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The Piezo Tronic is an ultrasonic scaler intended for use during dental cleaning and periodontal (gum) therapy to remove plaque and calculus and ultrasonic vibrating scaler tip to the teeth.

The Piezo Tronic consists of a main chassis containing a water control valve, an electric power supply, controls and displays, and ultrasonic generator. A footswitch is connected to the main chassis by a footswitch cord and a handpiece containing an ultrasonic scaler tip is connected to the main chassis by a handpiece cord.

When a dental professional has placed the tip in the proper position, the footswitch is depressed which activates the ultrasonic generator and opens the control valve to initiate water flow. The water flow and the level of ultrasonic energy delivered can be adjusted via operator accessible controls. A circular knob with an inked line on the front panel indicates the power level currently selected. Power level is adjusted by rotating the labeled knob clockwise on the front panel. Water flow is adiusted via a knob also on the front panel. When the foot switch is released, both ultrasonic energy and water flow stop immediately.

Safety of the operator and patient is ensured by compliance to IEC 601-1 and EMC 89/336/CEE.

The provided text describes a 510(k) premarket notification for an ultrasonic scaler called "AMD Piezo Tronic." The document focuses on establishing substantial equivalence to predicate devices and describes the device's functionality and intended use. However, it does not contain information about acceptance criteria or specific studies proving the device meets performance criteria beyond safety and effectiveness.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document is solely for a regulatory submission that focuses on equivalence.

Here's what can be extracted, albeit limited to what's available in the text:

Acceptance Criteria and Device Performance:

• No specific quantitative or qualitative acceptance criteria for performance (e.g., scaling effectiveness, patient comfort, tip durability) are mentioned.
• The document implies acceptance criteria revolve around substantial equivalence to predicate devices (Piezon Master 400, Dentsply Bobcat®, Cavitron® Model 3000) for its intended uses.
• Implied Performance:
  • Safety: Compliance to IEC 601-1 and EMC 89/336/CEE. (No specific reported performance data against these standards is provided in the summary).
  • Functionality: Delivery of ultrasonic movement and water to a stainless steel tip for:
    • Periodontal pocket lavage with simultaneous ultrasonic tip movement
    • Scaling and root planing
    • Removal of supra and subgingival calculus and stains from teeth
  • Equivalence to Predicates: The core claim is that it performs these functions similarly to the predicate devices.

Missing Information (Not Available in the Provided Text):

The following information cannot be provided as it is not present in the given text:

• Table of Acceptance Criteria and Reported Device Performance: No such table or specific performance metrics are detailed.
• Sample size used for the test set and the data provenance: No test studies or datasets are described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set evaluation is described.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No mention of such a study.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: Not applicable, as no ground truth creation process is described for performance evaluation.
• The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance/safety:

• Safety Standards: The device ensures safety of the operator and patient by compliance to IEC 601-1 and EMC 89/336/CEE. (No actual test results or acceptance criteria for these standards are listed, only the statement of compliance).
• Intended Use Validation (Implied by Equivalence): The device is considered substantially equivalent to predicate devices for its intended uses of scaling, root planing, and calculus/stain removal. This implies that if the predicate devices meet performance requirements for these tasks, the AMD Piezo Tronic is expected to as well, given its functional similarity.

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In vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood

The AMD Home Health Monitoring System consists of the home-use, blood glucose meter, the AMD Home Health Glucose Monitor, with accessories, and the companion physician's monitoring device, the AMD PC Monitoring Station. The AMD Home Health Glucose Monitor contains the glucose measurement technology of the MediSense Pen 2 device. MediSense Companion 2 Test Strips and Control Solutions are to be used with the AMD Home Health Glucose Monitor. The AMD Home Health Glucose Monitor testing system has been developed to allow rapid measurement of blood glucose (D-glucose) by using an electrochemical detection technique. This biosensor system employs a disposable dry reagent strip technology, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase (Aspergillus niger). When a blood drop is applied to the target area of the test strip, the glucose oxidase catalyzes the oxidation of glucose in the drop to produce gluconic acid. During the reaction, electrons are transferred by way of an electrochemical mediator to the electrode surface. This in turn generates a current that is measured by the Home Health Glucose Monitor. The size of the current generated is proportional to the amount of glucose present in the blood drop, thus giving an accurate reading of the blood glucose concentration. The computer-controlled Home Health Glucose Monitor facilitates efficient blood glucose testing and has an internal modem for the transmission of glucose test results to the remote AMD PC Monitoring Station. The AMD PC Monitoring Station is a personal computer-based system used in the clinical setting (e.g., physician's office, nurse's station, etc.) to receive and process blood glucose test data transmitted by the Home Health Glucose Monitor. This device allows remote clinical review of test results obtained in the patient's home.

The provided text is a 510(k) summary for the AMD Home Health Monitoring System, a self-monitoring blood glucose device. It details the device description, intended use, predicate devices, and a comparison chart. However, it does not contain information about acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth establishment relevant to the requested questions. The document focuses on demonstrating substantial equivalence to predicate devices based on design and operational characteristics, not on presenting performance study data against pre-defined acceptance criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text, as this information is absent.

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