(60 days)
The Sensor Medical Single Use Tonometer Prism is intended for use as a disposable applanating and optical doubling prism for Goldmann style applanation tonometers.
The Sensor Medical Single Use Tonometer Prism is used as the optical image doubling prism for Goldmann applanation style tonometers. The prism is a precise optical replacement for the current glass Goldmann tonometer. The Sensor Medical Single Use Tonometer Prism is made from PMMA. The corneal contact diameter is 6.6 +/-0.1mm. The total length of the prism is 30.0 +/- 0.1mm. The prism weighs 1.8 +/- 0.1 g.
Acceptance Criteria and Device Performance for Sensor Medical Single Use Tonometer Prism
This document summarizes the acceptance criteria and device performance for the Sensor Medical Single Use Tonometer Prism based on the provided FDA 510(k) summary. It's important to note that this submission did not include performance data to prove the device met specific criteria, but rather demonstrated substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Acceptance Threshold | Reported Device Performance (from 510(k) summary) |
|---|---|---|---|
| Intended Use | Disposable applanating and optical doubling prism for Goldmann style applanation tonometers. | Match predicate device's intended use. | Identical to the predicate device's intended use. Both are disposable, sterile applanating tonometer prisms used in Goldmann style tonometers for measurement of intraocular pressure, and both are prescription devices used by trained professionals. |
| Material | Made from PMMA. | Match predicate device's material. | Made from PMMA. |
| Corneal Contact Diameter | 6.6 +/- 0.1 mm | Match predicate device's specifications (implied, not explicitly stated for predicate in summary). | 6.6 +/- 0.1 mm |
| Total Length | 30.0 +/- 0.1 mm | Match predicate device's specifications (implied, not explicitly stated for predicate in summary). | 30.0 +/- 0.1 mm |
| Weight | 1.8 +/- 0.1 g | Match predicate device's specifications (implied, not explicitly stated for predicate in summary). | 1.8 +/- 0.1 g |
| Sterility | Provided sterile for single use. | Match predicate device's sterility. | Provided sterile for single use. |
| Principles of Operation | Optical image doubling prism for Goldmann style applanation tonometers. | Match predicate device's principles of operation. | Same principles of operation as the predicate device. |
| Safety and Effectiveness | No new questions of safety and effectiveness are raised. | Demonstrated through substantial equivalence to a legally marketed predicate device. | "No performance data is provided since no new questions of safety and effectiveness are raised." Substantial equivalence was claimed based on identical intended use and technological characteristics to the Luneau Tonometer Separation Prisms (K023838). |
Study Information
The provided document describes a 510(k) premarket notification for a medical device. This type of submission relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than conducting new clinical performance studies to prove specific acceptance criteria are met. Therefore, many of the requested details about a study are not applicable in this context.
Crucially, the document explicitly states: "No performance data is provided since no new questions of safety and effectiveness are raised." This means there was no new study conducted to generate performance data for this specific device.
Based on this, here is an explanation for the requested study information:
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2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No new test set data was generated for the Sensor Medical Single Use Tonometer Prism. The device's performance was not measured in a study; instead, its characteristics were compared to a predicate device.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No test set was created, and therefore, no experts were used to establish ground truth for a new performance study.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set was created or adjudicated.
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5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a tonometer prism, a physical ophthalmological instrument, not an AI software. No MRMC study was conducted.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No new ground truth was established for the device's performance in a study. The "ground truth" for substantial equivalence was the previously cleared predicate device and its known characteristics.
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8. The sample size for the training set
- Not Applicable. This device is a physical instrument, not a learning algorithm, so there is no concept of a "training set."
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9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
In summary: The Sensor Medical Single Use Tonometer Prism gained clearance through demonstrating substantial equivalence to an existing predicate device (Luneau Tonometer Separation Prisms, K023838). This pathway does not typically involve new clinical performance studies or the generation of new performance data against specific acceptance criteria for the new device, but rather a direct comparison of its attributes (intended use, technological characteristics, materials, size, weight, sterility, principles of operation) to the cleared predicate. The "study" here is essentially the comparison itself, showing that the new device is functionally identical to one already deemed safe and effective.
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.