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510(k) Data Aggregation
(203 days)
When used with the components of the Consensus Knee System:
The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.
- A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
- B. Failed osteotomy or unicompartmental replacements.
- C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
- D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
- E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.
When used as a component of the Consensus Revision Knee System:
The Consensus® Revision Knee System is designed as a system and is only intended to be used with compatible components of the Consensus® Knee System. The revision knee femoral and tibial components are intended for cemented use only.
The indications for use are:
- A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
- B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion. dvsfunction, or prior patellectomy)
- C. Failed osteotomy or unicompartmental replacements.
- D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
- E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
- F. Moderate valgus, varus, or flexion deformities
The VitalitE Tibial Insert is a vitamin E version of the UHMWPE tibial insert that has been a component of both the Consensus Knee System (CKS) and the Consensus Revision Knee System (RKS). The new insert still serves as the gliding surface between the metallic femoral component and the metallic tibial base plate of these knee systems. The new VitalitE insert will also be available in a cruciate retaining (CR) or ultra-congruent/ PCL substituting designs in sizes 0 through 6 and in thicknesses from 10 to 22 mm. The proprietary locking mechanism design on the underside of the insert will remain unchanged. The only difference will be the vitamin E additive in the UHMWPE which is a-tocopherol. This is the exact same polymer that is used in the Consensus VitalitE Acetabular insert but with a slightly lower radiation dose. Consensus will also offer our current CKS all-poly patellae in the new vitamin E UHMWPE material. This includes both the round and oval configurations with either a 7.5 mm or 10 mm thickness.
This document describes the 510(k) premarket notification for the Consensus Orthopedics VitalitE Tibial Insert & Patellar Components. This is a medical device, and the evaluation for such devices often focuses on substantial equivalence to existing legally marketed predicate devices, rather than a direct clinical performance study that proves specific acceptance criteria for a new AI/software device.
Therefore, the requested information elements (especially those related to AI/software performance metrics like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and specific ground truth establishment methods) are not applicable in the context of this 510(k) submission for a physical medical implant.
However, I can extract the relevant information regarding the acceptance criteria and how the device meets them based on the provided text, reinterpreting some of your categories to fit the context of a physical implant's regulatory review.
Here's the breakdown:
Acceptance Criteria and Device Performance for Consensus Orthopedics VitalitE Tibial Insert & Patellar Components
The core "acceptance criteria" for this device, within the scope of a 510(k) submission, revolve around demonstrating substantial equivalence to existing predicate devices. This means showing that the new device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on Substantial Equivalence) | Reported Device Performance/Evidence Provided |
|---|---|
| Design Equivalence: New device has the same design/form as predicate devices. | The VitalitE tibial insert "is the exact same design" as cleared for use with the Consensus Knee System (K932837, K953443 & K110950) and Consensus Revision Knee System (K100542). It is compatible with all metallic femoral and tibial components from those systems. The proprietary locking mechanism design on the underside remains unchanged. |
| Material Equivalence: New device uses materials that are either identical or demonstrably equivalent to predicate devices, especially regarding the key differentiating feature (Vitamin E). | The UHMWPE (GUR 1020) with α-tocopherol (Vitamin E) is the "same polymer" as cleared in K130652 for the Consensus VitalitE Acetabular Insert (with a slightly lower radiation dose). The use of Vitamin E infused UHMWPE tibial inserts for knee systems has been cleared for use in DJO/Encore systems via K091956 and K103223. The UHMWPE used in the current Consensus tibial inserts is GUR 1050 (implying the new GUR 1020 with Vitamin E is being compared for equivalence). |
| Performance Equivalence: The new device performs equivalently to predicate devices in critical functional aspects. | Non-Clinical Performance Data (Bench Testing): Included wear testing of the worst-case tibial insert. Included anterior disassembly testing of the locking mechanism (push-out testing) on a range of various sizes and types of inserts. The report states: "All of the observed results indicate that the VitalitE Tibial Inserts and Patellas are substantially equivalent to devices currently marketed." Biocompatibility Testing: Performed. Material Characterization: Performed. |
| Processing and Shelf-Life Equivalence: Manufacturing, packaging, and sterilization processes maintain equivalence. | The VitalitE inserts are "cleaned, packaged, and sterilized using the same validated processes as the current inserts." They will also have a "5 year shelf-life" (implicitly equivalent to or validated as acceptable for existing products). |
| Intended Use Equivalence: Indications for Use are consistent with predicate devices. | The "Indications for Use" statement (on page 5) lists specific primary intervention scenarios (rheumatoid arthritis, osteoarthritis, etc.), failed osteotomies, replacement of unsatisfactory components, and various deformities, which are standard for these types of knee systems and align with predicate devices. |
| Safety and Effectiveness: Overall safety and effectiveness is comparable to legally marketed predicates. | The FDA's final letter of substantial equivalence determination indicates that "the device is substantially equivalent... to legally marketed predicate devices." And the company states: "Therefore, the devices are as safe, as effective, and perform at least as safely and effectively as legally marketed predicates." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in terms of specific number of units for each bench test. For physical implant testing, "worst-case" scenarios are typically selected rather than a large statistical sample of every size/type. The document mentions "a range of various sizes and types of inserts" for the disassembly testing.
- Data Provenance: The data appears to be from internal bench testing and analysis conducted by Consensus Orthopedics, Inc. The document doesn't specify country of origin for the data, but the company is based in El Dorado Hills, CA, USA, implying the testing likely occurred in the US or at a certified lab. The data is retrospective in the sense that it was generated for this specific submission to demonstrate equivalence to already marketed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) for a physical implant. "Ground truth" as a concept with expert consensus is typically used for AI/software devices where human interpretative judgment is being compared to an algorithm's output. For physical implants, "ground truth" is established through engineering and material science standards, validated testing methods, and regulatory requirements (e.g., ISO standards, ASTM standards, FDA guidance).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in human expert interpretations, especially in clinical image analysis for AI. For engineering bench testing, results are typically quantitative and compared against predefined pass/fail criteria or against control/predicate device performance.
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:
- Not applicable. MRMC studies are specific to evaluating inter-reader variability and the impact of AI assistance on human performance, primarily in imaging diagnostics. This submission is for a physical knee implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physical implants demonstrating substantial equivalence, the "ground truth" is typically a combination of:
- Validated engineering standards: e.g., ASTM standards for mechanical properties and wear.
- Biocompatibility standards: demonstrating the material is safe for implantation.
- Performance of legally marketed predicate devices: The "known good" performance of existing devices serves as the benchmark.
- Material characterization: Chemical composition, physical properties, and manufacturing integrity are verified against specifications.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of a 510(k) for a physical medical device. This concept is relevant for machine learning algorithms.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device.
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(26 days)
The CS2™ Acetabular Cup System is designed for use with the various hip systems manufactured by Consensus Orthpedics, Inc. The CONSENSUS® HIP SYSTEM, CS2™ HIP SYSTEM, and the TAPERSET™ HIP SYSTEM are designed for total or partial hip arthroplasty and is intended to be used with compatible components of the CONSENSUS® HIP SYSTEM. The indications for use are:
A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. B.
C. Proximal femoral fractures.
D. Avascular necrosis of the femoral head.
Non-union of proximal femoral neck fractures. ﻨﻨﺎ
F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The CONSENSUS® hip stem is indicated for cemented or cementless use. The CS2™ and TAPERSET™ hip stems are indicated for cementless use.
The UNISYN™ HIP SYSTEM is indicated for significantly impaired joints resulting from theumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
A. Proximal femoral fractures.
B. Avascular necrosis of the femoral head.
C. Non-union of proximal femoral neck fractures.
D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
UNISYN™ stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN™ stems used with plasma/HA or HA coated bodies are intended for uncemented use only.
The CS2 Acetabular Cup System consists of a shell and a mating insert. The acetabular component is designed for cemented or uncemented use. The acetabular shell is manufactured from titanium alloy (Ti 6Al-4V ELI, ASTM F620 or ASTM F136), with a porous coating of commercially pure titanium beads (CP Ti ASTM F-67).
The acetabular shells are available with or without screw holes in hemispherical or flared rim versions. The component has matching circumferential scallops on the shell and insert that rotationally secure the insert in the shell and allow for dialing the insert in a desired orientation. The shells with screw holes have up to 10 anatomically placed holes which accommodate optional bone screws to augment initial fixation. An optional apical dome hole plug and cement pod spacer are available. The acetabular insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648); highly cross linked polyethylene (UHMWPE, ASTM F648), or VitalitE (UHMWPE, ASTM F2695). They all feature a titanium alloy X-ray marker (Ti 6Al-4V ELI, ASTM F136).
The cancellous bone screws are manufactured from wrought titanium alloy (Ti 6Al-4V ELI. ASTM F136). The cancellous bone screws are 6.5mm diameter and have a low profile head with a hex drive recess. These are provided with certain versions of the acetabular shell for the option of additional fixation.
The provided document describes a 510(k) submission for a Multi-Hole Shell for use with the CS2™ Acetabular Cup System. This is a medical device, and the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a study on artificial intelligence (AI) performance. Therefore, many of the requested categories related to AI studies (like ground truth, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable to this document.
The acceptance criteria for this type of device are primarily based on demonstrating substantial equivalence in terms of intended use, materials, and design features, and ensuring safety and effectiveness through non-clinical performance data (e.g., engineering design evaluations) if changes are made from predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Device maintains the same intended use as predicate devices. | The intended use of the Multi-Hole Shell for use with the CS2™ Acetabular Cup System is stated to be "substantially equivalent" to predicate devices. The system is designed for total or partial hip arthroplasty for various indications (e.g., impaired joints from arthritis, revision surgeries, fractures, avascular necrosis, etc.). |
| Materials: Device uses substantially equivalent or compatible materials as predicate devices. | The acetabular shell is manufactured from titanium alloy (Ti 6Al-4V ELI) with a porous coating of commercially pure titanium beads, consistent with previous versions. The inserts are manufactured from UHMWPE, highly cross-linked polyethylene, or VitalitE, also existing materials. The cancellous bone screws are titanium alloy. This aligns with or is compatible with predicate devices. |
| Design Features: Any new design features (e.g., additional screw holes) do not negatively impact safety or effectiveness. | The new Multi-hole shell offers up to 10 screw holes, compared to 3 to 5 in previously cleared versions. The submission states, "Engineering design evaluation of the additional screw holes being added to the acetabular shell shows that no additional biomechanical testing was required." This indicates that the design change was evaluated and deemed safe without further testing for this specific aspect, suggesting it met the internal engineering evaluation criteria. |
| Safety and Effectiveness: Overall safety and effectiveness are maintained and supported. | "The safety and effectiveness of the Multi-hole Shell are adequately supported by the substantial equivalence information and materials data provided within this 510(k) submission." |
| Compatibility: Device is compatible with legally marketed components. | The document lists several legally marketed devices from Consensus Orthopedics and Hayes Medical (now Consensus Orthopedics) that are compatible with the system, demonstrating adherence to component interchangeability and compatibility. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a medical device (acetabular cup system) seeking clearance based on substantial equivalence to predicate devices, not an AI/software device undergoing a clinical trial or performance study with a test set of data. The primary "test" was an engineering design evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. Ground truth is not a concept applied in this context for evaluating the device as it's not an AI/diagnostic algorithm.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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
- Not Applicable. See point 2. This device is an orthopedic implant, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See point 2.
7. The type of ground truth used
- Not Applicable. See point 2. The closest equivalent would be demonstrating equivalence to established physical properties and clinical performance of predicate devices, validated through engineering principles and material science, rather than a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of an AI study.
8. The sample size for the training set
- Not Applicable. See point 2.
9. How the ground truth for the training set was established
- Not Applicable. See point 2.
In summary, this 510(k) submission for the Multi-Hole Shell for use with the CS2™ Acetabular Cup System is based on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" proving it meets acceptance criteria primarily consists of engineering design evaluation and referencing established material data, rather than clinical trials or AI performance evaluations. The key acceptance criteria are that the device shares the same intended use, materials, and fundamental design characteristics as the predicate devices, and any modifications (like the increased number of screw holes) do not introduce new questions of safety or effectiveness and can be supported by existing non-clinical data.
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