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The SixFix™ Hexapod and Deformity Analysis and Correction Software (DACS) are intended to be used for posttraumatic 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; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

The SixFix™ Hexapod Fixator is a multilateral circular external fixation system. The system includes the following external fixator elements: rings, footplates, arches, struts, threaded rods, wires, external fixation accessories, and software. All of the elements are provided non-sterile and are for single use only.

The system is designed such that gradually adjusting the lengths of the struts in relation to one another alters the orientation of the rings and, consequently, the bone segments connected to the rings by half-pins and wires during the treatment period in order to achieve the patient's treatment goals.

The Deformity Analysis and Correction Software is an optional software component and is used to assist the physician in calculating the lengths of the struts connecting the rings to manipulate the bone fragments. The software receives inputs from the physician and allows the physician to visualize the moving bone position. The program computes the strut lengths necessary to implement any desired translation and/or rotation required by the surgeon.

The provided text describes the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) but does not detail specific acceptance criteria or a study that rigorously proves the device meets those criteria with quantitative performance metrics.

Instead, the document highlights:

• Substantial Equivalence: The primary assertion is that the SixFix™ Hexapod Fixator and DACS are "substantially equivalent" to predicate devices (Taylor Spatial Frame, Deformity Analysis and Correction Software (DASC), and Ilizarov External Fixation Wires). This means it performs as well as or better than legally marketed predicate devices without raising new questions of safety or effectiveness.
• Performance Data Overview: It mentions that "Static and dynamic mechanical testing were performed" and "Software verification and validation testing were conducted." However, it does not provide the results of these tests in terms of specific acceptance criteria.

Therefore, an answer using the requested format would mostly consist of "Not Provided" or "N/A" for many fields, as the document does not contain the level of detail asked for in the prompt regarding a specific study proving quantifiable acceptance criteria.

Here's an attempt to answer based on the given text, with the understanding that much information is missing:

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

2. Sample sized used for the test set and the data provenance
Not provided in the document. The text refers to "static and dynamic mechanical testing" and "software verification and validation testing" but does not specify sample sizes for these tests or the provenance of any data used (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. The document focuses on substantial equivalence based on mechanical and software testing, not on clinical performance evaluated against expert ground truth for interpretation or diagnosis.

4. Adjudication method for the test set
Not applicable/Not provided. No clinical test set or expert adjudication process is described in the provided text.

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/Not provided. This document does not describe an MRMC study. The DACS is software to assist the physician in calculating strut lengths and visualizing bone position, not for diagnostic interpretation by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the DACS is a standalone software component in terms of its execution, the performance demonstration focuses on its functional equivalence to a predicate software and its role in assisting a physician. No specific "standalone performance" study (e.g., accuracy of calculations compared to a gold standard without human input as part of the evaluation) is detailed with quantifiable results. The text states, "The DACS matches the functions performed by the predicate DACS."

7. The type of ground truth used
For the mechanical testing, the ground truth would likely be established engineering standards or validated predicate device performance data.
For the software testing, the ground truth would be the expected output or behavior according to the software requirements specification and comparison to the predicate software's known functionality.
Specific details are not provided.

8. The sample size for the training set
Not applicable/Not provided. The document describes software verification and validation, not a machine learning model that would require a "training set" in the conventional sense.

9. How the ground truth for the training set was established
Not applicable/Not provided. As no training set for a machine learning model is mentioned, this information is not relevant to the provided text.

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in:

1. Post-Traumatic joint contracture which has resulted in loss of range of motion ( not applicable for Smith & Nephew Rail System)
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
3. Open and closed fracture fixation
4. Pseudoarthrosis of long bones
5. Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X Fixator)
6. Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
7. Correction of segmental bony or soft tissue defects
8. Joint arthrodesis (not applicable for Smith & Nephew Rail System)
9. Infected fractures or nonunions
10. Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius (not applicable for Smith & Nephew Rail System)
11. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints. As well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (not applicable for Smith & Nephew Rail System)

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. External Fixation Instrumentation. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew External Fixation Systems and their cleared Indications for Use. Smith & Nephew External Fixation Instruments can be organized into instrument families which are categorized as follows: Tightening/Insertion, Alignment, Guides, and Drills.

The provided text is a 510(k) Premarket Notification for the "Smith & Nephew, Inc. External Fixation Instrumentation." This submission is for surgical instruments, not a device that generates performance metrics in the way an AI diagnostic or therapeutic device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment is not applicable to this type of regulatory submission.

This 510(k) submission establishes substantial equivalence to legally marketed predicate devices based on similarities in:

• Raw materials
• Manufacturing processes
• Sterilization procedures
• Nature of body contact
• Design and function

The FDA's review for this type of device focuses on ensuring these accessory instruments are safe and effective for their intended use alongside the cleared Smith & Nephew External Fixation Systems, and that they are substantially equivalent to existing predicate instruments. It does not involve a performance study with quantitative acceptance criteria as would be expected for a diagnostic or AI-driven device.

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Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotation, translation, lengthening, and shortening. The External Fixator also aids correction of bone deformities or defects associated with fractures and other pathological conditions of bone. The limb function is preserved if the External Fixator is properly applied.

CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring). Part of external fixator aiding trophism in the correction of bone deformities/defects. Same physical design as predicate, except aesthetically and tactual more pleasing with improved impression of superior strength and safe mobility. Radiolucent Carbon Fiber Composite utilizing Randomly orientated, pre-impregnated carbon strands resulting in a carbon fiber content of better than 62%.

The CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring) was evaluated against its predicate device, the Ilizarov External Fixation System (K962808). The study focused on demonstrating comparative performance rather than setting specific acceptance criteria for absolute performance.

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

1. Acceptance Criteria and Reported Device Performance

The document describes a comparative study, implying that the "acceptance criteria" were met by demonstrating superiority in certain mechanical tests compared to the predicate device.

2. Sample Size and Data Provenance

The document does not specify the precise sample size used for the comparative mechanical tests. It only states "Comparatively tested." The data provenance is not mentioned (e.g., country of origin) nor whether it was retrospective or prospective, but given it's a mechanical performance comparison, it would likely be laboratory-based testing.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the study described is a mechanical performance comparison of a medical device, not a study involving human interpretation of data where expert ground truth would be established (e.g., in medical image analysis).

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

5. MRMC Comparative Effectiveness Study

An MRMC (Multi Reader Multi Case) comparative effectiveness study was not conducted. The study described is a direct mechanical comparison of a new physical device against an existing physical device, not an evaluation of human reader performance with or without AI assistance.

6. Standalone Performance Study

A standalone performance study in the context of patient outcomes or clinical efficacy was not explicitly described for the CyberOrthology CIRfix. The "performance" described is a standalone mechanical performance comparison against a predicate device in a laboratory setting. The document highlights mechanical superiority of the new device (15-20% superiority in various tests) when compared to the predicate device.

7. Type of Ground Truth Used

The "ground truth" for this study was established through mechanical testing standards (e.g., ASTM F-1746 for Compression Stiffness) and direct comparison of measurable physical properties against a predicate device. This is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not a machine learning algorithm that requires a "training set" in the computational sense.

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

This information is not applicable for the reasons stated above.

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Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation aand treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.

External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.

The provided document (K012634) is a 510(k) Pre-Market Notification for "Reprocessed External Fixation Devices" by Alliance Medical Corporation. This type of submission is for "reprocessed" medical devices, meaning devices that were originally intended for single use but are being re-used after cleaning, sterilization, and sometimes repair. The testing described focuses on demonstrating that the reprocessed devices perform as intended, similar to their original, new counterparts, and that the reprocessing method is effective.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the reprocessed devices are identical in design, materials, and intended use as the predicate devices, implying that the acceptance criteria are met if these characteristics and the performance benchmarks are maintained after reprocessing. The specific quantitative acceptance criteria values (e.g., specific tensile strength, fatigue life, or sterilization sterility assurance levels) are not detailed in this summary, but are generally part of the underlying bench and laboratory testing reports.

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

The 510(k) summary does not explicitly state the sample size used for the test set in the performance, biocompatibility, or reprocessing validation studies. It only mentions "Bench and laboratory testing."

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for reprocessed devices, the data would typically be derived from controlled laboratory studies and possibly prior clinical use data of the original devices or reprocessed devices.

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

This type of submission for reprocessed devices typically relies on engineering and scientific experts to establish test protocols, analyze performance, and validate reprocessing methods, rather than clinical experts establishing a "ground truth" for a diagnostic or AI device. The document does not specify the number or qualifications of such experts involved in establishing the testing parameters or reviewing the results.

4. Adjudication Method for the Test Set

The concept of "adjudication method" (like 2+1, 3+1) is not applicable to this type of device submission. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reading images) where disagreement needs to be resolved to establish ground truth. For reprocessed external fixation devices, performance is assessed through objective physical, mechanical, and chemical tests.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images. External fixation devices are physical medical instruments, and their effectiveness is not assessed through human reader interpretation of cases.

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

No, a standalone (algorithm-only) performance study was not done. This concept applies to AI/ML algorithms that operate independently. The device here is a physical external fixation device.

7. The Type of Ground Truth Used

For this device, the "ground truth" is established by objective engineering specifications, material properties, and sterility standards for external fixation devices. For instance:

• Mechanical Integrity: The reprocessed devices must meet the same mechanical strength, fatigue, and other performance characteristics as new, predicate devices.
• Biocompatibility: The materials must remain biocompatible after reprocessing.
• Sterility: The reprocessing must render the devices sterile, typically validated to a Sterility Assurance Level (SAL) of 10^-6.
• Cleaning Effectiveness: The devices must be effectively cleaned to remove biological and other foreign material.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this type of device. Training sets are used in machine learning for AI algorithms. This submission is for reprocessed physical medical devices, not an AI/ML product.

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

As noted above, a "training set" is not applicable to this device.

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open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of bony or soft tissue defects. Titanium washers are intended to be used for fixation to distribute the load of the wire with stopper, for the diagnostic indications of osteoporotic bone. These components as part of the Ilizarov External Fixator System are for the diagnostic indications of fractures, pseudoarthrosis and correction of segmental or nonsegmental bony or soft tissue deformities

The titanium washers and titanium wires of the Ilizarov External Fixation System are single use devices designed for patients with the following indications: open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of bony or soft tissue defects. Titanium washers are intended to be used for fixation to distribute the load of the wire with stopper, for the diagnostic indications of osteoporotic bone. These components as part of the Ilizarov External Fixator System are for the diagnostic indications of fractures, pseudoarthrosis and correction of segmental or nonsegmental bony or soft tissue deformities. The titanium wires and washers have the same function as the existing stainless steel wires and washers. They are made of titanium for patients who have a sensitivity to stainless steel. The titanium components are primarily for patients that have allergy sensitivities. The washer and wires interconnect with the Ilizarov External Fixator System. The wires are inserted and attached to the rings of the circular fixator and rods of the Ilizarov External Fixator System. The wires are available with an olive shaped stopper to create interfragmentary compression or to add more stability to the assemblage. The washer may be used with the wires with stopper to provide surface area for the stopper to push up against.

This document is a Summary of Safety and Effectiveness for medical devices (implants). It describes the intended use and materials of the devices (titanium washers, wires for external fixation systems) and states that fatigue testing was performed on the wires, with acceptable results.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics in the way you've outlined in your request.

The request asks for details typically associated with the evaluation of AI/ML-powered diagnostic or predictive devices, focusing on performance metrics like sensitivity, specificity, AUC, and expert-based ground truth. The document provided is for a physical medical device (external fixator components) and focuses on mechanical properties like fatigue life, comparing new materials to existing ones.

Therefore, I cannot fulfill your request for the specific details listed, as they are not present in the provided text.

Here's why:

• No "device performance" in terms of diagnostic accuracy: The document discusses the mechanical performance (fatigue) of wires, not the diagnostic or predictive performance of an algorithm.
• No "acceptance criteria" related to diagnostic metrics: There are no explicit thresholds for sensitivity, specificity, etc. The acceptance criteria for the wire would likely be failure rates or cycles to failure under specific loads, which are not detailed here beyond "acceptable results."
• No "sample size" for test sets of clinical images/data: The testing mentioned is for the physical device's mechanical properties, not an algorithm's performance on a dataset.
• No "data provenance," "experts for ground truth," "adjudication methods," "MRMC studies," or "standalone performance": These concepts are entirely irrelevant to the mechanical testing of a medical implant and are not mentioned.
• No "ground truth" concept in the AI sense: For physical devices, "ground truth" might refer to known material properties or engineering specifications, but not expert-labeled data.
• No "training set" or "how ground truth for training set was established": These are AI/ML specific concepts.

In summary, the provided document is not relevant to the kind of performance evaluation questions you are asking.

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