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CS Model+ is intended for use as a front-end software tool for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design options, including dental casts and orthodontic appliances. These applications are based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

The use of CS Model+ requires the user to have the necessary training and domain knowledge in the practice of orthodontics.

CS Model+ is a software that allows practitioners to apply software imaging tools for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design. CS Model+ allows design of virtual models, also known as virtual dental casts. Those can be exported as STL or PLY files which may be used for fabrication of orthodontic models (dental casts). Then, which may be used to fabricate sequential aligner trays or retainers. The production of physical models and the other fabrication processes, such as thermoforming of aligner, is out of scope of Carestream Dental's manufacturing process. Those fabrication processes are done by the user and is under their sole control and responsibility.

CS Model+ is intended to be used with the following Carestream Dental's digital imaging devices including:

• -Intraoral scanners;
• -Extraoral devices with 3D object modality.

CS Model+ allows healthcare professionals to do the following:

• -Display digital 2D or 3D views of digital 3D models;
• Adjust the color and opacity of digital 3D models; -
• -Make indicative measurements of digital 3D models;
• Print and export images of digital 3D models; -
• -In a digital model, automatically detect the teeth cervical margins, teeth numbering and mesio distal orientations;
• -Generate an orthodontic report;
• Create virtual setups; -
• -Automatically generate virtual setups suitable for aligners treatment;
• Make automatic and customizable export of virtual models; -
• -Manage the intermediate steps;
• -Make refinement during treatment.

The provided text is a 510(k) Summary for the medical device CS Model+. It outlines the device's indications for use and compares it to a predicate device, Ortho System™. However, the document explicitly states that clinical testing was not performed and is not a requirement for this submission.

Therefore, the input does not contain the information requested in your prompt regarding acceptance criteria, reported device performance from a study, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth types for training and testing sets.

The document focuses on nonclinical testing (software verification and validation) to establish substantial equivalence, stating: "Testing confirmed that CS Model+ is stable and operating as designed." and "All test results have been reviewed and approved, showing the CS Model+ software to be substantially equivalent to the primary predicate Ortho System™ (K171634)."

Without a clinical study, it's impossible to create the table and answer the detailed questions about acceptance criteria and device performance based on the provided text.

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The Spectranetics LLD E is intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using the superior venous approach. The lead inner lumen must have an inner diameter (ID) range from 0.015 -0.026 inches (0.38 - 0.66 mm) and a length less than 33.5 inches (85 cm).

The Spectranctics LI.D E is a percutaneous wire stylets that are placed inside the central lumen of a pacemaker or defibrillator lead as a fixation mechanism to provide traction for the extraction of the lead.

The Spectranctics LLD E is comprised of two (2) wire loop handles and a core mandrel that has a stainless steel mesh fixation mechanism. This mesh is attached at the distal end within a radiopaque marker for visibility under fluoroscopy. The proximal end of the mesh is attached to a proximal connector that is used to deploy and lock the device into the pacing or defibrillator lead.

The proximal connector is seated on a crimped section of the core mandrel until it is deployed. The connector slides from the crimped section and deploys the mesh inside the lead.

The tip of the LLD E is comprised of a platinum/iridium coil that is affixed to the tapered tip with the use of tin/silver solder. This coil allows the stylet better maneuverability around tight curves as compared to the predicate device. The platinum/iridium materials of the coil also allow for visualization of the stylet tip under fluoroscopy.

Here's an analysis of the provided text regarding the Spectranetics LLD E stylet, focusing on acceptance criteria and the supporting study information:

The document is a 510(k) summary for the Spectranetics LLD E, a locking stylet used for transvenous removal of chronically implanted pacing or defibrillator leads. The "study" described is primarily bench testing to demonstrate substantial equivalence to a predicate device, rather than a clinical trial with human subjects.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for individual tests. It uses general terms like "samples tested."
• Data Provenance: The studies were retrospective bench tests performed by the manufacturer, The Spectranetics Corporation, in Colorado Springs, USA. There is no indication of clinical data or data from other countries.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. The "ground truth" for these bench tests would be the design specifications and predefined performance thresholds for the device and its components, as determined by the manufacturer's engineering and quality assurance teams. No external medical experts are mentioned as establishing ground truth for these specific bench tests.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The testing would be conducted by qualified engineers and technicians.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This was a series of objective bench tests against engineering specifications, not evaluations requiring subjective judgment or consensus among multiple human reviewers. The "adjudication" would involve comparing test results to predetermined pass/fail criteria.

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

• Was it done? No. This document describes bench testing only. MRMC studies typically involve human readers (e.g., radiologists) interpreting medical images or data, which is not relevant to this device's pre-market submission type.
• Effect Size of AI Improvement: Not applicable.

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

• Was it done? Yes, in a sense. The described tests are all standalone device performance tests. The device itself (the stylet) is the "algorithm" here, and its performance characteristics (tracking, locking, strength, visibility) were evaluated independently in a simulated environment or through material testing. There is no AI or software algorithm involved.

7. Type of Ground Truth Used

• Ground Truth Type:
  • Engineering Specifications: For mechanical tests (fatigue, tensile strength).
  • Predicate Device Performance/Design: For comparisons of dimensions, working length, and biocompatibility, the predicate LLD stylets served as a reference for equivalence.
  • Simulated Anatomical Models: For tracking and locking/unlocking capabilities.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device is a physical medical device, not a machine learning model that requires a training set. The "training" in the context of device development would refer to iterative design, prototyping, and testing, but not a formally defined "training set" of data.

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

• How Established: Not applicable, as there is no "training set" or AI model. The design and performance goals for the device were established based on the predicate device, engineering principles, and the intended use.

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The Propaq 200 Series monitors are intended to be used by skilled clinicians for multiparameter vital signs monitoring of neonatal, pediatric, and adult patients in health care facility bedside applications; as well as for intrafacility and interfacility transport.

The Propaq 200 Series monitors are small, light weight, portable, multi-parameter patient monitors equipped with either a monochrome or color display. The monitors provide real time monitoring and display of ECG, respiration, invasive blood pressure, noninvasive blood pressure, temperature, CO2 and SpO22. Rechargeable batteries power the monitors. The Propaq 200 Series monitors can communicate with Welch Allyn Protocol's Acuity® central station through a local area network. The communication link is bi-directional, ventral station and one a louity central station and remote control of the Propaq from the Acuity central station.

This 510(k) summary provides limited information regarding specific acceptance criteria and detailed study results. Based on the provided text, here’s a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantifiable acceptance criteria for the Propaq 200 Series Monitors' overall performance or for the improved SpO2 channel in a clear table format. The performance section states:

For the improved SpO2 channel, the device is considered "substantially equivalent to the SpO2 channel in the Nellcor model N-395 Pulse Oximeter," which was previously cleared. This implies that the performance of the improved SpO2 channel is expected to meet the same standards demonstrated by the predicate Nellcor N-395.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only generally states that testing was performed.

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

This information is not provided in the document. The type of testing mentioned relates to compliance with standards, not performance against expert-established ground truth for diagnostic accuracy in a clinical setting.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No MRMC comparative effectiveness study is mentioned. This 510(k) relies on substantial equivalence to predicate devices and compliance with recognized standards, not a comparative study demonstrating improvement with AI assistance (as AI is not explicitly mentioned as a component here).

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

The Propaq 200 Series monitors are patient monitors intended for use by "skilled clinicians." The document does not describe standalone algorithm performance without human intervention. The testing described appears to be for the device's adherence to engineering and safety standards.

7. The Type of Ground Truth Used

For the overall device, the "ground truth" seems to be compliance with "recognized national and international, performance, safety, and electromagnetic compatibility standards for medical devices and product specifications listed in the Propaq labeling."

For the improved SpO2 channel, the "ground truth" for substantial equivalence is implied to be the performance characteristics of the predicate Nellcor N-395 Pulse Oximeter, which presumably met its own set of performance standards at the time of its clearance. No specific clinical ground truth data (e.g., pathology, outcomes data, or expert consensus on clinical readings) is mentioned as being used for the Propaq 200 Series in this summary.

8. The Sample Size for the Training Set

This information is not provided. The development of the Propaq 200 Series monitors and its SpO2 channel would have involved development and verification processes, but specific "training set" sample sizes, as might be relevant for machine learning algorithms, are not discussed.

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

This information is not provided. Given the nature of medical device standards compliance and substantial equivalence claims for patient monitors, the concept of a "training set" and "ground truth establishment" in the context of diagnostic accuracy (as would be typical for AI/CAD devices) is not explicitly applicable or discussed in this document. The "ground truth" for development and verification would be derived from engineering specifications, established physiological principles, and compliance with recognized standards.

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