and engineering analysis. It lacks the elements typically associated with proving device performance against specific acceptance criteria in a clinical setting, particularly for AI/machine learning devices where the requested information is highly relevant.

Therefore, many of the requested fields cannot be filled from the given document.

Here's a breakdown of what information can and cannot be extracted based on your request:

Summary of Device Performance (Based on "Performance Data" section):

The "Performance Data" section describes non-clinical testing performed to demonstrate substantial equivalence. The device's performance is reported in terms of its ability to perform "substantially equivalent" to predicate devices under various mechanical tests.

Table of Performance (Based on H. Performance Data section):

Conclusion from document: The results demonstrate that the subject PRECICE Plating System is substantially equivalent to the predicates.

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The G3™ Active Plate® Large Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to

The subject G3™ Active Plate® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from stainless steel (316L) and medical grade titanium alloy (Ti-6Al-4V-ELI). The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath made from silicone that is bonded to the sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies for the G3™ Active Plate® Large Fragment System.

It's important to note that this document is a 510(k) summary for a medical device (bone fixation system), not an AI/software as a medical device (SaMD) submission. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable to this type of device and submission. The "device" in this context is a physical orthopedic implant.

Acceptance Criteria and Study Details for G3™ Active Plate® Large Fragment System

1. Table of Acceptance Criteria and Reported Device Performance

For a physical orthopedic implant like the G3™ Active Plate® Large Fragment System, performance is measured against established mechanical standards rather than typical statistical metrics like sensitivity/specificity for AI. The acceptance criteria are implicit in meeting or exceeding the performance of predicate devices or established ASTM standards.

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

• Sample Size (Test Set): The document does not specify exact "sample sizes" in terms of number of devices tested. For mechanical testing, samples are typically a set number of devices (e.g., 6 or 12 per test condition) to allow for statistical comparison to failure criteria or predicate performance. This information is usually detailed in the full test report, not the 510(k) summary.
• Data Provenance: The studies are mechanical laboratory tests performed on physical devices, not human subject data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.

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

• Not Applicable. This is a physical device submission undergoing mechanical testing, not a diagnostic or AI device requiring expert-established ground truth from clinical images or data. Performance is measured against engineering standards and against predicate device performance.

4. Adjudication Method for the Test Set

• Not Applicable. As this is mechanical testing of a physical device, there is no expert adjudication process for the test set. Results are quantitative measurements interpreted against established standards.

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

• No. An MRMC study is relevant for diagnostic performance, typically for imaging or other interpretation tasks performed by human readers. This is a physical orthopedic implant.

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

• No. This refers to AI/software performance. This device is a physical bone fixation system.

7. The Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance: For mechanical testing, the "ground truth" is typically defined by:
  • ASTM Standards: Established specifications for mechanical properties (e.g., minimum fatigue strength, stiffness range).
  • Predicate Device Data: Performance data from an already legally marketed, substantially equivalent device that the new device aims to match or exceed.
• Not Applicable to pathology, outcomes data, or expert consensus in the human health context.

8. The Sample Size for the Training Set

• Not Applicable. This concept is for AI/machine learning models. For a physical device, there isn't a "training set" in the same sense. Design and material selection are based on engineering principles and prior knowledge, not iterative training.

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

• Not Applicable. As there is no "training set" for this physical device, this question is irrelevant.

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The ISKD System intended for limb lengthening of the femur and tibia.
The ISKD is indicated for limb lengthening of the tibia and femur.

The ISKD System is an intramedullary limb lengthening system that provides gradual, controlled osteogenic distraction of the tibia and femur. The ISKD System consists of the telescoping internal limb lengthening device, titanium locking screws, instrumentation and an external handheld Monitor. As the patient performs rotational oscillations of the affected limb during normal ambulation, the ISKD distracts as the distal section of the implant gradually telescopes out of the proximal section. The the implant is controlled by a one-way clutch mechanism and a threaded and. A small magnet sealed within the ISKD implant rotates simultaneously as the implant distracts. The hand-held external Monitor is similar to an electronic compass and communicates with the magnet by detecting and tracking changes in the magnet poles. The external Monitor enables both trationing and physicians to monitor the daily limb lengthening progress. Titanium locking screws (2 proximal and 2 distal) secure the device in place in the intramedullary canal.

The provided text describes the Orthodyne ISKD System, an intramedullary limb lengthening system. However, it does not detail specific acceptance criteria with quantitative targets for device performance or a formal study designed to "prove the device meets acceptance criteria" in the way one might typically expect for a software or AI-driven medical device. Instead, the document presents a summary of biomechanical, animal, and clinical testing to demonstrate the device's safety, effectiveness, and substantial equivalence to predicate devices.

Let's break down what is available in the text according to your requested categories:

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

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance in relation to predicate devices and the intended use.

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

The document describes clinical studies rather than a "test set" in the context of an algorithm or AI.

• Pilot Study (Clinical): 9 patients. "Compassionate use" indicates these were likely very severe or difficult cases, possibly without strict prospective protocol adherence given their "last stage option" nature. Data provenance is not specified (e.g., country), but implied to be from a clinical setting.
• Feasibility Study (Clinical): 10 patients (11 lengthening procedures). This study appears to be prospective due to enrollment and follow-up. Data provenance is not specified (e.g., country).
• Animal Testing: 1 female sheep. This was a prospective animal study.

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)

This information is not applicable to the provided document. The clinical studies describe patient outcomes and physician assessments rather than a "ground truth" established by an expert panel for a test set (as would be relevant for an AI algorithm). The animal study involved radiographic evaluation and surgical removal of bone, implying veterinary and possibly pathology expertise, but no specific number or qualifications are given.

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

Not applicable. The studies described are clinical trials and animal studies, not an adjudication process for an AI algorithm's test set. Clinical outcomes were assessed by treating physicians and followed up clinically and radiographically.

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 MRMC comparative effectiveness study was done as the device is a mechanical implant, not an AI or imaging diagnostic tool.

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

Not applicable. The ISKD is a mechanical device with an external monitor for tracking, not an algorithm.

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

For the studies presented:

• Biomechanical Testing: Physical measurements and comparisons against established engineering standards and predicate devices (e.g., yield strength, stiffness, fatigue cycles).
• Animal Testing: Direct observation, radiographic evaluation of bone formation and distraction, and post-mortem pathological evaluation of the bone and implant site. The "ground truth" for lengthening was determined by counting threads on successive radiographs.
• Clinical Testing: Patient outcomes, including achieved limb length (measured clinically and radiographically), healing status (radiographic evaluation), adverse events, and physician assessment.

8. The sample size for the training set

Not applicable. The device is not an AI algorithm, so there is no "training set."

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

Not applicable.

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