Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
Rheumatoid arthritis;
Correction of functional deformity;
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
Revision procedures where other treatment or devices have failed.

The Renovis A400 Hip System is intended for cementless used with the Renovis Cemented Hip Stem.

Device Description

The subject of this application are Renovis 4.5mm femoral stems (and a 5.25 mm broach) which are an expansion of the FDA cleared Renovis A400 Surgical Hip Joint Replacement Prosthesis (K112897) which is now known as the Renovis Surgical Hip Replacement System. The 4.5mm and 5.25mm femoral stems are the same material, the same configuration and will be offered in the same standard and lateralized offsets, as are the FDA cleared Renovis A400 femoral stems.

In addition, this application includes an update of Letter-to-File expansions and changes to the Renovis Surgical Hip Replacement System.

Renovis implants and instruments comply with the following material standards:

ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-. 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes
ASTM F1537-11 Standard Specification for Wrought Cobalt-28Chromium-● 6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
ASTM A276-13a Standard Specification for Stainless Steel Bars and Shapes
ASTM A240-14 Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications

AI/ML Overview

The document provided is a 510(k) premarket notification decision letter from the FDA to Renovis Surgical Technologies, Inc., regarding their "Renovis Surgical Hip Replacement System." This document primarily focuses on the regulatory clearance of a medical device and describes its intended use, design, and comparison to a predicate device.

It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm's performance. The document is for a traditional surgical implant (hip replacement system), not a software device or an AI/ML-driven diagnostic or therapeutic tool.

Therefore, I cannot extract the requested information based on the provided text. The questions posed in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) are relevant to the evaluation of AI/ML-based medical devices, which this document does not cover.

The "Non-clinical Testing" section (G) refers to bench testing of the femoral stems according to ISO 7206-4 and coating characterization, but this directly relates to the mechanical performance and material properties of the physical implant, not the diagnostic accuracy or performance of a software algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.

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

Renovis Surgical Technologies, Incorporated % Sharyn Orton, Ph.D. Senior Consultant MEDIcept Incorporated 200 Homer Avenue Ashland, Massachusetts 01721

May 11, 2013

Re: K143647

Trade/Device Name: Renovis Surgical Hip Replacement System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: OQG, OQI, LPH, LZO Dated: April 10, 2015 Received: April 13, 2015

Dear Dr. Orton:

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 - Sharyn Orton, Ph.D.

(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,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K143647

Device Name Renovis Surgical Hip Replacement System

Indications for Use (Describe) Indications for Use:

The Renovis Surgical Hip Replacement System is indicated for patients suffering from:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
Rheumatoid arthritis;
Correction of functional deformity;
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
Revision procedures where other treatment or devices have failed.

The Renovis A400 Hip System is intended for cementless used with the Renovis Cemented Hip Stem.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Traditional 510(k) Summary as required by 21 CFR 807.92(a) K143647

A ) Submitted by:	Renovis Surgical Technologies1901 W. Lugonia Ave, Ste 340Redlands, CA 92374Phone: 909-557-2360Fax: 909-307-8571
Official Contact:	Anthony DeBenedictisVice President of Quality Assurance
Consultant:	Sharyn Orton, Ph.D.MEDIcept, Inc.200 Homer AveAshland, MA 01721
B) Common name:	Prosthesis, Hip Revision System
Proprietary Name:	Renovis Surgical Hip Replacement System
Device Class:	Class II
Regulations andClassification names:	21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis
Product codes:	OQILZOOQGLPH
Classification panel:	Orthopedic
C) Predicates:	K112897 Renovis A400 Surgical Hip Joint ReplacementProsthesis (femoral stems)
D) Date Prepared:	April 29, 2015

E) Device Description:

The subject of this application are Renovis 4.5mm femoral stems (and a 5.25 mm broach) which are an expansion of the FDA cleared Renovis A400 Surgical Hip Joint

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Replacement Prosthesis (K112897) which is now known as the Renovis Surgical Hip Replacement System. The 4.5mm and 5.25mm femoral stems are the same material, the same configuration and will be offered in the same standard and lateralized offsets, as are the FDA cleared Renovis A400 femoral stems.

In addition, this application includes an update of Letter-to-File expansions and changes to the Renovis Surgical Hip Replacement System.

Renovis implants and instruments comply with the following material standards:

ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-. 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes
ASTM F1537-11 Standard Specification for Wrought Cobalt-28Chromium-● 6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
ASTM A276-13a Standard Specification for Stainless Steel Bars and Shapes
ASTM A240-14 Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications

E) Intended Use/Indications For Use:

The Renovis Surgical Hip Replacement System is indicated for patients suffering from:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:

1. Rheumatoid arthritis;
1. Correction of functional deformity;

Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
Revision procedures where other treatment or devices have failed.

The Renovis A400 Hip System is intended for cementless applications unless used with the Renovis Cemented Hip Stem.

F) Substantial Equivalence Comparison and Discussion

The Renovis 4.5mm and 5.25mm femoral stems have the same Indications for Use, are manufactured from the same material, have the same configuration, will use the same offset options, and are provided sterile like the cleared Renovis A400 femoral stems. The difference is that they are offered in a smaller size and there is a change in the plasma spray manufacturing. The results of assessment and performance testing under design controls support that the 4.5 mm and 5.25 mm femoral stems do not raise new issues of safety and effectiveness.

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G) Non-clinical Testing

The 4.5mm and 5.25mm femoral stems have been assessed for risk per Renovis SOP and were either accepted into previous static/fatigue testing, or successfully completed fatigue testing per the following standard:

. ISO 7206-4: 2010 Implants for surgery - Partial and total hip-joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components
Additionally, coating characterization of the 4.5mm and 5.25mm femoral stems was conducted.

There is no change in biocompatibility, sterilization, packaging or shelf life.

Conclusion

The Renovis 4.5mm and 5.25mm femoral stems are substantially equivalent to the FDA cleared Renovis A400 femoral stems, and are expected to perform per their Indications for Use as evidenced by assessment and/or bench testing under Design Controls.

H) Additional Consensus Standards and Guidance

ASTM F565-04 (reapproved 2013) Standard Practice for Care and Handling of ● Orthopedic Implants and Instruments
ASTM F983-86 (reapproved 2013) Standard Practice for Permanent Marking of ● Orthopaedic Implant Components
Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained ● Cemented or Uncemented Prosthesis; guidance for Industry and FDA" dated April 30, 2002
Non-clinical Information for Femoral Stem Prostheses" dated September 17, 2007. ●

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.