(18 days)
The instrument is used for measuring the axial length, anterior chamber depth and lens thickness of the eye. It also is used for calculating the optical power of the IOL to be implanted during cataract surgery.
The AccuSonic A-Scan device is designed as a biometer, which uses pulsed echo ultrasound to measure the axial length, and the location of other structures of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulses, and provides a one-dimensional display of returning pulse echoes, with positive peaks to indicate the location of ocular structures. The distance between peaks can be measured.
The provided 510(k) summary for the AccuSonic A-Scan device primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations.
This submission is for an ultrasound biometer, a physical device that measures ocular structures. It precedes the widespread use and regulatory requirements for AI/ML-driven medical devices. Therefore, the information typically found in such reports (like sample size for test/training sets, ground truth establishment for AI, MRMC studies, etc.) is not applicable in this context. The 510(k) process for devices like this primarily relies on performance specifications, safety testing, and comparison to already cleared devices.
Here's a breakdown of the requested information based on the provided document and the limitations of an A-scan biometer submission from 2003:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in a single table as would be expected for a modern AI/ML device study. Instead, the "performance" is implicitly tied to its "substantially equivalent" claim to predicate devices. For an A-scan biometer, key performance aspects would relate to accuracy, precision, and reproducibility of measurements (axial length, anterior chamber depth, lens thickness). These are typically verified through internal testing and comparison to reference standards or predicate devices.
| Acceptance Criteria (Inferred from device type) | Reported Device Performance (Inferred from Substantial Equivalence) |
|---|---|
| Ability to accurately measure axial length of the eye | Demonstrated to be comparable to legally marketed predicate devices (e.g., Accutome Advent AB, Teknar Ophthasonic A-Scan, DGH 3000A A-Scan) |
| Ability to accurately measure anterior chamber depth | Demonstrated to be comparable to legally marketed predicate devices |
| Ability to accurately measure lens thickness | Demonstrated to be comparable to legally marketed predicate devices |
| Ability to function for IOL power calculation | Demonstrated to be comparable to legally marketed predicate devices |
| Safety and effectiveness for indicated uses | Assessed to be safe and effective for indicated uses, similar to predicate devices |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided: The document does not describe a clinical "test set" in the context of an AI/ML algorithm. For a physical device like an A-scan, performance is typically validated through engineering tests, phantom studies, and comparison to predicate devices, rather than a separate clinical test set to evaluate an algorithm's output. Clinical validation might involve a small number of patients, but this is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: Ground truth in the context of algorithmic performance is not relevant for this device's submission. The "ground truth" for an A-scan biometer's measurements would be the actual physical dimensions of the structures being measured, verified by precise physical standards or other highly accurate measurement methods, not expert consensus on image interpretation.
4. Adjudication method for the test set
- Not Applicable / Not Provided: Adjudication methods are typically employed in studies where human interpretation or labeling of data is involved, especially for AI/ML model training or evaluation. This is not
relevant to the performance evaluation described for the AccuSonic A-Scan.
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 is a submission for a physical diagnostic ultrasound device (biometer), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: There is no "algorithm only" performance reported in the context of AI for this device. The device itself is the standalone measurement system. Its performance is its ability to accurately measure ocular dimensions.
7. The type of ground truth used
- Inferred: Physical/Reference Standards: For an A-scan biometer, the ground truth would typically be established by:
- High-precision physical phantoms: Known dimensions are measured by the device and compared to the phantom's actual dimensions.
- Comparison to highly accurate predicate devices: Measurements obtained by the new device are compared to those from an already validated predicate device on the same subjects or phantoms.
- Cadaveric eyes or animal eyes: In some cases, direct measurements on excised eyes could serve as ground truth.
These methods ensure the device's measurements correlate accurately with physical reality.
8. The sample size for the training set
- Not Applicable / Not Provided: This device is not an AI/ML algorithm, so it doesn't have a "training set" in that sense. The device's design and calibration are based on engineering principles and physical laws of ultrasound.
9. How the ground truth for the training set was established
- Not Applicable: As there is no AI/ML training set, the concept of establishing ground truth for it is not relevant.
In summary: The provided document is a 510(k) summary for a traditional medical device (ultrasound biometer) from 2003. Its primary purpose is to show "substantial equivalence" to existing cleared devices rather than providing detailed performance metrics from an AI/ML study. Therefore, many of the requested categories related to AI/ML device evaluation are not applicable or not explicitly detailed in this type of regulatory submission. The performance is assessed based on the device's ability to produce measurements comparable to those of already cleared predicate devices.
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OCT 1 0 2003
510(k) SUMMARY AccuSonic A-Scan
| Applicant: | Accutome Inc. |
|---|---|
| Address: | 263 Great Valley ParkwayMalvern, PA 19355 |
| Contact Person: | Jeffrey L. WrightManager, Engineering, Manufacturing & QC |
| Telephone: | (610) 889-0200(610) 889-3233 fax |
| Preparation Date: | August 25, 2003 |
| Device Name: | AccuSonic A-Scan |
| Common Name: | Biometer |
| Classification: | System, Imaging, Pulsed Echo, Ultrasonic(see: 21 CFR 892.1560) Product Code: IYO Panel: 90 |
| Legally MarketedPredicate Devices: | Accutome Advent AB (K960765) previously by MentorOphthalmics and acquired by Accutome in December of1999. (However, the AccuSonic A-Scan does not functionas a B-Scan.); Teknar Ophthasonic A-Scan (K860757);Teknar Opthasonic A/P III (K903666); DGH 3000A A-Scan (K872726); DGH 4000 A-Scan/Pach (K913067) |
| Description of theDevice: | The AccuSonic A-Scan device is designed as a biometer,which uses pulsed echo ultrasound to measure the axiallength, and the location of other structures of the eye. Itutilizes an eye-contact probe to generate and receive theultrasound pulses, and provides a one-dimensional displayof returning pulse echoes, with positive peaks to indicatethe location of ocular structures. The distance betweenpeaks can be measured. |
| Indications for Use: | The instrument is used for measuring the axial length,anterior chamber depth and lens thickness of the eye. It isalso used for calculating the optical power of the IOL to beimplanted during cataract surgery. |
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles.
OCT 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey L. Wright Manager, Engineering, Manufacturing & QC Accutome, Inc. 263 Great Valley Parkway MALVERN PA 19355
Re: K032956
Trade Name: AccuSonic A-Scan Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: August 25, 2003 Received: September 22, 2003
Dear Mr. Wright:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducer intended for use with the AccuSonic A-Scan, as described in your premarket notification:
Transducer Model Number
A-mode 10 MHz
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
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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.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your 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 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) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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AccuSonic A-Scan 510(k) Notification
4.3 Indications for Use
K032956 510(k) Number (if known):_
Device Name: Accusonic A-Scan
Indications for Use:
The instrument is used for measuring the axial length, anterior chamber depth and lens thickness of the eye. It also is used for calculating the optical power of the IOL to be implanted during cataract surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use__/
Over-The Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy C hogdon
(Division Sign-C Division of Reproduct and Radiological Devices 510(k) Number
Page 4 of 19
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AccuSonic A-Scan 510(k) Notification
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | N | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative specify | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ specify | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial |
N= new indication: P= previously cleared by FDA: E= added under Appendix E
Additional Comments:
CONTINUE ON ANOTHER PAGE IF NEEDED.
evice Evaluation
System includes A-More ID H/A Transducer.
Nancy Hodgson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Numb
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.