(254 days)
The Renovis A400 Surgical Hip Joint Replacement Prosthesis is indicated for patients suffering from the following:
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Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
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Rheumatoid arthritis;
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Correction of functional deformity;
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Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
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Revision procedures where other treatment or devices have failed.
The Renovis A400 Surgical Hip Joint Replacement Prosthesis is intended for cementless applications.
The Renovis Surgical Technologies, Inc. A400 Surgical Hip Replacement System (Renovis A400 Hip System) is a family of components designed in a variety of standard clinically usable sizes for cementless total hip replacements (i.e. replacements where both the femur and acetabulum are replaced).
The system consists of four main components available in a variety of clinically usable sizes.
A) Femoral Stem (titanium alloy)
B) Femoral Head (CoCr and Biolox delta ceramic)
C) Acetabular Cup (titanium alloy)
D) Acetabular Liners (Mechanically annealed HXL polyethylene with and without alphatocopherol)
The Renovis A400 Hip System implant components are provided sterile and are for single use.
The provided text describes a 510(k) submission for the RENOVIS A400 Surgical Hip Replacement System. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comprehensive performance testing, rather than reporting on a study to meet pre-defined acceptance criteria with device performance results in a standalone clinical setting.
Therefore, many of the requested elements for acceptance criteria, device performance, and study details like sample size for test sets, expert involvement for ground truth, and comparative effectiveness studies are not applicable or not explicitly detailed in this 510(k) summary.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance results in the format typically seen for a new clinical study with pre-defined metrics. Instead, the "Performance Testing" section lists various tests performed to demonstrate safety, efficacy, and substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the Renovis A400 Hip System's performance meets the standards or guidance documents referenced (e.g., ISO, ASTM, FDA Guidance) and is comparable to the predicate devices, thereby raising no new questions of safety or effectiveness.
| Test Category & Standard | Implicit Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| A400 Hip System Tests | All tests reported to demonstrate system is "safe for its intended uses and is substantially equivalent to the predicate devices." | ||
| Distal Stem Fatigue (ISO 7206-4:2002) | Meets or exceeds ISO standard for fatigue life. | Not explicitly quantified, but met requirement for substantial equivalence. | Bench testing. |
| Proximal Stem Fatigue (ISO 7206-6:1992) | Meets or exceeds ISO standard for fatigue life. | Not explicitly quantified, but met requirement for substantial equivalence. | Bench testing. |
| Push-out Snap-Lock (ASTM F1820-97) | Meets ASTM standard for liner retention. | Not explicitly quantified, but met requirement for substantial equivalence. | Bench testing. |
| Lever-out and Torque-out Snap-Lock | Meets internal standards/comparable to predicates. | Not explicitly quantified, but met requirement for substantial equivalence. | Bench testing. |
| CoCr Head Attachment (ISO 7206-10:2003) | Meets ISO standard for head attachment strength. | Not explicitly quantified, but met requirement for substantial equivalence. | Bench testing. |
| BIOLOX delta Ceramic Heads Attachment (FDA Guidance) | Meets FDA Guidance for ceramic head attachment. | Not explicitly quantified, but met requirement for substantial equivalence. | Bench testing. |
| Range of Motion Analysis | Demonstrates appropriate range of motion. | Not explicitly quantified, but met requirement for substantial equivalence. | Bench testing. |
| Hip Simulator Wear Testing (ISO 14242-1) | Meets ISO standard for wear rates under normal conditions. | Not explicitly quantified, but met requirement for substantial equivalence. | Bench testing. |
| Hip Simulator Wear Testing (Abrasive Wear) | Meets ISO standard for wear rates under abrasive conditions. | Not explicitly quantified, but met requirement for substantial equivalence. | Bench testing. |
| Wear Debris Characterization (ASTM F1877-05) | Meets ASTM standard for debris characterization. | Not explicitly quantified, but met requirement for substantial equivalence. | Bench testing. |
| Porous Surface/Coating Tests | All tests reported to "evaluate the integrity of the porous surface/coating" and implicitly met for substantial equivalence. | ||
| Abrasion resistance (ASTM F1978) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Shear fatigue strength (ASTM F1160) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Static shear strength (ASTM F1044) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Static tensile strength (ASTM F1147) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Characterization (ASTM F1854) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Acetabular Liner (Poly) Char. Tests | All poly characterization test results "demonstrate that the A400 Hip System design is safe for its intended use and is substantially equivalent to the predicate devices." | ||
| Heat of fusion, melting point, % crystallinity (ASTM F2625/D3418) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Small punch test properties (ASTM F2183) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Oxidation measurement (ASTM F2102) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Trans-vinylene yield (ASTM F2381) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Crosslink density (ASTM F2214) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Tensile properties (ASTM D638) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Izod impact strength (ASTM D256 / F648) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| GCMS and LCMS extract analyses | Demonstrates material purity and absence of harmful leachables. | Not explicitly quantified. | Bench testing. |
| Vitamin E content | Verified as specified. | Not explicitly quantified. | Bench testing. |
| Fatigue crack propagation (ASTM E647) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Compressive modulus (ASTM D695) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Uniformity of radiation dose | Verified as specified. | Not explicitly quantified. | Bench testing. |
| Free radical content (Electron Spin Res.) | Verified as specified. | Not explicitly quantified. | Bench testing. |
| Consolidation verification | Verified as specified. | Not explicitly quantified. | Bench testing. |
| Density (ASTM D1505/D792) | Meets ASTM standard. | Not explicitly quantified. | Bench testing. |
| Polyethylene Biocompatibility Tests (ISO 10993) | All tests performed to demonstrate biocompatibility and implicitly met for substantial equivalence. | ||
| Systemic Toxicity (Rabbit Pyrogen Test) | Meets ISO 10993 standard for absence of pyrogenic reaction. | Not explicitly quantified. | In-vivo testing. |
| Systemic Toxicity (Acute Systemic Toxicity) | Meets ISO 10993 standard for absence of acute systemic toxicity. | Not explicitly quantified. | In-vivo testing. |
| In Vitro Cytotoxicity Study (ISO Elution) | Meets ISO 10993 standard for absence of cytotoxicity. | Not explicitly quantified. | In-vitro testing. |
| Genotoxicity (Chromosomal Aberration) | Meets ISO 10993 standard for absence of genotoxicity. | Not explicitly quantified. | In-vitro/in-vivo testing. |
| Genotoxicity (Mouse Micronucleus Assay) | Meets ISO 10993 standard for absence of genotoxicity. | Not explicitly quantified. | In-vivo testing. |
| Genotoxicity (Bacterial Reverse Mutation) | Meets ISO 10993 standard for absence of genotoxicity. | Not explicitly quantified. | In-vitro testing. |
| Irritation/Skin Sensitization (Intracutaneous Study) | Meets ISO 10993 standard for absence of irritation/sensitization. | Not explicitly quantified. | In-vivo testing. |
| ISO Muscle Implantation (Rabbits - 2 Weeks) | Meets ISO 10993 standard for tissue compatibility. | Not explicitly quantified. | In-vivo testing. |
| ISO Muscle Implantation (Rabbits - 13 Weeks) | Meets ISO 10993 standard for tissue compatibility. | Not explicitly quantified. | In-vivo testing. |
| Irritation/Skin Sensitization (Guinea Pig) | Meets ISO 10993 standard for absence of irritation/sensitization. | Not explicitly quantified. | In-vivo testing. |
| Systemic Toxicity (Sub-Chronic IV) | Meets ISO 10993 standard for absence of sub-chronic toxicity. | Not explicitly quantified. | In-vivo testing. |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in the document. The document refers to "comprehensive bench performance testing" and "the following device tests were performed," implying specific quantities of components were tested for each standard. For example, fatigue testing would involve multiple samples, but the exact number is not provided.
- Data Provenance: The tests are benchtop "performance testing" and
in-vitro/in-vivobiocompatibility testing, not human-patient data. The document does not specify the country of origin for the actual testing, but the submission is to the U.S. FDA.
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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)
- Not Applicable. This is a mechanical and biocompatibility testing submission for a hip implant, not an AI or diagnostic device requiring expert consensus for a "ground truth" on patient data. The "ground truth" for these tests is defined by the technical specifications and performance criteria within the referenced ISO, ASTM, and FDA guidance documents.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This type of adjudication is typically used for clinical study endpoints or image interpretation, not for standard bench and biocompatibility testing results. The results of these tests (e.g., fatigue life, wear rate, toxicity) are objectively measured against established standards.
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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
- No. An MRMC study is completely irrelevant for this 510(k) submission, which concerns a physical hip implant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a surgical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission are the established international and national standards (ISO, ASTM, FDA Guidance) for mechanical properties, wear characteristics, and biocompatibility of orthopedic implants. The device's performance is compared against these engineering and biological benchmarks, and against the known characteristics of the predicate devices.
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The sample size for the training set
- Not Applicable. This is not an AI/machine learning device; there is no "training set" in the conventional sense. The "training" for the design might refer to iterative design and testing, but no formal training set size is mentioned.
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How the ground truth for the training set was established
- Not Applicable. See point 7.
§ 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.