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The Cleo bracket line is intended to operate together with other orthodontic devices to apply forces to teeth. Under the supervision of a trained dental professional or orthodontist, this may result in changes to the position of teeth.

The Cleo bracket line is indicated for orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.

The Cleo bracket line of products are single-use ceramic orthodontic brackets intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth.

The Cleo bracket line of products are made of 99.9% alumina through the process of ceramic injection molding.

Visual placement aids (VPAs) are placed in the Cleo bracket line to help provide visual contrast at the arch wire slot and intertwin areas of the bracket. The VPA is removed from the bracket before orthodontic treatment begins; VPAs do not serve a function during the orthodontic treatment. The presence of the VPA within the bracket prior to treatment will not impact the safety and performance of the bracket during the device's intended use.

The VPAs are made of polyurethane raw material through the process of injection molding.

The provided text is a 510(k) summary for the "Cleo" orthodontic bracket. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI/software device.

Therefore, the information required to answer the requested questions about acceptance criteria, study design (sample size, data provenance, ground truth, expert adjudication, MRMC, standalone performance, training set details) is not present in the provided document.

This document describes a physical medical device (orthodontic brackets) and its comparison to existing similar devices based on material, design parameters, and intended use, rather than a software or AI-based device that would typically undergo the type of performance evaluation outlined in your questions.

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The purpose and function of the CLEO patient monitor is to monitor basic physiological parameters including

• NIBP (systolic and diastolic)
• SpO2
• ETCO2

The target population is for adults only.

It can be used in all hospital areas and hospital-type facilities. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The CLEO monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to three different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The CLEO Patient monitor can be powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

The associated accessories include:

• Sp02 Finger Sensors
• NIBP Monitor
• Blood Pressure Cuff
• ETCO2 Module

The provided document is limited to the FDA 510(k) summary for the CLEO Patient Monitor. This document outlines the device's regulatory status, intended use, and a summary of performance testing to support substantial equivalence to a predicate device.

It does not contain the detailed information needed to fully answer all aspects of your request, particularly regarding specific acceptance criteria values and a comprehensive study report with ground truth establishment and expert involvement, as would be expected for a comparative effectiveness study or a rigorous standalone algorithm performance study.

The information provided largely focuses on demonstrating compliance with recognized standards for medical devices rather than detailed clinical performance studies for a diagnostic algorithm.

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

Description of Acceptance Criteria and Device Performance

The document describes various performance tests conducted to support the substantial equivalence of the CLEO Patient Monitor. However, it does not explicitly state numerical "acceptance criteria" for each parameter in the way one might expect for a diagnostic algorithm. Instead, it lists the standards of compliance that the device met. The "reported device performance" is implicitly that the device complied with these standards.

Table of Acceptance Criteria (as inferred from Standards of Compliance) and Reported Device Performance:

Missing Information:

The document does not provide the following information that would be necessary to answer the remaining parts of your request:

1. Sample size used for the test set and the data provenance: The document mentions "performance tests" for NIBP, SpO2, and ETCO2 but does not specify the number of subjects, the type of data (e.g., patient data, simulated data), or its origin (e.g., country, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. The testing described seems to rely on standardized methods and calibrated equipment rather than expert human assessment for ground truth.
3. Adjudication method: Not applicable/not mentioned, as there isn't a human-expert-based ground truth outlined.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: No MRMC study is mentioned. This device is a physiological monitor, not a diagnostic imaging AI algorithm typically requiring MRMC studies.
5. If a standalone performance study was done: The document describes various performance tests ("Mechanical Testing," "SPO2 Performance Test," "NIBP Performance Test," "CO2 Measurement Accuracy and Drift") which could be considered standalone performance assessments against established standards. However, it's not a standalone algorithm performance in the sense of a machine learning model's output being compared to ground truth.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the physiological measurements would be derived from highly accurate reference instruments or test setups that simulate physiological conditions according to the respective standards (e.g., a calibrated pressure transducer for NIBP, a pulse oximeter simulator for SpO2, a gas analyzer for ETCO2). Expert consensus, pathology, or outcomes data are not relevant for establishing ground truth for these types of physiological measurements.
7. The sample size for the training set: This device is a traditional physiological monitor, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" would be the engineering design, calibration, and validation against known physical and physiological principles.
8. How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device with a training set.

In summary: The provided document is a 510(k) summary for a traditional patient monitor. It focuses on demonstrating compliance with established medical device safety and performance standards for its physiological measurement capabilities (NIBP, SpO2, ETCO2). It does not describe an AI/machine learning algorithm or the types of studies (MRMC, expert consensus for ground truth, training/test sets for AI) that your request specifically asks about. The "acceptance criteria" are implied by compliance with the listed international and national standards.

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The Cleo 90 Infusion Set is designed for subcutaneous infusion of medication (including insulin) only. The set is not intended for intravenous (IV) infusion or to infuse blood or blood products.

The Cleo™ 90 Infusion Set consists of an applicator that contains an adhesive site with cannula and needle and separate extension tubing set with buckle. The infusion set has a standard luer connection. After insertion of the needle and cannula into the subcutaneous tissue, the applicator automatically retracts the needle into the applicator housing providing needle protection. The infusion set buckle attaches to the site allowing infusion of medication through the extension tubing.

The Cleo™ 90 Infusion Set is a medical device designed for subcutaneous infusion of medication, including insulin. The manufacturer conducted functional testing and a simulated clinical use evaluation to support its safety and effectiveness.

Here’s a breakdown of the acceptance criteria and study information:

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 explicitly state the exact sample size for the simulated clinical use evaluation. It mentions "Individuals who participated in the evaluation included patients who routinely use an insulin pump and infusion set, parents or guardians of patients who insert an infusion set on behalf of a patient, and health care providers who instruct patients and caregivers on the use of infusion pumps and infusion sets."
• Data Provenance: The study was a simulated clinical use evaluation, implying it was conducted specifically for this device's validation. The country of origin is not explicitly stated, but the submission is to the US FDA, suggesting the study was likely conducted in the US or under US regulatory standards. It was a prospective evaluation tailored to assess the needle protection feature.

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

• The document does not mention the use of "experts" in the traditional sense for establishing ground truth regarding device performance during the simulated clinical use evaluation. Instead, the evaluation involved users of infusion sets (patients, parents/guardians, healthcare providers) who assessed the functionality and safety of the needle protection feature. Their reported experiences (or lack thereof, regarding needle sticks) served as the "ground truth" for the performance of the needle protection feature.
• Their qualifications are described by their roles: "patients who routinely use an insulin pump and infusion set," "parents or guardians of patients who insert an infusion set on behalf of a patient," and "health care providers who instruct patients and caregivers on the use of infusion pumps and infusion sets."

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method in the context of multiple independent assessments being reconciled. The simulated clinical use evaluation appears to have collected direct feedback and observations from individual participants regarding the operation of the needle protection feature and the occurrence of any needle sticks or injuries. The report simply states that "no needle sticks or injuries were reported in the evaluation by the participants," suggesting a summation of individual reports rather than a formal adjudication process.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The studies described are functional testing and a simulated clinical use evaluation focused on the device's performance, particularly its needle protection feature. This type of study is more common for diagnostic imaging devices where human interpretation is a key component.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• The concept of "standalone" performance typically applies to AI algorithms. This device is a physical medical device (an infusion set), not an algorithm. Therefore, the concept of a standalone study in this context is not applicable. The functional testing assessed the device's inherent mechanical and material properties.

7. Type of Ground Truth Used:

• For the functional testing, the ground truth was based on device specifications and biocompatibility standards.
• For the simulated clinical use evaluation, the ground truth for the needle protection feature's performance and safety was established by user feedback and reported outcomes (no reported needle sticks or injuries). This could be considered a form of "user reported safety/effectiveness data."

8. Sample Size for the Training Set:

• The document does not mention a "training set" as this device is a physical hardware product, not a machine learning model. Therefore, this question is not applicable.

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

• As there was no "training set" for a machine learning model, this question is not applicable.

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