Search Results

The Tono-Pen AVIA tonometer is used to measure the IntraOcular Pressure (IOP) during routine eye examination or when an increased IOP is suspected.

The Ocu-Shield tip cover is used to help protect the patient from cross contamination and protect the Tono-Pen AVIA sensor from eye fluids during use or debris during storage.

The indications for use include measuring intraocular pressure for suspected glaucoma or when an increased intraocular pressure is suspected.

The Tono-Pen AVIA is a precision electronic manual tonometer which measures intraocular pressure. The body of the instrument is ergonomically designed to fit comfortably in the user's hand to facilitate a technique that helps to ensure fast, precise measurements. The sensor must be covered with an Ocu-Shield tip cover to help protect the patient from cross contamination as well as provide protection of the sensor.

The Tono-Pen AVIA is an ergonomic hand held tonometer that measures intraocular pressure. The tip of the tonometer contains a sensor that houses a transducer assembly that converts applied pressure into an electrical signal. The electronics housed in the ergonomic Tono-Pen AVIA body, process and analyze the waveforms produced by each touch of the corneal surface of the eye, to produce an averaged IOP measurement. The measurement along with the number of data points collected is displayed on the Liquid Crystal Displays (LCD). The Ocu-Shield is a protective membrane shaped to cover the tip and is used to help protect the patient from cross contamination, and when used during storage, protects the sensor from damage. A replaceable battery compartment houses the Tono-Pen AVIA POWERCEL lithium manganese dioxide batteries.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests and their outcomes, which can be interpreted as the device meeting specific acceptance criteria. However, explicit numerical acceptance criteria values are not provided for all tests, nor are numerical performance results always given.

• ISO 10993-1:2003, Biological evaluation of medical devices Part 1 Evaluation . and Testing
• FDA G95-1, Required Biocompatibility Training and Toxicology Profiles for . Evaluation of Medical Devices, May 1, 1995" (Implies successful completion) |
  | Shelf Life Aging (Tip Cover) | Met acceptance criteria in initial shelf life functional testing for tonometer accuracy. | "The tip covers met the acceptance criteria in the initial shelf life functional testing for tonometer accuracy." (Implies successful completion) |
  | Operating Life (Tonometer) | Provide a 2500 nominal operating life for the tonometer. | "The battery pack met the acceptance criteria for providing the tonometer with a 2500 nominal operating life." (Implies successful completion) |
  | Bench Testing | Met acceptance criteria for operating range, accuracy, repeatability, sensitivity, angle of incidence, and battery life. | "The units under test met the acceptance criteria of the operating range, accuracy, repeatability, sensitivity, angle of incidence and battery life." (Implies successful completion) |
  | Electromagnetic Compatibility (EMC) & Electrical Safety | Compliance with BS EN 60601-1 and BS EN 60601-1-2 requirements for RF emission, immunity, magnetic immunity, and ESD testing. | "The RF emission and immunity testing, magnetic immunity and ESD testing passed for the Tonometer testing performed to BS EN 60601-1 and BS EN 60601-1-2 requirements." (Implies successful completion) |

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

The document does not explicitly state the sample size used for any of the non-clinical tests (biocompatibility, shelf life, operating life, bench testing, EMC/electrical safety). It only mentions "units under test" for bench testing and the "battery pack" for operating life.

The data provenance is not specified. It is likely that these were internal company tests conducted by Medtronic Xomed, Inc. There is no indication of country of origin of the data or whether it was retrospective or prospective.

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 tests described are primarily engineering and material science tests, not clinical studies requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the non-clinical tests, an adjudication method like 2+1 or 3+1 typically used for clinical diagnostic studies would not be applicable. The tests likely had predefined pass/fail criteria.

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

No, a MRMC comparative effectiveness study was not conducted or reported in this document. The submission focuses on non-clinical performance and substantial equivalence to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

The studies described (biocompatibility, shelf life, operating life, bench testing, EMC/electrical safety) are essentially standalone performance studies for the device itself or its components. They evaluate the device's technical specifications and compliance with safety and performance standards without involving a human operator in a diagnostic capacity (beyond potentially operating the device for the bench tests). These are algorithmic/device-only performance evaluations in a non-clinical context.

7. Type of Ground Truth Used

The ground truth for these non-clinical tests is based on:

• Established standards and regulations: ISO 10993-1:2003, FDA G95-1 for biocompatibility, BS EN 60601-1 and BS EN 60601-1-2 for EMC/electrical safety.
• Engineering specifications and design requirements: For operating life, accuracy, repeatability, sensitivity, angle of incidence, and battery life, the "acceptance criteria" themselves serve as the ground truth against which performance is measured. These would be derived from the device's intended performance specifications.
• Functional performance criteria: For shelf life, the "tonometer accuracy" serves as the ground truth.

8. Sample Size for the Training Set

This information is not applicable as the document does not describe the development or testing of an AI algorithm or a machine learning model that would require a "training set." The device described is a physical instrument for measuring intraocular pressure.

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

This information is not applicable for the same reason as above; there is no AI algorithm or machine learning model with an associated training set.

Ask a specific question about this device