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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 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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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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PRO-DENSE™ LoVisc Bone Graft Substitute 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 skeletal 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. PRO-DENSE™ LoVisc Bone Graft Substitute resorbs and is replaced with bone during process.

PRO-DENSE™ LoVisc Bone Graft Substitute 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 process.

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

PRO-DENSE™ LoVisc Bone Graft Substitute is a composite of calcium sulfate and calcium phosphate. The formulation consists 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.

Based on the provided text, the document describes a 510(k) premarket notification for a medical device called PRO-DENSE™ LoVisc Bone Graft Substitute. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily the PRO-DENSE Bone Graft Substitute (K181255/K182823).

The information provided focuses on the non-clinical evidence used to support this claim of substantial equivalence. There is no mention of a study involving AI assistance, human readers, or image analysis. The device is a bone graft substitute, and its evaluation parameters are material properties and performance in a surgical context, not diagnostic accuracy based on algorithmic performance.

Therefore, many of the requested sections related to acceptance criteria for an AI/imaging device, MRMC studies, standalone AI performance, and expert ground truth establishment for diagnostic purposes, are not applicable to the content of this document.

Here's a breakdown of the requested information based only on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Study for PRO-DENSE™ LoVisc Bone Graft Substitute

The provided text describes a 510(k) submission for a bone graft substitute, not an AI or imaging device. The "acceptance criteria" discussed are related to the material and mechanical properties of the bone graft substitute, demonstrating its equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied to be within the range of the predicate device's characteristics. The performance is reported in terms of chemical and mechanical properties.

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

These concepts are not applicable in the context of this device and submission type. The "test set" refers to the samples of the PRO-DENSE™ LoVisc Bone Graft Substitute tested for its material properties. There is no mention of sample sizes for individual tests. The "data provenance" would refer to where the bone graft material was manufactured and tested, which is not specified beyond "Wright Medical Technology, Inc." in Memphis, TN. Data is from benchtop testing, not human subjects.

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

This information is not applicable. The "ground truth" for a bone graft substitute is its inherent material properties and performance characteristics, measured through standardized assays (e.g., FTIR, XRD, mechanical testing). Experts would be involved in the design and interpretation of these bench tests, but not in establishing a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers in diagnostic studies. For material property testing, results are typically quantitative and objective measurements.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states "(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A", meaning no human clinical studies were performed or are being presented for this submission. Therefore, no information on human reader improvement with AI assistance is available.

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

No, a standalone algorithm performance study was not done. This device is a physical bone graft substitute, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through objective, standardized benchtop testing of chemical and mechanical properties. This includes:

• Fourier Transform Infrared Spectroscopy (FTIR)
• X-ray Diffraction Analysis (XRD)
• Dissolution
• Porosity
• Density
• Maximum Exothermic Temperature
• Dilute Slurry pH
• Vicat and Gilmore Set Time
• Injectability
• DTS (unspecified, likely a material property test)
• Hardware interaction
• Sterilization
• Biocompatibility
• Pyrogenicity
• LAL testing

8. The Sample Size for the Training Set

This concept is 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

This concept is not applicable.

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The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are additionally indicated for patients with a failed previous ankle surgery.

CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

The subject INBONE™ Total Ankle System, INFINITY™ Total Ankle System and INVISION™ Total Ankle Revision System are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. The systems include three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis.

This is a 510(k) summary for a medical device (an ankle replacement system), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is largely not applicable in the context of AI/ML performance evaluation.

However, I can extract the information that is present regarding the non-clinical performance and a general conclusion of equivalency:

Device Name: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System

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

The document lists "Applicable Standard" for various non-clinical performance bench tests. The specific acceptance criteria (e.g., minimum tensile strength value) are not explicitly stated within this summary, nor are the reported performance values. The study concludes that the device performs "at least as well as the predicate devices," implying it met the standards.

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The INBONE Total Ankle System and INFINITY Total Ankle System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The INBONE Total Ankle System and INFINITY Total Ankle System are additionally indicated for patients with a failed previous ankle surgery.

CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

The subject INBONE™ and INFINITY™ Total Ankle Systems are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. Both the INFINITY and INBONE systems include three components (tibial trays with or without stems, poly inserts, and talar domes) that are assembled together to create the two-piece prosthesis.

This is a 510(k) premarket notification for a medical device (INFINITY and INBONE Total Ankle Systems) and does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it demonstrates substantial equivalence to predicate devices, focusing on design, materials, and non-clinical performance.

Therefore, many of the requested points cannot be answered from the provided text. I will address the points that can be inferred or directly stated.

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

The document does not present acceptance criteria or reported device performance in the form of a table with numerical values for metrics like sensitivity, specificity, or image quality, as would be expected for a diagnostic or AI-driven device. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to predicate devices.

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