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The TriMed Threaded IM Nail System is indicated for the treatment of select fractures and corrective osteotomies of short tubular bones. Specific indications for TriMed Small Threaded IM Nails include:

1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies
2. Metacarpal fractures, non-unions, malunions and corrective osteotomies

TriMed Threaded Intramedullary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F 136 or 316L Stainless steel per ASTM F138. TriMed is adding 3.6mm Threaded IM Nails with length ranges between 30 and 70mm to the already cleared 1.8mm – 3.0mm diameter ranges

The provided document is a 510(k) summary for a medical device (TriMed Threaded Intramedullary Nail System), which primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and non-clinical performance testing. It does not describe acceptance criteria for an AI/software device or a study involving human readers or AI performance in a clinical context.

Therefore, most of the requested information (items 2-9) regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document as it pertains to AI/software performance, which is not the subject of this 510(k) submission.

However, I can extract the information related to the non-clinical performance testing conducted for this device to demonstrate its safety and effectiveness.

Here's the relevant information that can be extracted:

1. Table of acceptance criteria and the reported device performance:

The document refers to performance testing based on FDA guidance and ASTM standards. While specific numerical acceptance criteria (e.g., "must withstand X N-mm of torque") and the exact reported values are not provided in this summary, the types of tests and the conclusion can be presented.

Conclusion: The technological characteristics, indications for use, and performance testing support the substantial equivalence of the Threaded IM Nail System with the predicate devices.

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

• Sample Size: Not specified in the summary for the non-clinical tests.
• Data Provenance: Not applicable as these are non-clinical, in-vitro mechanical tests, not clinical data from patients.

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 for mechanical testing is based on objective, quantifiable physical properties and test methods, not expert consensus.

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

• Not applicable for non-clinical mechanical 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

• Not applicable. This is for a physical medical device (intramedullary nail), not an AI/software device.

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

• Not applicable. This is for a physical medical device (intramedullary nail).

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

• For the non-clinical tests, the "ground truth" is derived from the objective physical measurements obtained through standardized mechanical testing methods (e.g., torsional strength, driving torque, axial pullout strength) as defined by ASTM standards and FDA guidance.

8. The sample size for the training set

• Not applicable. This is for a physical medical device.

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

• Not applicable. This is for a physical medical device.

In summary, the provided document details a 510(k) submission for a physical orthopedic implant (a threaded intramedullary nail system), and the "study" referred to is a series of non-clinical, in-vitro mechanical performance tests to demonstrate substantial equivalence, not a clinical study involving AI or human readers.

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The TriMed Threaded IM Nail System is intented for the treatment of select fractures and corrective of short tubular bones.

Specific indications for TriMed Small Threaded IM Nails include:

1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies

2. Metacarpal fractures, non-unions, malunions and corrective osteotomies

TriMed Threaded Intramedulary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F136 or 316L Stainless steel per ASTM F138. TriMed Threaded IM Nails are offered in diameters ranging from 1.8mm - 3.0mm in diameter and lengths between 12mm and 70mm.

The provided text describes a 510(k) premarket notification for the "TriMed Threaded Intramedullary Nail System." This documentation focuses on establishing substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a study with acceptance criteria in the typical sense of a diagnostic or AI device.

Therefore, many of the requested details about acceptance criteria, test set, ground truth, and human reader performance are not applicable to this type of submission. The device is a bone fixation fastener, not a diagnostic tool or an AI-powered system where such metrics would be relevant.

However, I can extract information related to the non-clinical performance data that was used to demonstrate substantial equivalence, which can be seen as meeting "acceptance criteria" related to mechanical properties.

Here's a breakdown of the available information based on your request:

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

The submission refers to meeting the recommendations of specific standards and guidance documents, which inherently contain "acceptance criteria" for mechanical performance. The document doesn't explicitly state the numerical acceptance criteria values or the reported device performance values in a direct table format within the provided text. Instead, it states that tests were performed "per the recommendations" and "per ASTM F543-17." This implies that the device met the criteria outlined in those documents.

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

• Sample size for test set: Not explicitly stated. For mechanical tests like these, sample size would typically be determined by the specific ASTM standard (e.g., ASTM F543-17) and internal quality control procedures.
• Data provenance: Not explicitly stated in terms of country of origin of data. The tests are "non-clinical evidence" conducted on the device itself.

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

• Not Applicable. This is a mechanical device, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical measurement of the device's properties.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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 bone fixation fastener, 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 a bone fixation fastener, not an algorithm.

7. The type of ground truth used

• Physical Measurements/Engineering Standards: The ground truth for mechanical tests like Torsional Strength, Driving Torque, and Axial Pullout Strength is established by standardized physical measurements according to validated testing methods outlined in documents like ASTM F543-17.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not a machine learning model requiring a training set.

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

• Not Applicable. See point 8.

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Advanced Intramedullary Nail System is intended to be implanted into the medullary canal of limbs for alignment. stabilization, fixation of fractures caused by trauma or diseases.

Indications:

1. Ulna Nail: Indicated for the fixation of fractures and osteotomies of the ulna.

2.Fibular Nail: Indicated for fixation of fractures and osteotomies of the fibula.

3. Ankle Fusion Nail: Indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot: tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and subtalar joints; avascular necrosis of the ankle and subtalar joints; failed total ankle replacement with subtalar intrusion;failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints.

The method of intramedullary nail fixation is symmetrical central splint fixation; central fixati on is theoretically superior to cortical external fixation, which can reduce the moment arm, re duce the incidence of varus and valgus angulation and internal fixation failure. Intramedullary nail fixation of fractures is stress-distributed fixation rather than stress-shielded fixation, whi ch is beneficial to the plasticity of callus. Advanced Intramedullary Nail System are made of Ti-6Al-4V ELI following ASTM F136. Advanced Intramedullary Nail System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

This document is a 510(k) Pre-market Notification for a medical device called "Advanced Intramedullary Nail System." It is a submission to the FDA seeking clearance to market the device based on its substantial equivalence to previously cleared predicate devices.

Based on the provided text, there is no study conducted to prove the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device performance study.

The document describes a medical implant device, not an AI or software algorithm. The "Advanced Intramedullary Nail System" is a physical device used for fixation of fractures. The information provided is typical for a 510(k) submission for a physical medical device, focusing on material equivalence, design features, biocompatibility, and mechanical testing.

Therefore, many of the questions asked cannot be answered because they pertain to performance studies of AI/algorithmic devices, which are not relevant to this submission.

Let's break down why and what information is available:

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

• Not applicable in the context of an AI/algorithmic device. The document discusses the device's physical properties and its equivalence to predicate devices.
• The "acceptance criteria" here would be related to the mechanical performance standards (e.g., specific loads the nails can withstand, or how well the screws perform under torsion), which are tested against ASTM standards (F543-17 and F1264-16). However, specific numerical acceptance criteria and reported performance values are not explicitly stated in a table format in this summary. The summary only lists the types of tests performed.

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

• Not applicable in the context of an AI/algorithmic device. For mechanical testing, the "sample size" would refer to the number of physical nails and screws tested. This information is not provided in the summary.
• There's no data provenance in the sense of patient data because this is a physical device, not an AI output.

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. There is no "ground truth" in the diagnostic or clinical sense for this physical device as it's not an AI evaluating patient data.

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

• Not applicable. There is no clinical "test set" requiring adjudication for a physical device like 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:

• Not applicable. This study design is relevant for AI image analysis or diagnostic support systems, not for a physical orthopedic implant.

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

• Not applicable. This refers to AI algorithm performance.

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

• Not applicable. The "ground truth" for this device's safety and effectiveness relies on its mechanical properties (meeting ASTM standards) and biocompatibility with human tissue, demonstrating equivalence to already cleared devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable.

Summary of relevant information from the document related to "acceptance criteria" (understood as compliance with standards) and "study" (understood as non-clinical testing):

Acceptance Criteria (Implicit via Standards Compliance):

• Biocompatibility: The device should be biocompatible according to the FDA Guidance "Use of International Standard ISO 10993-1." Specific pass/fail criteria are not detailed in this summary but are inherent in the standard.
• Mechanical Performance: The device materials and mechanical properties should meet the requirements of:
  • ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws) for the locking screws.
  • ASTM F1264-16 (Standard Specification and Test Methods for Intramedullary Fixation Devices) for the intramedullary nail.
  • Specific acceptance values (e.g., minimum torque, maximum deflection) are not listed in this summary but would have been presented in the full 510(k) submission.

The Study that Proves the Device Meets the Acceptance Criteria:

The document refers to "Non-Clinical Performance Data" as the study justifying the device's safety and effectiveness and its substantial equivalence.

• Biocompatibility Testing: Conducted in accordance with FDA Guidance and ISO 10993-1. (No further details on methods or results are provided in this summary).
• Mechanical Testing: Performed on the Advanced Intramedullary Nail System.
  • Locking Screw Tests: Torsion Test, Insertion/Removal Test, Self-tapping Test, Pullout Test, Bending Test. (These tests implicitly compare the device's performance to the predicate device and relevant ASTM standards).
  • Intramedullary Nail Tests: Four-Point Bend Test, Static Torsion Test. (These tests implicitly compare the device's performance to the predicate device and relevant ASTM standards).

Conclusion: The supplied document is a 510(k) summary for a physical medical implant. It does not contain information about acceptance criteria or studies related to AI/algorithmic performance. The "studies" conducted are non-clinical (biocompatibility and mechanical testing) to demonstrate substantial equivalence to predicate devices by meeting recognized industry standards.

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The Flex-Thread™ Ulna Intramedullary Nail System is intended for use in the fixation of fractures and osteotomies of the ulna.

The Flex-Thread™ Ulna Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the intramedullary canal of the ulnar diaphysis from an antegrade approach and cortical screws to provide stability and articular support in the proximal ulna and olecranon.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for software or AI/ML.

The document is a 510(k) premarket notification for a medical device called "Flex-Thread™ Ulna Intramedullary Nail System". It focuses on establishing substantial equivalence to a predicate device through mechanical testing, not through performance metrics of a software or AI/ML component.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as these are not discussed in the context of the provided text. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that "[n]on-clinical performance testing demonstrates that the Flex-Thread™ Una Intramedullary Nail System is substantially equivalent to the predicate device." The tests mentioned are mechanical tests such as static four-point bend, static torsion, bending fatigue, and bending fatigue of interlocking screws, along with insertion torque and implant tip deflection. These are physical product performance tests, not AI/ML performance evaluations.

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Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.

In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (periprosthetic fractures).

Indications for the TRIGEN Hindfoot Fusion Nail (HFN) include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations of the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.

The TRIGEN Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

The TRIGEN InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures.

Knee Fusion Nails are intended for intramedullary knee arthrodesis.

The purpose of this Traditional 510(k) is to add the MR safety information to the labeling and update the information within the package insert for the Smith & Nephew Intramedullary Nail Systems. The Smith & Nephew Intramedullary Nail Systems consist of the following previously cleared devices:

• Trigen Antegrade Tibial/Retrograde Femoral Nailing System (K981529 S.E. . 7/9/1998, K051557 S.E. 6/30/2005 and K061019 S.E. 6/6/2006)
• Trigen Tan/Fan Nailing System (K981529 S.E. 7/9/1998, , K040929 S.E. 5/25/2004, ● and K111025 S.E. 7/1/2011)
• Trigen Hindfoot Fusion Nail System (K043052 S.E. 11/24/2004) .
• . Trigen Humeral Nail System (K032722 S.E. 10/1/2003)
• Trigen Intertan Intertrochanteric Antegrade Nail System (K040212 S.E. 2/20/2004) ●
• . Trigen Knee Fusion Nail System (K050938 S.E. 5/4/2005)
  The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices as a part of this subject 510(k).

The provided text describes a 510(k) premarket notification for Smith & Nephew Intramedullary Nail Systems. The primary purpose of this submission is to add MR safety information to the labeling and update the information within the package insert for existing, previously cleared devices. This means the device itself has not changed in design, material, sterilization, or manufacturing processes. Therefore, the "study that proves the device meets the acceptance criteria" is focused on Magnetic Resonance Imaging (MRI) compatibility testing.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a tabular format with specific performance metrics for the device itself (e.g., fracture healing rates, strength). Instead, the acceptance criteria relate to MRI compatibility, which is assessed against established standards and guidance documents. The "reported device performance" in this context refers to the successful completion of these tests.

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

The document does not detail the specific sample size of devices tested for MRI compatibility. The testing information is generic, referring to "MRI compatibility testing was conducted." Given the nature of medical device MR safety testing, it typically involves a representative sample of device configurations (e.g., different sizes, materials, locking mechanisms) rather than a large "dataset" of patient data.

The data provenance is implied to be laboratory testing conducted according to the listed ASTM and IEC standards. There is no mention of patient data (retrospective or prospective) from any specific country of origin, as the submission is about changes to labeling based on technical testing, not clinical performance.

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 to this submission. The "ground truth" for MRI compatibility testing is established by the scientific principles and methodologies outlined in the referenced international standards (ASTM, IEC, ISO/TS) and FDA guidance documents, not by expert consensus on clinical cases. Testing engineers and MR safety specialists would be involved in conducting and interpreting these tests, but they are not "experts establishing ground truth" in the way radiologists might for diagnostic imaging.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human reviewers assess the same case and discrepancies need to be resolved. This submission is about technical testing of device properties, not clinical assessment by human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study involves human readers (e.g., radiologists) assessing cases, often with and without AI assistance, to measure the impact of AI on their performance. This submission does not involve an AI component or the assessment of human reader performance.

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

No. This submission is for physical intramedullary nail systems, not a software algorithm or AI device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is derived from the established physical and electromagnetic principles and measurement standards for MRI compatibility. The tests measure physical parameters like temperature rise, displacement force, torque, and artifact generation under defined MR conditions, with the standards themselves defining acceptable limits and testing methodologies.

8. The Sample Size for the Training Set:

Not applicable. This submission does not involve a training set as it pertains to physical devices and their MRI compatibility testing, not machine learning algorithms.

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

Not applicable, as there is no training set.

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The TriMed Threaded IM Nail System is intented for the treatment of select fractures and corrective of short tubular bones.

Specific indications for TriMed Small Threaded IM Nails include:

1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies

2. Metacarpal fractures, non-unions, malunions and corrective osteotomies

TriMed Threaded Intramedullary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F136 or 316L Stainless steel per ASTM F138. TriMed Threaded IM Nails are offered in diameters ranging from 1.8mm - 3.0mm in diameter and lengths between 20mm and 70mm.

The provided document is an FDA 510(k) clearance letter and associated summary for the "TriMed Threaded Intramedullary Nail System." This document pertains to a medical device (a physical object), specifically an orthopedic implant, and not a software-as-a-medical-device (SaMD) or an AI/ML-based device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-based device evaluation (which would involve test sets, expert ground truth, MRMC studies, etc.) is not applicable to this submission.

The document discusses the following types of performance data for this physical medical device:

• Non-Clinical Evidence Performance Data:

  • Torsional Strength
  • Driving Torque
  • Axial Pullout Strength Calculation
  • These tests were conducted according to FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" and ASTM F543-17.

• Clinical Evidence: "Clinical testing was not necessary for the determination of substantial equivalence." This is common for 510(k) submissions of devices demonstrated to be substantially equivalent to existing predicate devices.

In summary, none of the questions related to AI/ML device validation can be answered from this document because it describes a traditional hardware medical device.

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The Adaptable Ortho Innovations Intramedullary Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.

The Adaptable Ortho Innovations Intramedullary Nail System consists of an adjustable length intramedullary nail, locking screws, and end caps. All implants are manufactured from Ti-6Al-4V ELI per ASTM F136. The nail system is available in a range of lengths and diameters to accommodate varying patient anatomy.

This FDA 510(k) Premarket Notification is for a medical device (intramedullary nail system), not an AI/ML software device. Therefore, the typical acceptance criteria and study designs associated with AI/ML systems (such as those involving sensitivity, specificity, AUC, human reader studies, and ground truth establishment) are not applicable.

The document demonstrates substantial equivalence to predicate devices through mechanical testing and comparison of technological characteristics, not through clinical performance metrics related to diagnostic accuracy or human interpretation.

Here's an analysis based on the provided document, but understand that the questions about AI/ML performance metrics are not relevant to this type of device clearance:

1. Table of acceptance criteria and the reported device performance:

Since this is a mechanical device, the "acceptance criteria" revolve around demonstrating comparable mechanical properties to predicate devices, ensuring safety and performance in a biological and mechanical context. The document states that testing was performed per ASTM standards.

Regarding the AI/ML specific questions:

2. Sample sizes used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML diagnostic. Testing involves physical samples of the nail system for mechanical property evaluation. The number of samples tested would be dictated by the relevant ASTM standards (e.g., F1264, F543).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device is established through engineering and material science standards (e.g., ASTM standards for material properties, strength, fatigue).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among human readers for image interpretation, which is not relevant here.
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 not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on engineering standards, material specifications, and validated mechanical performance data (e.g., yield strength, fatigue life, torsional rigidity) obtained from physical testing of the device and its components.
8. The sample size for the training set: Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary:

The acceptance criteria for the Adaptable Ortho Innovations Intramedullary Nail System focused on demonstrating substantial equivalence to legally marketed predicate devices through robust mechanical testing (adhering to ASTM standards), material characterization, sterilization validation, and packaging/shelf-life validation. The FDA's clearance is based on the premise that these non-clinical tests are sufficient to establish that the device is as safe and effective as its predicates.

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The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.

The Flex-Thread™ Distal Fibula Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a fibula and cortical screws to further enhance stability and fixation of the fibula.

The provided text describes a medical device, the "Flex-Thread™ Distal Fibula Intramedullary Nail System," and its 510(k) submission for FDA clearance. However, the document does not contain information related to software or AI performance.

Therefore, I cannot extract acceptance criteria or study details regarding device performance from the provided text in the context of an AI/Software device. The submission focuses on the mechanical and functional equivalence of the intramedullary nail system to a previously cleared predicate device.

Specifically, the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 4 details mechanical testing and a cadaver lab simulation, which are relevant to the physical device's characteristics and use, not software performance.

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The TTC Phantom® Intramedullary Nail system is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:

• · Post-traumatic or degenerative arthritis
• · Previously infected arthrosis
• Revision of failed ankle arthrodesis
• · Revision of failed total ankle arthroplasty
• · Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
• · Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
• · Rheumatoid arthritis
• · Osteoarthritis
• Nonunions or pseudarthrosis of hindfoot and distal tibia
• · Trauma (severe or malunited tibial pilon fracture)
• · Charcot foot (neuroarthropathy)
• · Severe end-stage degenerative arthritis
• · Instability and skeletal defects after tumor resection
• · Pantalar arthrodesis
• · Severe foot/ankle deformity

The Paragon 28® TTC Phantom® Intramedullary Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.

This document describes a 510(k) premarket notification for the TTC Phantom® Intramedullary Nail System, which is a medical device for tibiotalocalcaneal arthrodesis. It does NOT describe an AI/ML powered device, and therefore the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, sample sizes for training/test sets, expert involvement, and reader studies is not applicable to this submission.

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

1. Indications for Use: Listing the specific conditions for which the device is intended.
2. Device Description: Detailing the components of the system.
3. Preclinical Testing: Describing mechanical testing (static and dynamic per ASTM F1264-14), wear testing, and biocompatibility evaluation (per ISO 10993-1 and CDRH's 2016 Biocompatibility Guidance). Additional testing mentioned includes bacterial endotoxins and sterilization.
4. Conclusion: Stating that the device is substantially equivalent to predicates based on intended use, technological characteristics, and preclinical testing.

Therefore, I cannot provide details on AI/ML acceptance criteria or studies from the provided text.

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The TTC Phantom® Intramedullary Nail system is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:

• Post-traumatic or degenerative arthritis
• Previously infected arthrosis
• Revision of failed ankle arthrodesis
• Revision of failed total ankle arthroplasty
• Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
• Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
• Rheumatoid arthritis
• Osteoarthritis
• Nonunions or pseudarthrosis of hindfoot and distal tibia
• Trauma (severe or malunited tibial pilon fracture)
• Charcot foot (neuroarthropathy)
• Severe end-stage degenerative arthritis
• Instability and skeletal defects after tumor resection
• Pantalar arthrodesis
• Severe foot/ankle deformity

The Paragon 28® TTC Phantom® Intramedullary Nail System is comprised of intramedullary nails, screws and accessory components. The TTC Phantom® nails are offered in a variety of sizes and lengths to accommodate variations in patient anatomy. The TTC Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.

This is for the approval of a physical medical device (TTC Phantom® Intramedullary Nail System), not a medical AI device. Therefore, much of the requested information (like sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable here as these concepts are specific to the evaluation of AI/ML models.

However, I can provide information based on the provided text regarding the closest equivalent to acceptance criteria and the study performed for this physical device.

Acceptance Criteria and Device Performance (Closest Equivalent for a Physical Device)

Study Information (Based on Physical Device Evaluation):

1. Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML model evaluation. For this physical device, the "test set" would refer to the components undergoing engineering analysis and cadaveric implantation. The text does not specify the number of components or cadavers used, nor their specific provenance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like an intramedullary nail is established through engineering principles, material testing standards, and mechanical performance evaluation rather than subjective expert consensus on data interpretation.

3. Adjudication method for the test set: Not applicable for a physical device evaluation. Adjudication methods are typically employed in studies where multiple human readers interpret data that may have ambiguous findings, which is not the case for material and mechanical performance testing.

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 for a physical medical device, not an AI product.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device.

6. The type of ground truth used:

   • Engineering analysis: This implies adherence to established engineering principles and standards for material strength, durability, and biomechanical function.
   • Cadaveric implantation study: This provides practical, real-world (though ex-vivo) evidence of how the device performs within a biological context, assessing fit, stability, and potential issues during implantation.
   • The "ground truth" here is the objective measurement of mechanical properties and functional performance against established benchmarks and predicate device performance.

7. The sample size for the training set: Not applicable. This is for a physical medical device. The "training" for such a device involves design iterations, material selection, and manufacturing process optimization, not algorithm training data.

8. How the ground truth for the training set was established: Not applicable. For a physical device, continuous improvement and design validation are ongoing processes. The basis for design decisions and material choices would come from established engineering and medical device standards, previous product performance, and clinical needs.

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