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Bunkerhill AAQ is a radiological image processing system software indicated for use in the analysis of CT exams with or without contrast, that include the L1 – L5 region of the abdominal aorta, in adults aged 22 and older.

The device is intended to assist appropriately trained medical specialists by providing the user with the maximum axial abdominal aortic diameter measurement of cases that include the abdominal aorta. Bunkerhill AAQ is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate post-operative aortas.

The Bunkerhill AAQ results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a qualified interpreting physician. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.

Bunkerhill AAQ is a software-only medical device that employs deep learning algorithms to provide automatic maximal abdominal aortic diameter measurements from axial CT scans of the abdomen/pelvis, with or without IV contrast.

Bunkerhill AAQ receives DICOM instances and processes them chronologically by running the algorithm on relevant series to measure the maximum abdominal aortic diameter. Following the AI processing, the output of the algorithm analysis is transferred to standard radiology image review and reporting software.

Bunkerhill AAQ produces a preview image annotated with the maximum axial diameter measurement. The diameter marking is not intended to be a final output, but serves the purpose of visualization and measurement. The original, unmarked series remains available in the PACS as well.

The preview image presents an unofficial and not final measurement, and the user is instructed to review the full image and any other clinical information before making a clinical decision. The image includes a disclaimer: "Not for diagnostic use. The measurement is unofficial, not final, and must be reviewed by a qualified interpreting physician".

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter for Bunkerhill Abdominal Aortic Quantification (AAQ):

1. Table of Acceptance Criteria and Reported Device Performance

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The Bunkerhill BMD Algorithm is a post-processing AI-powered software intended for adults 30 years and above to assess estimated DXA-measured average areal bone mineral density of spinal bones from existing CT scans and outputs a flag for low bone density below a pre-specified threshold. It is not intended to replace DXA or any other tests dedicated to BMD measurement.

Bunkerhill BMD is an opportunistic AI-powered tool that enables:(1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure

The Bunkerhill BMD application is a software only medical device (SaMD) that includes deep- learning-based computer vision and post-processing algorithms that estimates the bone mineral density from previously obtained computed tomography (CT) images.

The results from Bunkerhill BMD are not intended to be used as the primary input for clinical decision making, but rather are intended to provide information that may assist the clinician to identify 'findings of interest' within existing imaging studies.

Here's a breakdown of the acceptance criteria and study details for the BunkerHill BMD device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance Study for BunkerHill BMD

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Test Set Sample Size: 371 CT studies
• Data Provenance: The studies were collected from four (4) geographically diverse sites. The retrospective nature of the study is explicitly stated ("stand-alone retrospective study").

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported in the provided text. The study described is a standalone performance evaluation of the algorithm.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The document states: "Bunkerhill BMD performance was validated in a stand-alone retrospective study for overall agreement of the device output compared to the established ground truth."

7. Type of Ground Truth Used

The type of ground truth used is implied to be based on DXA-measured average areal bone mineral density of spinal bones, as the device is intended to "assess estimated DXA-measured average areal bone mineral density." The text refers to "established ground truth" in relation to this assessment.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. It only describes the test set.

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

The document does not provide information on how the ground truth for the training set was established. It only refers to "established ground truth" for the test set evaluation.

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Bunkerhill AVC is a software device intended for use in detecting presence and estimating quantity of aortic valve calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (intended for informational purposes only) and quantification of detected calcium.

The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device-generated quantification can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, non-contrast CT scan; both are still available to be viewed and used at the discretion of the physician.

The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results.

Bunkerhill AVC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill AVC detects, localizes, and quantifies aortic valve calcification in non-gated, non-contrast chest CT studies. The core features of the product are:

• Detection of aortic valve calcification at an Agatston-equivalent score threshold of 0 AU. •
• . Estimation of the overall aortic valve calcification burden in the form of an estimated Agatston-equivalent Score.
• Localization of estimated calcium burden in the form of AVC region of interest applied . to a copy of the original CT scan.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The provided text describes specific performance metrics that were evaluated, although it doesn't explicitly present a formal "acceptance criteria table" with target values. Instead, it describes how the device's observed performance met the acceptance criteria.

Notes on Acceptance Criteria: The document states that "The acceptance criteria were derived from the performance of the predicate device and clinical literature in high impact journals that inter-reader agreement of manual segmentation." This indicates a benchmark against established clinical practice and a comparable device.

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

• Sample Size for Test Set: Not explicitly stated as a numerical count of patients or cases. However, the data for the pivotal study was "curated from thirty-three (33) sites."
• Data Provenance:
  • Country of Origin: United States ("thirty-three (33) sites across three geographical regions in the United States").
  • Retrospective or Prospective: Retrospective ("standalone retrospective study").

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

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set. It only mentions that the ground truth was "established."

4. Adjudication method for the test set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study assessing human reader improvement with AI assistance was not conducted or reported. The study described is a "standalone retrospective study for localization and agreement of the device output compared to the established ground truth." The device is intended as an "adjunctive information" tool, not a human-in-the-loop performance enhancer for diagnostic accuracy per se, but rather an aid for quantifying calcification.

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

Yes, a standalone study was done. The text explicitly states: "The Bunkerhill AVC performance was validated in a stand-alone retrospective study for localization and agreement of the device output compared to the established ground truth."

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

The type of ground truth used was "established ground truth." While this term is somewhat generic, given the context of Agatston-equivalent scores and "inter-reader agreement of manual segmentation" mentioned for acceptance criteria, it strongly implies ground truth established by expert (likely radiologist or cardiologist) review and manual measurement/segmentation. It is not stated to be pathology or outcomes data.

8. The sample size for the training set

The document does not provide the sample size for the training set. It only discusses the pivotal test set.

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

The document does not provide information on how the ground truth for the training set was established.

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The FootBridge Medical HyperFlex™ Bunion Correction System is intended for use in reconstruction (correction) of the hallux valgus deformity by holding the reduction of the 1st metatarsal intermetatarsal (IM) angle in adults and pediatric patients aged ≥13 years in which growth plates have fused.

The FootBridge Medical HyperFlex™ Bunion Correction System is an implantable device and accompanying instrumentation used to treat a hallux valgus deformity (bunion). It includes components that attach to the 1st and 2nd metatarsals which are joined by a suture. The system reduces the IM angle between the 1st and 2nd metatarsal without restricting range of motion in the sagittal plane. The implant will be offered in several sizes to fit the anatomical needs of the patient population.

I apologize, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the "HyperFlex Bunion Correction System," which indicates the device is substantially equivalent to a predicate device.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance: While it mentions various bench tests conducted (Static and Fatigue Tensile Testing, Screw Torsional Strength Testing, etc.), it does not provide specific acceptance criteria or the numerical results of these tests.
2. Sample size used for the test set and data provenance: No information on a test set, its size, or where the data came from is present. The document focuses on bench testing, not clinical data or human-derived test sets.
3. Number of experts and their qualifications for ground truth: Since no human-based test set or ground truth establishment is described, this information is not available.
4. Adjudication method: Not applicable as there is no human-based test set.
5. MRMC comparative effectiveness study: The document does not mention any multi-reader multi-case studies or the effect size of AI assistance.
6. Standalone (algorithm only) performance: This device is a physical bone fixation system, not a software algorithm, so standalone performance in that context is not relevant or discussed.
7. Type of ground truth used: Not applicable as there's no mention of a human-based test set for ground truth.
8. Training set sample size: No training set is mentioned as this is a physical medical device, not an AI/ML algorithm.
9. How ground truth for the training set was established: Not applicable.

The document primarily focuses on establishing "substantial equivalence" through bench testing and comparison to a predicate device (Arthrex Mini TightRope and Mini TightRope FT), rather than a detailed performance study against specific acceptance criteria with human or clinical data.

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KLS Mini Osteosynthesis System (K943347): The KLS Mini Osteosynthesis System is indicated for 1) Fractures, 3) Reconstruction procedures of the craniomaxillofial skeletal system.
KLS Chin Plate System (K943348): The KLS Chin Plate System is indicated for 1) Fractures, 3) Reconstruction procedures of the craniomaxillofacial skeletal system.
KLS-Martin Micro Osteosynthesis System (1.0MM) (K944561): The KLS-Martin Micro Osteosynthesis System (1.0MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractures. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS-Martin Micro Osteosynthesis System (1.5MM) (K944565): The KLS-Martin Micro Osteosynthesis System (1.5MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractures. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS Martin Centre-Drive Drill-Free Screw (K971297): The KLS Martin Centre-Drive Drill-Free Screws are in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device referenced.
KLS-Martin Temporary Condylar Implant (K990667): The KLS-Martin Temporary Condylar Implant is only intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMF or treatment of temporomandibular joint disease (TMD).
KLS-Martin Mandibular/Reconstruction System II (K032442): The KLS-Martin Mandibular/Reconstruction System II is intended for use in the stabilization of mandibular fractures and mandibular reconstruction.
KLS-Martin Ortho Anchorage System (K033483): The KLS-Martin Ortho Anchorage System is intended to be surgically placed in the mouth for use an an anchor for orthodontic procedures.
KLS-Martin Ortho Anchorage System (Plates) (K040891): The KLS-Martin Ortho Anchorage System (Plates) are implants intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures in patients.
KLS Martin Rigid Fixation - Sterile (K060177): The KLS Martin Rigid Fixation - Sterile is in sterile packaging, osteosynthesis products with the following indications for use:
K051236: The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
K032442: The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization of mandibular fractures and mandibular reconstruction.
K971297: The KLS Martin Centre-Drive Drill-Free screws are in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the predicate device reference
K944565: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
K944561: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS Martin Drill-Free MMF Screw (K042573): The KLS Martin Drill-Free MMF Screws is intended for use in maxilonandibular fixation of fractures of the maxilla, mandible, or both.
Drill Free MMF Screw (K083432): The Drill Free MMF Screw is intended for use in maxillomandibular fixation of fractures of the maxilla, mandible, or both.
KLS Martin L1 MMF System (K173320): The KLS Martin L1 MMF System is intended for temporary stabilization of maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).

KLS Mini Osteosynthesis System (K943347): The KLS Mini Osteosynthesis System consists of titanium non-locking plates ranging in thickness from 0.6mm - 2.5mm and titanium screws ranging in diameter from 1.5mm - 2.3mm.
KLS Chin Plate System (K943348): The KLS Chin Plate System consists of titanium plates ranging in thickness of 0.6mm and titanium screws ranging in diameter from 1.5mm - 2.3mm.
KLS-Martin Micro Osteosynthesis System (1.0mm) (K944561): The KLS-Martin Micro Osteosynthesis System is designed to aid in the alignment and stabilization of the skeletal system after a facial fracture or surgery. The bone plates, bone plates, bone screws and accessories of various shapes and sizes for use in oral-maxillo-cranio-facial surgery. The bone plates are manufactured from CP Titanium and range in thickness from 0.3mm - 0.6mm. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.0mm - 1.2mm.
KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565): The KLS-Martin Micro Osteosynthesis System is designed to aid in the alignment and stabilization of the skeletal system after a facial fracture or surgery. The bone plates and screws of various shapes and sizes for use in oralmaxillo-cranio-facial surgery. The bone plates are manufactured from CP Titanium and range in thickness from 0.3mm - 0.6mm. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.5mm - 1.8mm.
KLS Martin Centre-Drive Drill-Free Screw (K971297): The KLS Martin Centre-Drive Drill-Free Screws are designed to eliminate the need for pre-drilled pilot holes. They are self-tapping with one step insertion. They are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates where are contoured to fit the bone fragments. The bone fragments. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.0mm - 2.0mm.
KLS-Martin Temporary Condylar Implant (K990667): The KLS-Martin Temporary Condylar Implant is a solid condylar head which attaches with fastening screws to a KLS-Martin Fracture/ Reconstruction Plate. The implant is available for left and right placement. The KLS-Martin Temporary Condy intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to benign tumors requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
KLS-Martin Mandibular/Reconstruction System II (K032442): The KLS-Martin Mandibular/Reconstruction System II includes several different designs of titanium plates and screws intended for use in the stabilization and fixation of mandibular fractures and reconstruction. The plates are manufactured from either CP Titanium or Titanium Alloy and range in thickness from 1.0mm - 3.0mm. The screws are manufactured from either CP Titanium Alloy and range in diameter from 2.0mm - 3.2mm.
KLS-Martin Ortho Anchorage System (K033483): The KLS-Martin Ortho Anchorage System consists of a titanium screw designed to aid in dental movement by providing a rigid skeletal fixation point. The screw is intended to be surgically placed in the mouth for orthodontic procedures. The screws are manufactured from either CP Titanium or Titanium Alloy.
KLS-Martin Ortho Anchorage System (Plates) (K040891): The KLS-Martin Ortho Anchorage System (Plates) consists of titanium non-locking plates to aid in dental movement by providing a rigid skeletal fixation point. The plates are manufactured from either CP Titanium Alloy and are fixated with titanium screws and are utilized as an anchor for orthodontic procedures in the palatal, maxilla or mandible region.
KLS-Martin Drill-Free MMF Screw (K042573): The KLS-Martin Drill-Free MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture. The KLS-Martin Drill-Free MMF Screw is in maxillomandibular fixation to provide stabilization of fractures of the maxilla, or both. The screws are manufactured from either CP Titanium Alloy and are provided in 2.0mm diameter with lengths ranging from 8mm - 12mm.
KLS Martin Rigid Fixation - Sterile (K060177): The KLS Martin Rigid Fixation - Sterile includes titanium plates of various shapes and thickness, titanium screws of various length and diameter, stainless steel twist drills of various length and stainless steel sonotrode tips that are provided in sterile packaging. The KLS Martin Rigid Fixation - Sterile is intended to provide KLS Martin's previously cleared osteosynthesis products in sterile packaging.
Drill Free MMF Screw (K083432): The Drill Free MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture. The Drill Free MMF Screw is in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both. The screws are manufactured from Stainless Steel and are provided in 2.0mm diameter with lengths ranging from 8mm - 12mm.
KLS Martin L1 MMF System (K173320): The KLS Martin L1 MMF System is a bone-borne maxillomandibular fixation (MMF) system consisting of metalic archbars with sliding locking plates that attach to the dental arches with screws. The system is intended to provide temporary stabilization of mandibular and maxillary fractures as well as maintain properative bone fixation and postoperative bone healing (app. 6-8 weeks). The patient is brought into occlusion by wiring around the archbar wire hooks. The L1 MMF system plates are manufactured from CP Titanium (ASTM F67), are available in either a 7-hole siding plate configuration with two different lengths, and are 0.5mm in plate thickness. The L1 MMF system sliding locking plates are fixated with either 2.0 x 6 mm selfdrilling locking screws manufactured from Ti-6Al-4V (ASTM F136). Implants are available both sterile. The system also includes the necessary instruments to facilitate placement of the implants.

The document describes the KLS Martin Oral-Max Implants - MR Conditional, a bundled submission of various osteosynthesis systems and screws intended for use in craniomaxillofacial surgery. The purpose of this submission is to support the conditional safety and labeling modification of these devices in the magnetic resonance (MR) environment.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are implied by the non-clinical tests conducted to support MR Conditional safety, aligning with relevant ASTM standards and FDA guidance. The reported device performance is that the devices can be safely scanned under specified conditions.

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

The testing involved computational modeling and simulation (CM&S). The "test set" in this context refers to the simulated scenarios and device configurations.

• Sample Size for Test Set: "the entire portfolio of KLS Martin maxillofacial implants" was simulated. This implies that all devices grouped under "KLS Martin Oral-Max Implants - MR Conditional" were included in the simulations. The document also mentions "various in-vivo device positions and landmarks," "worst-case single and multiple devices," and simulations in "10 cm increments." This suggests a comprehensive set of simulated scenarios rather than a traditional physical sample size.
• Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective" in the same way clinical data is. The data is generated through computational modeling and simulation using MED Institute's FDA-qualified Medical Device Development Tool (MDDT) and the Duke virtual human anatomy. This is a form of prospective simulation data.

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

Not applicable in the traditional sense for this type of non-clinical, simulation-based study. The "ground truth" for the RF-induced heating simulations is derived from the established physics and engineering principles embedded in the FDA-qualified MDDT and the Duke virtual human anatomy model. The expertise lies in the development and validation of these computational tools and the interpretation of the simulation results by experts in MR safety and medical device engineering at MED Institute and the submitting company. The document does not specify the number or qualifications of individual experts validating the computational model, but implies that the MDDT itself is "FDA-qualified," indicating a level of expert review and agreement on its methodology.

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

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used for consensus building among human expert readers for clinical studies, especially when establishing ground truth from image interpretation. This study is based on physical property testing and computational simulations, not human interpretation of clinical data.

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

Not applicable. This is not a study involving human readers or AI-assisted diagnostic performance. It focuses on the physical safety of implants in an MR environment.

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

The RF-induced heating assessment involved "Computational modeling and simulation (CM&S) ... using MED Institute's FDA-qualified Medical Device Development Tool (MDDT) and in a clinically relevant position within the Duke virtual human anatomy." This is a standalone algorithm/model-based assessment without a human-in-the-loop for the performance evaluation itself. Human experts design the simulations, configure the models, and interpret the results, but the "performance" (temperature rise, SAR calculations) is computed by the algorithm.

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

For the non-clinical tests:

• Magnetically induced displacement force, torque, and image artifacts: The "ground truth" is based on the physical properties of the materials and device designs, measured or calculated according to established ASTM standards (F2052-21, F2213-17, F2119-07).
• RF-induced heating: The "ground truth" for the simulations is derived from the established electromagnetic physics and thermal dynamics principles implemented in the FDA-qualified Medical Device Development Tool (MDDT) and applied to the Duke virtual human anatomy model. The MDDT's qualification process by the FDA implicitly establishes the reliability of its results as a form of "ground truth" for simulation-based assessments.

8. The sample size for the training set

Not applicable. This is a non-clinical study for MR safety assessment, not a machine learning model requiring a training set in the typical sense. The "training" for the MDDT is its initial validation and qualification against known physical phenomena and experimental data, which is a separate process from this submission.

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

Not applicable, as there is no training set for a machine learning model in this context. The "ground truth" for qualifying the simulation tool (MDDT) would have been established through extensive validation against experimental measurements and recognized physical theories.

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SMART Bun-Yo-Matic X-Ray software is to be used by orthopaedic healthcare professionals for diagnosis and surgical planning in a hospital or clinic environment. The medical imaging type intended to be used as the input of the software is X-ray.

The SMART Bun-Yo-Matic X-Ray software provides:

· Visualization report of the three-dimensional mathematical models of the anatomical structures of the foot and ankle and three-dimensional models of orthopaedic fixation devices.

· Measurement templates containing radiographic measures of foot and ankle,

· Surgical planning application for visualization of foot and ankle anatomical three-dimensional structures, radiographic measures, and surgical instrument parameters.

The visualization report containing the measurements can be used for the diagnosis of orthopaedic healthcare conditions. The surgical planning application containing the visualizations of the measurements in the context of three-dimensional models, orthopaedic fixation device models and surgical instrument parameters can be used for the planning of treatments and operations to correct orthopaedic healthcare conditions of foot and ankle.

The SMART Bun-Yo-Matic X-Ray device is a software tool that takes x-rays of the foot and produces 3D axes on contextual bone models to help a user plan for hallux valgus correction. The final output of the device is a case report that provides images of the patient's axes, as well as measurements prior to correction and following a surgical correction selected by the user.

Device Acceptance Criteria and Performance Study: SMART Bun-Yo-Matic X-Ray

This response details the acceptance criteria and the study that proves the SMART Bun-Yo-Matic X-Ray device meets these criteria, based on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 97 x-ray and DRR (Digitally Reconstructed Radiographs) images.
• Data Provenance: The x-ray and CBCT DRR were collected from various sites across USA, Germany, UK, Finland, and Korea. The data was collected from patients with different ages and racial groups, with a minimum of 5% male/female within each dataset, mean age approximately 35 years, and representatives from White (Non-)Hispanic, Hispanic, and Native American racial groups. Each dataset was balanced in terms of subjects with different foot alignment, demographics, imaging devices, and subjects from clinical subgroups ranging from control/normal feet to pre-/post-operative clinical conditions such as Hallux Valgus, and undefined indications. This implicitly suggests a retrospective collection for the purpose of algorithm development and testing.

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

• Number of Experts: 2 clinicians.
• Qualifications: "Over five (5) years of experience practicing medicine."

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth on the test set is not explicitly detailed beyond "Each clinician was given the same image data to review dorsoplantar and lateral x-ray images. Each clinician then marks on a spreadsheet the presence of the bone in the image." This suggests either independent marking or a simple consensus approach, but no specific adjudication rule (e.g., 2+1, 3+1) is mentioned.

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

No, an MRMC comparative effectiveness study involving human readers assisting with or without AI and their improvement was not reported in this summary. The performance testing focused on the AI system's ability to meet preset technical/measurement accuracy criteria and its comparison to ground truth and manual measurements.

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

Yes, a standalone performance assessment study was done. The document states: "Performance testing was conducted. Testing included the following: AI/ML Testing. Comparison of the 2D-3D construction to manual measurements as well as ground truth. Comparison of the clinical acceptability of axes placement. Comparison of the planned surgical correction to the actual surgical correction." This indicates the algorithm's performance was evaluated against ground truth and manual measurements without direct human-in-the-loop interaction for the specific performance metrics. The training, tuning, and validation data were independent for this standalone assessment.

7. The Type of Ground Truth Used

The ground truth for the testing data was established by expert consensus (implied by 2 clinicians marking the presence of bone) and also involved manual measurements for comparison with the 2D-3D construction and the actual surgical correction for comparison with planned surgical correction.

8. The Sample Size for the Training Set

• AI algorithm for bone identification: 1,5776 (likely a typo, assumed to be 1,576 or 15,776) x-ray and CBCT DRR images.
• Metal identification: 15 x-ray and CBCT DRR images.

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

The document states that the "AI algorithm for bone identification was developed using 1,5776 x-ray and CBCT DRR and metal identification was developed using 15 x-ray and CBCT DRR." While it mentions the training and tuning data were independent, it does not explicitly describe how the ground truth for the training set was established. It can be inferred that a similar expert labeling process was likely used, but the details are not provided in this summary.

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SMART Bun-Yo-Matic CT software is to be used by orthopaedic healthcare professionals for diagnosis and surgical planning in a hospital or clinic environment. The medical imaging type intended to be used as the input of the software is Computed Tomography (CT).

SMART Bun-Yo-Matic CT software provides:

· Visualization report of the three-dimensional mathematical models of the anatomical structures of foot and ankle and three-dimensional models of orthopaedic fixation devices,

· Measurement templates containing radiographic measures of foot and ankle,

· Surgical planning application for visualization of foot and ankle anatomical three-dimensional structures, radiographic measures, and surgical instrument parameters.

The visualization report containing the measurements can be used for the diagnosis of orthopaedic healthcare conditions. The surgical planning application containing the visualizations of the threedimensional structural models, orthopaedic fixation device models and surgical instrument parameters combined with the measurements can be used for the planning of treatments and operations to correct orthopaedic healthcare conditions of foot and ankle.

The SMART Bun-Yo-Matic CT device is an automatic software tool that segments foot and ankle bones from computed tomography (CT) images and provides a case report showing images of a 3D model of the segmented structures with pre-operative and post-correction measurements. The correction is for hallux valgus through a Lapidus Arthrodesis procedure. The case report also provides parameters of an orthopedic surgical instrument and an example of an implant construct for the procedure.

The device includes machine learning derived outputs. Details on the validation are summarized below. The testing for 82 CT image series presented 100% correctly identified bones of foot and ankle. The existence of metal was identified correctly for 98.8% of the images (specificity 98%, sensitivity 100%).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Test Set Sample Size: 82 CT image studies.
• Data Provenance: The CT image series were collected from various sites across the USA and Europe, with a minimum of 50% of the images originating from the USA.
  • Patient Demographics: Patients of different ages and racial groups, with a minimum of 35% male/female within each dataset. Mean age approximately 47 years (SD 15 years). Representatives from White, (Non-)Hispanic, African American, and Native racial groups.
  • Clinical Conditions: Balanced in terms of subjects with different foot alignment, demographics, imaging devices, and with subjects from clinical subgroups ranging from control/normal feet (44% of test data) to pre-/post-operative clinical conditions such as Hallux Valgus, Progressive Collapsing Foot Deformity, fractures, or with metal implants (40% of test data).

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

• Number of Experts: Three (3).
• Qualifications: U.S. Orthopedic surgeons.

4. Adjudication method for the test set:

• Adjudication Method: Majority vote. Two same responses were required from the three experts to establish a ground truth for the presence of a bone and metal in each DICOM series.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No MRMC comparative effectiveness study was explicitly mentioned or detailed in the provided text. The study described focuses on standalone algorithm performance against expert-established ground truth.

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

• Yes, a standalone performance assessment was conducted for the SMART Bun-Yo-Matic CT software. The reported performance metrics (100% bone identification, 98.8% metal identification, model conformance, and measurement accuracy) refer to the algorithm's performance without human intervention in the interpretation phase.

7. The type of ground truth used:

• Expert consensus (majority vote of three U.S. Orthopedic surgeons).

8. The sample size for the training set:

• Bone identification algorithm: 145 CT image studies.
• Metal identification algorithm: 130 CT image studies.

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

• The document states that "The AI algorithm for bone identification was developed using 145 CT image studies and metal identification was developed using 130 CT image studies." It does not explicitly detail the method for establishing ground truth for the training data, beyond implying it was part of the algorithm development process. However, given the ground truth methodology for the test set, it is highly probable that a similar expert review or gold standard was used for training data labeling.

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The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bystem and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™HiMAX™ Implant System cleared in K142727, K181410 and K193452.

The subject devices branded as DynaBunion and DynaMet are additional plate confiqurations and screws being added to the predicate system, MotoBAND CP Implant System.

DynaBunion™ 4D Minimal-incision Bunion System:
The subject DynaBunion™ 4D Minimal-incision Bunion System includes the addition of the DynaBunion plates and screws to the MotoBAND CP Implant System. The Anti-Drift Bolt (ADB) is a modification of the MotoBAND CP Implant System screws for optional use with the subject DynaBunion plate to anchor the first metatarsal back to the base of the second metatarsal. DynaBunion instruments are used with the MotoBAND CP Implant System for the Lapidus procedure. The cut block and all associated instruments are Class I exempt instruments and may be used with previous versions of the MotoBAND CP Lapidus plates.

DynaMet™ Lesser TMT Fusion System:
The subject DynaMet™ Lesser TMT Fusion System includes the addition of the DvnaMet staple compression plates (SCP) to the MotoBAND CP Implant System. The subject plates have 8 configurations with templates and are compatible with 15mm or 18mm HiMAX C staples. The subject plates are compatible with the same MotoBAND CP screws cleared in K193452. The DynaMET plates are a variation of plate designs for a specific application.

The provided document is a 510(k) summary for the MotoBAND™ CP Implant System, which includes the DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System. This submission focuses on demonstrating substantial equivalence to predicate devices for these metallic bone fixation appliances.

It's important to note that this document does not describe a study involving device performance evaluated against acceptance criteria using patient data, AI, or human readers. Instead, it describes an engineering analysis to demonstrate substantial equivalence based on mechanical properties and design.

Therefore, I cannot provide information for many of the requested categories (e.g., sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) as they are not relevant to the type of submission described.

Here's an analysis based on the information provided, focusing on what is present:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No clinical or patient data test set was used. The evaluation was based on engineering analysis and comparison to predicate devices, focusing on mechanical properties and design.

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)

Not applicable. No ground truth based on expert review of clinical data was established. The "ground truth" here is the established mechanical performance of the predicate device.

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

Not applicable. No adjudication of clinical data was performed.

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

Not applicable. This is not an AI-enabled device, and no MRMC study was conducted.

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

Not applicable. This is a medical implant, not an algorithm, and no standalone algorithm performance was assessed.

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

The "ground truth" in this context refers to the established mechanical and material properties and performance of the legally marketed predicate devices. The subject device demonstrates substantial equivalence by showing that its engineering characteristics (strength, materials, design, intended use) are equivalent to or exceed those of the predicate devices.

8. The sample size for the training set

Not applicable. No training set was used. This is an engineering comparison, not a machine learning model.

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

Not applicable. No training set was used. The "ground truth" for comparison (predicate device performance) was established through prior regulatory clearances and mechanical testing of those predicate devices.

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The Better Bunion System is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot and ankle for adult and pediatric patients 12 years of age and older. Better Bunion cutting guides are intended for single use only.

The RedPoint Medical Better Bunion system includes single use, patient specific bone resection guides designed from DICOM files from a patients' CT scans and a surgeon's prescription. The Better Bunion system includes single use and reusable instruments to facilitate surgery. The Better Bunion patient specific bone resection guides assist the surgeon in cutting bone in the foot and ankle according to the pre-surgical plan. The quides are individually manufactured for each patient using a validated design and manufacturing process with strict procedures for transfer and conversion of patient images from DICOM files to digital models (STL files), and in turn to patient specific bone resection guides that are additively manufactured with titanium alloy conforming to ASTM F3001. The bone cutting guides are single use devices and provided clean, not sterile to the end user.

Here's a breakdown of the acceptance criteria and study information for the RedPoint Medical Better Bunion System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

As an AI, I need to point out that the provided text is an FDA 510(k) summary, which often provides a high-level overview of performance data rather than a detailed study protocol. Therefore, some of the requested information (like specific sample sizes for test sets, expert qualifications, or details about comparative effectiveness studies) is not explicitly stated in this document. I will extract what is available and note when information is not present.

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

• Sample Size: Not explicitly stated for the "simulated surgical studies." The text mentions "all guides" when referring to the IM angle performance, but doesn't quantify the number of guides or cases.
• Data Provenance: Not explicitly stated. The studies are described as "simulated surgeries," implying a controlled, prospective setup, but the specific origin (e.g., country) is not mentioned.

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

• This information is not provided in the summary. The "simulated surgical studies" suggest an objective measurement against a plan, but the role of experts in establishing ground truth for individual cases is not detailed.

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

• This information is not provided in the summary.

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

• A MRMC comparative effectiveness study is not mentioned. The performance data focuses on the device's accuracy in achieving a planned outcome in simulated surgeries, not on how it assists or improves human reader performance or diagnostic accuracy. The device is a surgical instrument/guide, not a diagnostic AI.

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

• The reported performance (simulated surgeries for correction of hallux valgus deformities) appears to be analogous to a "standalone" performance for the guide itself. The guide's accuracy is measured against the pre-surgical plan. While a surgeon would use the guide, the measurement of the guide's precision in achieving the planned angles in simulation reflects its inherent accuracy as designed, before human variability in actual surgery is introduced.

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

• The ground truth for the simulated surgery results (IM angle deviation) was the pre-surgical plan. The device's performance was measured by how closely it enabled the achievement of this predefined plan (e.g., final average IM angle of ±2º relative to plan, average deviation of 0.91º relative to plan).
• For the "fit and usability" verification, the ground truth was likely observational assessment and functional testing against engineering specifications and expected surgical workflow.
• For biocompatibility and sterilization, the ground truth was adherence to international standards (ISO 10993-1, AAMI/ISO 14927) and achieving specified performance targets (e.g., SAL of 10^-6^).

8. The sample size for the training set

• The device is a patient-specific surgical guide, designed from individual patient CT scans. It is not an AI algorithm in the sense of a machine learning model that requires a "training set" of patient data in the conventional way.
• The text describes a "validated design and manufacturing process with strict procedures for transfer and conversion of patient images from DICOM files to digital models (STL files), and in turn to patient specific bone resection guides." This process itself would have been developed and validated, but there isn't a "training set" of patient images in the typical AI sense for the device itself. The "training" would be more akin to software and manufacturing process validation.

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

• As noted above, there isn't a "training set" in the conventional AI sense for this type of device. The ground truth for the design and manufacturing process validation (which ensures accurate translation from DICOM to guide) would involve:
  • Metrological assessments: Comparing digital models (STL files) derived from DICOM data to known anatomical structures or highly accurate scans.
  • Prototyping and testing: Manufacturing guides and verifying their fit and accuracy on physical models or cadaveric specimens, ensuring they align with the pre-surgical plans generated.
  • Software validation: Ensuring the conversion software accurately transforms DICOM data into digital bone models and then into guide designs.

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The MIS Precision Chevron Bunion System is indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.

Based on the provided text, the device is the "MIS Precision Chevron Bunion System," which is a metallic bone fixation fastener (specifically, cannulated headless compression screws) used for foot osteotomies. The text does NOT describe an AI/ML-based device.

Therefore, many of the requested criteria such as acceptance criteria for AI performance (e.g., sensitivity, specificity), sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable. The provided document is a 510(k) summary for a medical device (surgical system), not for an AI/ML algorithm.

I can, however, extract the relevant performance evaluation information for this non-AI medical device.

Acceptance Criteria and Reported Device Performance (Non-AI Device)

For this type of medical device (bone fixation fastener and surgical system), acceptance criteria are typically related to mechanical performance, biocompatibility, sterility, and usability, rather than diagnostic accuracy metrics.

As this is not an AI/ML device, the following points are not directly applicable. However, I will state what could be inferred if one were to try to map the request to the provided information, noting the disclaimers.

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

  • Test Set (Performance/Usability Evaluation): 25 cadaveric surgical procedures (14 male, 11 female feet).
  • Data Provenance: Cadaveric tissue, implying a laboratory/simulated setting, no country of origin specified. Retrospective/Prospective is not applicable in this context; it's a prospective in vitro (cadaveric) study.

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

  • The "experts" were "trained foot and ankle physicians" who conducted the performance and usability testing. The number is not specified, but it was stated as "physicians" (plural). Their qualifications are "trained foot and ankle physicians." Ground truth in this context is successful completion of the procedure and proper placement as verified by fixation and fluoroscopy images, and the ability to position the guide on various foot sizes.

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

  • Not applicable in the context of device performance testing. The "adjudication" was the successful completion and observation of proper placement during the simulated surgeries by the performing physicians.

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

  • Not applicable. This is a physical medical device, not an AI system.

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

  • Not applicable. This is a physical medical device, not an AI system. The mechanical testing (Static Torsion, Driving Torque, Axial Pullout Strength) could be considered "standalone" in mechanical terms, but not in the context of an AI algorithm.

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

  • For mechanical tests: Engineering standards (ASTM F543) and FDA guidance for screws.
  • For usability/performance: Successful completion of surgical steps, proper guide positioning, and visual confirmation of osteotomy and implant placement via fluoroscopy images during simulated procedures. This is a form of "expert judgment/observation" within a cadaveric model.

• 8. The sample size for the training set:

  • Not applicable. There is no AI model to train.

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

  • Not applicable. There is no AI model to train.

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