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

FitboneTM 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 (K203399) by a bipolar feed line. The external FITBONE Control Set is the same as previously cleared for the reference device Fitbone TAA (K203399) and consists of a control electronics station and transmitter. 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 locking screws. The locking screws to be used with the subject nails are the same as cleared for the primary predicate Fitbone Trochanteric (K233867). Trial nails accessories are available for each variant of the Fitbone Trochanteric nails and are used to simulate the shape of the implant. The Fitbone Trochanteric nail and K-wire are provided in sterile conditions only. The trial nails are provided in non-sterile version only. The locking screws are available in both sterile and non-sterile versions. The subject Fitbone Trochanteric Nails and their accessories are made from implant grade stainless steel 1.4441 (AISI 316LVM) and Silicone Nusilmed.

The provided document is an FDA 510(k) clearance letter for the FitboneTM Trochanteric, an intramedullary fixation rod used for limb lengthening. This type of device is classified as a Class II medical device. The document focuses on demonstrating substantial equivalence to a predicate device through engineering and mechanical testing, rather than clinical studies involving human efficacy data. Therefore, many of the requested elements pertaining to clinical study design, such as human reader performance, ground truth establishment for a training set, and multi-reader multi-case studies, are not applicable here.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established through comparison to a predicate device and bench testing against recognized standards. The "performance" described primarily refers to mechanical properties.

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

• Sample Size for Test Set: The document does not specify a "sample size" in terms of patient data for a test set, as this was not a clinical study assessing patient outcomes. The testing described is bench testing (mechanical testing). For mechanical testing, samples of the physical device would be tested. The number of such samples is not explicitly stated but would typically involve multiple units for each configuration tested.
• Data Provenance: The data provenance is from bench testing conducted on the subject device, its primary predicate (K233867), and reference devices (K203399, K220234). This testing would have been done in a laboratory setting, likely at the manufacturer's facility or a third-party testing lab. The origin of the device is Italy (Orthofix S.r.l.). The data is prospective in the sense that the tests were conducted specifically for this submission to evaluate the design change.

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

Not applicable. Ground truth, in the context of this 510(k), is established through engineering specifications, material standards (e.g., ASTM F138-13), and validated mechanical testing methodologies, rather than human expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used for diagnostic devices where human readers interpret medical images or data, and an AI would assist in that interpretation. The FitboneTM Trochanteric is an implantable intramedullary lengthening nail, not a diagnostic AI software.

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

Not applicable. The FitboneTM Trochanteric is a physical medical device, not a software algorithm or AI. Its function is mechanical distraction, controlled by an external unit, but it does not have a "standalone algorithm" performance to report in this context.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on engineering specifications, material properties, and established mechanical testing standards. The primary method for establishing substantial equivalence involves comparing these aspects to a legally marketed predicate device and demonstrating that any differences do not raise new questions of safety or effectiveness.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of AI or machine learning. The device's design and materials are based on established engineering principles and prior device history, not on learning from a dataset.

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

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

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The OrthoNext™ Platform System is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery and post-operative planning of orthopedic treatment. The device allows for overlaying of Orthofix Product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.

The subject OrthoNext™ Platform System is a web-based modular software system, indicated for assisting healthcare professionals in planning of orthopedic surgery and treatment both preoperatively and postoperatively, including deformity analysis and correction with several Orthofix products.
The subject software system is intended for use by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures, in the operating theatre only.
The subject software functions are intended to inform the HCP on orthopedic procedure treatment planning when the Orthofix external or internal fixation systems are used. These functions are evidence-based tools that support HCP when considering treatment digital planning options for a patient. The software functions do not treat a patient or determine a patient's treatment.
The software enables the HCP to import radiological images, display 2D views (frontal and lateral) of the radiological images, overlay the positioning of the template and simulate the treatment plan option, and to generate parameters and/or measurements to be verified or adjusted by the HCP based on their clinical judgment.

Here's a breakdown of the acceptance criteria and the study details for the OrthoNext Platform System, based on the provided document:

Acceptance Criteria and Device Performance

The OrthoNext Platform System was evaluated for measurement accuracy and an AI/ML algorithm's performance for automatic marker detection.

Table of Acceptance Criteria and Reported Device Performance

• Mean error: 0.1 mm for linear measurements, 0.05 degrees for angular measurements.
• Mean percentage error: 0.24% (threshold 0.27% within 95th percentile) for linear measurements, 0.08% (threshold 1% within 95th percentile) for angular measurements.

For measurements made using mechanical axes:

• Mean error: 0.4 mm for linear measurements, 0.06 degrees for angular measurements.
• Mean percentage error: 1.73% (threshold 16.67% within 95th percentile) for linear measurements, 0.28% (threshold 1.27% within 95th percentile) for angular measurements. |
  | Sensitivity of Measurements | Not explicitly stated as a separate acceptance criterion, but device performance reported. | 1 mm for linear measurements, 1 degree for angular measurements. |
  | Specificity of Measurements | Not explicitly applicable as a direct acceptance criterion due to manual nature. | The device requires active user involvement for each measurement, relying on user expertise. |
  | AI/ML Algorithm Accuracy | Not explicitly stated as an isolated acceptance criterion, but reported. | 0.8 |
  | AI/ML Algorithm Specificity | Goal: zero false positives in the test set, resulting in a precision of 1. | 1 (Precision) |
  | AI/ML Algorithm Sensitivity | Not explicitly stated as an isolated acceptance criterion, but reported. | 0.75 (TPR/Recall) |
  | AI/ML Algorithm FPR | Not explicitly stated as an isolated acceptance criterion, but reported. | 0 |
  | AI/ML Algorithm F1 Score | Not explicitly stated as an isolated acceptance criterion, but reported. | 0.86 |
  | AI/ML Algorithm Intersection over Union (IoU) | Not explicitly stated as a direct acceptance criterion, but reported. | 79% |
  | AI/ML Algorithm Center MAE | Not explicitly stated as a direct acceptance criterion, but reported. | 4.83 px |
  | AI/ML Algorithm Center MAPE | Not explicitly stated as a direct acceptance criterion, but reported. | 0.38% |
  | AI/ML Algorithm Radius MAE | Not explicitly stated as a direct acceptance criterion, but reported. | 1.29 px |
  | AI/ML Algorithm Radius MAPE | Satisfying 3% Radius MAPE. | 3% Radius MAPE, contributing to an error of less than 1 mm. |

Study Details: Magnification Marker Detection Algorithm

The document focuses on the performance testing for the magnification marker detection algorithm, which is an AI/ML component of the OrthoNext Platform System.

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

   • Sample Size: 1000 X-ray images. Of these, 800 images depicted a magnification marker, and 200 images did not.
   • Data Provenance: The test set consisted of real X-ray images. The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that these images were "not used during training, ensuring independence."

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

   • Number of Experts: Not explicitly stated. The document mentions "qualified personnel" were used for the truthing process.
   • Qualifications of Experts: "Qualified personnel" are mentioned, but specific qualifications (e.g., radiologist with X years of experience) are not provided.

3. Adjudication method for the test set:

   • The document describes a "review and discard process" implemented to ensure the quality of the annotations, but it does not specify an adjudication method like "2+1" or "3+1". This suggests a quality control step for annotations rather than a formal consensus process among multiple readers for ground truth establishment.

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:

   • No MRMC comparative effectiveness study was done or reported in this document. The study evaluates the standalone performance of the AI/ML algorithm for magnification marker detection, not its impact on human reader performance.

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

   • Yes, a standalone performance evaluation of the AI/ML algorithm for magnification marker detection was explicitly done and reported. The performance metrics (Precision, Accuracy, TPR/Recall, FPR, F1 Score, IoU, MAE, MAPE) are all indicative of standalone algorithm performance.

6. The type of ground truth used:

   • Expert Consensus (Annotation): The ground truth was established through a "truthing process... conducted by qualified personnel, who carefully overlaid a circular shape on each magnification marker using annotation software."

7. The sample size for the training set:

   • Training Set Composition: 1500 X-ray images with random areas depicting magnification markers.
   • These 1500 magnification markers were randomly overlaid on top of 4000 X-ray images.
   • Image augmentation techniques (random rotations, brightness adjustments) generated 24,000 unique X-ray images for training.

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

   • The training set involved synthetic images. Specifically, "1500 X-ray images with random areas depicting magnification markers" were created, and these markers were "randomly overlaid on top of 4000 X-ray images." Image augmentation was then applied. This suggests that the ground truth for the training set markers was generated as part of the synthetic image creation process (i.e., the location and characteristics of the overlaid markers were known by design). A "hash check" was used to ensure the uniqueness of these synthetic images.

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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 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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"FITBONE Transport and Lengthening system" is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of the long bones. The "FITBONE Transport and Lengthening system" is indicated for adult only.

The subject “FITBONE® Transport and Lengthening System” consists of the implantable intramedullary transport or lengthening nail and its trial nail accessories. The Subject device is implanted into the medullary canal of the femur or tibia and connected to the additional predicate intracutaneous Receiver by a bipolar feed line. The external FITBONE Control Set is identical to that previously cleared for the additional predicate Fitbone TAA device (K203399) and consists of a control electronics station and transmitter. There are no changes to this 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 FITBONE Transport and Lengthening Nail with voltage, when actioned. The subject nail is anchored to the bone by locking screws through medial-lateral and AP holes in the nail depending on the configuration holes in the nail. 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 size model of the FITBONE Transport (TN) and FITBONE Transport or Lengthening (TLN) nails and are used to simulate the shape of the implant. The subject nails and trial nails are provided in sterile conditions only and 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). • 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 For the implantation and removal of the subject device the same instruments of the additional predicate Fitbone TAA (K203399) may be used.

The provided text is a 510(k) summary for a medical device (FITBONE® Transport and Lengthening System). It details the device's indications for use, technological characteristics, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based medical device.

The document describes mechanical testing (bench testing) to demonstrate the equivalence of the subject device to its predicates for physical attributes like bending, fatigue, and torsional strength, and current consumption of the motor. This is typical for implantable mechanical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device, including details about sample sizes, data provenance, expert qualifications, ground truth establishment, or MRMC studies, as these concepts are not applicable to the content provided in the input text.

The document discusses performance in terms of mechanical and functional equivalence of a physical medical device, not the performance of an AI/ML algorithm.

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The JPS JuniOrtho Plating System™ is internal fixation and stabilization of fractures, osteotomies, malunions and non-unions of long bones of the lower limb.

The JPS JuniOrtho Plating System™ is indicated for internal fixation of femoral and tibial fractures, osteotomies, mal-unions and non-unions.

Indications include:

• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or pertrochanteric fractures
• Proximal and distal metaphyseal fractures
• Pathological and impeding pathological fractures

Use of the JPS JuniOrtho Plating System™ is indicated in pediatric (excluding newborns) and small statients.

The Subject Device is a line extension of the existing locking and non- locking screws with same indications and intended use, diameters and new lengths, and with a modified geometry, to be used in addition to those already cleared for use (JPS JuniOrtho Plating System K200246).
The predicate device, screws are offered both in sterile and non-sterile packaging configurations and are made from Stainless steel AISI 316LVM, according to ASTM F138 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".

This is a medical device submission (510k) for a bone fixation system, not an AI/ML device. Therefore, the requested information about acceptance criteria and study details related to AI/ML device performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable to this document.

The document discusses the substantial equivalence of the JPS JuniOrtho Plating System™ (a line extension) to a predicate device, focusing on mechanical performance, biocompatibility, and intended use.

Here's the relevant information provided:

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

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

• Not applicable as this is a medical device (bone fixation system) and not an AI/ML device. The "test set" refers to mechanical testing of the physical device components. Specific sample sizes for the mechanical tests are not detailed in this summary, but are typically defined by the ASTM standard or internal protocols.

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. Ground truth, in the context of AI/ML, refers to labels or diagnoses. For a physical medical device, "ground truth" relates to engineering specifications and performance standards which are met through physical testing and quality control processes.

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

• Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations.

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. MRMC studies are relevant to devices that assist human interpretation, particularly in diagnostic imaging or clinical decision support AI/ML tools.

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

• Not applicable. This pertains to AI/ML algorithm performance.

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

• Not applicable as an AI/ML ground truth. For this device, the "ground truth" for its performance is defined by adherence to established mechanical standards (e.g., ASTM F543 – 17) and engineering specifications, ensuring safety and efficacy consistent with its intended use and predicate device.

8. The sample size for the training set

• Not applicable. Training sets are used for AI/ML model development.

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

• Not applicable. This relates to AI/ML model development.

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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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The SOLE™ Medial Column Fusion Plate is intended to provide bone fixation. The SOLE™ Medial Column Fusion Plate is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include: - Arthrodesis; - Joint depression stabilization; - Fracture and/or osteotomy fixation; - Reconstruction; - Revision to be performed for conditions such as Charcot neuroarthropathy.

The SOLE™ Medial Column Fusion Plate consists of plate's sizes and shapes ranges, designed to accept locking and non-locking bone screws, which are available in a variety of diameters and lengths, in order to address demands of stabilization, fixation and fusion of small bones and small joints within the anatomical area of the foot and ankle. The implants will be offered both in sterile and non-sterile packaging configurations. Plates and screws are intended for single use only. Screws are not intended for use in the spine. The Subject device implants, bone plates and bone screws, are made from Stainless Steel AISI 316 LVM according to Standard ISO 5832-1/ASTM F138. Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments offered by Orthofix are classified as class I devices Exempt from 510(k), under the product code LXH, according to 21CFR 888.4540 Orthopedic Manual surgical instrument. These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 301, AISI 303, X15TN) and Aluminum alloy (EN-AW 6082 T6). SOLE™ Medial Column Fusion Plate is designed to be used in the operating theatre only.

The provided document is a 510(k) premarket notification for a medical device called the SOLE™ Medial Column Fusion Plate. This documentation focuses on establishing substantial equivalence to existing predicate devices through non-clinical performance data and does not involve AI or machine learning. Therefore, many of the requested criteria (e.g., sample size for test/training set, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth for AI) are not applicable to this submission.

However, I can extract the acceptance criteria and the study type used to prove the device meets these criteria based on the information provided in the "Performance Analysis" section.

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)

The document primarily relies on bench testing and engineering assessments and a review of current clinical literature on predicates and similar devices. It does not describe a clinical study with human subjects, therefore, traditional "test set" and "data provenance" in the context of clinical data are not applicable. The bench testing would involve physical samples of the device; the number of samples is not specified.

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 is a device submission based on non-clinical performance data and substantial equivalence to predicates, not a study requiring expert-established ground truth for diagnostic accuracy.

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

Not applicable. No clinical test set requiring adjudication is described.

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 not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

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

For the mechanical performance testing, the "ground truth" or reference for acceptable performance are the specified requirements of the referenced ASTM and ISO standards. For the substantial equivalence argument, the performance of the predicate devices serves as a comparative ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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The OrthoNext ™ Platform system is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of Orthofix Product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.
The OrthoNext ™ Platform system is not to be used for mammography.

The OrthoNextTM Platform is a web-based platform module system, to allow surgeons to evaluate digital images while performing various pre-operative treatment planning, evaluation of images and post-operative treatment planning. This software application enables surgeons to import radiological images, display various 2D views of the images, overlays the positioning of the Orthofix devices template and simulate the treatment options, generate parameters and/or measurements to be verified or adjusted by the surgeons based on their clinical judgment.

The provided document is a 510(k) summary for the OrthoNext™ Platform System. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with specific acceptance criteria and detailed performance metrics as would be found in a PMA or de novo submission.

Based on the document, here's what can be extracted and what is not explicitly provided:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it relies on demonstrating equivalence to the predicate device and successful non-clinical testing. The "Performance Analysis" section states: "Subject device has similar configuration, and operating principle as the predicate device. Non-clinical software testing on operative treatment planning of orthopedic surgery using OrthoNext ™ Platform system produces results comparable to planning using acetate overlays but with the additional advantages of digital planning and simulations including ease of use, library, case documentation, access to a wider arrange of tools, and secure accessibility."

The "Conclusion" section indirectly describes the "performance" by stating that "The successful non-clinical testing demonstrates the safety and effectiveness of the OrthoNext ™ Platform system when used for the defined indications for use and demonstrates that the subject device, for which this Traditional 510(k) is submitted, performs as well as or better than the legally marketed predicate devices."

The types of testing performed are listed: "Unit, System/Integration and Acceptance test levels. Testing included also security, negative testing, error message handling, stress testing, platform testing, workflow testing, functional testing, multi-user/external access testing, data integrity testing, compatibility testing, load testing, regression testing, and hazard mitigation testing." However, specific acceptance criteria for each of these tests are not provided.

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

This information is not provided in the document. The filing focuses on non-clinical software testing: "Non-clinical software testing on operative treatment planning of orthopedic surgery using OrthoNext ™ Platform system produces results comparable to planning using acetate overlays..." The nature of this "testing" doesn't seem to involve a "test set" of patient data in the typical sense of a clinical trial.

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 provided. The document mentions that the device is "indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery" and that "Clinical judgments and experience are required to properly use the software." However, it does not detail any expert review process for a test set or ground truth establishment.

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

This information is not provided.

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

An MRMC comparative effectiveness study was not performed or at least not reported in this 510(k) summary. The document states: "The review of clinical literatures on similar devices support the clinical performance of the Subject device with no additional clinical data." This indicates that no new clinical study (like an MRMC) was conducted for this submission.

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

A standalone performance study of the algorithm alone (without human-in-the-loop) was not explicitly described with specific performance metrics. The nature of the device, which "assists healthcare professionals" and requires "clinical judgments and experience," implies a human-in-the-loop interaction as its primary mode of use. The software testing mentioned is "non-clinical software testing," which would assess the software's functionality and accuracy in performing its intended tasks (e.g., measurements, template overlay) rather than a diagnostic standalone performance.

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

For the non-clinical software testing, the document suggests the "ground truth" or reference for comparison was "planning using acetate overlays." This implies that the accuracy of the software's measurements and template positioning was compared against established practices using physical overlays. No mention of expert consensus, pathology, or outcomes data for establishing ground truth is made for the device's performance evaluation in this document.

8. The sample size for the training set

This information is not provided. The document describes "non-clinical software testing," and given the nature of the device (a planning and measurement tool, not an AI for diagnosis), a "training set" in the context of machine learning model development is most likely not applicable or not disclosed. The device performs functions like overlaying templates and performing measurements, which are rule-based software operations rather than typically requiring a "training set" in the AI sense.

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

As a training set is likely not applicable or not disclosed, the method for establishing its ground truth is also not provided.

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The JPS JuniOrtho Plating System™ is internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions of long bones of the lower limb.

The JPS JuniOrtho Plating System™ is indicated for internal fixation of femoral and tibial fractures, osteotomies, mal-unions and non-unions.

Indications include:

• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or pertrochanteric fractures
• Proximal and distal metaphyseal fractures
• Pathological and impeding pathological fractures

Use of the JPS JuniOrtho Plating System™ is indicated in pediatric (excluding newborns) and small stature adult patients.

The JPS JuniOrtho Plating System™ consists of plate's sizes and shapes ranges, designed to accept locking and cortical bone screws, which are available in a variety of diameters and lengths, in order to support internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions in long bones of lower limbs. The JPS JuniOrtho Plating System™ is designed according to the anatomic region of clinical application: femur and tibia. The implants would be offered both in sterile and non-sterile packaging configurations.

The subject device implants, bone plates and bone screws, are made from Stainless steel AISI 316LVM, according to ASTM F138 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".

Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments and accessories offered by Orthofix are classified as class I devices exempt from 510(k), under the product code LXH, according to 21 CFR 888.4540 Orthopedic Manual Surgical Instrument, and product code FSM according to 21 CFR 878.4800 Manual surgical instrument for general use.

These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 420B, AISI 303, X15TN), Aluminum alloy (EN-AW 6082 T6), and plastic material (PP-H PROPILUX).

JPS JuniOrtho Plating System™ is designed to be used in the operating theatre only.

This is a medical device 510(k) summary, not a study report for an AI/ML powered device. As such, it does not contain any information about:

• Acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes or data provenance for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

This document describes a traditional medical device, the "JPS JuniOrtho Plating System™," which consists of physical plates and screws for internal fixation of bones. The performance analysis mentioned refers to bench testing and engineering assessments of the mechanical properties of the hardware, compared to predicate devices, to demonstrate substantial equivalence.

Therefore, I cannot provide the requested table and information based on the provided text.

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