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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.

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