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Intended Use

CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans.

Indications for Use

The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures:

• Unicondylar Knee Replacement (UKR)
• Total Knee Arthroplasty (TKA)
• Primary Total Hip Arthroplasty (THA)
• Primary Anatomic Total Shoulder Arthroplasty (aTSA)
• Primary Reverse Total Shoulder Arthroplasty (rTSA)

Coriograph Pre-Op Planning and Modeling Services (CORIOGRAPH) are Software as a Medical Device (SaMD) that provide pre-operative planning for orthopedic surgical procedures based on patient imaging, surgeon preferences and implant geometry. CORIOGRAPH is comprised of several medical software systems (modules), and these modules share a set of non-medical function software applications called the Case Processing System.

CORIOGRAPH is a Software Medical Device System. The medical function modules share a graphic user interface where the surgeon provides their case preferences and patient imaging, retrieves PDF plans generated by the Pre-Op Plan modules, and launches the Modeler modules.

CORIOGRAPH Pre-Op Plan Modules

Using patient-specific information, patient imaging, and surgeon inputs, a pre-operative plan is generated by Smith+Nephew personnel. The plan provides initial alignment recommendations to the surgeon on implant placement based on the geometries of the implant and of the generated bone models.

CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler Modules

CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler are web-based software applications intended for surgeons to modify the patient-specific pre-operative plan and to evaluate the impact of the modifications through the impingement analysis tools such as Impingement-free Range-of Motion (ROM) and Activities of Daily Living (ADL) simulations.

The provided text is a 510(k) clearance letter and summary for a medical device called CORIOGRAPH Pre-Op Planning and Modeling Services. It details the device's intended use, indications for use, and a comparison to predicate devices, focusing on the addition of shoulder arthroplasty procedures.

However, the document does not contain the specific information requested regarding acceptance criteria and the detailed study proving the device meets these criteria. It mentions non-clinical bench testing, software verification testing (IEC 62304), credibility evaluation of kinematic models and ADL simulations, and summative usability validation testing (IEC 62366). It states that "Design verification and validation testing demonstrated that CORIOGRAPH Pre-Op Planning and Modeling Services (v 3.0) meets all design requirements and is as safe and effective as its primary and secondary predicate devices." and "The credibility evaluation demonstrated that the kinematic models and Activities of Daily Living (ADLs) simulations utilized in the subject device are clinically relevant."

Crucially, it does not provide:

• Specific acceptance criteria for accuracy, precision, or performance metrics.
• Quantifiable reported device performance against those criteria.
• Sample sizes for test sets used for performance evaluation (other than mentioning "representative users" for usability).
• Data provenance (country of origin, retrospective/prospective) for performance data.
• Details on expert ground truth establishment (number of experts, qualifications, adjudication method).
• Information on MRMC comparative effectiveness studies.
• Standalone (algorithm-only) performance.
• Type of ground truth used (e.g., pathology, outcomes data) for clinical performance, if any.
• Sample size for the training set or how its ground truth was established.

The document is a high-level summary confirming regulatory clearance based on substantial equivalence, implying that the detailed testing data would have been part of the full 510(k) submission, but is not included in this public-facing summary.

Therefore, based only on the provided text, I cannot complete the requested tables and details about acceptance criteria and study proof. The document confirms that testing was done and results met requirements, but does not provide the specifics of those results or the criteria themselves.

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The MedCAD® AccuStride™ System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or guide surgical instruments in nonacute, non-joint replacing osteotomies in the foot for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System surgical guides are intended for single use only. The MedCAD® AccuStride™ System surgical guides should only be used when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., CT).

The MedCAD® AccuStride™ System is a collection of two individual pieces of software and associated additive manufacturing equipment intended to provide a variety of outputs to support non-acute, nonjoint replacing osteotomies in the foot. The system uses electronic medical images of the patient's anatomy or with input from the physician, to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system includes anatomical models, surgical guides, and patient-specific case reports.

Following the MedCAD® Quality System and specific Work Instructions, trained employees utilize Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical Computed Tomography (CT) images to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during and prior to delivery of the final outputs. It should be noted that the system is operated only by trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session.

The FDA 510(k) summary for the MedCAD® AccuStride™ System provides information about the device's acceptance criteria and the studies conducted. However, it does not provide detailed acceptance criteria and performance metrics for the software's ability to perform preoperative planning or guide marking, as typically expected for pure AI/ML software. Instead, the performance testing focuses on the physical components (surgical guides and anatomical models) produced by the system.

Here's an attempt to extract and infer the requested information based on the provided text, while also highlighting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document focuses on the outputs of the system (surgical guides and anatomical models) rather than the standalone performance of the software in performing planning or marking. The "acceptance criteria" presented here are high-level outcomes of physical tests related to these outputs. There are no explicit metrics for the accuracy or efficacy of the "surgical instrument to assist in preoperative planning and/or in guiding the marking of bone" as a software component itself.

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

• Wear Debris Testing: No specific sample size is provided beyond "Cutting / drilling instruments were used on a worst-case titanium surgical guide."
• Simulated Use Cadaver Validation Testing: No specific sample size is given for the number of cadavers used. It mentions "Guides were created to support bunion and metadductus, metatarsal 2+3, akin, and calcaneal osteotomies," implying a variety of cases were tested.
• Data Provenance: The cadaver validation testing is experimental ("simulated surgeries in cadavers") rather than derived from retrospective or prospective patient data. There is no information on the country of origin.

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

The document states, "The process requires clinical input and review from the physician during and prior to delivery of the final outputs." However, it does not specify the number of experts, their qualifications, or how they established the ground truth for the performance testing. The input and review from physicians appear to be part of the operational process rather than a formal ground truth establishment for a validation study.

4. Adjudication Method for the Test Set

No specific adjudication method (e.g., 2+1, 3+1) is mentioned for the performance testing. The "clinical input and review from the physician" is described as part of the normal workflow.

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

No MRMC comparative effectiveness study is mentioned. The performance testing focuses on the physical guides in a simulated cadaver environment, not on human readers' improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device description explicitly states: "the system is operated only by trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session." This indicates that the system is not a standalone AI algorithm without human-in-the-loop. It's a system where trained MedCAD employees (a human element) use software to develop outputs based on physician input and feedback. The performance testing reflects this human-in-the-loop process for generating the physical guides.

7. The Type of Ground Truth Used

• Wear Debris Testing: The ground truth for this test is implicit in "less than that reported in the literature to be safe." This refers to established safety thresholds for wear debris.
• Simulated Use Cadaver Validation Testing: The ground truth for this test appears to be "pre-surgical plans" for angle and position data, and subjective evaluation of "usability and fit." This is an engineering/design validation approach rather than pathology, expert consensus, or outcomes data from clinical cases.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set size. The system uses "Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical Computed Tomography (CT) images." This suggests the core image manipulation algorithms might be pre-trained components within the COTS software, or the system does not involve machine learning in a way that requires a specifically defined "training set" for the AccuStride™ System's unique functionalities.

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

Since no training set is described for the MedCAD® AccuStride™ System functionality, there is no information on how its ground truth was established.

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The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening or Closing Wedge Osteotomy, Distal Femoral Medial or Lateral Closing Wedge Osteotomy, High Tibial Lateral Closing Osteotomy, High Tibial Anterior Closing Osteotomy, Distal Femoral Lateral Opening Wedge Osteotomy and Distal Femoral Medial or Lateral Derotational Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.

The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices (PSI Guides). The PSI Guides are surgical drilling/cutting guides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies around the knee. They are single-use devices provided non sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of the Newclip Activmotion Range devices. The purpose of this 510(k) notification is to add PSI Guides for High Tibial Lateral and Anterior Closing osteotomies. Material: Polyamide (PA2200).

The provided document is a 510(k) Summary for the Newclip Patient-matched instrumentation non sterile PSI. It includes information on the device, its intended use, and a comparison to a predicate device (K240415). The document also outlines the performance data used for verification and validation but lacks specific quantitative acceptance criteria or detailed study results for objective efficacy.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it describes acceptance in qualitative terms, primarily relying on comparison to the predicate device and satisfactory outcomes in simulated use.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for the "worst-case guide design and manufacture" or the "simulated use" scenarios. It mentions "worst-case guide design" and "worst-case and subject PSI guides." This implies a limited, representative set rather than a large statistical sample.
• Data Provenance: The studies were conducted by Newclip Technics, a French company (Sponsor Address: F-44115 Haute-Goulaine, FRANCE). The studies were internal verification and validation activities. The country of origin of the data subjects (if any beyond the guides themselves) is not specified, nor whether it was retrospective or prospective. Given the nature of a 510(k) submission for mechanical surgical guides, it's likely a laboratory/simulated environment and not involving human patient data directly for performance validation at this stage.

3. Number of Experts and Qualifications for Ground Truth

• Manufacturing Validation: "Three NewClip operators with low, medium, and high levels of experience (novice, intermediate, expert)" were involved in the manufacturing validation. Their specific qualifications (e.g., years of experience, specific certifications) beyond their experience level are not detailed.
• Simulated Surgery: "The same three novice surgeons" performed the simulated use. Their specific qualifications (e.g., years of surgical experience, board certification) are not detailed other than being designated "novice."

4. Adjudication Method

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating performance. For the manufacturing validation, it involved comparison of dimensions, design, correction, and placement, presumably against predefined design specifications or an established 'true' state. For the simulated surgery, it seems the observation of the three novice surgeons' ability to achieve the desired outcomes (positioning, correction, hinge preservation) against unnamed criteria formed the basis of acceptability.

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

• No MRMC comparative effectiveness study was done. The performance data section describes internal verification and validation activities rather than a comparative study of human readers with and without AI assistance. The device is a surgical guide, not an AI diagnostic tool that assists human readers in interpreting images.

6. Standalone Performance Study

• The performance data described focuses on the device itself (manufacturing precision and simulated usability) and its comparison to a predicate device. It is a standalone assessment of the algorithmic design and physical manufacturing of the guides, though its use is demonstrated in a simulated human-in-the-loop context (by surgeons). The "algorithm" here refers to the design software that creates the patient-matched guides.
  • Manufacturing Test: The assessment of "precision and accuracy of design, correction, and manufacture" of the PSI guides can be considered a standalone algorithm/device performance evaluation as it assesses the output of the CAD/CAM process.
  • Simulated Use: This evaluates the physical guides in use by surgeons, which is a human-in-the-loop scenario, but the performance of the guide itself (its fit, its ability to guide instruments correctly) is the primary focus.

7. Type of Ground Truth Used

• Manufacturing Validation: The ground truth for manufacturing precision and accuracy would be the original digital design specifications of the patient-matched instrumentation. The manufactured guides were compared against these known dimensions and design elements.
• Simulated Surgery: The ground truth for the simulated surgery was the planned surgical correction and the expected function of the guide (e.g., correct positioning, preservation of the hinge). This is established based on the pre-operative planning and surgical goals.

8. Sample Size for the Training Set

• The document does not mention a "training set" in the context of an AI/machine learning model. The device (Patient-matched instrumentation) leverages CT images to create customized physical guides, which are then 3D printed. There is no indication of an AI algorithm being "trained" on a dataset in the typical sense. The "training" here would be for the CAD/CAM software to accurately generate the patient-specific geometry based on the CT scan data, which is typically a deterministic process rather than a machine learning one.

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

• As no training set for an AI/ML model is indicated, this question is not applicable based on the provided text. The "ground truth" for the device's function relies on accurate anatomical segmentation from CT scans and precise mechanical design parameters encoded in the CAD/CAM software.

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The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening or Closing Wedge Osteotomy, Distal Femoral Medial or Lateral Closing Wedge Osteotomy. Distal Femoral Lateral Opening Wedge Osteotomy and Distal Femoral Medial or Lateral Derotational Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.

The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices (PSI Guides). The PSI Guides are surgical drilling/cutting quides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies around the knee. They are single-use devices provided non sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of the Newclip Activmotion Range devices. The primary purpose of this 510(k) notification is to add PSI Guides for closingwedge and derotation osteotomies.

The provided text describes the Newclip Patient-matched instrumentation non sterile PSI, a device used in osteotomy procedures around the knee. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, but it does not include explicit acceptance criteria, detailed study designs, or specific performance metrics typically expected for AI/Machine Learning-enabled devices.

The device is described as "patient-matched instrumentation," which implies that the design process involves processing patient imaging data (CT scans) to create custom surgical guides. However, the document does not elaborate on the algorithmic aspects of this patient-matching process or how its accuracy is evaluated in a standalone or comparative study setting.

Given the information provided, here's an attempt to answer the questions, highlighting the limitations due to the lack of specific details concerning AI/ML evaluation as per your request:

1. Table of acceptance criteria and the reported device performance

Based on the provided document, explicit quantitative acceptance criteria for the "Newclip Patient-matched instrumentation non sterile PSI" are not stated. The performance is broadly described in terms of "precision and accuracy" in simulated-use cadaver surgeries. No specific numerical thresholds or target values are provided.

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

The document mentions "simulated-use cadaver surgeries" for performance verification. However:

• Sample Size for Test Set: Not specified. The number of cadavers or surgical approaches evaluated is not provided.
• Data Provenance: Not specified, but given the nature of cadaver studies, it would be laboratory-based rather than from real-world patient data. The study is described as "simulated-use," suggesting a prospective evaluation within a controlled environment.

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

The document states "Surgeon evaluation of precision and accuracy."

• Number of Experts: Not specified.
• Qualifications of Experts: Identified as "Surgeon," but no further details such as specialty (e.g., orthopedic surgeon), years of experience, or specific board certifications are provided.

4. Adjudication method for the test set

The document only states "Surgeon evaluation." There is no mention of an adjudication method (such as 2+1, 3+1 consensus, or independent review) for establishing ground truth or assessing outcomes in the simulated-use cadaver surgeries.

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

• MRMC Study: Not mentioned. The study described is a "Surgeon evaluation of precision and accuracy based on simulated-use cadaver surgeries." This focuses on the performance of the device itself in guiding surgical actions, rather than an MRMC study comparing human reader performance with and without AI assistance for tasks like diagnosis or planning.
• Effect Size of AI/Human Improvement: Not applicable, as no such MRMC study is described. The device's role is to guide surgical instruments, not to assist human readers in interpreting images or making diagnostic decisions.

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

The document describes the "patient-matched instrumentation" as derived from CT images and used to guide surgical instruments. This implicitly means there is computational work done to generate these custom guides. However, no specific standalone algorithm-only performance study results are provided. The evaluation mentioned is "Surgeon evaluation of precision and accuracy based on simulated-use cadaver surgeries," which represents a human-in-the-loop scenario where the surgeon uses the device. A standalone validation of the algorithm's ability to precisely match anatomy or generate optimal guide designs is not explicitly detailed.

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

For the "precision and accuracy" evaluation in cadaver surgeries, the ground truth or reference standard against which the device's performance was measured is not explicitly stated. It's likely an assessment by the evaluating surgeon(s) based on intra-operative observation or post-operative measurements of the osteotomy characteristics (e.g., angles, cuts) against the pre-operative plan, but the method for establishing this ground truth is not detailed.

8. The sample size for the training set

The document does not provide any information regarding a training set sample size. This suggests that if an algorithm is used for patient-matching guide design, it was either not developed using a distinct "training set" in the machine learning sense, or the details of its development and validation outside of the simulated-use cadaver study are not included in this summary. The process likely involves computational design based on individual patient CT data rather than a generalizable AI model trained on a large dataset.

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

Not applicable, as no information about a training set is provided.

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Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Service is intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Service is indicated for use for the following procedures:

• unicondylar knee replacement (UKR)
• . total knee arthroplasty (TKA)

The subject CORIOGRAPH Knee Pre-Op Plan is a medical function module within the CORIOGRAPH Pre-Op Planning and Modeling Service. This service is an additional offering being introduced by Smith & Nephew to allow for preoperative planning for surgical procedures based on patient imaging for total knee arthroplasty (TKA) and unicondylar knee replacement (UKR). The CORIOGRAPH Knee Pre-Op Plans will be generated for specific patients and anatomy by Smith and Nephew personnel using the CORIOGRAPH Knee Pre-Op Plan Software System V1.0, which is the subject of this submission. The CORIOGRAPH Knee Pre-Op Plans will output bone models of the patient anatomy and will generate patient-specific pre-operative plans which may be used on the REAL INTELLIGENCE CORI Surgical System.

The provided text is a 510(k) summary for the CORIOGRAPH Knee Pre-Op Plan. It discusses the device's substantial equivalence to a predicate device and details non-clinical testing. However, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and a study proving those criteria are met.

Here's a breakdown of what can be answered and what information is missing:

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

The document states, "Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Knee Pre-Op Plan and demonstrated the safety and effectiveness of the generated CORIOGRAPH Knee Pre-Op Plan when used as an input to the CORI Surgical System. Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment. Smith and Nephew, Inc. has concluded that all design inputs have been met and that the verification and validation testing performed did not raise any new questions of safety or effectiveness."

This is a general statement of compliance, not a detailed table of specific acceptance criteria (e.g., accuracy metrics, specific tolerances) and their corresponding reported performance values. Therefore, a table cannot be fully constructed.

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 provided in the text. The document refers to "verification and validation testing" and "summative usability testing" but does not specify the sample size for these tests or the origin/nature of the data used.

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 information is not provided in the text. The document mentions "participating surgeons" in the usability testing, but their number or specific qualifications (beyond being surgeons) are not detailed. It does not mention experts establishing ground truth for a test set in the context of performance metrics.

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

This information is not provided in the 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 does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is a "Knee Pre-Op Plan" which suggests it aids in surgical planning, not necessarily in interpretation tasks typically associated with MRMC studies with human readers.

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

The document states, "Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Knee Pre-Op Plan and demonstrated the safety and effectiveness of the generated CORIOGRAPH Knee Pre-Op Plan when used as an input to the CORI Surgical System." This implies standalone testing of the software's output, as well as its interaction as an input to another system. However, specific metrics of "algorithm-only" performance are not provided.

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

This information is not explicitly provided in the text. Given the device provides "pre-operative planning for surgical procedures based on patient imaging," the ground truth for evaluating its accuracy would likely be related to the accuracy of anatomical landmark identification, implant positioning, or surgical outcomes, but this is not specified.

8. The sample size for the training set

This information is not provided in the text. The document discusses "software applications" and "planning tools and processes" but does not detail any machine learning models or training sets.

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

This information is not provided in the text, as no training set details are given.

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Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Fine Osteotomy™ disposable instrumentation is intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine Osteotomy™ is a patient-specific device.

Fine Osteotomy™ is a system for planning osteotomies of the distal femur and proximal tibia, and for stabilizing the bone with bone screws and a patient-specific bone plate that fits the patient's anatomy " consists of patient-specific surgical planning and instrument guides designed from images of the patient-specific bone plate designed from the patient's images, compression and/or locking bone screws, and class 1 reusable manual instruments. The bone plate is a patient-specific, single-use implant; the surgical planning and instrument guides are patient-specific, single-use, and discarded after surgery. Fine Osteotomy™ is offered in three configurations: 1) as a system of patient specific implants and single use instruments for performing osteotomies and implanting hardware to stabilize the resection, 2) as patient specific single use instruments alone for performing osteotomies, and 3) as a patient specific bone plate and screws for stabilizing a bone resection or fracture.

When used as a system, Fine Osteotomy™ enables the surgeon to perform and stabilize the bone around the knee that matches the pre-surgical plan using the patient-specific cutting quides and bone planning quides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy around the knee the presurgical plan using the patient-specific cutting guident's CT images. When the bone plate and screws are used alone, Fine Osteotomy™ enables the surgeon to stabilize fractured or resected bone per the pre-surgical plan using the patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to quide placement of the implants and alignment of bone. The Fine Osteotomy System is provided clean, not sterile to the user.

Materials: Wrought Titanium-6Alum ELI Alloy (Ti6A4V ELJ; ASTM F136-13) for the bone plates and screws, additively manufactured Nylon-12 for patient specific, single use resection guides and models.

This FDA 510(k) summary for the Fine Osteotomy™ system (K240066) explicitly states that the technological characteristics and indications for use of the subject device are identical to its primary predicate device (K231314), with the exception of updates and additions to single-use instrumentation and shelf-life.

Therefore, the document does not contain the detailed information necessary to answer some of the questions regarding acceptance criteria and performance studies, specifically:

• A table of acceptance criteria and the reported device performance: This is not provided because substantial equivalence is claimed based on identity to a cleared predicate, not on new performance data demonstrating meeting specific criteria.
• Sample sized used for the test set and the data provenance: No new test set data is reported.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Based on the provided text, here is what can be extracted regarding the "study" that proves the device meets acceptance criteria:

The "study" or rather the justification for meeting acceptance criteria is a demonstration of substantial equivalence to a previously cleared predicate device.

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

The document does not provide a table of acceptance criteria and reported device performance in the context of a new clinical or non-clinical performance study. Instead, the device's acceptance is based on its substantial equivalence to a predicate device already on the market.

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

No new test set was used or described for this 510(k). The regulatory submission relies on the substantial equivalence to the predicate device K231314.

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

Not applicable, as no new test set requiring expert ground truth establishment for performance evaluation is described.

4. Adjudication method for the test set

Not applicable, as no new test set is described.

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 MRMC comparative effectiveness study is mentioned.

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

No standalone algorithm performance study is mentioned.

7. The type of ground truth used

Not applicable, as no new performance study is described. The acceptance is based on substantial equivalence.

8. The sample size for the training set

Not applicable, as no new algorithm development requiring a training set is described. The device is a patient-specific surgical guide system, not an AI/ML algorithm that identifies or diagnoses.

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

Not applicable.

Summary of "Study" to Prove Acceptance:

The provided document indicates that the Fine Osteotomy™ system (K240066) achieves acceptance (i.e., substantial equivalence to a predicate device) through the following:

• Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b)):
  • Verification and validation (V&V) activities included:
    • Mechanical Engineering Analysis of updated and new single-use instruments demonstrating no new worst-case scenarios.
    • Modification of Shelf-Life Referential for Fine Osteotomy Systems.

This implies that the key "study" involved analyzing the updated and new single-use instruments (from an engineering perspective) and reassessing the shelf-life, to confirm that these changes do not alter the fundamental safety and effectiveness demonstrated by the predicate device. The performance data for the core technology is implicitly referenced as that of the predicate device (K231314).

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The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening Wedge Osteotomy and Distal Femoral Lateral Opening Wedge Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.

The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices. The subject devices are surgical drilling/cutting quides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or guiding surgical instruments in orthopaedic surgery (High Tibial Medial Opening Wedge Osteotomy and Distal Femoral Lateral Opening Wedge Osteotomy). They are single-use devices provided non sterile for sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of Newclip High Tibial Osteotomy System or the Newclip Activmotion Range devices.

The provided text is a 510(k) summary for the Newclip Patient-matched instrumentation non sterile PSI. It does not contain the specific acceptance criteria or details of a study structured to prove the device meets said criteria as requested.

The document states that "Verification and validation (V&V) activities included... Surgeon evaluation of precision and accuracy based on human clinical cases." It further mentions that "Precision and accuracy of the subject device was demonstrated in published human clinical studies by surgeon-users on patients in Europe using Newclip Patient-matched instrumentation non sterile PSI guides." However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance. (It refers to "human clinical cases" and "published human clinical studies" but gives no numbers or details on whether the data was retrospective or prospective, or from which specific countries beyond "Europe.")
• Number and qualifications of experts for ground truth.
• Adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers improving with/without AI assistance. (This device is a patient-matched surgical guide, not an AI or imaging diagnostic tool, so an MRMC study is unlikely to be relevant in the traditional sense, but the question was asked.)
• If a standalone performance (algorithm only) was done. (Again, not directly applicable as this is a physical surgical guide.)
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides). It lists verification and validation activities conducted, but these are described in broad terms rather than as a detailed study report with specific metrics and results.

Therefore, based solely on the provided text, I cannot fulfill the request for detailed information about acceptance criteria and a study proving those criteria were met.

If this were a medical imaging AI device, the lack of such details in an FDA 510(k) summary would be a red flag. However, for a patient-matched surgical instrument, the V&V activities mentioned (surgeon evaluation, precision/accuracy in design/manufacturing, wear testing, cleanliness/sterilization, dimensional verification) are typical, though the specific data from these activities is not included in this summary.

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MedCAD® AccuPlan® Orthopedics System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models of the fibula and ilium. surgical guides for harvesting bone grafts from the fibula or ilium, and surgical planning case reports for use in maxillofacial reconstructive surgeries. MedCAD® AccuPlan® Orthopedics System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. The MedCAD® AccuPlan® Orthopedics System is indicated for use in adolescents (greater than 12 to 21 years of age) and adults.

The MedCAD® AccuPlan® Orthopedics System is a collection of software and associated additive manufacturing equipment intended to provide a variety of outputs to support harvesting of bone to support maxillofacial reconstructive surgeries. The system uses electronic medical images of the patient's anatomy with input from the physician to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system include anatomical models, surgical guides, and patient-specific case reports.

Following the MedCAD® Quality System and specific Work Instructions, trained employees utilize Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical Computed Tomography (CT) images to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during and prior to delivery of the final outputs. While the process and dataflow vary somewhat based on the requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, and how they interact to produce the defined system outputs. It should be noted that the system is operated only by trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session.

The MedCAD® AccuPlan® Orthopedics System is made up of two individual pieces of software for the design and various manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical guides, and patient-specific planning reports for harvesting of bone from the fibula and ilium for use in maxillofacial reconstructive surgeries.

The MedCAD® AccuPlan® Orthopedics System requires an input 3-D image file from medical imaging systems (i.e., CT). This input is then used, with support from the prescribing physician to provide the following potential outputs to support maxillofacial reconstructive surgery. Each system output is designed with physician inout and reviewed by the physician prior to finalization. All outputs are used only with direct physician involvement to reduce the criticality of the outputs.

System outputs include:

• Anatomical Models
• Surgical Guides
• Patient-Specific Case Reports

Here's a breakdown of the acceptance criteria and study information for the MedCAD® AccuPlan® Orthopedics System, based on the provided FDA 510(k) summary:

This device is primarily a software system for surgical planning and the creation of physical outputs (anatomical models and surgical guides) based on CT scan data. The performance testing detailed here focuses on the physical outputs rather than an AI-driven diagnostic or assistive algorithm's accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Wear Debris Testing: Not explicitly stated, but "worst-case titanium surgical guide" indicates at least one such guide was tested.
• Fit and Form Validation: "All samples" were tested. The exact number of samples is not explicitly stated.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). However, since the system processes patient-specific CT imaging, the "data" would be the CT scans themselves.

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

• The document states that "The process requires clinical input and review from the physician during and prior to delivery of the final outputs" and "All outputs are used only with direct physician involvement to reduce the criticality of the outputs."
• For the performance testing itself, the identity and number of "experts" (e.g., those determining if a fit was "PASS") are not specified. The ground truth for fit and form seems to be established by physical/optical measurement against a 3D model and representative anatomical model.
• For the broader system design and physician input, "the prescribing physician" provides input and review, but their qualifications and number are not detailed beyond "physician."

4. Adjudication Method for the Test Set

• No specific adjudication method (e.g., 2+1, 3+1 consensus) for the performance tests is described. The "PASS" result suggests a clear acceptance/rejection criteria was applied.
• For the general operation of the system, it notes that the "physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session." This implies an iterative, interactive process rather than a formal adjudication of a test set.

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

• No, an MRMC comparative effectiveness study was not performed or described. The device is a surgical planning and manufacturing system, not an AI diagnostic aid evaluated for human reader improvement. The performance testing focuses on the physical properties and accuracy of the manufactured outputs.

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

• The performance testing performed (wear debris, fit and form, sterilization, biocompatibility) relates to the outputs of the system (surgical guides, anatomical models) rather than the standalone algorithmic accuracy of image segmentation or planning.
• The system itself relies on "trained MedCAD employees" and "clinical input and review from the physician." Therefore, it's not a purely standalone AI algorithm without human involvement in its operational workflow.

7. The Type of Ground Truth Used

• For Fit and Form Validation: The ground truth appears to be the digital 3D model ("alignment with the 3D model") and a representative anatomical model ("fitting the guide over the corresponding defect"). These are objective measurements and physical fit evaluations.
• For Wear Debris Testing: The ground truth for safety is published literature values of safe wear debris.
• For Sterilization and Biocompatibility: Ground truth is established by international standards (ISO 17665, ISO 10993-1) and FDA guidance documents, which define accepted levels and methodologies.

8. The Sample Size for the Training Set

• Not applicable / Not provided. This device is described as using "Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical Computed Tomography (CT) images." There is no mention of a machine learning model that requires a dedicated training set. The "software" component appears to be tools for engineers and physicians to interact with and refine 3D models.

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

• Not applicable. As no training set for a machine learning model is mentioned, there's no ground truth establishment process to describe for a training set.

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Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Fine Osteotomy™ disposable instrumentation is intended to assist in pre-operative planning and/or the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine OsteotomyTM is a patient-specific device.

Fine Osteotomy™ is a system for planning and performing osteotomies of the distal femur and proximal tibia and for stabilizing the bone with bone screws and a patientspecific bone plate that fits the patient's anatomy. Fine Osteotomy™ consists of patientspecific surgical planning and instrument guides designed from images of the patient's bones, a patient-specific bone plate designed from the patient's images, compression and/or locking bone screws, and class 1 reusable manual instruments. The bone plate is a patient-specific, single-use implant; the surgical planning and instrument guides are patient-specific, single-use. Fine Osteotomy™ is offered in three configurations: 1) as a system of patient specific implants and single use instruments for performing osteotomies and implanting hardware to stabilize the resection, 2) as patient specific single use instruments alone for performing osteotomies, and 3) as a patient specific bone plate and screws for stabilizing a bone resection or fracture.

When used as a system, Fine Osteotomy™ enables the surgeon to perform an osteotomy and stabilize the bone around the knee that matches the pre-surgical plan using the patient-specific cutting guides and bone plate. When the planning guides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy around the knee that matches the pre-surgical plan using the patientspecific cutting guides designed from the patient's CT images. When the bone plate and screws are used alone, Fine Osteotomy™ enables the surgeon to stabilize fractured or resected bone per the pre-surgical plan using the patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to guide placement of the implants and alignment of bone. Fine Osteotomy is provided clean, non-sterile.

The purpose of this Special 510(k) Device Modification is to notify the FDA of changes and additions to the single use instruments and added software option for segmentation of images and creation of STL files of the bone models.

Materials: Wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6Al4V ELI: ASTM F136-13) for the bone plates and screws, additively manufactured Nylon-12 for patient specific, single use resection guides and models.

The provided text does not contain detailed information about specific acceptance criteria, a study that proves the device meets those criteria, or the performance of the device in relation to such criteria. The document is a 510(k) summary for a medical device (Fine Osteotomy™) being submitted to the FDA, asserting substantial equivalence to a previously cleared predicate device.

Here's what can be extracted and what information is missing based on your request:

Missing Information:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications used to establish ground truth for the test set.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size of human reader improvement with AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

Information provided in the document related to performance/validation:

The document mentions "Verification and validation (V&V) activities" but details are limited.

G. PERFORMANCE DATA

Verification and validation (V&V) activities included the following:

• Engineering analyses of updated and new single-use instruments demonstrating "no new risks and no new worst case." (This is a safety assessment, not a performance metric against acceptance criteria).
• Surgeon user evaluations demonstrating the new and updated instruments "to work as intended." (This is a qualitative statement, lacking specific metrics or criteria).
• Validation of the new software option for segmentation of patient image files and creation of STL files and virtual models "with similar resolution as previously 510(k) cleared Bodycad segmentation software." (This hints at a comparative resolution study, but no specific acceptance criteria or quantitative performance data are provided).

In summary, the provided FDA 510(k) summary focuses on establishing substantial equivalence for device modifications rather than detailing a comprehensive clinical or performance study with defined acceptance criteria and quantitative results, which would typically be included in a more extensive study report.

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MyPAO patient-specific guides are devices intended to be used as anatomical guides are specifically designed based on the CT images of the patient (i.e., pelvis, proximal femur). The guides are intended to assist the surgeon in the positioning of the acetabular fragment during periacetabular osteotomies to treat patients who require to undergo periacetabular osteotomy. MyPAO guides are intended for single use only.

The MyPAO Guides enlarge Medacta's MyPAO realignment system, already including MyPAO Planning report, in order to provide the surgeons a further help in the realignment phase after a Periacetabular Osteotomy.

Specifically, the current submission aims at obtaining the clearance for the changes made to MyPAO Planning report and for the following new devices:

• Reposition PSI guides (Pre-op drill guide, Ilium and Acetabulum Rep Guides, Realignment Arc):
• Preoperative and postoperative bone models;
• Reusable instruments to be used with the guides.

MyPAO Guides are patient specific guides designed on the basis of the patient's preoperative CT scan and subsequent preoperative planning and they aim at replicating the desired correction before the final fixation of the acetabular fragment.

The MyPAO Guides as well as their bone models are single-use and they are provided non-sterile.

The 3D pre-operative planning based on the patient's CT scans is performed through MyPAO software that is the same software already used to generate MyPAO Planning Report. The only change made to the already cleared MyPAO Planning report (K200589) regards the addition of two parameters in the report, i.e. 3D femoral head coverage and acetabular anteversion.

The provided text describes the MyPAO Guides, a medical device intended to assist surgeons during periacetabular osteotomies. While the document mentions performance data and clinical studies, it focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance (510(k)), rather than establishing specific acceptance criteria for an AI/algorithm-driven device and proving its performance against those.

The MyPAO Guides are patient-specific anatomical guides based on CT images and preoperative planning, but the description does not indicate that the core "device" itself is an AI algorithm that makes diagnostic or treatment recommendations. The "MyPAO software" mentioned is for planning, and the guides themselves are physical devices.

Therefore, the information required to answer the prompt (acceptance criteria for an AI device, sample sizes for AI test sets, expert adjudication methods for AI ground truth, MRMC studies, standalone AI performance, etc.) is not present in the provided document, as it pertains to the clearance of physical surgical guides with software for planning.

However, I can extract the relevant performance data related to the clinical study cited for the MyPAO Guides, even though it's not structured as an AI acceptance criteria study.

Here's what can be extracted based on the provided text, interpreted in the context of the prompt's questions, acknowledging the limitations mentioned above:

Acceptance Criteria and Device Performance (for the clinical study performed related to MyPAO Guides, not an AI algorithm):

Details of the Clinical Study Related to MyPAO Guides:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: 10 patients.
   • Data Provenance: The study was a "single-arm study with a literature control." It was "conducted outside of the United States." The data is prospective, involving actual patient treatments.

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

   • The "ground truth" for this study was the post-operative correction results compared to the pre-operative planned correction. Measurements were done using "2D planar x-rays to measure the final lateral center edge and acetabular index."
   • The document states "10 patients were treated by three surgeons using the MyPAO surgical planning software and guides." It doesn't specify if these 3 surgeons (or others) were involved in establishing the "ground truth" measurements from the x-rays, or their qualifications.

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

   • The document does not describe any specific adjudication method for the measurements.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. The clinical study was a single-arm study evaluating the MyPAO system (guides + planning software) against a literature control for conventional surgical technique accuracy. This is not designed to assess human reader improvement with AI assistance.

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

   • The "MyPAO Guides" are physical devices. The "MyPAO software" is for planning. The study evaluated the system (software + guides) in facilitating surgical outcomes. No standalone algorithm performance study (where an AI algorithm performs measurements or diagnoses without human input) is described. The device's primary function is as an anatomical guide for human surgeons.

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

   • The ground truth was based on a comparison of pre-operative planned correction versus post-operative correction results measured from 2D planar x-rays. This is a form of outcomes data directly related to the surgical correction achieved. The acceptance criteria themselves were based on literature for conventional surgical accuracy, implying that the "ground truth" for acceptable performance was derived from expert consensus in the broader medical literature.

7. The sample size for the training set:

   • The document describes a 510(k) submission for a physical medical device (MyPAO Guides) assisted by planning software. It is not an AI algorithm clearance with explicit training and test sets in the typical AI/ML sense. Therefore, no "training set" sample size for an AI model is provided or applicable as per the document's content.

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

   • As there's no explicitly defined "training set" for an AI algorithm in this context, this question is not applicable to the provided document. The planning software's underlying data or algorithms are not detailed in terms of their "training" in this regulatory submission.

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