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Dolphin Imaging software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.

The software contains eight major components (modules) for achieving its basic functionalities. They are ImagingPlus™, Ceph Tracing, Treatment Simulation, Arnett/Gunson FAB, McLaughlin Dental VTO, Impanner™, Dolphin 3D, and Dolphin Letter System.

ImagingPlus™ is the foundation of the Dolphin product suites. It allows the user to capture, organize, edit, print, store and present patient image records.

Ceph Tracing allows the user to digitize landmarks on a patient's radiograph, trace cephlometric structures, view cephalometric measurements, and superimpose images for analysis.

Treatment Simulation (VTO) Module provides a tool to simulate orthodontic and surgical treatment results using Visual Treatment Objective (VTO).

Amett/Gunson FAB Analyses performs face, ainway, bite analysis, and simulate treatment for orthodontic and surgical cases based on the methodologies of Dr. William Arnett.

The McLaughlin Dental VTO is an interactive treatment-planning and case presentation software program based on the theories of Dr. Richard P. McLaughlin, a renowned clinician, author and lecturer. It analyzes and evaluates tooth positions and dental treatment options, which assists clinicians in planning precise, quantifiable movement of dentition using clinical examination and treatment planning values.

Dolphin Implanner Module is for planning implant procedures. Using this module, simulated dental implants can be placed on a patient's lateral or panoramic x-ray images.

The Dolphin 3D module contains features for generating a multitude of views of the volumetric data, including simulated x-ray views and 3D-rendered views of the volume.

Dolphin Letter System generates letters that include the images and diagnostic questionnaire data entered by the user can choose a pre-defined letter template or create a custom template.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria. The document is primarily a 510(k) premarket notification for the Dolphin Imaging software, focusing on its intended use, description of modules, and demonstrating substantial equivalence to predicate devices.

However, based on the general information provided, we can infer some aspects and highlight what is not present.

Inferred Acceptance Criteria (Based on typical software validation in medical devices):

• Functional Correspondence: The software's features and output should align with its described functionalities (e.g., image acquisition, storage, manipulation, cephalometric tracing, treatment simulation, 3D visualization, reporting).
• Accuracy/Consistency of Measurements: If the software performs measurements (e.g., cephalometric measurements), these should be consistent and accurate when compared to manual methods or established standards.
• Image Quality/Integrity: Images should be acquired, stored, and displayed without degradation.
• Data Integrity: Patient data and image records should be stored and retrieved accurately and securely.
• Usability/User Interface: The software should be intuitive and easy for trained practitioners to use as intended.
• Compatibility: Compatibility with various imaging devices (TWIN, DICOM) and standard image formats.
• Performance/Reliability: The software should perform its functions reliably without crashes or errors.
• Safety: The software should not introduce new risks to patient safety.

Reported Device Performance (Implicit from the document):

The document states: "Dolphin Imaging has successfully completed integration testing/verification testing and Beta validation. In addition, potential hazards have been evaluated and controlled to an acceptable level."

This indicates that internal testing validated the software's performance against its design specifications and risk controls, but specific performance metrics (e.g., numerical accuracy, sensitivity, specificity, processing speed) are not reported.

Detailed Breakdown of Information (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

• Sample Size for Test Set: Not specified. The document mentions "integration testing/verification testing and Beta validation," but does not provide details on the number of cases or images used in these tests.
• Data Provenance: Not specified. It's likely internal testing data, but no explicit mention of country of origin, retrospective/prospective nature, or type of patients (e.g., specific conditions, age groups).

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

• Not specified. The document mentions "trained and licensed practitioners" for interpretation and "medical professional" for decision-making, but does not detail expert involvement in ground truth establishment for testing. Given the clearance year (2011), formal ground truth establishment involving multiple experts for an AI study was less common for this type of device.

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

• Not specified. This level of detail is not present in the document.

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 explicitly done or reported. The document describes the software as assisting in treatment planning and diagnosis, and that results are dependent on practitioner interpretation. It does not claim improvement of human readers with AI assistance nor provides any effect sizes. The clearance is based on substantial equivalence to predicate devices, not on a demonstrated improvement in reader performance.

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

• A standalone performance study of an "algorithm" as typically defined for AI was not reported. The device is a software suite with various tools, not presented as a single standalone diagnostic algorithm. Its functionalities (like cephalometric tracing) involve algorithms, but their performance is not reported in isolation with metrics like sensitivity/specificity compared to a ground truth. Rather, the software is consistently described as a tool for a "trained and licensed practitioner" whose interpretation is key.

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

• Not specified. Given the nature of the device (image management and analysis tools for dental practitioners), "ground truth" might pertain to the accuracy of digitized anatomical landmarks, consistency of measurements, or correctness of image manipulation functions rather than a definitive medical diagnosis. However, the exact methods are not detailed.

8. The sample size for the training set

• Not applicable / Not specified. The document does not describe the use of machine learning models that would require a separate "training set" in the modern sense. The software's functionalities are based on established algorithms (e.g., for image processing, geometric calculations for cephalometry) rather than data-driven AI models that are "trained."

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

• Not applicable / Not specified. As no machine learning training set is described, there's no information on how its ground truth would have been established.

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The Porous Titanium Acetabular Shells are indicated for cemented or non-cemented use in total hip replacement in cases of:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.

Specific indications for compatible components (femorals, heads, liners, and screws) that can be used with the Regenerex™ Hip Products include:
Freedom® Constrained Liners (K030047): The Biomet Freedom® Constrained liner is indicated for use as a component of a total hip prosthesis in primary and/or revision patients at hip dislocation due to history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Tri-Polar System (K991990): Indication #5 (Revision of previously failed total hip arthroplasty) is further specified to include recurrent dislocation.
OSS/Salvage Systems/Total Femur (K974558, K002757, K021380, K033871): Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrodesis.
Interlocking Stems (K990830, K042774): Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
HA PMI Hip Femoral Stems (K030048): Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
Gross Hip Femoral (K001580) and Bohn Hip Femoral (K000262): These femoral components are also indicated for treatment in conjunction with tumor resection and trauma.
Taper 2 ™ Porous Femoral (K050441) and Balance Microplasty (K050251): Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. These stems are indicated for the revision of previously failed femoral head resurfacing component.
Color Buffed Femoral (K992903), CB DDH Femoral (K012019), Bi-Metric Hip (K992058), CB Answer Femoral (K991987), Reach Femoral (K982367): Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, "Revisions of hip replacement components".
150mm Bi-Metric Hip Stem (K983710): Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. They are not indicated for revision procedures.
Zirconia Ceramic Heads (K964431 and K991708): Indication #4 (Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques) is not applicable to these Zirconia Ceramic Heads.
Biolox® delta Ceramic Heads (K042091), Rx90™ Standard/Lateralized Femoral (K023085), Portrait Femoral (K010560), MalloryHead Smooth Femoral (K994007), Generation 4 Polished Femoral (K031734), Modular Reach Femoral (K994038), Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, "Revision procedures where other treatment or devices have failed".
Medallion Modular Hip System (K041850): Same list of five indications but cleared for uncemented use only.

Porous Titanium Acetabular Shells are Intended for use in reconstruction of the hip joint due to disease, deformly, or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant. This submission includes acetabular shells for use as reconstructive components. The acetabular shells range In size (OD) from 52mm to 80mm in 2mm Increments. The shell is constructed of a porous titanlum allov (Ti-6Al-4V) and has been designed for cemented or non-cemented use with the option of using screws for added fixation to the native bone. The wall of the shell is composed entirely of the porous material. The rim of the implant is solld titanlum for reinforcement and provides the mating geometry necessary to mate with the instrumentation. The acetabular shells are designed for use with commercially available all polyethylene acetabular liners. These polyethylene ilners are to be cemented into the acetabular shells.

The provided text is a 510(k) Summary for a medical device (Porous Titanium Acetabular Shells) seeking substantial equivalence to predicate devices. It does not present any acceptance criteria or a study proving that the device meets those criteria from an AI/algorithm performance perspective.

Instead, it focuses on demonstrating substantially equivalent technological characteristics and intended use compared to existing devices already on the market.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the context of AI/algorithm performance. The document only states the following regarding testing:

• Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its Intended use."
• Clinical Testing: "None provided as a basis for substantial equivalence."

This indicates that the FDA clearance for this device was based on engineering and material testing (non-clinical) to show it performed similarly to existing devices, not on a study evaluating an AI's diagnostic or predictive performance.

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The KODAK DirectView CR Long-Length Imaging System is used with the KODAK DirectView CR 800/ CR 900 Systems which are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiology applications. The Long Length Imaging feature is used for examinations of long areas of anatomy such as the leg and spine.

The Kodak DirectView CR Long-Length Imaging System extends the capability of the Kodak CR 800 and CR 900 computed radiography systems to allow the capture of long length images with an image area up to 130 cm high x 43 cm wide. Individual CR images are limited to the size of a CR cassette, the largest being 35 x 43 cm. The Kodak Long-Length Imaging System includes a vertical cassette holder, which can hold up to four CR screens and image stitching software, which will operate on the CR 800 or CR 900 system. Image capture is accomplished using standard x-ray equipment and technique. The CR screens are then removed form the vertical cassette holder and placed in the CR 800 or CR 900 system to be scanned. The image stitching software processes the images correcting for magnification, translation, and rotation differences among the images, eliminates redundant pixels in the overlap region and stitches together the individual images. The resulting single composite image covers an image area of up to 130 cm x 43 cm, and can be stored to a PACS workstation or printed to film using a laser imager.

The provided text is a 510(k) summary for the Kodak DirectView CR Long-Length Imaging System. It describes the device, its intended use, and substantial equivalence to existing devices.

However, the document does not contain the following information required to answer your request:

• Acceptance criteria: There is no mention of specific performance metrics that the device needs to achieve.
• Study details: While it discusses the device's functionality, there is no description of a study conducted to prove the device meets any performance criteria.
  • Reported device performance: No specific performance results are provided.
  • Sample size and data provenance for the test set: Not mentioned. The document describes how the system works without detailing a test set.
  • Number of experts and qualifications for ground truth: Not mentioned.
  • Adjudication method: Not mentioned.
  • Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
  • Standalone performance: Not mentioned.
  • Type of ground truth used: Not mentioned.
  • Sample size for the training set: Not mentioned as there's no mention of a training process.
  • How ground truth for the training set was established: Not mentioned.

This 510(k) summary is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing a rigorous performance study with acceptance criteria. It describes the technology and functionality of the image stitching software, emphasizing that it corrects for "magnification, translation, and rotation differences among the images, eliminates redundant pixels in the overlap region and stitches together the individual images." However, it does not quantify how well it performs these tasks or list any acceptance metrics for that performance.

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