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Intended Use: The Incompass Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

Indications for Use: The Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

Incompass™ Total Ankle System is a total ankle replacement system consisting of implants and instruments.

Incompass™ Total Ankle System will harmonize the Infinity™ and Inbone™ Total Ankle Systems into one comprehensive system consisting of modular stemmed and low-profile pegged tibial trays, tibial inserts, and talar domes. The harmonized system is facilitated by sharing the same tibial resection geometry between the pegged and the stemmed tibial tray designs.

The provided text is a 510(k) clearance letter for the Incompass Total Ankle System. It outlines the device's indications for use, its classification, and declares its substantial equivalence to predicate devices based on non-clinical evidence.

However, the clearance letter explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

This means that the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typical for studies proving a device meets acceptance criteria, especially for AI/ML-based devices or those requiring clinical trials) is not included in this document. The clearance was based on non-clinical performance bench testing to demonstrate substantial equivalence in wear, articular stability, lock detail, manufacturing processes, static strength, fatigue strength, fretting, corrosion, and MRI safety, rather than clinical efficacy studies.

Therefore, I cannot provide the requested information from this document. If this were a submission for a device that required clinical performance data to demonstrate safety and effectiveness (e.g., an AI/ML device), this section would typically contain summaries of those studies.

Based on the provided document, here's what can be inferred or explicitly stated regarding the acceptance criteria and study proving adherence to them:

The device in question is a Total Ankle System, a type of orthopedic implant, not an AI/ML-based device or one that underwent a clinical efficacy study for its 510(k) clearance.

The "study" that proves the device meets acceptance criteria, in this context, refers to non-clinical performance bench testing.

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

Since no clinical efficacy study was conducted for this 510(k) clearance, there's no data to populate such a table detailing clinical performance metrics (like sensitivity, specificity, or human reader improvement).

The acceptance criteria for this device were related to substantial equivalence through bench testing. The document states:

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

• Sample Size: Not specified in the document, as it refers to engineering and materials testing (bench testing) rather than a dataset of patient cases. For bench testing, "samples" would refer to the number of devices or components tested.
• Data Provenance: Not applicable in the context of clinical patient data (e.g., country of origin, retrospective/prospective), as the evidence was non-clinical bench testing. The testing would have been conducted in a laboratory setting.

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

• Not applicable. Ground truth as typically defined for AI/ML or clinical studies (e.g., expert consensus on medical images) was not established. The "ground truth" for bench testing is determined by engineering standards, material science principles, and established testing methodologies.

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

• Not applicable. This is relevant for studies involving human reviewers or AI output, not for materials and mechanical bench 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. This type of study is specifically for AI/ML-assisted diagnostic devices. The Incompass Total Ankle System is a physical medical implant.

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

• No. This is relevant for AI/ML algorithms.

7. The type of ground truth used:

• The "ground truth" for this clearance was established through engineering standards, material specifications, and validated bench testing protocols comparing the device's physical and mechanical properties against those of legally marketed predicate devices. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm.

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The Prophecy® Surgical Planning System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Surgical Planning Guides and Reports are intended for use with the Inbone®. Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (e.g. CT scans and X-rays). The Prophecy® Surgical Planning guides are intended for single use only.

The Prophecy® Surgical Planning System is composed of three components:

• Prophecy® patient-specific guides
• Prophecy® 3D Planner
• Prophecy® Preoperative report

The Prophecy® Surgical Planning System is compatible with the Inbone®, Infinity®, and Invision® Total Ankle Systems.

The provided text describes a 510(k) premarket notification for the Prophecy® Surgical Planning System. The submission focuses on modifications to the Prophecy® 3D Planner software. The information available details non-clinical testing performed to demonstrate substantial equivalence, but it does not provide specific acceptance criteria or an explicit study proving performance against those criteria in a format you requested for a device that involves performance against defined metrics (e.g., accuracy, sensitivity, specificity).

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "All test results met the acceptance criteria, demonstrating the subject device performs as intended and is substantially equivalent to the predicate device." However, the text does not explicitly list the specific acceptance criteria or the reported device performance metrics in a quantitative manner.

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

The document mentions "Software verification testing," "Software validation," "Usability test," and "Cybersecurity testing." These are general descriptions of testing types. No specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) are provided in the given text.

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

The document states, "Clinical testing was not necessary for the determination of substantial equivalence." This implies that the validation did not rely on expert-established ground truth in a clinical context for performance metrics as you typically find for AI diagnostic devices. For the usability testing, the number and qualifications of intended users (surgeons or engineers) involved in establishing ground truth are not specified.

4. Adjudication method for the test set

Since specific acceptance criteria involving expert-reviewed ground truth are not detailed, no adjudication method is mentioned or implied 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

The document explicitly states, "Clinical testing was not necessary for the determination of substantial equivalence." Therefore, no MRMC comparative effectiveness study was performed or is referenced.

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

The Prophecy® Surgical Planning System is described as a tool that "assists in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning," and involves "user interface software intended to be used by orthopedic surgeons" and "trained employees/engineers." This suggests a human-in-the-loop process. While software verification and validation would test the algorithm's performance, the context implies it's not a standalone diagnostic AI, but rather a planning and guidance tool. The text does not explicitly detail a standalone algorithm-only performance study in the manner of a diagnostic AI.

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

Given that clinical testing was not performed for substantial equivalence, the "ground truth" for the software's performance would likely be based on engineering specifications, design requirements, and possibly simulated or phantom data for accuracy of measurements and guide design. For usability, it would relate to user feedback and completion of tasks as per the system's design. The document mentions "software verification testing to ensure all design outputs meet all specified requirements" and "software validation to ensure software specifications conform to user needs and intended uses," which aligns with this interpretation.

8. The sample size for the training set

The document refers to a "Prophecy® 3D Planner" software update. It does not mention any machine learning or AI model training. Therefore, a training set size is not applicable or provided in this context.

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

As there's no mention of a traditional machine learning training set, this question is not applicable. The "ground truth" for the software's development (not training) would have been established through engineering design processes and requirements.

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The PROstep™ MIS 5mm Chamfer Screw is indicated for fixation of bone reconstruction. Examples include:

• Arthrodesis of the first metatarsal cuneiform joint to reposition and stabilize metatarsus primus varus
• Calcaneus/cuboid arthrodesis
• Talar/navicular arthrodesis

The PROstep™ MIS 5mm Chamfered Screw is designed to facilitate internal fixation for minimally invasive reduction of hallux valgus deformity and subsequent fusion of the first metatarsal cuneiform joint. The subject cannulated screw is made from titanium alloy (ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and features multiple lengths. The subject screw is sterile and provided with both sterile and non-sterile instrumentation.

This FDA 510(k) summary describes a medical device, the PROstep™ MIS 5mm Chamfer Screw System, and its substantial equivalence to a predicate device. However, it does not contain information typically associated with acceptance criteria and a study proving device performance as would be found for a diagnostic AI/ML device.

The document is for a metallic bone fixation fastener, which is an orthopedic implant. For such a device, "acceptance criteria" and "study proving device meets acceptance criteria" are generally evaluated through non-clinical mechanical, material, and biocompatibility testing, rather than studies involving extensive data sets, ground truth establishment, or human reader performance as seen in AI/ML or diagnostic imaging device submissions.

Here's a breakdown of the requested information based on the provided text, highlighting what is (and isn't) present:

A. Table of Acceptance Criteria and Reported Device Performance:

For this type of device, the "acceptance criteria" refer to compliance with material standards, mechanical performance benchmarks, and sterility requirements. The "reported device performance" refers to the results of the non-clinical tests demonstrating this compliance.

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

• Sample Size: Not applicable in the context of a "test set" for diagnostic performance. The tests described are engineering and material tests, not clinical studies with patient data.
• Data Provenance: Not applicable. The "data" comes from laboratory and engineering testing, not patient populations.

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

• Not applicable. "Ground truth" in this context would refer to the established material properties, mechanical limits, and sterility standards defined by the ASTM and ANSI/AAMI standards, which are developed by committees of experts, but not in the sense of adjudicating individual cases for a diagnostic study.

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

• Not applicable. This is methodology for expert review of cases, not for material or mechanical testing.

E. 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. This is relevant for diagnostic imaging devices, especially those incorporating AI. This device is an orthopedic implant.

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

• No. This is relevant for AI/ML devices.

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

• The "ground truth" for this device's performance is adherence to established engineering standards and material specifications (e.g., ASTM F543 for mechanical testing, ASTM F136 for material composition, ANSI/AAMI ST 72 for pyrogenicity, ASTM F2182, F2062, F2213, F2119 for MRI compatibility). The performance is compared against these predefined standard criteria and the characteristics of the legally marketed predicate device.

H. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

In summary: The provided document is a 510(k) summary for an orthopedic implant. The "acceptance criteria" and "proof" primarily revolve around demonstrating compliance with recognized engineering standards, material specifications, and substantial equivalence to a predicate device through non-clinical testing. This differs significantly from the type of performance evaluation and ground truth establishment required for diagnostic software or AI/ML devices.

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The Prophecy® Preoperative Navigation Alignment System is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Preoperative Navigation Alignment Guides and Reports are intended for use with the Inbone®, Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Prophecy® Preoperative Navigation Alignment Guides are intended for single use only.

The Prophecy® Preoperative Navigation Alignment System is composed of three components:

• Prophecy® patient-specific guides
• Prophecy® 3D Planner
• Prophecy® Preoperative report

The Prophecy® Preoperative Navigation Alignment guides are patient-specific devices that are designed based on preoperative planning software and assist surgeons in transferring their preoperative plan to surgery by guiding the marking of bone and/or guiding surgical instruments.

The Prophecy® 3D Planner software is a web-based application. The user interface software is intended to be used by orthopedic surgeons, as a preoperative planning and intraoperative viewing software for total ankle replacement surgery.

The Prophecy® Preoperative reports are patient-specific reports created from imaging scans to provide surgeons a template of the patient's distal tibial and proximal talar anatomy and offers relevant information for a successful total ankle replacement surgery.

The Prophecy® Preoperative Navigation Alignment System is compatible with the Inbone™, InfinityTM, and Invision™ Total Ankle Systems.

The Prophecy® Preoperative Navigation Alignment System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Preoperative Navigation Alignment Guides and Reports are intended for use with the Inbone®, Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Prophecy® Preoperative Navigation Alignment Guides are intended for single use only.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify the exact sample sizes used for the software verification, validation, or usability tests. It only states that the testing was conducted "in-house." The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective).

3. Number and Qualifications of Experts for Ground Truth

Not applicable. The study is focused on software verification, validation, and usability for a surgical planning system, not on diagnostic accuracy requiring expert panel review for ground truth.

4. Adjudication Method

Not applicable. This type of testing (software V&V, usability) does not typically involve adjudication methods like 2+1 or 3+1.

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

No MRMC comparative effectiveness study was mentioned. The submission states that "Clinical testing was not necessary for the determination of substantial equivalence."

6. Standalone Performance (Algorithm Only)

The testing described (software verification, validation, and usability) evaluates the performance of the software components of the device, which would include the algorithm's functionality. However, it's not explicitly stated as a standalone "algorithm only" performance study in the context of comparative effectiveness or diagnostic accuracy. The Prophecy® 3D Planner software allows surgeons to modify implant type, size, and orientation, indicating an interaction with a human user.

7. Type of Ground Truth

For software verification and validation, ground truth would be defined by the design requirements and functional specifications. For usability testing, ground truth would involve evaluating whether the software performs as expected for the intended users and uses, likely based on pre-defined tasks and performance metrics. Pathology or outcomes data are not applicable to the described non-clinical tests.

8. Sample Size for Training Set

Not applicable. This document describes testing for a device that involves software for surgical planning and patient-specific guides generation, not a machine learning model that requires a training set in the traditional sense for diagnostic or predictive tasks.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no mention of a training set for a machine learning model.

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PRO-DENSE LoVisc™ resultant pastel is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the sketal system (i.e., the extremities, and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE LoVisc™ paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-DENSE LoVisc™ is provided sterile for single use only.

PRO-DENSE LoVisc™ Bone Graft Substitute is a calcium sulfate formulation consisting of a powder component and aqueous mixing solutions. When the two component types are mixed according to directions, an injectable paste is formed. This paste is subsequently injected and/or digitally packed into a bone void where the graft cures and hardens via hydration reactions.

The provided text is a 510(k) summary for the PRO-DENSE LoVisc™ Bone Graft Substitute. It does not describe a study involving an AI device or present acceptance criteria and performance data for such a device. Instead, it focuses on demonstrating substantial equivalence of a medical device (bone graft substitute) to a predicate device based on non-clinical evidence.

Therefore, I cannot extract the requested information regarding an AI device's acceptance criteria, study details, expert involvement, or ground truth establishment from this document.

The document states:

• "SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE: N/A"
• "Ejection testing and LAL testing demonstrated that subject with increased working time, adjusted fill volumes, and updated kit accessories are equivalent to the predicate."

This indicates that the equivalence was established through non-clinical testing, not a clinical study involving human readers or AI performance metrics.

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The PHALINX™ Hammertoe System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Cannulated Implants in the PHALINX™ Hammertoe Fixation System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market a gamma sterilized version of the PHALINX Hammertoe system. The subject PHALINX® Hammertoe System implants are designed to facilitate fixation of osteotomies and reconstruction of the lesser toes. The implants have barbed proximal and interrupted distal threads fixation features and are offered in multiple sizes. The subject PHALINX hammertoe implant is single piece titanium device offered in straight cannulated and angled 10° solid options and remains identical to the predicate in design. The subject cannulated hammertoe implanted temporarily with k-wires (0.9, 1.1, 1.4 mm) to stabilize outlying joints. These k-wires were originally cleared under K 142585 and a minor modification to the length of the k-wire is being made in this submission.

This document describes a 510(k) premarket notification for the Sterile PHALINX Hammertoe System. This submission primarily focuses on introducing a gamma-sterilized version of an already cleared device and making a minor modification to the length of k-wires.

Therefore, the information typically associated with complex AI/ML device studies (like those involving acceptance criteria for diagnostic performance, multi-reader multi-case studies, or extensive ground truth establishment) is not applicable or present in this context. This is a submission for a physical orthopedic device, not an AI/ML algorithm.

Here's the breakdown of the requested information based on the provided text, highlighting what is missing or not applicable:

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

The provided document does not contain a table of acceptance criteria in the context of device performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it discusses the results of non-clinical tests to demonstrate equivalence to a predicate device.

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

This information is not applicable as this submission is for a physical orthopedic device and does not involve a "test set" of patient data for performance evaluation in the context of AI/ML. The "testing" refers to non-clinical laboratory evaluations of the device's physical properties and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. "Ground truth" in the context of clinical expert consensus for AI/ML performance evaluation is not relevant for this device submission.

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

This is not applicable. There was no "test set" requiring adjudication 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

This is not applicable. An MRMC study is relevant for diagnostic or AI-assisted devices that involve human interpretation. This submission is for a surgical implant.

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

This is not applicable. This is not an algorithmic or software-only device.

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

This is not applicable. As explained above, "ground truth" in the context of clinical AI/ML studies is not relevant here. The evaluation relies on established engineering standards and tests.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable. There is no "training set" or "ground truth" in this context.

Summary of the Study that Proves the Device Meets the "Acceptance Criteria"

The study primarily supporting this 510(k) submission consists of non-clinical testing to demonstrate the substantial equivalence of the Sterile PHALINX Hammertoe System to its predicate device (PHALINX Hammertoe, K150252). The key aspects of this study were:

• Pyrogenicity Testing: Performed using the bacterial endotoxins test on the subject device according to ANSI/AAMI ST 72. This demonstrates the device's acceptable level of pyrogens, a critical safety aspect for implants.
• MR Compatibility Evaluation: Engineering analysis was conducted to assess the magnetic resonance (MR) compatibility of the device. This involved evaluating:
  • RF Heating per ASTM F2182.
  • Induced Force / Induced Torque per ASTM F2062 and ASTM F2213.
  • Image Artifact per ASTM F2119.
    These tests ensure the device is safe for patients undergoing MRI procedures and does not significantly interfere with image quality.
• Design and Material Comparison: The submission explicitly states that the subject PHALINX hammertoe implants are "identical to the predicate in implant design, material, and intended use." Minor modification was made to k-wire length.
• Sterilization Method Change: The primary change is the introduction of a gamma-sterilized version. The non-clinical testing data supports the safety and effectiveness of this sterilization method for the device.

Clinical testing was not required for this submission because the device is substantially equivalent in design, material, and indications for use to an already cleared predicate device, with the main difference being the sterilization method and a minor k-wire length adjustment, which are addressed through non-clinical performance data and established regulatory pathways.

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The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the device. Screws gre intended for single use only.

The DART-FIRE EDGE Cannulated Screw System contains partially and fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from titanium alloy (ASTM F136).

Here's a summary of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

Not applicable. The study was non-clinical and involved performance testing of the device itself rather than a test set of data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This was a non-clinical study based on engineering performance tests.

4. Adjudication Method for Test Set

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

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

Not applicable. This was a non-clinical study for a bone fixation device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical implant, not an algorithm. The performance described is for the device's physical properties.

7. Type of Ground Truth Used

The ground truth or benchmark for performance was the performance of the legally marketed predicate device (K082320: Wright Compression Screws, K080850: DARCO Headless Compression Screw, K183696: PERFORM Reverse). The study aimed to demonstrate "substantial equivalence" to these devices through various mechanical and MR Safety tests.

8. Sample Size for Training Set

Not applicable. This was a non-clinical study for a physical device, not an AI model.

9. How Ground Truth for Training Set Was Established

Not applicable. There was no training set in the context of this device.

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The FuseForce™ Flex Dynamic Compression System is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.

The FuseForce™ Flex Dynamic Compression System consists of bone staple implants with two-leg and four-leg configurations. The system features low-profile and wide bridges, as well as multiple leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant and instruments for implantation. The implant is designed to provide compression to facilitate bone fusion.

This looks like a 510(k) summary for a medical device called the FuseForce™ Flex Dynamic Compression System. This document does not pertain to the performance of an AI/ML device, but rather a physical bone staple system.

Therefore, the requested information for an AI/ML study, such as acceptance criteria table, sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, is not applicable and cannot be extracted from this document.

The document discusses the substantial equivalence of the FuseForce™ Flex Dynamic Compression System to a predicate device based on non-clinical evidence (performance testing and engineering analysis) and states "N/A" for clinical evidence.

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Wright's PROPHECY™ Preoperative Navigation Alignment System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The PROPHECY™ Preoperative Navigation Alignment Guides and Reports are intended for use with Wright's INBONE™, INFINITY™ and INVISION™ Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY™ Preoperative Navigation Alignment Guides are intended for single use only.

The PROPHECY™ Preoperative Navigation Alignment System is composed of two components:

• . PROPHECY™ Preoperative report
• . PROPHECY™ patient-specific guides

The PROPHECY™ Preoperative reports are patient-specific reports created from imaging scans to provide surgeons a template of the patient's distal tibial and proximal talar anatomy and information relevant to the successful implantation of a total ankle replacement. The PROPHECY™ Preoperative Navigation Alignment guides are patient-specific devices that are based on preoperative planning software and assist surgeons in transferring this preoperative plan to the surgery by guiding the marking of bone and/or guiding surgical instruments. The PROPHECY™ patient-specific guides are accompanied by the preoperative report and serve as a template for traditional alignment instrumentation used with Wright Medical's INBONE™, INFINITY™, and INVISION™ Total Ankle Systems.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria for the PROPHECY™ Preoperative Navigation Alignment System.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

Specifically, the document states under "(b)(1). Substantial Equivalence - Non-Clinical Evidence":

• "The following evaluations were conducted to support the safety and effectiveness of the PROPHECY™ Navigation Alignment System changes to the PROPHECY™ Preoperative report: Board Certified Surgeon content, layout and accuracy verification and validation"
• "These evaluations concluded the subject device is substantially equivalent to the predicates and is adequate to perform as intended."

And under "(b)(2). Substantial Equivalence- Clinical Evidence":

• "N/A" (Not Applicable)

This indicates that a formal clinical study with performance metrics against acceptance criteria, as typically seen for novel devices or significant performance claims, was not provided or required for this particular 510(k) submission. The "Board Certified Surgeon content, layout and accuracy verification and validation" seems to be a qualitative assessment for the report's changes, not a quantitative performance study with the details requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, sample sizes, expert qualifications, or detailed study methodology because this information is not present in the provided text.

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The ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is indicated for complex intra- and extraarticular fractures, osteotomies, and non-unions of the distal tibia, and fracture fixation of the fibula in skeletally mature patients. This includes periarticular stabilization and fixation of fragments in fresh fractures.

ORTHOLOC™ 3Di Locking Screws are intended for use with Wright's ORTHOLOC 3Di Plating Systems of the same base material.

ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, ostectorny, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

The subject ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is designed to facilitate fracture fixation of the fibula and tibia. The system achieves its intended effect through the use of the various titanium alloy (Type II Anodized) straight, anatomical, and contoured plates and both locking and non-locking screws.

This document, a 510(k) Premarket Notification from the FDA, pertains to a medical device: the "ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System". It describes the device, its intended use, and comparative testing performed to demonstrate substantial equivalence to predicate devices, but does not involve an AI/ML component. Therefore, most of the requested information regarding AI/ML acceptance criteria and study details (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

The document discusses non-clinical evidence to support substantial equivalence, primarily mechanical testing and engineering justification. It explicitly states "N/A" for clinical evidence.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not:

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

The document does not provide a table of acceptance criteria in the context of an AI/ML model's performance. Instead, it describes mechanical testing conducted to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" here are implicitly meeting the performance of the predicate device.

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

This information is not applicable as the document describes non-clinical mechanical testing, not a study involving patient data for an AI/ML model. The "test set" in this context refers to the physical devices undergoing mechanical stress tests. The document does not specify the number of devices tested, but rather the standards followed (ASTM F382, ASTM F2182).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable. There is no "ground truth" established by experts in the context of mechanical testing. The results are based on objective physical measurements and engineering evaluations.

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

This is not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert consensus for labeling data, which is not present 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

This is not applicable. This document does not describe the evaluation of an AI-assisted device. There were no human readers whose performance was being assessed.

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

This is not applicable. This document does not describe an algorithm or AI model.

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

This is not applicable. The "ground truth" for this device's evaluation relies on established engineering standards and physical properties, not clinical or pathological outcomes.

8. The sample size for the training set

This is not applicable. There is no AI/ML model described in this document, and therefore no training set.

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

This is not applicable. No training set or associated ground truth establishment process is relevant to this device's submission.

In summary: The provided FDA document is a 510(k) for a traditional medical device (bone fixation plates and screws). It demonstrates substantial equivalence through mechanical and engineering testing, not through clinical or AI/ML performance studies. Therefore, most of your questions, which are highly relevant to AI/ML device evaluations, are not addressed by this document.

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