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The GIRO™ Growth Modulation System is intended as a temporary implant to aid in the correction of the angle of growth of long bones by modulating growth of the physis in pediatric (child and adolescent) patients. It is indicated for the following conditions:

• [ Femur and tibia: varus, valgus, flexion, or extension deformities of the knee.
• □ Humerus: valgus or varus deformities of the elbow.
• □ Radius and ulna: flexion or extension deformities of the wrist.
• □ Ankle: varus, valgus or plantar flexion deformities of the ankle.
• □ Limb length discrepancy of the femur and tibia.

The GIRO™ Growth Modulation System is a tether device used for quided growth and deformity correction. It includes two couplings linked via a flexible cable and anchored to the bone via screws and bi-cortical posts. By tethering the growth plate, angular deformities can be corrected. The implants are manufactured in medical grade 316L stainless steel (ASTM F138) and offered in two sizes: 4.5 and 6.0.

The provided text describes a 510(k) premarket notification for a medical device called "The GIRO™ Growth Modulation System." It outlines the device's intended use, description, and the basis for claiming substantial equivalence to legally marketed predicate devices.

However, the text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI or algorithm-based system. The "Non-clinical Performance Data" section describes bench testing and mechanical property analyses comparing the GIRO™ System to predicate devices, focusing on the physical performance of the implant itself (e.g., tension, torque, bending, pullout). The "Clinical Performance Data" section explicitly states: "No clinical testing is provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information as it is not present in the given document. The document is for a mechanical orthopedic implant, not an AI/algorithm-based diagnostic or treatment device that would typically have the kind of acceptance criteria and study designs you're asking about (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.).

If you have a document describing an AI/algorithm-based medical device, I would be happy to analyze it for the criteria you've outlined.

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This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening/shortening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.

The Fassier-Duval Telescopic IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation. The nail is composed of two sliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Peqa Medical Fassier-Duval Telescopic IM System can be attached to bony structures without disrupting the bone growth plates.

This Special 510(k) Premarket Notification is submitted for the additional offering of gamma sterilized Ø3.2 – Ø6.4 stainless steel Fassier-Duval implant components. All subject components have previously been cleared as non-sterile implants. All other components of the Fassier-Duval Telescopic IM System will remain non-sterile to be sterilized by end-user.

This document is a 510(k) Premarket Notification summary for a medical device called the Fassier-Duval Telescopic IM System. It is a submission to the FDA regarding a change to an already cleared device, specifically the addition of gamma sterilized stainless steel components.

Based on the provided information, there is no study to prove the device meets acceptance criteria in the traditional sense of an AI/software performance study for which the specified information (sample sizes, ground truth experts, etc.) would be provided.

Instead, this document describes a renewal/modification to an existing device (K020885 & K041393) where the primary change is the sterilization method and packaging for certain components. The "acceptance criteria" here relate to the successful validation of this new sterilization and packaging process, and adherence to established regulatory and engineering standards.

Here's a breakdown of the requested information based on the provided text, while noting that most of the requested parameters are not applicable to this type of submission:

1. Table of acceptance criteria and reported device performance:

Notes:

• The "device performance" in this context refers to the validated efficacy and safety of the new sterilization and packaging process, not clinical outcomes or algorithmic performance.
• The primary "acceptance criteria" for the original device are related to its mechanical properties, biocompatibility, and functionality as an intramedullary fixation rod, which are not explicitly detailed in this document but were part of the previous 510(k) clearances (K020885 & K041393).

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

• Not applicable (N/A) in the context of an AI/software performance study. For sterilization validation, the "sample size" would refer to the number of devices or test units subjected to the sterilization and packaging validation tests. This specific number is not provided in the document.
• Data Provenance: The tests for sterilization and packaging would have been conducted internally by Pega Medical Inc. or by a contracted laboratory. The document does not specify country of origin for these test results.

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

• N/A. This information pertains to studies where human experts establish ground truth for clinical data, which is not applicable here. Sterilization validations are typically performed by qualified microbiologists and technicians following established protocols.

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

• N/A. Adjudication methods are used for resolving disagreements among multiple human readers of clinical data. This is not relevant to sterilization validation.

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:

• N/A. This device is a physical medical implant, not an AI/software device. No MRMC study was conducted.

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

• N/A. This device is a physical medical implant, not an AI/software algorithm.

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

• N/A. In the context of sterilization and packaging, the "ground truth" would be established by validated scientific and regulatory standards (e.g., successful sterilization to a defined sterility assurance level, successful package integrity, acceptable endotoxin levels).

8. The sample size for the training set:

• N/A. This is a physical device, not an AI algorithm requiring a training set.

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

• N/A. (See point 8)

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The Simple Locking IntraMedullary (SLIM) System is intended as a temporary implant for alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes:

• Femur and tibia in the pediation (child and adolescent), and small-stature adults such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases.
  . Humerus, ulna, fibula in all patient populations

The Simple Locking Intra-Medullary (SLM) system consists of intramedullary fixation devices for use in long bones. The solid shaft, bevelled point, and pre-determined or blank length options is designed for easy insertion in the medullar canal. Anchorage of the device is achieved through a conical thread to obtain a stable fixation in the epiphyses or cortical bone, which aims to reduce the risk of migration. Internal features, such as a hexagonal drive and an internal mechanical thread in the device, are designed for capture and guidance during insertion and retrieval. Additional proximal and distal locking holes allow pinning to ensure fixation with locking pegs when required, and the Bullet screws allow fixation of smaller diameter shafts that cannot be cross-pinned due to their size. The SLIM implants are manufactured in medical grade Stainless Steel (SS316L, ASTM F138). The rods are available in seven diameters: 2.0.2.6.3.2. 4.0. 4.8. 5.6 and 6.4 mm, from 80mm up to 400 mm in length allows end user to customize the length of the rod.

The provided text describes a medical device's 510(k) submission to the FDA, focusing on substantial equivalence to predicate devices, rather than detailed acceptance criteria and a study proving device performance against such criteria. As such, much of the requested information is not available in the text.

Here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not specified, but based on the nature of the tests (bench testing, animal model) and the "non-clinical" designation, it would be laboratory-generated data.

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

• Not Applicable. This submission details non-clinical bench testing and an animal model, not studies requiring expert review for ground truth establishment.

4. Adjudication method for the test set:

• Not Applicable. No human-based adjudication methods were mentioned as this was non-clinical testing.

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

• No, an MRMC study was not done. This is a mechanical device, not an AI-powered diagnostic tool.

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

• Not Applicable. This device is an implant, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" would be established by validated test methodologies and measurements against engineering specifications or comparative performance to predicate devices (e.g., comparing load-bearing capacity, fatigue life, pull-out strength).
• For the animal model validation, the "ground truth" would be related to successful surgical technique demonstration and expected biological/mechanical outcomes in the animal.

8. The sample size for the training set:

• Not Applicable. This device doesn't involve a "training set" in the context of machine learning or AI.

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

• Not Applicable. (See above)

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

The text describes a series of non-clinical, bench-top mechanical tests and validation in an animal model to demonstrate the substantial equivalence of “The Simple Locking IntraMedullary (SLIM) System” to its predicate devices. The primary goal was to ensure that new components (Bullet screws, new pins/pegs, SLIM blanks) and the system as a whole performed equivalently or better than previously-cleared components and predicate devices.

Key tests performed include:

• Static four-point bending bench testing
• Fatigue four-point bending bench testing
• Pull-out & Push-out strength
• Surgical technique validation on an animal model
• Evaluation of Shaft to Bullet assembly migration resistance (static and cyclic loading)
• Static and fatigue four-point bending of the Bullet screws
• Comparative loading in a physiologically relevant setting of the SLIM and Bullet against the predicate device
• Functional testing of a cutting operation for an associated instrument (Intro-OP Implant Cutter (ICON) Prototype).

The conclusion of these tests was that the Bullet screws were "found equivalent for their intended uses," and the locking pegs were "considered that they perform equivalently" to simple locking pins in terms of torsion, drive torque, and axial pull-out. The SLIM blanks were deemed to have the same mechanical resistance due to identical materials and dimensions, and new pins/pegs were expected to have the same or higher mechanical resistance due to similar or larger diameters and materials.

No clinical testing was provided as a basis for substantial equivalence. The justification for this device's acceptance relied entirely on these non-clinical performance data and the conclusion that the "anticipated benefits of such a system clearly outweigh the possible residual risks."

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The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension of proximal femoral osteotomies (PFO) and fractures in the pediatric (ages 2 to 21 years old) population. Indications for use include the following:

*Inter and subtrochanteric valgus osteotomies

*Inter and subtrochanteric varus osteotomies

*Inter and subtrochanteric derotation osteotomies

*Inter and subtrochanteric flexion and extension osteotomies,

*Inter and subtrochanteric fractures.

The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension, of proximal femoral osteotomies (PFO) and fractures in the pediatic population. PFOs are widely performed reconstructive surgeries in children with hip deformities, such as Coxa Valga, Coxa Vara and other congenital deformities. The implants are made of medical grade 316L Stainless Steel (ASTM F138) and are offered in four sizes: infant, child, adolescent and adolescent HD. The system is comprised of a set of plates, connectors, locking cortical screws, polyaxial compressions screws, and all the instrumentation required for implantation and retrieval of the device.

The provided document is a 510(k) summary for the "The Locking Pediatric Osteotomy Plate (LolliPOP) System" and does not describe a study involving an AI/CADe device or an imaging device. Instead, it describes a mechanical bone fixation appliance. Therefore, many of the requested fields (such as "effect size of how much human readers improve with AI vs without AI assistance", "standalone performance", "training set", "ground truth for the training set", etc.) are not applicable.

Here's an analysis based on the information provided in the document for the medical device in question, which is a physical orthopedic implant system:

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)

This device is an orthopedic implant system, not a data-driven AI/CADe device. Therefore, the concept of a "test set" in the context of data points is not directly applicable.

• Mechanical Testing: Bench testing was performed on the device and a predicate device (Synthes CAPOS System). The exact sample size (number of devices or constructs tested) for these mechanical tests is not specified in the summary document. The "data provenance" would be laboratory testing.
• Clinical Evidence Review: A systematic search of scientific literature was conducted. This would involve reviewing existing published studies; no new clinical data was generated for this submission. The provenance would be the published scientific literature.

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

Not applicable for a mechanical device. "Ground truth" in this context would be established by engineering standards and mechanical test results, and by established clinical knowledge from the scientific literature review.

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

Not applicable for a mechanical device.

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

Not applicable. This is a mechanical orthopedic implant, not an AI/CADe device.

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

Not applicable. This is a mechanical orthopedic implant, not an AI/CADe device.

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

For the mechanical testing, the "ground truth" would be the engineering specifications, performance standards, and the measured mechanical properties of the predicate device. For the clinical evidence review, the "ground truth" was derived from published peer-reviewed scientific literature related to the intended uses and the predicate devices.

8. The sample size for the training set

Not applicable. This is a mechanical orthopedic implant, not an AI/CADe device that uses a training set.

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

Not applicable.

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The Y3 Proximal Femoral Plate System is intended for the temporary internal fixation of fractures and osteotomies of the greater trochanter or of the proximal femur.

It is indicated for the following:

• Re-attachment of the greater trochanter following osteotomy in THA
• Trochanteric and intertrochanteric fractures
• Extended trochanteric osteotomy
• Periprosthetic femoral fractures
• Comminuted fractures
• Mal-unions and non-unions
• Fractures in osteopenic bone

The Y3 Proximal Femoral Plate System is an innovative fixation device intended for the treatment of proximal femoral fractures and osteotomies. The unique Y-shape design divides the proximal portion of the plate into anterior and posterolateral branches, thus intended for stability at the Greater Trochanter level both in rotation and translation while reducing the prominence of the implant. Fixation options include locking and non-locking screws in addition to cerclage cables. The Y3 Proximal Femoral Plate System is manufactured in medical grade Titanium Alloy Ti-6AI-4V ELI as per ASTM F136. The Y3 Proximal Femoral Plate System is available in four lengths: 135, 185, 235 and 285 mm. Left and right versions are offered to accommodate the anatomical shape of the proximal femur.

The provided text describes a 510(k) premarket notification for the Y3 Proximal Femoral Plate System, a medical device for internal fixation of fractures and osteotomies. The FDA determined that the device is substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain information about:

• Acceptance criteria for device performance in a clinical study. The provided document focuses on mechanical equivalence and non-clinical performance data.
• A study proving the device meets specific acceptance criteria.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set.
• How ground truth for the training set was established.

The document explicitly states: "No clinical testing is provided as a basis for substantial equivalence." This means that the FDA's determination of substantial equivalence for this device was based on non-clinical performance data (bench testing, calculations) and a review of scientific literature, rather than data from a clinical trial with specific performance metrics against acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document, nor can I provide information regarding clinical study design elements such as sample sizes, expert involvement, adjudication, or ground truth establishment, as these were not part of the submission described.

The document focuses on demonstrating that the Y3 Proximal Femoral Plate System is substantially equivalent to existing devices based on:

• Intended Use: Similar indications.
• Design: Similar fixation methods (screws, cerclage cables) and materials (Titanium Alloy).
• Mechanical Properties: Bench testing and calculations showing equivalent or superior performance (stiffness, yield strength, bending strength) to the predicate device.
• Literature Review: Analysis of published literature on trochanteric fixation to address identified clinical hazards.

Non-clinical Performance Data Summary (as provided):

Study Proving Equivalence (Non-Clinical):

• Verification Calculations: Evaluated resistance and mechanical properties of the Y3 system components in comparison to predicate systems.
• Static and Fatigue Bench Testing: Confirmed the validity of calculations and demonstrated equivalent performance to the predicate NCB system.
• Scientific Literature Search/Clinical Evidence Review: Identified and analyzed published peer-reviewed literature regarding trochanteric fixation, specifically for the two predicate systems, to establish substantial equivalence by addressing clinical hazards from the device Risk Analysis.
• Cadaveric Study (cited from literature): A biomechanical hip extension study on cadaveric models showed the antero-lateral locking plate (referring to a plate with similar design principles to Y3) significantly reduced greater trochanter anterior migration compared to a lateral locking plate.

Regarding the other requested information, the document states:

• Sample size used for the test set and the data provenance: Not applicable as no clinical test set for performance was used. Non-clinical bench testing was performed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set requiring expert ground truth was performed.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical implant, not an AI diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical implant.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the non-clinical testing, "ground truth" would be the measured physical properties and performance metrics established through validated testing procedures. For the literature review, the "ground truth" would be the findings reported in peer-reviewed scientific publications.
• The sample size for the training set: Not applicable as there is no AI component or training set described.
• How the ground truth for the training set was established: Not applicable.

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The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) ages 2 to 21. It is indicated for correction of the following conditions:

• Diaphyseal fracture of the femur, tibia and humerus ●
• . Fractures of the femoral neck
• Subtrochanteric, intertrochanteric and combination fractures ●
• . Correction of deformities (OI, Coxa vara, Coxa valga)
• . Nonunions and malunions

The GAP Endo-Exo Medullary System consists of an intramedullary cannulated nail linked to various types of plates via lag and/or mechanical screws creating a combined Endomedullary/ Exomedullary osteosythesis device. The nail is available is diameters ranging from 4.8 to 12.0mm in 0.8mm increments. Lengths available range from 160 to 320mm. 2.5, 3 and 4mm cortical screws are used to secure the nail to the bone.

The provided text is a 510(k) summary for the Pega Medical Inc.'s GAP Endo-Exo Medullary System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through clinical studies in the way an AI diagnostic device would.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device (especially an AI-driven one) meets those criteria. Specifically:

• It does not present a table of acceptance criteria or reported device performance for an AI device.
• It does not mention sample sizes for test sets, data provenance, or details about ground truth establishment by experts.
• It doesn't discuss adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
• There's no mention of training sets or their ground truth establishment.

Instead, this document details a biomedical device's substantial equivalence to a predicate device based on design, materials, manufacturing, and in-vitro biomechanical testing for a design modification. It explicitly states:

• "No Animal or Clinical testing was performed."
• "No clinical testing is provided as a basis for substantial equivalence."

The "Non-clinical Performance Data" section describes bench testing:

• Study: Bench testing in static and fatigue loading with an offset axial compression test set-up.
• Purpose: To evaluate the modified design of the distal holes of the 4.8 mm GAP Nail.
• Finding: The new design increases mechanical resistance and fatigue life compared to the predicate Ø4.8mm GAP Nail design.

This information is relevant to the mechanical properties of an implant, not the diagnostic performance of a device, especially an AI one.

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The SLIM System is intended as a temporary implant for alignment, stabilization of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes the femur, tibia, humerus, ulna and fibula of the pediatric population (child and adolescent) , and patients with small intramedulary canals affected by skeletal displasias, osteogenesis imperfecta or other bone diseases.

The Simple Locking IntraMedullary (SLIM) System consists of intramedullary fixation devices for use in long bones. The solid shaft and bevelled point are designed for quided insertion through the medullary canal. Anchorage of the device is achieved through a conical thread for a wedged fixation in the epiphyses or cortical bone, which aims to reduce the risk of migration. Internal features, such as a hexagonal drive and an internal mechanical thread in the device, allow for capture and quidance during insertion and retrieval. Additional proximal and distal locking holes provide supplementary pinning options when required. The SLIM, single-use, implants are manufactured in medical grade Stainless Steel (SS316L, ASTM F138). The rods are available in seven diameters: 2.0, 2.6. 3.2, 4.0. 4.8, 5.6 and 6.4 mm, from 80mm up to 400 mm in length.

The provided document is a 510(k) premarket notification decision letter and summary for a medical device called "The Simple Locking IntraMedullary (SLIM) System." This type of document establishes substantial equivalence to existing devices and generally does not contain detailed acceptance criteria and studies as would be found in a clinical trial report for an AI/CADe device.

Therefore, many of the requested details, particularly those related to AI/CADe performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment, are not applicable or not present in this document.

However, I can extract information related to the device's performance based on the non-clinical performance data section, which focuses on mechanical properties.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device, the "acceptance criteria" are related to mechanical properties and equivalence to a predicate device. The document does not explicitly state numerical acceptance criteria in a pass/fail format but rather compares the SLIM system's performance to a predicate.

Regarding the other requested information:

• 2. Sample size for the test set and data provenance:

  • Sample size: Not specified. The studies mentioned are "four-point bending bench testing" on the SLIM system and the STEN system. The number of samples (e.g., number of rods tested) is not provided.
  • Data provenance: Bench testing results. Location of testing and design of the test samples are not mentioned.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for mechanical testing would be the measured physical properties, not expert consensus.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Mechanical test results do not involve adjudication by experts in this context.

• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical intramedullary rod, not an AI/CADe system for image interpretation.

• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical performance data was objective mechanical measurements (e.g., strength, fatigue resistance).

• 8. The sample size for the training set: Not applicable. There is no AI/machine learning component mentioned, thus no training set in the AI sense.

• 9. How the ground truth for the training set was established: Not applicable.

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The Free-Gliding SCFE Screw System is indicated as a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in all pediatric patients (less than or equal to 21 years old) with the exclusion of newborn and infants under 2 years of age.

The Free Glidinq SCFE Screw is a self-extending cannulated screw for use in fixation of slipped capital femoral epiphysis and femoral neck fractures. The design of the screw includes a male component (which is attached to the lateral cortex) and a female component (which is attached at the proximal epiphysis). Anchorage of the components is achieved through screw-type fixation. The screw has a built-in feature that allows for free extension of its length as the slipped capital physeal plate heals and normal patient growth continues. Stable fixation and rotational stability is created at the fracture (slip) site while avoiding compression forces thus avoiding premature closure of the physeal plate.

Here's an analysis of the provided text regarding the acceptance criteria and study for "The Free-Gliding SCFE Screw System":

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document explicitly states "No clinical testing is provided as a basis for substantial equivalence." This means that acceptance criteria for clinical outcomes (e.g., success rates, complication rates in patients) were not established or met through a clinical study for this device's 510(k) clearance. The substantial equivalence was based solely on non-clinical (biomechanical) testing and comparison to predicate devices.

Here's the breakdown of the other requested information, based on the provided document:

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

• Sample Size (Test Set): Not specified for the biomechanical tests. The document refers to "tests" but does not detail the number of samples tested for each biomechanical assessment (e.g., number of screws for four-point bending, torsional strength, or pullout strength).
• Data Provenance: The biomechanical testing was performed in Canada by Pega Medical Inc. (the applicant). This is an in-vitro (laboratory) study, not a human retrospective or prospective study.

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

• Not Applicable. Since this was a biomechanical (engineering) study, the "ground truth" was established by objective physical measurements according to specified ASTM standards and engineering analyses, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. No human-based adjudication was involved, as it was a biomechanical study.

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

• No. No MRMC study was conducted. The device is a physical implant, not a diagnostic imaging or AI-assisted system that would involve human readers.

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

• Not Applicable. This is a physical medical device (screw system), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Objective Mechanical Measurements: The ground truth for the biomechanical tests was based on objective measurements of physical properties (e.g., force, displacement, torque) as prescribed by ASTM F1264 and standard engineering principles. The comparison was made against the measurements obtained from predicate devices.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device. There is no concept of a "training set" as understood in machine learning or AI.

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

• Not Applicable. As there is no training set, this question is not applicable.

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The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surqically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) age 2 to 21. It can be used to correct the following conditions:

• Diaphyseal facture of the femur, tibia and humerus .
• Fractures of the femoral neck .
• . Subtrochanteric, intertrochanteric and combination fractures
• . Correction of deformities (OI, Coxa vara, Coxa valga)
• . Nonunions and malunions

The GAP Endo-Exo Medullary System consists of an intramedullary cannulated nail linked to various types of plates via and/or mechanical screws creating a a combined laq Endoamedullary/ Exomedullary osteosythesis device. 3 and 4mm cortical screws are used to secure the nail to the bone.

The provided document describes the GAP Endo-Exo Medullary System, an intramedullary nail system for pediatric patients. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study on specific acceptance criteria and device performance as would be expected for an AI/ML medical device.

Therefore, many of the requested sections regarding AI/ML study specifics (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it pertains to a mechanical medical device with no AI/ML component described.

Here's the information that can be extracted from the provided text, adapted for the context of this device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The tests were biomechanical, likely using multiple samples of the device and possibly bone simulants or cadaveric bone, but specific numbers were not provided.
• Data Provenance: The tests were "Biomechanical Testing" performed to demonstrate safety. The document does not specify the country of origin of the test data (e.g., where the lab was located), nor does it indicate if the data was retrospective or prospective in a clinical sense, as these were laboratory biomechanical tests.

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

• This question is not applicable as the document describes a mechanical device. "Ground truth" in the context of biomechanical testing typically refers to established engineering principles, material properties, and adherence to test standards, rather than expert consensus on medical images or diagnoses. The expertise would lie in the conducting and interpretation of the biomechanical tests according to ASTM standards.

4. Adjudication method for the test set

• This question is not applicable as the document describes a mechanical device. Adjudication methods like 2+1 or 3+1 are used for reconciling expert opinions on diagnoses or image interpretations, which is not relevant to biomechanical testing of an intramedullary nail.

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

• This question is not applicable. The device is a mechanical intramedullary nail, not an AI/ML algorithm or software. No MRMC study was conducted or described, nor would it be relevant for this type of device. The document explicitly states: "No clinical testing was provided as a basis for substantial equivalence. A clinical data report based on equivalent products can be found in Appendix H." This further confirms that no clinical studies (including those involving human readers or AI assistance) were part of the submission for this particular device's performance.

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

• This question is not applicable. The device is a mechanical intramedullary nail, not an AI/ML algorithm.

7. The type of ground truth used

• For the biomechanical tests, the "ground truth" was based on adherence to the specified ASTM standard 1264 "Standard Specifications and Test Method L for Intramedullary Fixation Devices" and the resulting performance (strength, durability) being within acceptable ranges for safety and intended use. This is a scientific/engineering ground truth defined by established test methods and safety criteria.

8. The sample size for the training set

• This question is not applicable. The device is a mechanical intramedullary nail, not an AI/ML algorithm that requires a training set.

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

• This question is not applicable. The device is a mechanical intramedullary nail, not an AI/ML algorithm that requires a training set.

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The Hinge Pediatric Plating System is indicated as a temporary implant to aid in the correction of the angle of growth of long bones by inhibiting longitudinal growth of the physis in pediatric patients. It can be used to correct the following conditions:

• Femur and tibia: varus, valgus, flexion or extension deformities of the knee. .
• . Humerus: valgus or varus deformities of the elbow.
• Radius and Ulna: flexion or extension deformities of the wrist. .
• Ankle: varus, valgus or plantar flexion deformities of the ankle. .

The Hinge Pediatric Plating System is a three-component device made of Medical Grade Stainless Steel. The components are a plate and two screws of different sizes.

This document describes the Hinge Pediatric Plating System, a medical device for correcting angular deformities in pediatric patients' long bones. The provided text indicates that the submission is a 510(k) summary, aiming to establish substantial equivalence to previously marketed predicate devices.

Based on the provided text, there is no information related to a study that establishes acceptance criteria for an AI/algorithm-based device, nor is there any device performance data in the context of AI. The entire document focuses on the regulatory submission for a physical medical device (pediatric bone plates and screws) and its substantial equivalence to existing predicate devices based on design, function, and biomechanical testing.

Therefore, I cannot populate the requested table or answer the subsequent questions, as they are not applicable to the provided content. The document explicitly states:

"Clinical Testing: No clinical testing was provided as a basis for substantial equivalence."

This further confirms that no clinical studies, which would typically involve human subjects and generate performance data against acceptance criteria, were provided for this submission. The "Biomechanical Testing" mentioned refers to physical tests on the device itself, not performance in a clinical or AI context.

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