The Topcon Model BV-1000 Automated Subjective Refraction System provides sphere, cylinder, and axis measurements of the eye. The BV-1000 assists the eyecare professional in evaluating pre and post operative eye procedures and is used as an aid in prescribing eyeglasses and contact lenses.

Device Description

The Topcon Model BV-1000 is a safe and effective instrument. In essence, it is a combination of three Class I devices:

Ophthalmic Refractometer ... an AC-powered device that consist of a fixation system, a measurement and recording system and an alignment system.
Visual Acuity Chart ... a device, with a Landolt "C" chart in graduated sizes to test visual acuity
Onthalmic Motorized Refractor ... a device that incorporates a set of lenses of various dioptric powers intended to measure the refractive power of the eyc.
The BV-1000 is designed to perform binocular, simultaneous auto-refraction. It incorporates subjective refinement steps after the objective measurements have been obtained. The BV-1000 reduces the amount of time that eyecare professionals need to spend in refracting their patients as a substantial portion of the traditional refraction can be accomplished in the "pre test" room.

AI/ML Overview

The provided document is a 510(k) summary for the Topcon Model BV-1000 Automated Subjective Refraction System. Based on the information available, a detailed description of acceptance criteria and the study proving it is not present in the typical format of an AI/ML device study.

This document describes a medical device from 2003, which predates the widespread regulatory framework for AI/ML medical devices. Therefore, the information requested, particularly regarding AI-specific criteria like training sets, ground truth establishment for AI, MRMC studies for AI assistance, and standalone AI performance, will not be found in this document.

However, I can extract information related to the device's performance specifications and how it was compared to predicate devices, which serves as a form of "acceptance criteria" and "study" in the context of a 510(k) submission from that era.

Here's the breakdown of what can be inferred and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds against which the device was tested. Instead, it demonstrates substantial equivalence by comparing the BV-1000's performance specifications, particularly its measurement ranges, with those of legally marketed predicate devices. The implicit acceptance criteria are that the device's performance falls within a comparable and safe range to these predicates.

Parameter	Acceptance Criteria (Implied by Predicate Devices)	Reported Device Performance (Topcon BV-1000)
Sphere (S)	Predicate devices range from -28.00D to +20.00D to -12.00D to +20.00D.	Objective Mode: -25.00D to +22.00DSubjective Mode: -18.00D to +18.00D
Cylinder (C)	Predicate devices range from 0 to -7.75D, 0 to ±8.00D, 0 to ±6.00D, 0 to ±7D.	Objective Mode: 0.00D to -8.00DSubjective Mode: 0.00D to -8.00D
Axis (A)	Predicate devices all state 0° to 180° or 0° to 180°.	Objective Mode: 1° to 180°Subjective Mode: 1° to 180°
Refraction Method	Predicate devices use various methods like Manual Retinoscopy, Built-In Rotary Prism, Built-In Continuously Variable Sphere & Cylinder.	Objective Refraction: Built-In Rotary PrismSubjective Refraction: Landolt Charts; Jackson Cross Cylinder (after objective measurements have been obtained)
Illumination	Predicate devices use Halogen, 680nm LED, Tungsten.	Objective Refraction: 680nm LEDSubjective Refraction: Tungsten
Test Types	Predicate devices mention Snellen Charts, Jackson Cross Cylinder, Simulcross Cross Cylinder, Presbyopic Charts.	Subjective Refraction: Landolt Charts; Jackson Cross Cylinder
Type of Refraction	Predicate devices offer Objective and Subjective Refraction.	Performs binocular, simultaneous auto-refraction and incorporates subjective refinement steps after objective measurements.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. The document focuses on performance specifications and comparison to predicates, not a clinical trial with a specific patient sample size for testing.
Data Provenance: Not specified. Given it's a 510(k) from 2003, such details were often less rigorously documented in the summary unless critical for equivalence demonstrations (e.g., specific clinical study data if equivalence was not clear from technological comparison). It's likely based on internal testing and engineering assessments rather than a large clinical test set described in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available and is not relevant for this type of device and submission from this era. "Ground truth" in the context of refractive measurements is often established by established clinical methods (e.g., best-corrected visual acuity determined by an optometrist/ophthalmologist) or comparison to existing gold-standard devices. Experts would be involved in designing and interpreting the performance data, but not typically in the "ground truth" establishment as understood in AI/ML validation studies.

4. Adjudication method for the test set

Not applicable/Not available. Adjudication methods are typically associated with resolving discrepancies in expert labeling or diagnoses, especially in AI/ML studies. This document doesn't describe a study design that would necessitate such a method.

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

No, this device is not an AI-assisted device. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted and is not applicable. The device's purpose is to assist eyecare professionals by providing objective measurements and streamlining subjective refinement, not to provide AI diagnostics or interpretations.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a piece of hardware that takes measurements. It is not an algorithm designed to perform diagnostics "stand-alone." Its output (sphere, cylinder, axis measurements) still requires interpretation and use by an eyecare professional. The "Automated Subjective Refraction System" name implies it automates parts of the subjective refraction process, but the human is still in the loop for the overall prescription.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a device like this, ground truth would implicitly be established through comparison to established clinical methods and predicate devices. For example, the accuracy of its refractive measurements would be compared against the results obtained by experienced clinicians using traditional phoropters or other auto-refractors considered gold standards at the time. The document doesn't detail the specific ground truth process but relies on the device producing measurements within expected clinical ranges, comparable to predicates.

8. The sample size for the training set

Not applicable/Not available. This is not an AI/ML device, so there is no "training set" in the sense of data used to train a machine learning model. The device's "training" would be its engineering design, calibration, and validation against physical measurement standards and clinical performance expectations.

9. How the ground truth for the training set was established

Not applicable. As a non-AI/ML device, there is no "training set ground truth" as understood in current AI/ML terminology.

Summary

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DEC 1 9 2003

031831

510(K) SUMMARY

Applicant:	Topcon Medical Systems, Inc.37 West Century Road, Paramus, NJ 07652
Telephone Number:	(201) 261-9450, ext. 204
Facsimile Number:	(201) 387-2710
Contact Person:	Donald H. Winfield
Date:	June 6, 2003
Device Proprietary Name:	Model BV-1000, Automated Subjective Refraction System
Device Classification Name:	Refractometer, Ophthalmic
Device Common Name:	Refractometer/Auto-refractor
Device Class:	I
Product Code:	HKO, HOX, HKN
Regulation Number:	886.1760, 886.1150, 886.1770
Intended Use:	The Topcon Model BV-1000 Automated SubjectiveRefraction System provides sphere, cylinder, and axismeasurements of the eye. The BV-1000 assists the eyecareprofessional in evaluating pre and post operative eyeprocedures and is used as an aid in prescribing eyeglassesand contact lenses.

Description:

The Topcon Model BV-1000 is a safe and effective instrument. In essence, it is a combination of three Class I devices:

1. Ophthalmic Refractometer ... an AC-powered device that consist of a fixation system, a measurement and recording system and an alignment system.
1. Visual Acuity Chart ... a device, with a Landolt "C" chart in graduated sizes to test visual acuity
1. Onthalmic Motorized Refractor ... a device that incorporates a set of lenses of various dioptric powers intended to measure the refractive power of the eyc.

The BV-1000 is designed to perform binocular, simultaneous auto-refraction. It incorporates subjective refinement steps after the objective measurements have been obtained. The BV-1000 reduces the amount of time that eyecare professionals need to spend in refracting their patients as a substantial portion of the traditional refraction can be accomplished in the "pre test" room.

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COMPARISONS
Manufacturer / Distributor	Model	Objective Refraction	Subjective Refraction			Range
		Method	Illumination	Distance	Near	Method	Illumination
Bausch & Lomb	IVEX	Manual Retinoscopy	Halogen	X	X	Snellen Charts; Jackson Cross Cylinder	Fluorescent	(S) -28.00D to +19.75D(C) 0 to -7.75D(A) 0° to 180°
Reichert Ophthalmic Instruments	SR-IV	Manual Retinoscopy	Halogen	X	X	Snellen Charts; Simulcross Cross Cylinder	Tungsten	(S) -20.00D to +20.00D(C) 0 to ±8.00D(A) 0° to 180°
Zeiss-Humphrey	515/530/ 560/570	Built-In Continuously Variable Sphere & Cylinder	680nm LED	X	X	Cross Cylinder	Tungsten	(S) -12.00D to +20.00D(C) 0 to ±6.00D(A) 0° to 180°
Topcon	6500	Built-In Rotary Prism	680nm LED	X	X	Snellen Charts; Jackson Cross Cylinder	Tungsten	(S) -25.00D to +22.00D(C) 0 to ±7D(A) 0° to 180°
Topcon	7000S	Built-In Rotary Prism	680nm LED	X	X	Snellen Charts; Presbyopic Charts	Tungsten	(S) -25.00D to +22.00D(C) 0 to ±7D(A) 0° to 180°
Topcon	BV-1000	Built-In Rotary Prism	680nm LED	X	X	Landolt Charts; Jackson Cross Cylinder	Tungsten	Objective Mode:(S) -25.00D to +22.00D(C) 0.00D to -8.00D(A) 1° to 180°Subjective Mode:(S)-18.00D to +18.00D(C) 0.00D to -8.00D(A) 1° to 180°

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is positioned to the right of the department's name, which is written in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Topcon Corporation c/o Donald H. Winfield Topcon Medical Systems, Inc. 37 West Century Road Paramus, NJ 07652

Re: K031831

R051031
Trade/Device Name: Topcon Model BV-1000 Automated Subjective Refraction System Trade Dovice Name: 10 CFR 886.1760; 21 CFR 886.1150; 21 CFR 886.1770 Regulation Name: Ophthalmic refractometer; Visual acuity chart; Manual Refractor Regulatory Class: Class I Product Code: HKO; HOX; HKN Dated: September 17, 2003 Received: September 22, 2003

Dear Mr. Winfield:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booker one the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use sured in the encreatives the Medical Device Amendments, or to devices that provision in may 20, 1970, and coardance with the provisions of the Federal Food, Drug, and Cosmetic nave been rechassified in acceration of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general merelors, maintons of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r 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 ally rederal statutes and regulation abut not limited to: registration and listing (21 CFR Part an the Het beequencements, as a sol ); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A halyi Rosenthal

A. Ralph Rosenthal, 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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STATEMENT OF INDICATION FOR USE

The Topcon Model BV-1000 Automated Subjective Refraction System provides sphere, cylinder and axis measurements of the eye. The BV-1000 assists the eyecare spitere, cymider and and measure post operative eye procedures and is used as an aid in prescribing eyeglasses and contact lenses.

Prescription Use
(Per 21 CFR 801.109)

MKB Nichols

MLB Nicholas

vision Sign-Off) >ivision of Ophthalmic Ear, ംse and Throat Devises

510(k) Number K031831

Regulation Number and Section

§ 886.1760 Ophthalmic refractometer.

(a)
Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.