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 Cemented Hip Stem is intended for cemented applications.

Device Description

The Renovis Cemented Hip Stem is for use with bone cement only, is offered in multiple sizes, and is manufactured from CoCr. The taper connection of the Renovis Cemented Hip Stem is the same as the existing Renovis FDA cleared Renovis uncemented hip stems (K112897) to allow use with the existing FDA cleared femoral heads (CoCr and ceramic femoral heads; K112897 and K131354). A distal plug and distal centralizers are also offered and are manufactured from PMMA.

AI/ML Overview

The provided document describes the Renovis Cemented Hip Stem and its substantial equivalence to predicate devices, but it does not detail acceptance criteria and a study proving those criteria are met in the way typically expected for an AI/CADe device. Instead, the document focuses on the regulatory clearance process for a hip implant.

Therefore, many of the requested items (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, training set details) are not applicable to this particular type of medical device submission.

However, I can extract information related to the performance testing and materials that serve as the "acceptance criteria" and "study" for this orthopedic implant.

Here's a summary tailored to the provided document, addressing the applicable points and noting where information is not present or relevant:

Acceptance Criteria and Device Performance Study for Renovis Cemented Hip Stem

The Renovis Cemented Hip Stem received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through material compliance, design similarity, and successful performance testing according to recognized international standards. These standards implicitly define the "acceptance criteria" for the mechanical and material integrity of the implant.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Compliance)	Reported Device Performance
Material Compliance:
ASTM F799-11 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (for hip stems)	Renovis Cemented Hip Stems comply with this standard.
ASTM D5436-13 Standard Specification for Cast Poly(Methyl Methacrylate) Plastic Rods, Tubes, and Shapes (for distal centralizer and distal plug)	Distal centralizer and distal plug comply with this standard.
ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes (for instruments)	Cemented hip stem specific instruments comply with this standard.
Mechanical Performance (Fatigue Testing):
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	Femoral stem fatigue testing was successfully conducted per this standard for worst-case Renovis stems. (Specific endurance limit values or cycles are not detailed in the summary but successful completion implies meeting the standard's criteria).
ISO 7206-6:1992 Implants for surgery — Partial and total hip joint prostheses — Part 6: Determination of endurance properties of head and neck region of stemmed femoral components	Femoral neck fatigue testing was successfully conducted, compared to the standard's criteria. (Successful completion implies meeting the standard's criteria for endurance properties).
Sterilization & Packaging Standards:
ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose	Compliance with this standard is asserted.
ISO 11607-2:2009 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes; Operational Qualification Section 5.3 and Performance Qualification Section 5.4	Compliance with this standard is asserted.
ASTM F1980-07 (reapproved 2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices	Compliance with this standard is asserted.
ASTM D4169-09 Standard Practice for Performance Testing of Shipping Containers and Systems	Compliance with this standard is asserted.
ISTA 2A Partial Simulation Performance Tests; Packaged-Products weighing 150 lb (68 kg) or Less	Compliance with this standard is asserted.
ANSI/AAMI/ISO 11135-1:2007- Part 1, Sterilization of healthcare products-Ethylene Oxide-Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices	Compliance with this standard is asserted.
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals, for limited exposure device type.	Compliance with this standard is asserted.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document mentions "worst case Renovis stems" were tested for femoral stem fatigue. However, it does not specify the exact number of stems or individual components tested.
Data Provenance: The document does not specify the country of origin for the data, but it is implied to be from Renovis Surgical Technologies, Inc. internal testing or contracted labs, as part of their submission to the US FDA. The studies are prospective in the sense that they were conducted specifically for the regulatory submission to demonstrate compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the ground truth for mechanical testing of an orthopedic implant is established by compliance with a predetermined engineering standard, not by expert consensus on interpretations of data in the way an AI/CADe device would be evaluated. The "experts" are the engineers and material scientists defining and performing the tests per ISO/ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This question is not applicable. Mechanical and material testing of implants typically relies on direct measurement and comparison against predefined thresholds within the standards, not on expert adjudication of ambiguous cases.

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:

This question is not applicable, as the Renovis Cemented Hip Stem is a physical implant, not an AI/CADe device intended for interpretation by human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This question is not applicable, as the Renovis Cemented Hip Stem is a physical implant, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device is derived from established international and national engineering standards for materials, mechanical performance (fatigue life), and sterilization. Successful compliance with the specifications and performance metrics outlined in these standards serves as the ground truth for the device's safety and effectiveness.

8. The sample size for the training set:

This question is not applicable. There is no "training set" in the context of an AI algorithm, as this is a physical medical device. The design and manufacturing processes are informed by engineering principles and prior device designs, but not in the sense of a machine learning training set.

9. How the ground truth for the training set was established:

This question is not applicable for the same reasons as point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, representing health and human services.

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

September 2, 2014

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

Re: K141370

Trade/Device Name: Renovis Cemented Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI Dated: June 4, 2014 Received: June 5, 2014

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

{1}------------------------------------------------

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 vours.

Lori A. Wiggins -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K141370

Device Name Renovis Cemented Hip Stem

Indications for Use (Describe)

The Renovis A400 Surgical Hip Replacement System is indicated for patients suffering from:

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

The Cemented Hip Stem is intended for cemented applications.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Traditional 510(k) Summary as required by 21 CFR 807.92(a) K141370

A) Submitted by: Renovis Surgical Technologies 1901 W. Lugonia Ave, Ste 340 Redlands, CA 92374 Phone: 909-557-2360 Fax: 909-307-8571
Official Contact: Anthony DeBenedictis Vice President of Quality Assurance
Consultant: Sharyn Orton, Ph.D. MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721
Prepared: August 26, 2014
B) Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Common Name:	Hip joint metal/polymer semi-constrained cemented prosthesis
Proprietary Name:	Renovis Cemented Hip Stem
Device Class:	Class II
Regulationand Product Code:	21 CFR 888.3350JDI
Classification panel:	Orthopedic
Predicate:	K970351, K963509 Smith & Nephew Global Taper Spectron HipStems (for cemented hip stems)

D) Device Description

{4}------------------------------------------------

Materials

Cemented hip stems comply with ASTM F799-11 Standard Specification for Cobalt-28 ● Chromium-6Molybdenum Alloy Forgings for Surgical Implants
Distal centralizer and distal plug comply with ASTM D5436-13 Standard Specification ● for Cast Poly(Methyl Methacrylate) Plastic Rods, Tubes, and Shapes
. Cemented hip stem specific instruments comply with ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes
E) Intended Use/Indications For Use:

The Renovis A400 Surgical Hip Replacement System is indicated for patients suffering from:

Noninflammatory 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.
Revision procedures where other treatment or devices have failed.

The Cemented Hip Stem is intended for use in cemented applications.

F) Substantial Equivalence Comparison

The Renovis Cemented Hip Stem has similar Indications for Use, material, dimensions, operating principle and basic design as the predicate device, and both offer the stems as gamma sterilized. Fatigue testing of worst case Renovis stems was successfully conducted.

H) Performance Testing

Per "Guidance for Industry and FDA Staff – Non-clinical Information for Femoral Stem Prostheses, September 2007, the following performance testing was successfully conducted:

Femoral stem fatigue per 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
. Femoral neck fatigue, as compared to standards criteria per ISO 7206-6: 1992 Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components

I) Compliance with Other Standards

ASTM F983-86 (Reapproved 2013) Standard Practice for Permanent Marking of . Orthopaedic Implant Components
ASTM F565-04 (Reapproved 2013) Standard Practice for Care and Handling of . Orthopedic Implants and Instruments
. ISO 11137-2:2013 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose

{5}------------------------------------------------

. ISO 11607-2: 2009 Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes; Operational Qualification Section 5.3 and Performance Qualification Section 5.4
ASTM F1980-07 (reapproved 2011) Standard Guide for Accelerated Aging of Sterile . Barrier Systems for Medical Devices
ASTM D4169-09 Standard Practice for Performance Testing of Shipping Containers and . Svstems
ISTA 2A Partial Simulation Performance Tests; Packaged-Products weighing 150 lb (68 . kg) or Less
ANSI/AAMI/ISO 11135-1:2007- Part 1, Sterilization of healthcare products-Ethylene . Oxide-Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide . sterilization residuals, for limited exposure device type.

Conclusion

The Renovis Cemented Hip Stem does not raise new issues of safety or effectiveness and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.