The Sensor Medical Single Use Tonometer Prism is intended for use as a disposable applanating and optical doubling prism for Goldmann style applanation tonometers.

Device Description

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.

AI/ML Overview

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:

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.
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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set was created or adjudicated.
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.
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.
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.
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."
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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 13, 2015

Sensor Medical Technology, LLC % Ms. Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864

Re: K152308

Trade/Device Name: Sensor Medical Single Use Tonometer Prism Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKY Dated: August 13, 2015 Received: August 17, 2015

Dear Ms. O'Connell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Deborah L. Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Sensor Medical Single Use Tonometer Prism

Indications for Use (Describe)

The Sensor Medical Single Use Tonometer Prism is intended for use as a disposable applanating and optical doubling prism for Goldmann style applanation tonometers.

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY

Sensor Medical Technology LLC Sensor Medical Single Use Tonometer Prism

Name of Device and Name/Address of Sponsor

Sensor Medical Single Use Tonometer Prism

Sensor Medical Technology LLC 23175 224th Place SE, Suite C Maple Valley, WA 98038

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 (978) 207-1245 Phone:

Date Prepared: July 24, 2015

Common or Usual Name Tonometer Prism

Classification Name and Regulation

Manual Tonometer 21 CFR 886.1930. HKY Ophthalmic Panel

Predicate Devices

Luneau Tonometer Separation Prisms (K023838)

Intended Use / Indications for Use

The Sensor Medical Single Use Tonometer Prism is intended for use as a disposable applanating and optical doubling prism for Goldmann style applanation tonometer.

Device Description

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

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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.

Performance Data

No performance data is provided since no new questions of safety and effectiveness are raised.

Substantial Equivalence

Sensor Medical Technology, LLC believes that the Sensor Medical Single Use Tonometer Prism described in this notification and for use under the conditions of proposed labeling is a Class II device which is substantially equivalent to a legally marketed predicate device.

The Sensor Medical Single Use Tonometer Prism is substantially equivalent to the Luneau Tonometer Separation Prisms (K023838) (the "predicate device") that the FDA has already cleared. The Sensor Medical Single Use Tonometer Prism has the same intended use, technological characteristics. and principles of operation as the previously cleared predicate.

The intended use of the Sensor Medical Single Use Tonometer Prism and the intended use of the Luneau Tonometer Separation Prisms cleared in K023838 are identical. Both devices are disposable, sterile applanating tonometer prisms used in Goldmann style tonometers for measurement of intraocular pressure. Both devices are prescription devices used by trained professionals.

The Sensor Medical Single Use Tonometer Prism has the same technological characteristics as the Luneau Tonometer Separation Prisms cleared in K023838. Both devices are disposable applanating and optical doubling prisms for use in Goldmann style applanation tonometers for measurement of intraocular pressure. Both devices are provided sterile for single use. Both devices are made from PMMA and both devices have the same size and weight.

In summary, Sensor Medical Single Use Tonometer Prism has the same intended use as the previously cleared predicate device. In addition, the Sensor Medical Single Use Tonometer Prism has the same technological characteristics as its predicate. Therefore, the Sensor Medical Single Use Tonometer Prism is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.