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.

Device Description

The Renovis Porous Acetabular Cup System ("Porous shell") are titanium, hemispherical cups consisting of varying sizes (outer diameter of 44 - 66 mm) and screw hole options (no hole shell and cluster hole shells) to accommodate patient anatomy and/or surgical technique. Instrumentation is provided with the system.

The Renovis Porous Acetabular Cup System is part of the Renovis Surgical Hip Replacement System and is to be used with Renovis Surgical Hip Replacement System acetabular and femoral components.

AI/ML Overview

The provided text is a 510(k) summary for the Renovis Surgical Porous Acetabular Cup System, a medical device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device through design comparison, materials, and performance testing against recognized standards. It does not typically involve clinical studies with acceptance criteria in the same way a diagnostic AI device would.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this document. The document describes performance testing bench studies to ensure the device meets certain engineering and material standards, rather than clinical studies establishing diagnostic accuracy or efficacy in patients.

Here's an attempt to answer the questions based only on the provided text, acknowledging that much of the requested information is absent because it's not a clinical study for an AI device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a way that would typically be seen for a diagnostic AI device. Instead, it states that "Performance testing was successfully completed" and lists various standards the device complies with. Compliance with these standards implies meeting their embedded acceptance criteria.

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied)
Coating Characterization (21 CFR 888.3358)	Meets coating characterization criteria.
Orthopedic Implants with Modified Metallic Surfaces (FDA Guidance)	Complies with guidance document.
Stereological Evaluation of Porous Coatings (ASTM F1854-09)	Complies with standard.
Shear Testing of Calcium Phosphate and Metallic Coatings (ASTM F1044-05)	Complies with standard.
Tension Testing of Calcium Phosphate and Metallic Coatings (ASTM F1147-05)	Complies with standard.
Disassembly of Modular Acetabular Devices (ASTM F1820-97:2009)	Complies with standard.
Sterilization Dose (ISO 11137-2:2013)	Sterilization validation studies conducted and complies with standard.
Accelerated Aging of Sterile Barrier Systems (ASTM F1980-07)	Shelf life validation studies conducted and complies with standard.
Packaging Validation (ISO 11607-2:2009)	Packaging validation studies conducted and complies with standard.
Shipping Performance Tests (ISTA 2A, ASTM D4169-09)	Shipping validation studies conducted and complies with standards.
Materials Compliance (various ASTM standards)	Complies with material standards (e.g., ASTM F136-13, ASTM F620-11, etc.).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document describes bench testing rather than testing on a "test set" of patient data. The "samples" would refer to the physical devices or materials tested according to engineering standards. No information on data provenance (country, retrospective/prospective) is relevant or mentioned for this type of testing.

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

This information is not applicable and not provided. The "ground truth" for material and mechanical performance testing is established by engineering specifications and objective measurements, not by human expert consensus on clinical cases.

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

This information is not applicable and not provided. Adjudication methods are relevant for human interpretation in clinical studies, not for bench testing of medical devices.

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 information is not applicable and not provided. An MRMC study is designed for evaluating diagnostic devices, especially those involving human interpretation, and often with AI assistance. This document describes a physical hip implant, not a diagnostic AI device.

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

This information is not applicable and not provided. This question pertains to AI algorithm performance.

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

For the performance testing bench studies, the "ground truth" implicitly used is adherence to established engineering and material standards (e.g., tensile strength, shear strength, porosity characteristics, sterilization efficacy, packaging integrity). This is determined by standardized measurement techniques guided by the listed ASTM and ISO standards, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

This information is not applicable and not provided. This question pertains to AI algorithm training, which is not relevant to this device submission.

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

This information is not applicable and not provided. This question pertains to AI algorithm training, which is not relevant to this device submission.

Summary

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure, possibly representing the department's focus on health and human well-being. The figure is composed of three overlapping profiles facing to the right.

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

November 4, 2014

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

Re: K141676

Trade/Device Name: Renovis Surgical Porous Acetabular Cup 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: LPH Dated: September 30, 2014 Received: October 3, 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 (21

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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 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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Indications for Use

510(k) Number (if known) K141676

Device Name

Renovis Surgical Porous Acetabular Cup System

Indications for Use (Describe)

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.

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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Traditional 510(k) Summary as required by 21 CFR 807.92(a) K141676

A ) Submitted by: Renovis Surgical Technologies Inc. 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
Date prepared: September 25, 2014
B) Device Name: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
- Common Name: Total Hip Arthroplasty - Acetabular Components
- Proprietary Name: Renovis Surgical Porous Acetabular Cup System
- Device Class: Class II
- Regulation number: 21 CFR 888.3358
- Regulation name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
- Product code: LPH
- Classification panel: Orthopedic
C) Predicates:

K112897	Renovis A400 Surgical Hip Joint Replacement System (acetabular shells)
K132312	Renovis Tesera Trabecular Technology (T3) Acetabular Shell System
K974093	Encore Orthopedics Foundation Porous Coated HemisphericalAcetabular Cup

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D) Device Description:

The Renovis Porous Acetabular Cup System is part of the Renovis Surgical Hip Replacement System and is to be used with Renovis Surgical Hip Replacement System acetabular and femoral components.

The Renovis Surgical Porous Cup System complies with the following material standards:

o ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or
ASTM F620-11 Standard Specification for Titanium Alloy Forgings for Surgical ● Implants in the Alpha Plus Beta Condition
ASTM F67-13 Standard Specification for Unalloyed Titanium, for Surgical Implant ● Applications (UNS R50250, UNS R50400, UNS R50550 and UNS R50700)
ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-● Hardening Stainless Steel Bars and Shapes
E) Indications For Use:

The Renovis 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.
F) Substantial Equivalence Comparison and Discussion

The Renovis Surgical Porous Acetabular Cup System has similar Indications for Use, operating principle and basic design, sizes and geometries, biocompatible materials, and is offered gamma sterilized, like the predicate devices. The manufacturing processes used for the outer coating differ between the Renovis Surgical Porous Acetabular Cup System and two of the predicate devices. The Renovis Surgical Porous Acetabular Cup System meets the coating characterization criteria in 21 CFR 888.3358, and expected performance testing. The Renovis Surgical Porous Acetabular Cup System is substantially equivalent to the predicate devices.

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G) Performance Testing Bench
Performance testing was successfully completed.

The Renovis Surgical Porous Acetabular Cup System complies with:

21 CFR 888.3358 ●
0 FDA "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", April 8, 1994
ASTM F1854-09 Standard Test Method for Stereological Evaluation of Porous Coatings ● on Medical Implants
o ASTM F1472-08e1 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
ASTM F1044-05 (2011) Standard Test Method for Shear Testing of Calcium Phosphate o Coatings and Metallic Coatings
ASTM F1147-05 (2011) Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
ASTM F1820-97:2009 Standard Test Method for Determining the Forces for ● Disassembly of Modular Acetabular Devices

Sterilization, shelf life, packaging and shipping validation studies have been conducted. The Renovis Surgical Porous Acetabular Cup System complies with:

o ISO 11137-2:2013 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
ASTM F1980-07 (reapproved 2011) Standard Guide for Accelerated Aging of Sterile ● Barrier Systems for Medical Devices
ISO 11607-2:2009: Packaging for terminally sterilized medical devices Part 2: ● Validation requirements for forming, sealing and assembly processes
ISTA 2A Partial Simulation Performance Tests; Packaged-Products weighing 150 lb (68 kg) or Less
ASTM D4169-09: Standard Practice for Performance Testing of Shipping Containers and Systems

Conclusion

Renovis Surgical Porous Acetabular Cup System is substantially equivalent to the predicate devices, and does not raise new issues of safety or effectiveness.

H) Other Standards
- o 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

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.