(195 days)
The OPD-Station software is indicated for use in analyzing the corneal shape and refractive powers measured by the OPD-Scan Models ARK-9000 or ARK-10000, and to display the data in the form of maps, and manage the data.
Nidek has developed a stand-alone software option for users of the OPD-Scan™ device called OPD-Station, which will run on an independent PC (i.e., separate from the OPD-Scan™ device). The OPD-Station software is able to access data measured by the OPD-Scan™ device via a separate Nidek data management software package called NAVIS.
The OPD-Station uses the same software as that used for the OPD-Scan device so that a physician can view OPD-Scan data on their PC of choice. However, the OPD-Station software has the following new functions:
- Maps of Point Spread Function (PSF), Modulation Transfer Function (MTF), MTF . graphing, and Visual Acuity mapping
- Improved color mapping .
The provided text describes the Nidek Incorporated OPD-Station software, which is a standalone software option for users of the OPD-Scan™ device. The software analyzes corneal shape and refractive powers measured by the OPD-Scan Models ARK-9000 or ARK-10000, displaying the data in various maps and managing the data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting specific performance acceptance criteria like sensitivity, specificity, or accuracy metrics. The primary "acceptance criterion" implied throughout this document is substantial equivalence to the predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The OPD-Station software uses the same software as the OPD-Scan and has new functions (PSF, MTF maps, improved color mapping). A comparison of technological characteristics was performed, demonstrating equivalence to marketed predicate devices. The performance data indicate the OPD-Station software meets all specified requirements and is substantially equivalent. |
2. Sample size used for the test set and the data provenance
The document does not specify any sample size used for a test set (clinical or otherwise) or the data provenance (e.g., country of origin, retrospective/prospective). The performance data mentioned is described very generally as indicating "all specified requirements" without detailing the nature of this data or how it was gathered.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention any experts used to establish ground truth or their qualifications. Given that this is a 510(k) for software intended to display and manage existing data from an already cleared device (OPD-Scan), the focus is on the software's functionality and its output being consistent with the predicate device's capabilities, rather than a clinical accuracy study requiring expert adjudication of a test set.
4. Adjudication method for the test set
The document does not describe any adjudication 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
An MRMC comparative effectiveness study was not conducted or mentioned. The OPD-Station software is not described as an AI-assisted device directly improving human reader performance but rather as a tool for analyzing and displaying existing data from another ophthalmic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document is about a standalone software ("OPD-Station software") that operates independently on a PC to analyze and display data from the OPD-Scan device. While it's standalone software, the performance described is its ability to access and process data from the OPD-Scan and display it; it's not an "algorithm only" performance in the sense of an AI algorithm making diagnostic decisions without human involvement. The software itself is the "device" in question operating independently.
7. The type of ground truth used
The document does not specify the type of ground truth used. The verification process appears to rely on comparing the new software's functionality and output with that of the predicate devices. This implies that the "ground truth" for demonstrating equivalence would be the established functionality and output of the cleared predicate devices.
8. The sample size for the training set
The document does not mention a training set or its sample size. This suggests that the software development did not involve machine learning or AI models that require training sets. The software's design likely follows deterministic algorithms based on established ophthalmic principles and data processing techniques from the original OPD-Scan.
9. How the ground truth for the training set was established
As there is no mention of a training set, there is no information on how its ground truth would have been established.
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SUMMARY OF SAFETY AND EFFECTIVENESS NIDEK INCORPORATED OPD-STATION SOFTWARE
SUBMITTER INFORMATION
| A. | Company Name: | Nidek Incorporated |
|---|---|---|
| B. | Company Address: | 47651 Westinghouse Drive.Fremont, CA 94539-7474 |
| C. | Company Phone:Company Fax: | (510) 353-7719(510) 226-5750 |
| D. | Contact Person: | Mr. Hiro MatsuzakiRegulatory and QA ManagerNidek Incorporated |
| E. | Date Summary Prepared: | August 22, 2005 |
DEVICE IDENTIFICATION
| A. | Generic Device Name: | Ophthalmic, aberrometerTopographer, corneal, ac-powered |
|---|---|---|
| B. | Trade/Proprietary Name: | OPD-Station software |
| C. | Classification: | Class I 886.1760 |
| D. | Product Code: | NCF, MMQ |
SUBSTANTIAL EQUIVALENCE
The Nidek Incorporated OPD-Station software is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| TopographicModeling System | Computed Anatomy | K944207 | Dec. 7, 1994 |
| Nidek OPD-Scan | Nidek Co. Ltd. | K003299 | March 9, 2001 |
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DEVICE DESCRIPTION
Nidek has developed a stand-alone software option for users of the OPD-Scan™ device called OPD-Station, which will run on an independent PC (i.e., separate from the OPD-Scan™ device). The OPD-Station software is able to access data measured by the OPD-Scan™ device via a separate Nidek data management software package called NAVIS.
The OPD-Station uses the same software as that used for the OPD-Scan device so that a physician can view OPD-Scan data on their PC of choice. However, the OPD-Station software has the following new functions:
- Maps of Point Spread Function (PSF), Modulation Transfer Function (MTF), MTF . graphing, and Visual Acuity mapping
- Improved color mapping .
INTENDED USE
The OPD-Station software is indicated for use in analyzing the corneal shape and refractive powers measured by the OPD-Scan Models ARK-9000 or ARK-10000, and to display the data in the form of maps, and manage the data.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the OPD-Station software and the predicate devices has been performed, and the results of this comparison demonstrate that the OPD-Station software is equivalent to the marketed predicate devices
PERFORMANCE DATA
The performance data indicate that the OPD-Station software meets all specified requirements, and is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, arranged in a way that resembles a bird in flight. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
AUG 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nidek Co., Ltd. % Ms. Carol L. Patterson, President Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, CA 92630
Re: K050336
Trade/Device Name: OPD-Station Software Regulation Number: 21 CFR 886.1760 Regulation Name: Ophthalmic Refractometer Regulatory Class: Class I Product Code: NCF, MMQ Dated: July 15, 2005 Received: July 18, 2005
Dear Ms. Patterson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or do Jeer Code of Federal Regulations, 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 rease of action and 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 or any I outhal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic roluct 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) I his letter will anow you to oegh manteling your antial equivalence of your device to a legally premarket notification: The PDF mailing of bassification 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 If you desire specific davies in 1984 at 1991) 827-8910. Also, please note the regulation entitled, Contact the Office of Collifed of Collines of CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responsive Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
David M. Whipple Acting 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
K 050336 510(k) Number:
Device Trade Name:
Indications For Use:
OPD-Station Software
The OPD-Station software is indicated for use in analyzing the corneal shape and refractive powers measured by the OPD-Scan Models ARK-9000 or ARK-10000, and to display the data in the form of maps, and manage the data.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) |
|---|
| Division of Ophthalmic Ear, |
| Nose and Throat Devises |
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 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.