(249 days)
The Royale® AE 9045 injector is intended as a reusable instrument to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. It is designed to incorporate Alcon cartridges Type C for foldable intraocular lenses. The cartridge is loaded into the injector body and by pushing the piston. The lens will be removed out of the cartridge and delivered to the desired position.
The injector is an autoclavable, reusable titanium hand piece which is used to deliver folded intraocular lenses into the eye for replacement of the human crystalline lens.
The provided text is a 510(k) summary for the "Injector" device, a reusable titanium handpiece for delivering folded intraocular lenses (IOLs) during cataract surgery. To provide the requested information about acceptance criteria and study details, I need to extract this from the provided text.
Based on the provided document, here's an analysis of the acceptance criteria and study information:
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials with precise acceptance criteria and performance metrics in the same way a PMA (Pre-Market Approval) submission would.
Here's what can be inferred and what is not explicitly stated in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Deliver IOL cartridges (Type C Cartridges with corresponding ACYSOF® Lens Models) without adversely affecting the overall power, shape resolution, or cosmetic attributes of the lenses. (From Section 5: "The performance tests for the injector will show that it can be used to deliver IOL cartridges... without adversely affecting the overall power, shape resolution or cosmetic attributes of the lenses.") | "The results of the non clinical performance testing will be subject to particular passing criteria that will support claim of substantial equivalence." (From Section 6: Summary of the Performance Data). The specific numerical results or how these 'passing criteria' were met are not detailed in this summary. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided 510(k) summary. The document mentions "performance tests" but does not detail the number of IOLs, cartridges, or test runs conducted.
- Data Provenance: Not specified. The manufacturer is Anton Meyer & Co. Ltd. in Nidau, Switzerland, suggesting the testing could have occurred there, but this is not explicitly stated.
- Retrospective or Prospective: Unclear, but typically, performance tests for a 510(k) submission are conducted prospectively as part of the device development and validation process.
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 and not specified. The "performance tests" described focus on the physical delivery of the IOL and its integrity, not on subjective expert assessment of an outcome which would require ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable and not specified. Adjudication methods are typically used when there's an ambiguity in interpretation (e.g., image analysis, clinical outcome assessment). The described performance tests are likely objective measurements of physical attributes.
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. The device is a mechanical injector for IOLs, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device itself is a mechanical "standalone" instrument. There is no algorithm being evaluated in this context. The performance tests would be of the device's mechanical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the acceptance criteria would be based on objective physical measurements and visual inspection to ensure the IOL's "overall power, shape resolution or cosmetic attributes" are not adversely affected. This would likely involve:
- Dimensional measurements to verify shape resolution and overall power (if measurable after delivery).
- Optical inspection (e.g., microscopy) for cosmetic attributes (scratches, deformations).
- Functional tests to confirm the lens is delivered smoothly and correctly.
The document doesn't detail the specific methods for these measurements.
8. The sample size for the training set
Not applicable. The "Injector" is a mechanical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an AI model.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
{0}------------------------------------------------
K0237337
JUL 1 4 2003
SECTION 10 510(k) Summary Injector
MPLYCO
diamond technology Anton Meyer &Co. Ltd. Helmstrasse 1 CH- 2560 Nidau Switzerland
510 (k) Summary "Injector"
October, 30th 2002
Submitted by:
Thomas Meyer Director Marketing and Sales Anton Meyer & Co. Ltd. Helmstrasse 1 CH-2560 Nidau/Switzerland Tel: +41-32-332 91 11 Fax: +41-32-331 52 57
{1}------------------------------------------------
Common Name: Injector Classification Name: Intraocular lens guide, CFR 886.4300
1. Predicate Device:
The predicate devices to which we are claiming equivalence are:
- a) Hand piece of Micra Instument Ltd. Lens Insertion System K 011392
- b) Hand piece of MONARCH® II IOL; K 003768
- c) Hand piece of Micro STAAR™ Injector; K983129
- d) Hand piece of AMO Phacophlex II; K961242
2. Device Description
The injector is an autoclavable, reusable titanium hand piece which is used to deliver folded intraocular lenses into the eye for replacement of the human crystalline lens.
3. Intended Use
The Royale® AE 9045 injector is intended as a reusable instrument to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. It is designed to incorporate Alcon cartridges Type C for foldable intraocular lenses. The cartridge is loaded into the injector body and by pushing the piston. The lens will be removed out of the cartridge and delivered to the desired position.
4. Summary of the Technological Characteristics of the Device
The injector reusable hand piece accepts the cartridges with a sterile single use cartridge which incorporates the folded lens and delivers the lens by using a plunger to express the lens. The plunger's head is contoured to provide a good contact to the lens as well as an adequate clearance for the trailing haptic. The plunger is advanced by direct forward motion applied to the syringe type plunger. Due to the ball bearing technology a smooth and well controlled lens delivery is ensured.
-
- Summary of the Performance Characteristics
{2}------------------------------------------------
The performance tests for the injector will show that it can be used to deliver IOL cartridges (Type C Cartridges with the corresponding ACYSOF® Lens Models) without adversely affecting the overall power, shape resolution or cosmetic attributes of the lenses.
6. Summary of the Performance Data
The results of the non clinical performance testing will be subject to particular passing criteria that will support claim of substantial equivalence.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with wavy lines suggesting movement or flow.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2003
Anton Meyer & Co., Ltd. c/o Thomas Meyer Director, Marketing and Sales Helmstrasse 1 CH-2560 NIDAU Switzerland
Re: K023737
Trade/Device Name: Injector, Royale® AE9045 Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: May 09, 2003 Received: May 14, 2003
Dear Mr. Thomas Meyer:
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.
{4}------------------------------------------------
Page 2 - Mr. Thomas Meyer
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,
Akeri 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
{5}------------------------------------------------
SECTION 2 Statement of Indication for Use
510(k) Number (if known): _KQ23737
Device Name: Injector
Indications for Use:
The Royale® AE 9045 injector is intended as a reusable instrument to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. It is designed to incorporate Alcon cartridges Type C for foldable intraocular lenses. The cartridge is loaded into the injector body and by pushing the piston. The lens will be removed out of the cartridge and delivered to the desired position.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joel R. Yahr
(Division Sign-Off Division of Ochthalmic Ear. Nose and Throat Devis
510(k) Number K023737
(Optional Format 3-10-98)
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.