Search Results

The TonoPach Ultrasonic Tonometer/Pachymeter Model P-201 is a diagnostic instrument that is intended for use in the measurement of both intraocular pressure and corneal thickness. It is intended for use during or following surgery and as a screening, monitoring or diagnostic aid in patients with normal, disease-induced or surgically altered anatomy, or in glaucoma suspects under current therapeutic guidelines.

The TonoPach is a portable, battery operated, handheld ophthalmic instrument which measures both intraocular pressure (IOP) and corneal thickness (CT) simultaneously and at the same locus on the cornea. The device uses the principles of applanation pneumatometery to measure IOP and the principles of reflection pulsed ultrasound pachymetry to measure CT. The system is comprised of the TonoPach electronics, transducer handpiece, protective membranes and optionally, a foot pedal.

The provided 510(k) summary for the RetinaPharma TonoPach Ultrasonic Tonometer/Pachymeter Model P-201 primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a rigorous study report with specific performance metrics against those criteria. However, I can extract the information that is present and highlight what is missing based on your request.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in the typical format of sensitivity, specificity, accuracy, or other performance metrics. Instead, it refers to performance specifications being "met or exceeded" and data generally showing "accuracy and reproducibility."

Missing from the table: Specific numerical acceptance criteria for sensitivity, specificity, or overall accuracy values (e.g., "sensitivity > 90%"). The document makes general statements about meeting or exceeding specifications but doesn't quantify those specifications.

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

• Pachymetry Test Set: The document does not explicitly state a separate independent test set for pachymetry for which detailed performance metrics are provided. The "inanimate" and "animal" studies included pachymetry evaluation.
  • Inanimate: Polycarbonate wafers of varying thicknesses.
  • Animal: Live rabbit eyes.
• Tonometry Test Set:
  • Sample Size: "347 eyes" were tested in a clinical trial for comparison to Goldmann tonometry.
  • Data Provenance: "Eye clinic volunteers who required tonometery." Location not specified, but likely within the U.S. as it's a U.S. company submitting to FDA. Retrospective or Prospective is not explicitly stated for the clinical trial, but the description "All patients who agreed to volunteer were admitted to the study" suggests a prospective collection of data for the purpose of the study.
  • Animal: Three porcine eyes were used for a reproducibility study at each 10 mmHg pressure over a range of 5 to 80 mmHg. (This is for reproducibility, not accuracy against a ground truth). Live rabbit eyes were also used for evaluation.

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

• Pachymetry: The ground truth for inanimate models (polycarbonate wafers) would be the known, precisely measured thickness of the wafers. For animal studies, the ground truth source is not specified (e.g., calibrated caliper, optical pachymetry). No human experts are described as establishing ground truth for pachymetry in the provided text.
• Tonometry: The ground truth for the clinical trial was Goldmann tonometry. Goldmann tonometry is a widely accepted clinical standard for measuring IOP. While this inherently involves a human operator (likely an ophthalmologist or trained technician), the document does not specify the "number of experts" or their "qualifications" involved in performing the Goldmann measurements to establish ground truth for the 347 eyes.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method for either the pachymetry or tonometry test sets. For the clinical tonometry comparison, it's a direct comparison against Goldmann tonometry, implying the Goldmann reading itself was considered the reference, not an adjudicated value from multiple observers.

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

• No MRMC comparative effectiveness study was performed or reported. The TonoPach is a diagnostic instrument that provides a direct measurement (IOP and CT), not an interpretive imaging device for which human readers would typically "improve with AI vs without AI assistance." Its primary use is as a measurement tool, analogous to a thermometer or blood pressure cuff, which is operated by a healthcare professional.

6. Standalone Performance

• Yes, standalone performance was assessed. The entire testing described (inanimate, animal, and human clinical trial) is a "standalone" evaluation of the TonoPach device's ability to measure IOP and CT and its agreement with established methods/standards. There is no human-in-the-loop component where the device's output is modified or interpreted by a human to produce the final result. The device provides its measurement, which a clinician then uses.

7. Type of Ground Truth Used

• Pachymetry:
  • Inanimate: Known thickness of polycarbonate wafers.
  • Animal: Not explicitly stated, but implies methods to independently measure corneal thickness for comparison.
• Tonometry:
  • Inanimate: Water-filled spherical membrane with a manometer (acting as a controlled, known pressure).
  • Animal: Not explicitly stated for performance against a "ground truth" for accuracy, more for reproducibility.
  • Clinical Trial: Goldmann tonometry was used as the reference standard for comparison.

8. Sample Size for the Training Set

• The document does not provide any information about a "training set" or how the device was developed using machine learning or AI. The product description suggests it operates on known physical principles (applanation pneumatometry for IOP, reflection pulsed ultrasound pachymetry for CT). Devices cleared under the 510(k) pathway, especially from 2004, often did not involve machine learning and thus would not have separate training data sets in the AI sense. The "testing" described is for verification and validation of accuracy and reproducibility.

9. How Ground Truth for the Training Set Was Established

• As no training set is mentioned (likely because the device does not employ machine learning that would necessitate one), this information is not applicable/not provided.

Ask a specific question about this device