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3Dicom MD software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals. imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information.

3Dicom MD displays and manages diagnostic quality DICOM images.

3Dicom MD is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only.

3Dicom MD is not intended for diagnostic use on mobile devices.

Contraindications: 3Dicom MD is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.

3Dicom MD is a software application developed to focus on core image visualization functions such as 2D multi-planar reconstruction, 3D volumetric rendering, measurements, and markups. 3Dicom MD also supports real-time remote collaboration, sharing the 2D & 3D visualization of the processed patient scan and allowing simultaneous interactive communication modes between multiple users online through textual chat, voice, visual aids, and screen-sharing.

Designed to be used by radiologists and clinicians who are familiar with 2D scan images, 3Dicom MD provides both 2D and 3D image visualization tools for CT, MRI, and PET scans from different makes and models of image acquisition hardware.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the tested accuracy for the lowest clinical range (1-10mm) was found to be slightly inferior (98.8%) due to the resolution of the input scan and screen.

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

• Sample Size for Test Set: 81 Digital Reference Objects (test cases).
• Data Provenance: The Digital Reference Objects were "created...representative of the clinical range typically encountered in radiology practice." The text does not specify a country of origin or whether they were retrospective or prospective data in the clinical sense, as they are synthetically created for testing.

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

The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications. It mentions that "usability testing involving trained healthcare professionals" was performed, but this is distinct from establishing ground truth for the measurement accuracy tests. For the measurement accuracy tests, the ground truth was "known values" from the "Digital Reference Objects."

4. Adjudication Method for the Test Set

Not applicable. The ground truth for measurement accuracy was established using "known values" from Digital Reference Objects, not through expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or presented in the provided text. The study described focuses on the device's standalone measurement accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done for the measurement accuracy. The reported percentages (e.g., 99.3% accuracy for length > 10mm) represent the device's performance in measuring known values from Digital Reference Objects. There is no indication of human-in-the-loop performance in these specific metrics.

7. Type of Ground Truth Used

The ground truth used for the measurement accuracy tests was known values from Digital Reference Objects. These objects were created to represent the clinical range.

8. Sample Size for the Training Set

The document does not provide information about the sample size for a training set. The descriptions focus on verification and validation activities for the device's performance, not on a machine learning model's training.

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

As no information about a training set for a machine learning model is provided, there is no description of how its ground truth was established.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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PC/MAC version:
The RealGUIDE software is intended for the following uses:

1. Support to the diagnosis for trained professionals. The input DICOM files acquired by a CT/CBCT scanner are not modified in any way but they are showed to the doctor through the classical imaging and volume rendering techniques. It is a stand-alone product. No information of the patient is modified, all the parameters used for the image processing are read from the DICOM file itself. Neither automatic diagnosis is made, nor automatic disease detection is performed. This software is not connected to any medical instrumentation and it doesn't control any medical or energy supplying device. The user imports DICOM data coming from any CT/CBCT imaging device and the software enables him to view the Patient exam in different multi-planar 2D images and easily reconstruct the 3D volume for an immediate visualization of bone structures and surrounding tissues.
2. Virtual oral and maxillofacial surgery planning. Doctors can plan virtual implants and surgeries on 2D/3D reconstructions and export the projects in open or proprietary format for further processing. The user can choose different implant models (for example dental implants models) from a library provided by the Manufacturers and simulate the positioning in the Patient reconstructed volume (this operation is called "virtual plan")
3. Dental/maxillofacial surgical guides and prosthetic modelling. The virtual plan is used to design a surgical guide that is used by the doctor to drive the surgery drills according to the planned implants direction and depth. This surgical guide can be manufactured by any 3D printer working from STL files. The user can also design the patient (typically a denture) with the surface and volume free-form tools implemented in the result is exported in STL format for 3D printing or CAD/CAM technologies.

Mobile version:
The RealGUIDE software APP is intended for the following uses:

1. Projects visualization and editing. The input PROJECT files, pre-processed with the RealGUIDE desktop version, are used by trained professionals to evaluate the implants projects, edit them with other colleagues through the cloud, as well as for a more effective Patient treatment communication.
   The RealGUIDE APP version is NOT INTENDED for managing a 3D diagnosis starting from DICOM images, due to the mobile devices screen resolution limitations. For this reason, the APP is not reading directly the DICOM files but only pre-processed project files, exported through the cloud by the RealGUIDE desktop version.

RealGUIDE Graphic Station is a fully-featured 3D imaging application in medicine. Its unique open architecture and modular framework make customization options trivial. RealGUIDE Graphic Station is meant to be a multiplatform application, running on PC, MAC and mobile devices (not provided by 3DIEMME). The RealGUIDE software is capable of displaying oral/maxillofacial radiology. The user is then able to navigate through different views, segmented analysis (cross sections), and 3D perspective. In addition, the user is able to simulate various objects within the radiograph for the purpose of treatment planning.
Once treatment planning and visual simulation is complete, users can generate reports and simulated images for the purpose of evaluation and diagnosis, as well as perform a surgical guide and prosthesis modelling, to be exported in STL format for the manufacturing with any RP or CAD/CAM machine.
The output format of the software is a STL file, mainly focused on dental, maxillofacial and orthognatic surgery. A list of the possible devices that can be modelled with the software is reported below:

• -Surgical guides for dental implants and surgical screws planning
• -Bone cutting and bone reduction guides for maxillofacial surgery
• -Bone graft models for mandible/maxilla regenerative procedures
• -Dental and maxillofacial prosthesis

Here's an analysis of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates). Instead, it makes general claims about the device being tested and functioning as intended, and being substantially equivalent to predicate devices.

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

• Sample Size: The document states that "Significant clinical studies have been performed by different medical professionals on many CT/CBCT images." It does not provide an exact number or range for the "many" CT/CBCT images.
• Data Provenance: The document does not explicitly state the country of origin of the data. It mentions "The input DICOM files acquired by a CT/CBCT scanner" for the PC/MAC version. The retrospective or prospective nature of the data is not specified directly, though using "input DICOM files acquired" could imply retrospective use of existing data.

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

• Number of Experts: The document states that "Significant clinical studies have been performed by different medical professionals". It does not specify the exact number of medical professionals involved.
• Qualifications of Experts: The document refers to them as "different medical professionals" and "leading doctors" who have published relevant scientific literature. It does not provide specific qualifications such as years of experience or subspecialty (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

The document does not indicate that an MRMC comparative effectiveness study was performed to measure how much human readers improve with AI assistance. The described "clinical studies" focused on the software's effectiveness in improving surgical planning and diagnostic approach, and verifying data correspondence, but not in a comparative "with AI vs. without AI" reader study setup. The RealGUIDE software as described primarily functions as an imaging and planning tool, not an AI-driven diagnostic aid that assists human readers in real-time interpretation. It explicitly states: "Neither automatic diagnosis is made, nor automatic disease detection is performed."

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

The "PC/MAC version" is described as a "stand-alone product" in the context of its diagnostic support function and not being connected to medical instrumentation. However, this refers to the software itself not requiring external hardware to function, rather than an "algorithm-only" performance evaluation. The overall use of the device is for "trained professionals" for "Support to the diagnosis" and "Virtual oral and maxillofacial surgery planning," implying a human-in-the-loop workflow.

7. The Type of Ground Truth Used:

The document implies that the ground truth for "verifying that the data shown by RealGUIDE were correspondent to the patient's anatomical features" was established through clinical assessment and comparison to actual patient anatomy/features (presumably from the original CT/CBCT images and potentially outcomes). It also states that "Results of these studies are provided in a separate supplement" and "Relevant scientific literature has been published... on the effectiveness of medical imaging technology," suggesting comparison to established medical understanding and potentially expert consensus on anatomical representations.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size used for the training set for the software. This is common for 510(k) summaries where the focus is on performance validation rather than details of the development process.

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

Since no information is provided about a training set, there is no information on how its ground truth was established.

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The ORTHOLOC® 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodessis, in conjuction with osteotomies of the distal tibia, talus, and calcaneus.

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

The subject Universal Anterior Plate is designed to facilitate arthrodesis of the ankle and is composed of titanium alloy. The plate features poly-axial locking screw holes and one compression slot. It accepts screws of multiple diameters and lengths.

The provided text is a U.S. FDA 510(k) premarket notification document for a medical device. This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device.

The document does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device or a diagnostic device. It is for a mechanical orthopedic implant (an ankle fusion plating system).

The "study" referenced in this document is a "non-clinical" engineering analysis (Finite Element Analysis and cross-sectional analysis) rather than a clinical trial or performance study against specific acceptance criteria for diagnostic output.

Therefore, most of the information requested in your prompt (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, ground truth, MRMC study, standalone performance) is not applicable or not present in this document because it pertains to a different type of medical device evaluation.

However, I can extract the relevant information from the document as best as possible, focusing on how substantial equivalence was demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance

For this orthopedic implant, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device in terms of mechanical performance. The study aimed to show that the new device's bending strength was comparable to the predicate and did not introduce a new worst-case scenario.

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

• Sample Size: Not applicable. The "test" here refers to non-clinical engineering analysis (Finite Element Analysis and cross-sectional analysis), not a traditional clinical sample size or dataset for diagnostic performance.
• Data Provenance: Not applicable. As an engineering analysis, it relies on material properties, design specifications, and computational models, not patient data from a specific country or retrospective/prospective studies.

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

Not applicable. Ground truth, in the context of diagnostic performance, is not relevant for this mechanical engineering analysis.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not a diagnostic tool evaluated by human readers.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

Not applicable. For a mechanical device evaluated through engineering analysis, "ground truth" as typically understood in diagnostic studies (e.g., pathology, outcomes data, expert consensus) is not applied. The "truth" is established by the laws of physics and engineering principles applied in the analysis.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a mechanical device evaluated through engineering analysis, not an AI/ML algorithm.

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

Not applicable. There is no "training set" or "ground truth" in the context of an engineering analysis for a mechanical device.

Summary of the Study for Substantial Equivalence:

The study performed was a non-clinical evaluation consisting of:

• Finite Element Analysis (FEA)
• Cross-sectional analysis

These analyses were conducted to compare the bending strength of the new ORTHOLOC® 3Di Universal Anterior Plate to its predicate device (K121425: ORTHOLOC® 3Di Ankle Fusion Plating System). The conclusion was that the new plate demonstrated substantial equivalence in bending strength and did not introduce a new worst-case scenario into the system. This type of evaluation is standard for demonstrating the safety and effectiveness of mechanical orthopedic implants for 510(k) clearance, rather than the clinical performance studies typically required for AI/ML or diagnostic devices.

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The ORTHOLOC® 3Di Small Bones Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles. The system can be used in both adult and pediatric patients. Examples include:

• Metatarsal, metacarpal, or phalangeal fractures and osteotomies
• Lesser metatarsal shortening osteotomies (e.g. Weil)
• Fifth metatarsal fractures (e.g. Jones Fracture)

The ORTHOLOC® 3Di comprises of variety of plates and screws for fixation of bone fragments. The subject device is composed of titanium alloy per ASTM F136. This system consists of plates in left, right, and universal configurations. The plates can feature polyaxial locking holes and compression holes. The plates are provided non-sterile.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) premarket notification for the ORTHOLOC® 3Di Small Bones Plating System, outlining its substantial equivalence to previously marketed devices. It primarily discusses the device's intended use, technological characteristics, and non-clinical and clinical evidence provided for FDA clearance.

The document states:

• (b)(1). Substantial Equivalence - Non-Clinical Evidence: "Performance testing and analysis demonstrated substantial equivalence in static and fatigue bending."
• (b)(2). Substantial Equivalence Clinical Evidence: "N/A"

This indicates that the clearance was based on non-clinical performance testing against a predicate device, rather than a clinical study with detailed acceptance criteria, ground truth establishment, or human reader performance evaluations as typically seen for AI/software-as-a-medical-device (SaMD) products.

Therefore, I cannot provide the requested table or details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information based on this document.

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Wright's ORTHOLOC® 3Di Ankle Fracture Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

• Lateral Malleolar Fractures ●
• Syndesmosis Injuries
• Medial Malleolar Fractures
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• Vertical Shear Fractures of the Medial Malleolus
• Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• Medial Malleolar Avulsion Fractures
• Lateral Malleolar Avulsion Fractures

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

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

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

The ORTHOLOC® 3Di Ankle Plating System consists of plates belonging to 1 of 2 general categories-distal tibia and fibula-based on the contouring of each plate. All plates feature poly-axial locking screw holes while some plates feature compression slots. The plates are made from titanium alloy and are compatible with 2.7mm and 3.5mm ORTHOLOC® 3Di locking screws, 3.5mm and 4.0mm ORTHOLOC® Bone Screws, and 4.0mm Wright Compression Screws.

The provided text is a 510(k) summary for the ORTHOLOC® 3Di Ankle Fracture Plating System. This document focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as understood in the context of clinical performance of an AI/Software as a Medical Device (SaMD).

Instead, the submission relies on demonstrating substantial equivalence through non-clinical performance testing and engineering analysis of the physical components (plates, screws, washers) against legally marketed predicate devices.

Here's an analysis of the information provided in relation to your request:

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

• Acceptance Criteria for Substantial Equivalence (Implicit): The implicit acceptance criterion is that the subject device's performance characteristics (e.g., static and fatigue bending strength, insertion/removal torque, pull-out strength, torsional strength) are "at least as well as" or "substantially equivalent" to the predicate devices.
• Reported Device Performance: The document states that "Performance testing, engineering analysis and rationale was performed to demonstrate substantial equivalence in static and fatigue bending strength." It also mentions "An engineering analysis was performed for the subject device screws to demonstrate substantial equivalence with respect to insertion/removal torque, pull-out strength and torsional strength, and bending strength."
• Missing Specifics: The actual numerical acceptance values (e.g., minimum bending strength in Nm) and the corresponding test results for the ORTHOLOC® 3Di Ankle Fracture Plating System are not provided in this summary document. These would typically be in the full 510(k) submission, but only the conclusion is summarized here.

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 in this context: Since this is a physical medical device (bone plating system) being evaluated for substantial equivalence through non-clinical (mechanical) testing, terms like "test set," "data provenance," "country of origin," "retrospective," or "prospective" are not relevant. The "sample size" would refer to the number of physical devices tested in the engineering lab, but this detail is not present in the summary.

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: This type of information is relevant for AI/SaMD where human expert consensus is used to establish ground truth for diagnostic or prognostic tasks. For a bone plating system, ground truth is established by objective engineering principles and measurements.

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

• Not Applicable: Adjudication methods are used to resolve disagreements among human experts in clinical studies, particularly for AI/SaMD. This is not relevant for the mechanical testing of a surgical implant.

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: MRMC studies are used to evaluate the performance of diagnostic tools, often imaging-based AI solutions, and their effect on human reader performance. This device is a surgical implant, not a diagnostic tool, and there is no AI component mentioned.

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

• Not Applicable: This question pertains to AI/SaMD performance. The ORTHOLOC® 3Di Ankle Fracture Plating System is a physical implant.

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

• Engineering Standards/Measurements: The "ground truth" for the non-clinical tests would be established by universally accepted engineering standards and validated measurement techniques for properties like strength, torque, and pull-out resistance. The predicate devices serve as the benchmark for "acceptable" performance.

8. The sample size for the training set

• Not Applicable: This concept relates to machine learning models (AI). There is no "training set" for a physical medical device like this, which is evaluated through mechanical testing.

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

• Not Applicable: As there is no training set, this question is not relevant.

In summary:

This 510(k) document demonstrates substantial equivalence through non-clinical performance testing and engineering analysis of the physical hardware (plates, screws, washers). It explicitly states:

• (b)(1). Substantial Equivalence - Non-Clinical Evidence: "Performance testing, engineering analysis and rationale was performed to demonstrate substantial equivalence in static and fatigue bending strength. An engineering analysis was performed for the subject device screws to demonstrate substantial equivalence with respect to insertion/removal torque, pull-out strength and torsional strength, and bending strength."
• (b)(2). Substantial Equivalence - Clinical Evidence: "N/A" (Not Applicable), indicating no clinical studies were performed to establish effectiveness for this submission.
• (b)(3). Substantial Equivalence - Conclusions: "The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices."

The study that "proves the device meets the acceptance criteria" is the non-clinical performance testing and engineering analysis comparing the ORTHOLOC® 3Di Ankle Fracture Plating System to its predicate devices, showing "substantial equivalence" in mechanical properties. Specific numerical details of these tests are not provided in this summary.

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The Thora-3Di is intended for a one-time measurement of respiratory rate as part of a vital signs assessment. The device is indicated for hospital or clinical use in adult patients. The device is intended to be operated by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

The Thora-3Di is not intended to monitor vital signs. This device is not an apnea monitor.

The Thora-3Di uses Structured Light Plethysmography (SLP) to derive respiratory rate. With the Thora-3Di, a structured grid pattern of light is projected onto the thoracoabdominal wall and two digital video cameras record changes in the grid pattern due to movement of the wall. A dedicated parallel processor executes real-time pattern recognition algorithms to identify the position of each part of the virtual grid in each camera. The system computes the 3-dimensional coordinates of the different markers to assess respiratory rate.

The Thora-3Di does not include any wireless transmission features, nor does it include a cloud or other remote functionality (no cybersecurity-related features).

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

1. Table of Acceptance Criteria and Reported Device Performance

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The ORTHOLOC® 3Di Foot Plating Reconstruction System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. Specific examples include:

Mid / Hindfoot Fusions

• · LisFranc Arthrodesis and/or Stabilization
• · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• · Intercuneiform Fusions
• · Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• · Calcaneo-Cuboid (CC) Fusion
• Medial Column Fusion

First metatarsal osteotomies for hallux valgus correction including:

• · Opening base wedge osteotomy
• · Closing base wedge osteotomy
• · Crescentic osteotomy
• Proximal Chevron osteotomy
• · Distal Chevron osteotomy (Austin)

First metatarsal fracture fixation

Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• · Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• · Revision MTP Fusion
• · Revision of failed first MTP Arthroplasty implant
• Flatfoot Osteotomies
• · Lateral Column Lengthening (Evans Osteotomy)
• · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

The ORTHOLOC® 3Di Foot Reconstruction System Line Extension (ORTHOLOC® 3Di CrossCHECK Module) is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The implants included in this system are designed to provide highly anatomic and versatile plating options for an array of fusions and stabilizations. The plates include straight, right, and left configurations, as well as locking and non-locking screws.

The provided document is a 510(k) premarket notification for a medical device called the ORTHOLOC® 3Di Foot Plating Reconstruction System. This document focuses on demonstrating the substantial equivalence of the new device to previously approved predicate devices, primarily through non-clinical performance testing. It does not describe a study involving a device that uses artificial intelligence (AI), machine learning (ML), or any software-based diagnostic or prognostic capabilities that would require acceptance criteria related to accuracy, sensitivity, specificity, or reader studies.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable to this particular submission.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the 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)

• Sample Size: The document does not specify a "sample size" in the context of clinical data or patient outcomes, as the assessment was based on non-clinical engineering performance testing (static bending). For the non-clinical testing, the sample size would refer to the number of physical devices or components tested. This information is not explicitly provided in the summary.
• Data Provenance: Not applicable, as this was non-clinical engineering testing, not human data.

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. The ground truth for engineering performance testing (e.g., bending strength) is established by engineering standards and measurement equipment, not clinical expert consensus.

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

Not applicable. Adjudication methods are typically for clinical studies with expert reviewers, not non-clinical engineering tests.

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, an MRMC comparative effectiveness study was not done. This device is a metallic bone fixation appliance, not an AI-powered diagnostic or decision support system.

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

Not applicable. This device is a physical implant, not an algorithm.

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

The "ground truth" for this device's performance assessment was established through engineering standards and measurements (e.g., measuring static bending strength) in comparison to established performance of predicate devices.

8. The sample size for the training set

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

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

Not applicable.

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The SALVATION™ 3Di Plaing System is indicated for the treatment of fracture stabilization/fixation, revision procedures, osteotonies, and reconstruction/arthrodesis of small bones, as well as patients with osteopenic bone. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for neuropathy (Charcot).

The SALVATION™ 3Di Plating System consists of titanium alloy plates and screws used for midfoot reconstruction. The system features plates of various sizes and styles, as well as locking and non-locking screws.

The provided text is a 510(k) summary for the SALVATION™ 3Di Plating System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a full clinical study with a detailed test set, ground truth, and statistical analysis as would be done for a novel AI/software device.

Therefore, many of the requested categories are not applicable (N/A) in the context of this 510(k) submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• N/A. The submission relies on non-clinical performance testing (in vitro/bench testing) rather than a clinical study with a 'test set' of human data. The specific sample sizes for these bench tests are not disclosed in this summary.
• Data Provenance: Not specified, but generally, such testing is performed in a controlled laboratory environment.

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

• N/A. As it's a non-clinical submission, there was no clinical test set requiring expert-established ground truth. Expert input would relate to the design and interpretation of the bench testing, but not in the same way as establishing ground truth for a diagnostic AI.

4. Adjudication method for the test set

• N/A. No clinical 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

• N/A. This is a device for bone fixation, not an AI/software device intended to assist human readers.

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

• N/A. This is a physical medical device (bone plate system), not an algorithm or AI.

7. The type of ground truth used

• N/A. For this non-clinical submission, "ground truth" would correspond to the engineering specifications and results of the physical performance tests (e.g., measured bending strength, torque values). These are measured directly from the device components, not established via expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• N/A. This is not an AI/machine learning device that requires a training set. The "training" in this context would be the design iterations and engineering development of the physical device prior to the final performance testing.

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

• N/A. As above, not an AI/ML device. The "ground truth" for the device's design and manufacturing would be based on established engineering principles, material science, and predicate device characteristics.

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Wright's ORTHOLOC® 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

• Lateral Malleolar Fractures
• Syndesmosis injuries
• Medial Malleolar Fractures
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• Vertical Shear Fractures of the Medial Malleolous
• Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• Medial Malleolar Avulsion Fractures
• Lateral Malleolar Avulsion Fractures

ORTHOLOC® 3Di Locking Screws:
The ORTHOLOC® 3Di locking screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.

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

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

The ORTHOLOC® 3Di .Ankle Plating System contains plates belonging to 1 of 2 general categories-distal tibia and fibula-based on the contouring of each plate: All plates feature polyaxial locking screw holes. Some plates have k-wire holes, compression slots, or syndesmosis slots. The plates are made from titanium alloy and accept 2.7mm ORTHOLOC® 3Di locking screws. 2.7mm. 3.5mm and 4.0mm ORTHOLOC® Bone Screws, and 4.0mm Wright™ Compression Screws (cleared under K082320, now branded DART-FIRE®). Washers are also available for use with the ORTHOLOC® Bone Screws.

Here's an analysis of the provided text regarding the Ortholoc® 3Di Ankle Plating System, focusing on acceptance criteria and study details:

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

The provided document (K131093) is a 510(k) summary for a medical device. For a 510(k) submission, the primary acceptance criteria for a new device are typically Substantial Equivalence to a legally marketed predicate device. This means the new device must be as safe and effective as the predicate.

The document does not outline specific, quantitative acceptance criteria in terms of performance metrics (e.g., bone healing rates, complication rates, specific mechanical load tolerances against a statistically defined threshold). Instead, it relies on a comparison to the predicate device.

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

The document explicitly states: "(b)(2). Substantial Equivalence - Clinical Evidence N/A". This indicates that no clinical test set (human patient data) was used in this 510(k) submission. The comparison for substantial equivalence was based on non-clinical evidence (mechanical analysis and comparison of design/materials/indications to the predicate). Therefore, there is no sample size for a clinical test set, no data provenance (country, retrospective/prospective) to report for human studies.

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)

Since no clinical test set was used, and specifically no human data requiring expert assessment for ground truth, this information is not applicable to this submission. The "ground truth" for the submission was established by comparing the device's design and mechanical properties to those of the predicate device, likely by Wright Medical Technology's internal engineering and regulatory teams, and subsequently reviewed by the FDA.

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

As no clinical test set was utilized requiring expert adjudication, this information is not applicable.

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 study was done. This device is a bone plating system, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation. The nature of the device (implantable hardware) means this type of study is irrelevant.

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

This question is not applicable as the device is a bone plating system and does not involve algorithms or AI for diagnostic or interpretive purposes. Performance is related to its mechanical properties and biocompatibility as an implant.

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

For this 510(k) submission, the "ground truth" for the device's safety and effectiveness was established by:

• Comparison to the Predicate Device: The predicate device, ORTHOLOC® 3Di Ankle Plating System (K102429), serves as the primary "ground truth" reference. The new device must demonstrate it is as safe and effective as this previously cleared device.
• Non-Clinical Mechanical Analysis: This involves engineering evaluations (e.g., stress testing, fatigue testing) to ensure the new plates do not represent a "new worst-case" scenario compared to the predicate. The "ground truth" for these tests would be established by validated engineering standards and methods.

8. The sample size for the training set

Since no clinical studies were performed, and no AI/algorithm components are part of this device, there is no training set in the context of machine learning or clinical trials. The "development" of the device would involve engineering design and validation, not a training set of data.

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

As there is no training set for this device type within the context of the 510(k) submission, this question is not applicable.

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