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

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. 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.
   The Renovis Surgical Porous Coated Acetabular Shell System is intended for cementless applications.
   The Cemented Hip Stem is intended for cemented applications.
   The Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System is intended for cementless applications.
   The Bipolar Head is for use in conjunction with Renovis femoral heads and femoral stems.
   Bipolar outer heads are not for use with acetabular shells and liners.

The subject of this application is Renovis Extended Lateral Offset Femoral Stems which are an expansion of the FDA cleared Renovis Surgical Hip Replacement System. Extended Lateral Offset Femoral Stems are provided in a variety of sizes to fit patient need. This application also includes a new device specific neck trial and X-ray template, and additional implants and instruments.
The Extended Lateral Offset Femoral Stems are manufactured from the same material as other FDA cleared Renovis femoral stems. The instruments are manufactured from the same material as other instruments included in FDA cleared submissions.

This document is a 510(k) summary for a medical device (Renovis Surgical Hip Replacement System), not a clinical study report. Therefore, it does not contain the information required to answer your questions regarding acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system.

The document discusses the substantial equivalence of an expansion to an existing device (Extended Lateral Offset Femoral Stems) to previously cleared predicate devices. It relies on bench performance testing and material equivalence, rather than a clinical study with human subjects or AI-assisted diagnostic performance.

Here's why the requested information cannot be extracted from this document:

• AI/Machine Learning Context: The document is about a physical medical device (hip prosthesis components), not a software or AI-driven diagnostic/decision support system. Therefore, concepts like "acceptance criteria" for AI performance, "test set," "training set," "ground truth," "experts," or "MRMC studies" are not applicable in this context.
• Study Type: The "study" mentioned is "Performance Testing - Bench," which refers to laboratory tests of the device's physical properties and durability, not clinical trials or comparative effectiveness studies involving human readers or AI.
• Device Performance: The "reported device performance" refers to successful completion of specific ISO and ANSI/AAMI standards for physical and sterilisation properties, not diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).

Summary of what can be extracted, and why the rest cannot:

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

   • Acceptance Criteria (implicit): Compliance with ISO 7206-4, ISO 7206-6, ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11137-2, ANSI/AAMI ST72:2011(R)2016 for bacterial endotoxin testing, and material standards like ASTM F136-13, ASTM A564-13, ASTM A276-17.
   • Reported Device Performance: "Renovis successfully completed the following performance tests." (Lists the standards). "endotoxin limits are in compliance with ANSI/AAMI ST72:2011(R)2016." The results indicate the device met the requirements of these standards.
   • Why partial: These are engineering and material performance criteria for a physical implant, not diagnostic performance metrics for an AI system.

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

   • Cannot be provided. This refers to bench testing of physical components, not a clinical study or AI model evaluation. There is no "test set" of patient data in the sense you're asking about.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Cannot be provided. This is not relevant to a physical device's bench testing. "Ground truth" in this context would be physical measurements and material properties confirmed by engineering and quality control experts, not clinical diagnosis.

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

   • Cannot be provided. This is for clinical or AI performance evaluation, not bench testing.

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:

   • Cannot be provided. This type of study is for AI-assisted diagnostic tools, not physical implants.

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

   • Cannot be provided. This is about an algorithm's performance, which is not applicable to this device.

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

   • Cannot be provided (in the AI/clinical sense). For bench testing, the "ground truth" is adherence to established engineering standards (e.g., fatigue limits, material composition specifications).

8. The sample size for the training set:

   • Cannot be provided. There is no "training set" for a physical device in this context, as there is no AI model being trained.

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

   • Cannot be provided. Not applicable.

In conclusion, the provided FDA document is for a traditional medical device (hip prosthesis) and focuses on engineering, material, and sterilization compliance, not AI algorithm performance or clinical diagnostic accuracy.

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

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

2. Rheumatoid arthritis;

3. Correction of functional deformity;

4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and

5. 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.

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

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.

Ask a specific question about this device