The LM-70 (lidofilcon A) Spherical Soft Contact Lens for daily wear aisre indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either a chemical or heat disinfecting system.

The LM-70 (lidofilcon A) Toric Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected using either a chemical or heat disinfecting system.

Device Description

The LM-70 Spherical and Toric Soft Contact Lens is fabricated from lidofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (lidofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warned however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The non-ionic lens material, (lidofilcon A) is a terpolymer of N-vinyl-2-pyrrolidone (NVP) and methyl methacrylate (MMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and Allyl methacrylate (AMA). It consists of 30% lidofilcon A and 70% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 70% water by weight.

AI/ML Overview

This document is a 510(k) summary for a soft contact lens, which means it's focused on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial data for novel devices. Therefore, much of the information typically found in an "acceptance criteria and study" report for a high-risk medical device (like AI diagnostics) will not be present.

Based on the provided text, here's what can be extracted and what cannot be provided:

Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in the format one might expect for a quantitative performance study (e.g., "sensitivity must be >X%"). Instead, the acceptance criteria are implicitly defined by demonstrating substantial equivalence to a legally marketed predicate device, the "LL-70" manufactured/distributed by Lombart Lenses, LTD. The "performance" is therefore the similarity in material properties and intended use.

Acceptance Criteria Category (Implicit)	Condition	Reported Device Performance (LM-70)	Predicate Device Performance (LL-70)
Intended Use	Visual correction in Not-aphakic persons with non-diseased eyes that myopic or hyperopic	Visual correction in Not-aphakic persons with non-diseased eyes that myopic or hyperopic	Visual correction in Not-aphakic persons with non-diseased eyes that myopic or hyperopic
Functionality	Act as a refractive medium that focus light rays from near and distant objects on the retina.	After machining from the optical blank, the contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina.	After machining from the optical blank, the contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina.
Indications	Daily wear, Soft (hydrophilic) contact lens	Daily wear, Soft (hydrophilic) contact lens	Daily wear, Soft (hydrophilic) contact lens
Production Method	Lathe-cut	Lathe-cut	Lathe-cut
FDA Group #	Group # 2 >50% Water, Nonionic Polymers	Group # 2 >50% Water, Nonionic Polymers	Group # 2 >50% Water, Nonionic Polymers
Water Content	70% ± 2 %	70% ± 2 %	70% ± 2 %
Oxygen Permeability	Comparable oxygen permeability for a soft contact lens	38.5 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).	34.7 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).
Specific Gravity	Comparable specific gravity	1.061	1.073
Refractive Index	1.52 (dry) 1.41 (hydrated)	1.52 (dry) 1.41 (hydrated)	Not explicitly stated for predicate in summary table, but implicitly comparable from overall equivalence claim.
Light Transmission	greater than 95%	greater than 95%	Not explicitly stated for predicate in summary table, but implicitly comparable from overall equivalence claim.
Material Composition	Non-ionic terpolymer of N-vinyl-2-pyrrolidone (NVP) and methyl methacrylate (MMA), cross-linked with EGDMA and AMA (lidofilcon A)	Terpolymer of N-vinyl-2-pyrrolidone (NVP) and methyl methacrylate (MMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and Allyl methacrylate (AMA) (lidofilcon A)	(lidofilcon A) Implicitly the same material from predicate's name "LL-70 (lidofilcon A)"

Study Information

Sample size used for the test set and the data provenance:
The document describes a submission for substantial equivalence based on material properties, manufacturing, and intended use, rather than a clinical "test set" in the context of an AI device. There is no mention of a specific patient-based test set or its provenance (country, retrospective/prospective). The "study" here is mainly a comparison of technical specifications and existing safety profiles.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for this submission is established through the chemical and physical properties of the lens material and its manufacturing process, as well as its comparison to a predicate device. This is not a diagnostic device requiring expert interpretation of images or data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no "test set" requiring adjudication in the context of this 510(k) submission.
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. This device is a contact lens, not an AI diagnostic or assistance tool, so no MRMC study comparing human readers with or without AI was performed or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a contact lens, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission consists of:
- Scientific and engineering data: Physical and chemical properties of the lidofilcon A material (water content, oxygen permeability, specific gravity, refractive index, light transmission).
- Manufacturing standards: Compliance with specified process controls and an ISO 9001/9002 and CGMP quality assurance program.
- Preclinical toxicology and manufacturing/chemistry data: Established safety profile of the LM-70 material reported as equivalent to the predicate.
- Comparison to a predicate device: Benchmarking against the LL-70 (lidofilcon A) lens to establish substantial equivalence in terms of intended use, materials, physical construction, and safety & effectiveness.
The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set. The "training" for this device would be the extensive research and development involved in material science and manufacturing, which is not quantified as a "training set" in this context.
How the ground truth for the training set was established:
Not applicable as there is no training set mentioned for this type of device.

Summary

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K991015

Applicant information:

Date Prepared:	March 24, 1999
----------------	----------------

Name:Address	Lamda Polytech Limited1 Lincoln Park Borough RoadBrackley NorthantsEngland NN13 7BE
Contact Person:Phone number:	Ian Atkins44-1280 705500
USA Consultant:	Med-Vice Consulting Inc.

USA Consultant.	Med-vice Consulting, inc.
Phone number	(970) 243-5490
Fax number	(970) 243-5501
	Martin Dalsing

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lenses, Soft Contact, Daily Wear
Trade Name:	LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lensfor Daily Wear (clear, lathe-cut)

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Equivalent Devices:

The LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lens is substantially equivalent to the following predicate device in terms of intended use and design. Predicate device: "LL-70" manufactured/distributed by Lombart Lenses, LTD.

Device Description:

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 70% water by weight. The physical properties of the lens are:

Refractive Index	1.52 (dry) 1.41 (hydrated)
Light Transmission	greater than 95%
Water Content	70% ±2%
Specific Gravity	1.061 (hydrated)
Oxygen Permeability	38.5 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).

Intended Use:

The LM-70 (Udofilcon A) Spherical Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either a chemical or heat disinfecting system.

The LM-70 (lidofilcon A) Toric Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves that are myopic or hyperopic and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected using either a chemical or heat disinfecting system.

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Substantial Equivalence:

The LM-70 Soft Contact Lens will be manufactured according to specified process controls and an ISO 9001/9002 and CGMP quality assurance program currently in place. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the LM-70 material is equivalent to the predicate device identified previously. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above.

The following matrix illustrates the production method, lens function and material characteristics of the LM-70 Spherical and Toric Soft Contact Lens, as well as the predicate device.

	General S.E. Areas	Lamda PolytechLM-70 (lidofilcon A)	Predicate DeviceLL-70 (lidofilcon A)
1.)	Intended Use	Visual correction in Not-aphakicpersons with non-diseased eyesthat myopic or hyperopic	Visual correction in Not-aphakicpersons with non-diseased eyesthat myopic or hyperopic
2.)	Functionality	After machining from the opticalblank, the contact lenses act as arefractive medium that focus lightrays from near and distant objectson the retina.	After machining from the opticalblank, the contact lenses act as arefractive medium that focus lightrays from near and distant objectson the retina.
3.)	Indications	Daily wear, Soft (hydrophilic)contact lens	Daily wear, Soft (hydrophilic)contact lens
4.)	Production Method	Lathe-cut	Lathe-cut
5.)	FDA Group #	Group # 2 >50% Water, NonionicPolymers	Group # 2 >50% Water, NonionicPolymers
6.)	Water Content	70% ± 2 %	70% ± 2 %
7.)	Oxygen Permeability	38.5 X 10-11 (cm2/sec)(ml 02/ml x mm Hg @ 35 degreesC), (revised Fatt method).	34.7 X 10-11 (cm2/sec)(ml 02/ml x mm Hg @ 35 degreesC), (revised Fatt method).
8.)	Specific Gravity	1.061	1.073

Substantial Equivalence Matrix

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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 perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 1999

Lamda Polytech Limited c/o Mr. Martin Dalsing Offical Representative and Consultant for Lamda Polytech Limited MedVice Consulting, Inc. 623 Glacier Drive Grand Junction, Co 81503

Re: K991015

Trade Name: LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lens for Daily Wear (clear, lathe-cut) Regulatory Class: II Product Code: 86 LPL Dated: October 5, 1999 Received: October 8, 1999

Dear Mr. Dalsing:

We have reviewed your Section 510(k) 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 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect

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Page 2 - Mr. Martin Dalsing

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lens for Daily Wear Device Name: (clear, lathe-cut)

INDICATIONS FOR USE:

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Orus

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_k 9905

Image /page/5/Picture/11 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801.109)" in a smaller font. There is a line through the text, indicating that it is not applicable. The text is likely related to the regulatory requirements for prescription drug labeling.

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 886.5925 Soft (hydrophilic) contact lens.

(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.