The AMO®PhacoFlex® II Insertion System is used to fold and assist in inserting the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eye.

Device Description

The AMO®PhacoFlex® II Insertion System is used to fold and assist in the insertion of an AMO®PhacoFlex® II (SLM-2/UV) silicone intraocular lens (IOL) into the eye following cataract extraction. The materials used in the AMO®PhacoFlex® II Insertion System are similar to the materials used in predicate devices. The AMO®PhacoFlex® II Insertion System is a Bartell-type injector system comprised of the following components: AMO®PhacoSert™ Handpiece (Model #PSH-ST), AMO®PhacoSert™ Soft Tip, Single-use soft tip holder, and AMO® PhacoSert™ Cartridge (Model #PSC-ST).

AI/ML Overview

The provided 510(k) summary for the AMO®PhacoFlex® II Insertion System primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics. As a result, many of the requested elements for a detailed study description are not explicitly provided.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria for each variable are not explicitly stated in the document. Instead, the summary indicates that "All test results indicate that like the predicate device, the AMO®PhacoFlex® II Insertion System reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens optical performance, lens dimensions, or cosmetic appearance."

This implies that the acceptance criteria were likely qualitative (e.g., "no significant impact") or aligned with the performance of the predicate device.

Variable Evaluated	Reported Device Performance	Acceptance Criteria (Implied)
Impact on IOL dioptric power	Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens optical performance.	No significant impact on IOL optical performance (relative to predicate or baseline).
IOL resolution return/fold recovery	Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens optical performance.	Acceptable fold recovery and resolution return (relative to predicate or baseline).
Overall lens diameter and haptic angle	Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens dimensions.	No significant impact on overall lens diameter and haptic angle (relative to predicate or baseline).
IOL decentration, tilt and compression force testing	Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens dimensions.	Acceptable levels of decentration, tilt, and compression force (relative to predicate or baseline).
IOL haptic pull strength	Not explicitly detailed beyond general statement.	Acceptable haptic pull strength (relative to predicate or baseline).
Force required to advance the IOL	Not explicitly detailed beyond general statement.	Acceptable force required for IOL advancement (relative to predicate or baseline).
IOL release characteristics	Not explicitly detailed beyond general statement.	Reliable IOL release (relative to predicate or baseline).
Streaks on IOL	Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting cosmetic appearance.	No significant streaks on the IOL (relative to predicate or baseline).
IOL optic body marks/damage	Reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting cosmetic appearance.	No significant optic body marks/damage on the IOL (relative to predicate or baseline).
Biocompatibility (Cytotoxicity, Ocular Irritation, Sensitization)	Materials are non-toxic, non-irritating, non-inhibitory, and non-sensitizing. (Specific to soft tip and soft tip holder; cartridge biocompatibility established for predicate).	Materials pass specified ISO/USP biocompatibility tests (non-toxic, non-irritating, non-inhibitory, non-sensitizing).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample size used for the in vitro performance testing. The term "all test results" implies multiple instances, but a numerical count is absent.
Data Provenance: The testing was "in vitro performance testing," meaning it was conducted in a laboratory setting, not on human subjects. There is no mention of country of origin or whether it was retrospective or prospective in the context of human data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable or not specified. In vitro performance testing typically relies on standardized measurement techniques and instruments, not expert human assessment to establish "ground truth" in the clinical sense.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. As this was in vitro performance testing, there's no mention of human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No. This type of study is used for evaluating human reader performance, often with AI assistance, and is not relevant for in vitro device performance testing of an IOL insertion system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done? Yes, in a sense. The in vitro performance testing describes the standalone performance of the device (the AMO®PhacoFlex® II Insertion System) in delivering IOLs, entirely independent of human interaction beyond operating the system according to its design. There is no "algorithm" in the sense of AI; it's a mechanical device.

7. Type of Ground Truth Used

For the in vitro performance tests (e.g., IOL dioptric power, dimensions, marks): The "ground truth" would be established by objective measurements using calibrated laboratory equipment and standard test methods (e.g., refractometers, microscopes, micrometers, force gauges).
For the biocompatibility tests: The "ground truth" was established by the results of standardized biological assays (e.g., ISO Agarose Overlay Method, ISO Elution Method, USP Agar Diffusion, Ocular Irritation Study, Delayed Contact Sensitization Study).

8. Sample Size for the Training Set

Sample Size: Not applicable. As this is a mechanical device, there is no "training set" in the context of machine learning or AI algorithms. The device's design and materials are based on engineering principles and predicate device characteristics, not a data-driven training process.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable. There is no training set or ground truth in the context of AI. The "truth" for the device's development lies in engineering specifications, material properties, and performance validation against those specifications, often informed by predicate device performance.

Summary

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510(k) Notification AMO®PhacoFlex® II Insertion System

JUN 17 1996

K961242

Page 170

510(k) Summary

In accordance with 21 CFR 807.92, Allergan is providing this 510(k) summary.

1. Submitter's name, address, and telephone number, a contact person, and the date the summary was prepared:

Allergan, Inc. 2525 Dupont Drive Irvine, California 92713-9534 (714) 246-2281

Contact person: Maureen Weiner Regulatory Affairs Analyst

Date summary prepared: March 29, 1996

Name of the device, including trade or proprietary name, common or usual 2. name, and classification name:

Trade/proprietary name: AMO®PhacoFlex® II Insertion System

Common/usual name: lens insertion guide

Classification name: intraocular lens guide

3. Identification of the predicate device or legally marketed device to which substantial equivalence is claimed:

510(k) K941603, cleared on 7/6/94, filed by Allergan Medical Optics, AMO PhacoFlex® Inserter Disposable Cartridge

510(k) K930320, cleared on 4/7/94, filed by Allergan Medical Optics, AMO®PhacoFlex® Inserter

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4. Description of the device that is the subject of the premarket notification submission, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device such as device design, material used, and physical properties:

The AMO®PhacoFlex® II Insertion System is a Bartell-type injector system comprised of the following components:

AMO®PhacoSert™ Handpiece (Model #PSH-ST)

All handpiece components are composed of titanium, a material commonly used for reusable surgical instruments. The handpiece rod is designed to accept a single-use silicone rubber soft tip. This handpiece is reusable and is designed to withstand conventional inoffice steam autoclaving. The titanium handpiece is provided to the customer in a plastic box in a non-sterile state.

AMO®PhacoSert™ Soft Tip

The soft tip is a single-use component composed of medical grade silicone which contains blue pigment to enhance its visibility during tip application and IOL implantation. The tip is provided sterile in the single-use soft tip holder.

Single-use soft tip holder

This component is composed of an optically clear version of acrylic resin. The tip holder facilitates application of the soft tip to the handpiece rod and eliminates direct handling of the soft tip during application. The tip holder is discarded following application of the soft tip to the titanium rod and does not directly contact either the IOL or the patient. The tip holder is provided sterile.

AMO® PhacoSert™ Cartridge (Model #PSC-ST)

The cartridge is a single-use component composed of lubricated polypropylene and is provided sterile.

ડ. . Statement of intended use:

The AMO®PhacoFlex® II Insertion System is used to fold and assist in inserting the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eye.

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Statement of how the technological characteristics (i.e., design, material, ર્ . chemical composition, energy source) compare to the predicate device:

TechnologicalCharacteristic	AMO®PhacoFlex® IIInsertion System	PredicateDevices*
Intended Use	To fold and assist in insertingthe AMO®PhacoFlex® II(SLM-2/UV) family of intraocularlenses, specifically the SI-30NB andSI-40NB, into the eye	To fold and insert a foldable IOL(AMO®PhacoFlex® II) into theeye during normal small incisioncataract surgery
OperatingPrinciple	IOL is loaded into the cartridgeand the IOL is pushed throughthe cartridge and delivered intothe eye	same operating principle
Materials:
handpiece	titanium	titanium or medical-grade stainlesssteel
cartridge	lubricated polypropylene	lubricated polypropylene
soft tip	silicone	N/A
soft tip holder	acrylic	N/A
Design:
handpiece	reusable	reusable
cartridge	1 piece (insertion chamber)disposable, single use only	1 piece (insertion chamber)disposable, single use only
soft tip	disposable, single use only	N/A
soft tip holder	disposable, single use only	N/A
SterilizationMethod	handpiece is provided non-sterilecartridge, soft tip, and soft tipapplicator are EtO sterilized	handpiece is provided non-sterilecartridge is EtO sterilized
Portion of Devicethat Contacts theEye	tip of cartridge and soft tip	tip of cartridge

PhacoFlex® Inserter Disposable Cartridge and the AMOª

Allergan, Inc. - Strictly Private

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7. Brief summary of nonclinical tests and results:

The in vitro performance testing conducted on the AMO®PhacoFlex® II Insertion System evaluated the following variables:

Impact on IOL dioptric power .
IOL resolution return/fold recovery ●
Overall lens diameter and haptic angle
IOL decentration, tilt and compression force testing
IOL haptic pull strength
Force required to advance the IOL
IOL release characteristics
Streaks on IOL
. IOL optic body marks/damage

All test results indicate that like the predicate device, the AMO®PhacoFlex® II Insertion System reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens optical performance, lens dimensions, or cosmetic appearance.

The following biocompatiblity testing has been conducted by a qualified independent testing laboratory on the AMO@PhacoFlex® II Insertion System:

Cytotoxicity Test -- ISO Agarose Overlay Method (soft tip) .
Cytotoxicity Test -- ISO Elution Method (soft tip) .
In Vitro Inhibition of Cell Growth (ICG, One-Point Assay) (soft tip) .
. Ocular Irritation Study (soft tip)
Delayed Contact Sensitization Study (soft tip)
Cytotoxicity Test -- USP Agar Diffusion (soft tip holder) .
. Cytotoxicity Test -- ISO Elution Method (soft tip holder)

The test results indicate that the materials are non-toxic, non-irritating, noninhibitory, and non-sensitizing. Please note that biocompatibility for the carridge was established in the predicate device 510(k) #K941603. No new materials have been added to the cartridge since this 510(k) was cleared.

Based on the performance and biocompatibility testing, we conclude that this system is a safe and effective device for delivering the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eve.

Regulation Number and Section

§ 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.