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The MAXFRAME AUTOSTRUT System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused or will not be crossed with hardware:

• · fracture fixation (open and closed)
• · pseudoarthrosis of long bones
• · limb lengthening (epiphyseal or metaphyseal distraction)
• · joint arthrodesis
• · infected fractures or nonunions
• correction of bony or soft tissue deformities
• · correction of segmental defects.

The MAXFRAME AUTOSTRUT System is comprised of a control system, software, and six length-adjustable struts powered by a motor. The devices are used in conjunction with the DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software, except that the MAXFRAME struts are substituted with the MAXFRAME AUTOSTRUT Hexapod Struts.
This submission is solely for the clearance of a sterile version of the MAXFRAME AUTOSTRUT Hexapod Struts. The MAXFRAME AUTOSTRUT Hexapod Struts are provided sterile and are comprised of telescopic rods made of stainless steel and aluminum and a motor adapter made from polymeric material. The MAXFRAME AUTOSTRUT Hexapod Struts are available in three lengths - short, medium, and long.
The MAXFRAME AUTOSTRUT Control System and Software have been cleared under K202810.

The provided text describes the 510(k) clearance for the DEPUY SYNTHES MAXFRAME AUTOSTRUT System. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of effectiveness for a diagnostic or therapeutic purpose.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (AutoStrut G2 K202810), primarily based on changes to the sterilization method of the Hexapod Struts (from non-sterile to sterile).

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them, as this information is not present in the provided text. The document explicitly states: "Clinical Performance Data was not necessary for the determination of substantial equivalence."

Here's a breakdown of what is mentioned, which largely pertains to non-clinical performance and a comparison to the predicate device:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics an AI or device output would be measured against. The "acceptance" here relates to demonstrating comparable safety and effectiveness to a predicate device.
• Reported Device Performance: The primary "performance" discussed is that "Bench testing demonstrates that the sterile MaxFrame AutoStrut Hexapod Strut is as safe and effective as its predicate device." This implies the new sterile version performs mechanically equivalent to the predicate, as validated by non-clinical tests.

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

• Not applicable as no clinical or diagnostic efficacy study is mentioned for this 510(k) submission. The testing performed was "Non-Clinical Performance Testing," including Mechanical Testing, Shelf-Life Validation, Packaging Validation, Sterilization Validation, and Biocompatibility Evaluation. No specific sample sizes for these tests are provided in the summary, nor is data provenance in terms of origin or retrospective/prospective nature.

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

• Not applicable as no diagnostic or clinical performance study with "ground truth" established by experts is described.

4. Adjudication method for the test set:

• Not applicable for the same reasons as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states, "Clinical Performance Data was not necessary for the determination of substantial equivalence."

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

• Not applicable. This device is an external fixation system (hardware), not a diagnostic algorithm. While it has a control system and software (cleared under K202810), this specific submission is only for sterile struts and does not detail a standalone algorithm performance study.

7. The type of ground truth used:

• Not applicable as no clinical or diagnostic performance study requiring ground truth (e.g., pathology, outcomes data) is mentioned. "Ground truth" for the non-clinical tests would be defined by engineering standards and test protocols.

8. The sample size for the training set:

• Not applicable as this is not a machine learning or AI algorithm development study.

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

• Not applicable for the same reasons as point 8.

In summary, the provided document focuses on regulatory clearance based on substantial equivalence for a medical device (external fixation system) where the primary change is the sterilization method of a component. It does not contain information about clinical performance trials, diagnostic accuracy studies, or AI algorithm validation against performance acceptance criteria.

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The Paragon 28 External Ring Fixation System is indicated in pediatric patients and adults for the treatment and fixation of:

• Open and closed fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis, infected union, non-union, or malunion of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity (e.g. orthoplastic surgery)
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures
• Bone transport

The Paragon 28 External Ring Fixation System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• Lisfranc dislocations
• Ankle distraction (arthrodiastasis)
• Septic fusion

The Paragon 28 External Ring Fixation System is a modular, ring-based, external fixation system designed for the treatment and fixation of a variety of conditions in pediatric and adult patients. The Paragon 28 External Ring Fixation System utilizes wires, pins, struts, rods, bolts, fasteners, clamps, and plates that connect to rings statically placed or gradually manipulated in order to fixate or correct the bone. The modular design of the system allows for a customized treatment for the patient.

Components of the Paragon 28 External Ring Fixation System may be used in conjunction with all Paragon 28 legally marketed devices.

The components of the device are offered in a variety of sizes, which allow for a truly customized external fixation device.

This document is a 510(k) Summary for the Paragon 28 External Ring Fixation System, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study or for evaluating AI performance. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided text.

The document focuses on:

• Indications for Use: Listing the medical conditions the device is intended to treat.
• Device Description: Describing the components and modular nature of the system.
• Predicate Devices: Identifying legally marketed devices to which the Paragon 28 system claims substantial equivalence.
• Performance Testing Summary: Stating that non-clinical testing was performed according to ASTM F1541, which is a standard for external fixation devices. This is mechanical performance testing, not clinical performance for diagnostic accuracy or effectiveness with human intervention.
• Comparison of Technological Characteristics: Arguing that the subject device shares material, design, and operating principles with the predicate devices.
• Conclusion: Stating that the device is substantially equivalent based on the provided information.

In summary, the provided FDA 510(k) clearance letter and summary are for a traditional medical device (an external ring fixation system) and do not contain information related to AI or a study designed to evaluate its clinical performance against specific acceptance criteria as you've outlined.

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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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AutoStrut G2 is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and will not be crossed with hardware:

• fracture fixation (open and closed)
• pseudoarthrosis of long bones
• limb lengthening (epiphyseal or metaphyseal distraction)
• joint arthrodesis
• infected fractures or nonunions
• correction of bony or soft tissue deformities ●
• correction of segmental defects. ●

The AutoStrut G2 is comprised of control system, software, and six length-adjustable struts powered by a motor. The devices are used in conjunction with the DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software, except that the MAXFRAME struts are substituted with the AutoStrut G2 motorized struts.

The MAXFRAME was cleared with software that generates a treatment plan for the patient, detailing how much each strut should be extended after a given amount of time. The output of this software is downloaded to the AutoStrut G2 control box which will then automatically extend the motorized struts the predetermined amount at the prespecified times. The AutoStrut G2 struts are provided in three (3) sizes, Large, Medium and Small corresponding to the MAXFRAM and should be steam sterilized by the user prior to use.

The provided text describes a medical device called AutoStrut G2 and its substantial equivalence to a predicate device, AutoStrut (K191241). However, the document does not contain information about acceptance criteria, reported device performance in those terms, or a study specifically designed to prove the device meets acceptance criteria related to clinical or diagnostic accuracy.

The "Performance Data" section lists various engineering and electrical safety tests, and mentions "Software characterization and validation," "Speed and accuracy evaluation," "Reliability, force and accuracy test," but does not explicitly state acceptance criteria or the results of these tests in a way that matches the requested output format.

Therefore, I cannot fully complete the table or the requested detailed information about a study proving the device meets acceptance criteria in the manner requested. The document focuses on demonstrating substantial equivalence through technological characteristics and bench testing, rather than a clinical performance study with defined acceptance criteria for diagnostic or treatment effectiveness.

I will fill in what information is available and indicate when requested information is not present in the provided text.

Acceptance Criteria and Device Performance

No specific acceptance criteria for clinical or diagnostic performance are provided in the document. The performance data section lists various engineering and safety tests, but does not detail numerical acceptance criteria or reported performance results in a table format for the device's functional or clinical effectiveness.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (AutoStrut K191241) through technological characteristics and bench testing. The "Performance Data" section lists several types of tests conducted:

Study Details

The provided document describes bench testing to demonstrate performance and substantial equivalence, not a clinical study to establish acceptance criteria for efficacy or diagnostic performance.

1. Sample size used for the test set and the data provenance: Not applicable, as this refers to bench testing rather than a clinical test set. The document does not specify sample sizes for the materials/devices tested in the listed engineering tests. Data provenance (e.g., country of origin, retrospective/prospective) is also not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The tests performed are engineering and electrical safety tests, not requiring expert ground truth for clinical interpretation.
3. Adjudication method for the test set: Not applicable.
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, an MRMC study was not described. The device is an external fixation system with automated struts, not an AI-assisted diagnostic or interpretation tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Software characterization and validation" and "Speed and accuracy evaluation" for the device, which operates automatically. This implicitly confirms standalone algorithm (control system) performance testing was done, but details of this testing (acceptance criteria, results) are not provided. The device's function is to automatically extend motorized struts based on a pre-determined treatment plan (generated by separate software, mentioned as MAXFRAME software, and downloaded to the AutoStrut G2 control box).
6. The type of ground truth used: For the engineering and electrical tests, the "ground truth" would be the specifications and requirements of the ASTM, IEC, and ISO standards referenced. For the "Speed and accuracy evaluation" and "Reliability, force and accuracy test," the ground truth would be the expected or target speed, accuracy, and force output of the struts.
7. The sample size for the training set: Not applicable. The document refers to bench testing and substantial equivalence, not a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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