The Saiph® Knee System is intended for cemented only in the U.S. It is intended for single use in total knee arthroplasty surgery for the reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis and avascular necrosis;
Inflammatory degenerative joint disease including rheumatoid arthritis;
Correction of varus, valgus, or post traumatic deformity;
Correction or revision of unsuccessful osteotomy or arthrodesis;
Revision procedures where other treatments or devices have failed; and
Treatment of fractures that are unmanageable using other techniques.

Device Description

The Saiph® Knee System is used in total knee replacement to replace articulating surfaces of the femur, tibia and patella. The device is intended for cemented fixation only. The patella is optional depending upon surgeon preference and is cemented use only. The femoral and tibial tray components are made from cast cobalt chrome. The tibial bearing and patella components are made from ultra-high molecular weight polyethylene (UHMWPE). The femoral component is highly polished to articulate with the tibial bearing. All devices are gamma irradiated.

AI/ML Overview

The provided document describes the Saiph® Knee System, a knee prosthesis, and its submission for 510(k) premarket notification. The information pertains to the device's technical characteristics and performance testing to establish substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, training set sample size, ground truth for training set) are not applicable to this document.

However, I can extract information regarding the device's performance, the type of studies conducted, and the ground truth used for validation.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Tibial tray fatigue strength meets in-vivo expectations	"The Saiph® Knee System has been evaluated for tibial tray fatigue strength... The testing confirms that the Saiph® Knee System is capable of withstanding loads in excess of those expected in vivo."
Insert locking mechanism strength meets in-vivo expectations	"The Saiph® Knee System has been evaluated for... insert locking mechanism strength... The testing confirms that the Saiph® Knee System is capable of withstanding loads in excess of those expected in vivo."
Tibiofemoral range of motion acceptable	"The Saiph® Knee System has been evaluated for... tibiofemoral range of motion..." (No specific quantitative acceptance criterion stated, but implied to be acceptable for substantial equivalence)
Tibiofemoral range of constraint acceptable	"The Saiph® Knee System has been evaluated for... tibiofemoral range of constraint..." (No specific quantitative acceptance criterion stated, but implied to be acceptable for substantial equivalence)
Patellofemoral range of constraint acceptable	"The Saiph® Knee System has been evaluated for... patellofemoral range of constraint..." (No specific quantitative acceptance criterion stated, but implied to be acceptable for substantial equivalence)
Tibiofemoral contact stress acceptable	"The Saiph® Knee System has been evaluated for... tibiofemoral contact stress... The testing confirms that the Saiph® Knee System is capable of withstanding loads in excess of those expected in vivo."
Patellofemoral contact area and contact stress acceptable	"The Saiph® Knee System has been evaluated for... patellofemoral contact area and contact stress. The testing confirms that the Saiph® Knee System is capable of withstanding loads in excess of those expected in vivo."
Substantial equivalence to predicate devices	"The testing confirms that the Saiph® Knee System... is substantially equivalent to the competitive legally marketed knee systems." Additionally, "The Saiph® Knee System was found to be substantially equivalent to the predicate devices based on non-clinical testing."
Safety and effectiveness in clinical use	"Clinical data from the National Joint Registry in the UK and data from a post-market clinical study being conducted in Australia and the UK show that the Saiph® Knee System is safe and effective. There have been no device related failures." (Specifically, 127 procedures in UK registry with max 4.8 years follow-up, 0 revisions. Multi-center post-market study with 282 implants, average 1.9 years follow-up, 3 revisions, 0 device-related failures).
Surgical instruments meet user needs	"Clinical usage in Europe (England and Belgium) and Australia validated that the specific surgical instruments included with this system meet user needs."

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

Non-clinical tests: The document does not specify a separate "test set" sample size for the non-clinical (physical) tests. These tests are typically conducted on a representative number of device components based on engineering standards and protocols.
Clinical data:
- UK National Joint Registry: 127 procedures. Data provenance: UK, retrospective.
- Multi-center post-market study: 282 implants. Data provenance: Australia and UK, prospective (ongoing study).

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

This information is not applicable to the provided document. The "ground truth" for the non-clinical tests would be defined by engineering standards and measurements, while the "ground truth" for clinical outcomes (revisions, device failures) is based on medical records and follow-up data as reported by healthcare providers and registries. There is no mention of experts establishing a ground truth for a test set in the context an AI/ML study.

4. Adjudication Method for the Test Set

Not applicable. The clinical outcomes (revisions, device failures) are reported events, not interpretations by multiple experts requiring adjudication in the context of an AI/ML algorithm evaluation.

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. This device is a physical knee prosthesis, not an AI/ML diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical knee prosthesis, not an AI/ML algorithm.

7. The Type of Ground Truth Used

Non-clinical tests: Engineering and biomechanical measurements, established through standardized testing methods (e.g., fatigue strength, contact stress). The "ground truth" is based on the physical properties and performance of the device under simulated conditions.
Clinical data:
- Registry data: Patient outcomes (e.g., presence or absence of revision surgery) as recorded in a national joint registry. This reflects actual clinical outcomes.
- Post-market study data: Patient outcomes (e.g., revisions, device-related failures) collected during an ongoing prospective clinical study. This also reflects actual clinical outcomes.

8. The Sample Size for the Training Set

Not applicable. This device is a physical knee prosthesis and does not involve AI/ML "training sets."

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

Not applicable. There is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 17, 2014

MatOrtho Limited % Mr. Marcos Velez-Duran President M-Squared Associates Incorporated 815 King Street Alexandria, Virginia 22314

Re: K140222

Trade/Device Name: Saiph® Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 9, 2014 Received: October 14, 2014

Dear Mr. Velez-Duran:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Marcos Velez-Duran

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140222

Device Name Saiph® Knee System

Indications for Use (Describe)

The Saiph® Knee System is intended for cemented only in the U.S. It is intended for single use in total knee arthroplasty surgery for the reduction or relief of paintined only in the U.S. It is intended to single use in total knear patients with the following

1. Non-inflammatory degenerative joint disease resulting from osteoarthritis and avascular necrosis;
1. Inflammatory degenerative joint disease including rheumatoid arthritis;
1. Correction of varus, valgus, or post traumatic deformity;
1. Correction or revision of unsuccessful osteotomy or arthrodesis;
1. Revision procedures where other treatments or devices have faily and

Treatment of fractures that are unmanageable using other techniques.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Submitter Information
Name	MatOrtho Limited
Address	13 Mole Business ParkRandalls RoadLeatherheadSurreyKT22 7BAUnited Kingdom
Phone number	+44 (0)1372 224 200
Fax number	+44 (0)1372 366 343
Establishment RegistrationNumber	9035148
Name of contact person	Marcos Velez-Duran
Date prepared	October 8, 2014
Name of device
Trade or proprietary name	Saiph® Knee System
Common or usual name	Knee Prosthesis
Classification name	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (Class II)
Classification panel	Orthopedic
Regulation	21 CFR 888.3560
Product Code(s)	87JWH
Legally marketed device(s)to which equivalence isclaimed	K020214 - Medial Rotation Knee™ (MRK) System (JWH)K023211 - NexGen® Complete Knee Solution CruciateRetaining (CR)-Flex Femoral Components (JWH)K003910 - NexGen® Complete Knee Solution CrosslinkedPolyethylene Cruciate Retaining (CR) ArticularSurface Components (JWH)K963148 - NexGen® Complete Knee Solution (JWH)K031729 - Triathlon® PS Knee (JWH)K935080 - Insall Burstein IIK931466 - PFC Modular Total Knee System
	K932070 - Duracon® Constrained PS Knee
Reason for 510(k)submission	New device
Device description	The Saiph® Knee System is used in total knee replacement toreplace articulating surfaces of the femur, tibia and patella.The device is intended for cemented fixation only. The patellais optional depending upon surgeon preference and iscemented use only. The femoral and tibial tray componentsare made from cast cobalt chrome. The tibial bearing andpatella components are made from ultra-high molecularweight polyethylene (UHMWPE). The femoral component ishighly polished to articulate with the tibial bearing. Alldevices are gamma irradiated.
Intended use of the device	Cemented total joint replacement intended to replace diseasedor severely worn articulating surfaces of the knee joint.
Indications for use	The Saiph® Knee System is intended for cemented only in theU.S. It is intended for single use in total knee arthroplastysurgery for the reduction or relief of pain and/or improved kneefunction in skeletally mature patients with the followingconditions:1. Non-inflammatory degenerative joint diseaseresulting from osteoarthritis, traumatic arthritis andavascular necrosis;2. Inflammatory degenerative joint disease includingrheumatoid arthritis;3. Correction of varus, valgus, or post traumaticdeformity;4. Correction or revision of unsuccessful osteotomy orarthrodesis;5. Revision procedures where other treatments ordevices have failed; and6. Treatment of fractures that are unmanageable usingother techniques.

K946088 - Genesis® PS Knee

510(k) Summary

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Summary of the technologies

The Saiph® Knee System is comprised of the multiple components including femorals, tibial trays and bearings, and patella, as well as instrumentation.

The technological characteristics are the same as the predicate devices (K020214, K023211, K003910. K963148 and K031729) in terms of design. materials, and principle of operation with the exception of the slight modifications outlined in this 510(k) submission.

The femur, tibia and patellar components utilize the identical manufacturing processes as the predicate, Medial Rotation Knee™ (MRK) System (K020214). This includes the same cemented (stippled) surface and "barb" locking mechanism used for the tibial tray and tibial bearing. Non-clinical tests were used to characterize the physical aspects of the design and to demonstrate substantial equivalence to the predicate devices. A summary of physical testing is given in the Performance Data (Non-clinical) section below. Physical testing is considered acceptable and equivalent to predicate devices. Clinical evidence of the Saiph is available in Australia and Europe and the device has been in use since 2009. A summary of Clinical Data is given below.

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS

Performance Test Summarv-New Device

The Saiph® Knee System has been evaluated for tibial tray fatigue strength, insert locking mechanism strength, tibiofemoral range of motion, tibiofemoral range of constraint, patellofemoral range of constraint, tibiofemoral contact stress and patellofemoral contact area and contact stress. The testing confirms that the Saiph® Knee System is capable of withstanding loads in excess of those expected in vivo and is substantially equivalent to the competitive legally marketed knee systems.

SUMMARY OF CLINICAL TESTS

Clinical usage in Europe (England and Belgium) and Australia validated that the specific surgical instruments included with this system meet user needs.

A total of 127 procedures have been registered by the National Joint Registries in the UK. Maximum follow up is 4.8 years (minimum 1.6 years). There have been no reports of revisions.

A multi-center, post-market study is ongoing in the Australia and the UK with 282 implants. The implants have been followed for average 1.9 years (range 0.6 to 5 years). There have been 3 revisions.

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There have been no device related failures.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The Saiph® Knee System was found to be substantially equivalent to the predicate devices based on non-clinical testing. Clinical data from the National Joint Registry in the UK and data from a post-market clinical study being conducted in Australia and the UK show that the Saiph® Knee System is safe and effective. There have been no device related failures.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.