(525 days)
The Noncon Robo Pachy F&A is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea.
The Noncon Robo Pachy F&A specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo Pachy, K980357. The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.
Konan NonCon Robo Pachy F&A: Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Konan NonCon Robo Pachy F&A are based on the agreement and variability of its analysis methods for corneal endothelial cell density, coefficient of variation, and percent hexagonality, when compared to manual and center methods. The reported performance is presented as the mean difference and 95% limits of agreement between these methods for agreement, and standard deviation (within-image) for variability.
Acceptance Criteria & Reported Performance Table:
| Parameter | Analysis Method Comparison | Acceptance Criteria (Implied) | Reported Device Performance (Mean Difference & 95% Limits of Agreement) | Reported Device Performance (Variability - Standard Deviation (within-image) as % of mean value) |
|---|---|---|---|---|
| Cell Density | Manual vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 0.06%, LoA: -0.78% to 0.9% | 1.14% (PC-Assist with redrawing) |
| Manual vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 0.00%, LoA: -2.3% to 2.3% | 0.78% (PC-Assist without redrawing) | |
| Center vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: -0.11%, LoA: -1.47% to 1.25% | 1.23% (Center Method) | |
| Center vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: -0.17%, LoA: 2.37% to 2.71% | ||
| Manual vs Center Method | Close agreement, narrow limits of agreement | Mean Diff: 0.16%, LoA: -1.1% to 1.42% | ||
| Coefficient of Variation | Manual vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 0.43%, LoA: -2.35% to 3.21% | 4.23% (PC-Assist with redrawing) |
| Manual vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 0.24%, LoA: -5.62% to 6.10% | 8.02% (PC-Assist without redrawing) | |
| Center vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 2.38%, LoA: -4.18% to 8.94% | 6.60% (Center Method) | |
| Center vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 2.18%, LoA: -4.18% to 8.94% | ||
| Manual vs Center Method | Close agreement, narrow limits of agreement | Mean Diff: -1.96%, LoA: -8.58% to 4.66% | ||
| Percent Hexagonality | Manual vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: -0.08%, LoA: -3.32% to 3.16% | 3.87% (PC-Assist with redrawing) |
| Manual vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 1.47%, LoA: -3.63% to 6.57% | 12.67% (PC-Assist without redrawing) | |
| Center vs PC-Assist (with redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 2.13%, LoA: -3.03% to 7.29% | 6.42% (Center Method) | |
| Center vs PC-Assist (without redrawing) | Close agreement, narrow limits of agreement | Mean Diff: 3.67%, LoA: -3.13% to 10.47% | ||
| Manual vs Center Method | Close agreement, narrow limits of agreement | Mean Diff: -2.23%, LoA: -7.03% to 2.57% |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria thresholds. Instead, it presents the "Agreement Between Methods of Analysis" and "Variability Associated with the Analysis Methods" as performance data to demonstrate substantial equivalence to the predicate device. The implied acceptance is that the device's performance, as measured by these metrics, is comparable to, or an improvement on, the predicate device and clinically acceptable.
Additionally, the study explicitly states: "Agreement and variability of the analysis methods was obtained using a sample that included virtually no eyes with Percent Hexagonality <45, Coefficient of Variation >0.41, or Cell Density <2100. Agreement and variability of the analysis methods is not known for eyes with parameters beyond these values." This indicates a limitation of the device's validated performance to a specific range of corneal health parameters.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 40 images of eyes.
- Data Provenance: Not explicitly stated, but the submission is from Konan Inc., Japan, suggesting the data could be from Japan, though this is not confirmed. The study is described as a "clinical test," implying prospective data collection, but no further details are provided.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Four "classifiers" were used.
- Qualifications of Experts: Not specified. The document only refers to them as "classifiers."
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated as typical "2+1" or "3+1." However, the description indicates:
- Each of the four classifiers analyzed each of the 40 images three times.
- "For a given analysis method, the standard deviation of the within-image results was calculated as a measure of variability." This suggests that the multiple readings by each classifier were used to assess within-observer variability, and potentially implicitly contributed to agreement calculations.
- The "Mean Difference" and "Limits of Agreement" are calculated by comparing the results of different analysis methods (Manual, PC-Assist, Center Method).
Therefore, it appears a form of repeated reading by multiple classifiers was used as part of the evaluation, rather than a specific consensus-based adjudication method for a "ground truth" label.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
The study performed does not appear to be a traditional MRMC comparative effective study comparing human readers with AI assistance versus without AI assistance. Instead, it compares different analysis methods (Manual, PC-Assist, Center Method) for a standalone device.
- PC-Assist represents the device's algorithm, with and without redrawing functionality.
- The Manual method represents a human-driven analysis.
- The Center Method is another analysis method, presumably also algorithm-driven as it's compared in a similar manner.
The study aims to show agreement between these methods, suggesting the new PC-Assist algorithm is comparable to existing or manual methods. It does not measure the improvement of human readers with AI assistance, but rather evaluates the performance of the device's algorithms alongside manual analysis.
6. Standalone Performance Study
Yes, a standalone study was done for the device's algorithm.
The "PC-Assist (with redrawing)" and "PC-Assist (without redrawing)" methods represent the algorithm's performance. The "Agreement Between Methods of Analysis" tables directly report the performance of these algorithm-driven methods against "Manual" and "Center" methods, showing its ability to analyze images independently. The "Variability Associated with the Analysis Method" table also presents standalone variability for the PC-Assist methods.
7. Type of Ground Truth Used for the Test Set
The ground truth used is effectively "agreement with other established analysis methods."
The study assesses agreement between the device's PC-Assist methods and "Manual" analysis and a "Center Method," which are implied to be reference standards or established practices. It's not based on external pathology, or long-term clinical outcomes, but rather on the consistency of measurements obtained through different analytical approaches on the same images.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. It only mentions that the device is an improvement to an original model and includes an "improved cell counting algorithm." The new software and algorithm were validated, but details about the training data or its size are not provided.
9. How Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. It only states that there is an "improved cell counting algorithm" and that "A new software validation test has been done, to validate the new software." This implies that the algorithm was developed and refined, but the process of creating its training data and establishing ground truth for that data is not described in this 510(k) summary.
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Konan F&A
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Konan Medical Inc. Konan NonCon Robo Pachy F&A 510(k) Submission
510(k) Summary
( 1 ) Submitter Information
Name: Konan Inc.
Address: 10-29 Miyanishi-Cho Nishimomiya 662 Japan
Telephone Number: 011-81-798363456
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703
Date Prepared: October 31, 2007
(2) Name of Device:
876
Trade Name: Konan NonCon Robo Pachy F&A Common Name: Specular Endothelial Microscope and Camera and optical pachymeter Classification Name: Camera, Ophthalmic, AC-powered
(3) Equivalent legally-marketed devices:
Konan Noncon Robo Pachy, K980357
(4) Description
The Noncon Robo Pachy F&A specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo Pachy, K980357.
The device permits visual inspection and photography of the corneal endothelium and measurement of the corneal thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.
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Konan F&A
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(5) Intended Use
The Konan Noncon Robo Pachy F&A is a specular microscope and optical pachymeter, manufactured by Konan Inc. It is a non-contact ophthalmic microscope and camera intended for examination of the corneal endonelium, with the additional capability of measuring the corneal thickness by optical means. Cell counting endomalysis programs are included, and are indicated when it is desired to analyze the images of the cell distribution of the eye.
(6) Technological characteristics
The Konan Noncon Robo Pachy is technically the same as the predicate device, the Konan Noncon Robo F&A, with the addition of an improved cell counting algorithm and a new computer. The computer program that controls the system has been modified to be used with the new computer and to include the new algorithm.
(b) Performance data
(1) Non-clinical tests
The non-clinical tests done for the original Noncon Robo Pachy to the Noncon Robo Pachy F&A, since the device is essentially the same. A new software validation test has been done, to validate the new software. ISO 60601-1 and IS) 60601-1-2 have been repeated because of the new electronics, and a test has been done on the new algorithm.
(2) Clinical tests
A clinical test was performed with four "classifiers", each analyzing the same 40 images of eyes. Each classifier analyzed each image three. The analyses of the classifiers were analyzed for cell density, hexagonality, and coefficient of variation.
Agreement and variability of the analysis methods was obtained using a sample that included virtually no eyes with Percent Hexagonality <45, Coefficient of Variation >0.41, or Cell Density <2100. Agreement and variability of the analysis methods is not known for eyes with parameters beyond these values.
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Agreement Between Methods of Analysis
For a single image from each cye, cell density, coefficient of variation and percent hexagonality were determined by each analysis method. For a given parameter and pair of methods of image analysis, agreement between outputs was assessed. This was done by taking the difference between the two outputs for each image and then calculating the mean difference, and the 95% limits of agreement. These measures of agreement between analysis methods were calculated for each parameter. Note that each measure estimates the degree of agreement between the different methods of analysis applied to a single image. It does not take into account variation due to repeated image capture. Variations between different images of the same eye will significantly reduce agreement. The listed values should not be taken as estimates of the agreement of the measurements associated with repeated image capture.
| Agreement Between Methods of Analysis forCell Density | |||
|---|---|---|---|
| AnalysisMethods | MeanDifference1 (%)-Note: anegativenumberindicates thatfirst methodgives lowerresults thanthe second | Limits of Agreement2 (%):-95% of Differences should fallbetween these figures | |
| Lower 95%Limit ofAgreement(MeanDifference -2*sd) | Upper 95%Limit ofAgreement(MeanDifference +2*sd) | ||
| Manual vsPC-Assist(withredrawing) | 0.06 | -0.78 | 0.9 |
| Manual vsPC-Assist(withoutredrawing) | 0.00 | -2.3 | 2.3 |
| Center vsPC-Assist(withredrawing) | -0.11 | -1.47 | 1.25 |
| Center vsPC-Assist(withoutredrawing) | -0.17 | 2.71 | 2.37 |
| Manual vsCenterMethod | 0.16 | -1.1 | 1.42 |
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Konan F&A
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| Agreement Between Methods of Analysis forCoefficient of Variation | |||
|---|---|---|---|
| AnalysisMethods | MeanDifference1 (%)Note: anegativenumberindicates thatfirst methodgives lowerresults thanthe second | Limits of Agreement2 (%):-95% of Differences should fallbetween these figuresLower 95%Limit ofAgreement(MeanDifference -2*sd) | Upper 95%Limit ofAgreement(MeanDifference +2*sd) |
| Manual vsPC-Assist(withredrawing) | 0.43 | -2.35 | 3.21 |
| Manual vsPC-Assist(withoutredrawing) | 0.24 | -5.62 | 6.10 |
| Center vsPC-Assist(withredrawing) | 2.38 | -4.18 | 8.94 |
| Center vsPC-Assist(withoutredrawing) | 2.18 | -4.18 | 8.94 |
| Manual vsCenterMethod | -1.96 | -8.58 | 4.66 |
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| Agreement Between Methods of Analysis forPercent Hexagonality | |||
|---|---|---|---|
| AnalysisMethods | MeanDifference1 (%) | Limits of Agreement2 (%):-95% of Differences should fallbetween these figures | |
| Note: anegativenumberindicates thatfirst methodgives lowerresults thanthe second | Lower 95%Limit ofAgreement(MeanDifference -2*sd) | Upper 95%Limit ofAgreement(MeanDifference +2*sd) | |
| Manual vsPC-Assist(withredrawing) | -0.08 | -3.32 | 3.16 |
| Manual vsPC-Assist(withoutredrawing) | 1.47 | -3.63 | 6.57 |
| Center vsPC-Assist(withredrawing) | 2.13 | -3.03 | 7.29 |
| Center vsPC-Assist(withoutredrawing) | 3.67 | -3.13 | 10.47 |
| Manual vsCenterMethod | -2.23 | -7.03 | 2.57 |
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- Mean Difference is the average across images of: 100 . (Cell Density ... . Cell Density ................................. 1 (Cell Density.... .: Cell Density......... /2 )
-
- Approximately 2.53 of differences would be expected to fall below the Lower limit of Agreement and about 2.5% would be expected to fall above the Upper Limit of Agreement. The Limits of Agreement are defined as:
The Mean Difference (footnote 1, above) i 2(standard deviation). The standard deviation is calculated across all of the 40 Differences as defined in footnote 1, above.
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Variability Associated with the Analysis Methods
The variability of the results associated with each analysis method was assessed. For each of the forty images, cell density, coefficient of variation and percent hexagonality were determined by each method. Each analysis was repeated on the same image three (presentation was randomized) by each of four "classifiers." For a given analysis method, the standard deviation of the within-image results was calculated as a measure of variability. Note that this measure estimates the variability associated only with repeated application of the analysis method to a single image. Differences between two or more images of the same eye will significantly increase variability. The listed values should not be taken as estimates of the variability of the measurements associated with repeated image capture.
| Variability Associated with the Analysis Method | |||
|---|---|---|---|
| Method ofAnalysis | Standard Deviation (within-image)Expressed as a percentage of the mean value* | ||
| Cell Density | Coefficient ofVariation | PercentHexagonality | |
| PC-Assist (withredrawing) | 1.14 | 4.23 | 3.87 |
| PC-Assist (withoutredrawing) | 0.78 | 8.02 | 12.67 |
| Center Method | 1.23 | 6.60 | 6.42 |
- Value in table is the mean across 40 images of the variability standard deviation (square root of the sum of the "within-observer" variance pius the "between-observer" variance) divided by the mean value for the image (expressed as a percentage) .
(3) Conclusions
The Konan Noncon Robo Pachy F&A is equivalent in safety and efficacy to the legally marketed predicate devices.
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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes wrapped around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 22 2008
Konan Medical, Inc. c/o George Myers Medsys, Inc 377 Route 17 South Hasbrouck Heights, NJ 07604
Re: K062763
Trade/Device Name: Konan NonCon Robo Pachy F&A Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered Slip Lamp Biomicroscope Regulatory Class: Class II Product Code: NQE Dated: January 23, 2008 Received: January 25, 2008
Dear Dr. Myers:
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 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.
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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Malina Beplete, und
Malvina B. Eydelman, M 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): _ K062736
Device Name: Konan Noncon Robo Pachy F&A
Indications For Use:
The Noncon Robo Pachy F&A is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of corneal endothelium and for measurement of the thickness of the cornea.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
and the comments of the count
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MARBlickins
ivision of Ophthalmic Ear. Nose and Throat Devises
510(k) Number K062763
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§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.