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The Tahoe Unicompartmental Knee System (TUKS) is designed as a system and is not intended for substitution of components from other systems. The indications for use are as follows:

Primary medial or lateral compartmental intervention of (1) primary non-inflammatory degenerative disease, including osteoarthritis, traumatic arthritis, or osteonecrosis; (2) posttraumatic degenerative disease; (3) varus or valgus deformities; and (4) damage due to previous surgical intervention when the opposite compartment is preserved and when the anterior cruciate, posterior cruciate, medial collateral, and lateral collateral ligaments are present and functional.

All TUKS implants are single use only, and are intended for implantation only with bone cement.

The Tahoe Uni Knee System (TUKS) is a primary fixed-bearing, round-on-flat unicompartmental knee system offering flexibility to restore function in the affected medial or lateral tibial compartments. The femoral and tibial components are intended use only. The femoral component is made from cast CoCr alloy (ASTM F75), whereas the tibial baseplate is made from wrought CoCr alloy (ASTM F1537). The tibial insert is made from UHMWPE (ASTM F648) or Vitamin-E polyethylene (VitalitE, ASTM F2695). The tibial insert is designed to snap into the baseplate via an anterior-posterior locking mechanism.

I am sorry, but the provided text is a document from the FDA related to a 510(k) premarket notification for a medical device (Tahoe Uni Knee System). It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.

The document discusses:

• The product name, classification, and indications for use.
• The device description and its components.
• Substantial equivalence to predicate devices.
• Non-clinical performance data, which includes bench testing, FEA simulations, and engineering justifications for the physical knee implant components, such as fatigue testing and contact characteristics. It mentions "Wear testing was deemed unnecessary due to meeting the minimum requirement for poly thickness in the load bearing region (6mm) per ISO 21536. Pyrogenicity testing was completed and was deemed to be within 20 Endotoxin Units per surgical construct per the FDA Guidance Document Pyrogen and Endotoxins Testing."

This information pertains to the physical characteristics and safety of the knee implant itself, not to the performance or validation of an AI/ML device. Therefore, I cannot extract the requested details regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML device from this text.

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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.
F. Stemmed baseplates of the CKS Plus Knee System are intended for cemented use only

The CKS Plus extension to the Consensus Knee System (CKS) is a primary fixed bearing total knee system offering flexibility to restore knee function using either cruciate retaining (CR) or posterior stabilizing (PS) components with the option of tibial cancellous screw, tibial intramedullary (IM) stem fixation, and tibial augments

The provided text describes a 510(k) premarket notification for the "CKS Plus Knee System." It details the device, its indications for use, and claims substantial equivalence to predicate devices. Crucially, as a 510(k) summary for a medical device (a knee prosthesis), the focus is on demonstrating substantial equivalence through comparison to existing devices and bench testing, not on clinical performance studies involving AI or complex statistical analyses of diagnostic accuracy. Therefore, many of the requested elements for an AI/diagnostic device study (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable to this type of document.

The document primarily discusses non-clinical performance data (bench testing) to verify the safety and effectiveness of the CKS Plus Knee System's components, focusing on mechanical properties and stability rather than diagnostic accuracy or human interpretation.

Here's an attempt to address the request based only on the provided text, highlighting what is (and isn't) present:

A. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a formal table with reported performance side-by-side, as would be typical for a diagnostic device's clinical study. Instead, it lists the types of bench tests performed and implies that the device "meets" the requirements by stating it passed. The criteria are implicit in the ASTM standards and other specified tests.

B. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in terms of number of devices or components tested. The document mentions "bench testing" was carried out, but does not provide specific sample quantities for each test.
• Data Provenance: The tests are "bench testing," meaning they are performed in a laboratory setting on components or full devices, not on human subjects. Thus, there is no country of origin for human data, nor is it retrospective or prospective in that context.

C. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Experts: Not applicable. This is not a study requiring expert consensus for ground truth on diagnostic performance. The "ground truth" for mechanical testing is adherence to validated ASTM standards and engineering principles.

D. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not an image-based or diagnostic study requiring adjudication of expert interpretations.

E. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

• MRMC Study: No, an MRMC study was not done. This device is a knee prosthesis, not an AI or diagnostic tool that relies on human interpretation of cases. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.

F. If a Standalone (algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical medical device (knee implant), not an algorithm or AI system.

G. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the performance claims for this device is based on engineering standards, ASTM specifications, and mechanical testing results. For example, ASTM F1800-12 defines criteria for tray fatigue, and success is determined by meeting those predefined engineering benchmarks.

H. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes the testing of a physical medical device, not the training of an AI algorithm.

I. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for an AI algorithm.

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The PS2 KNEE SYSTEM is designed as a system and is not intended for substitution of components from other systems.

The indications for use are:

• 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 PS2 KNEE SYSTEM is intended for cemented use.

The PS2 Knee System is a primary fixed bearing total knee system offering flexibility to restore knee function using either cruciate retaining (CR) or posterior stabilizing (PS) components with the option of tibial cancellous screw and tibial stem fixation. The uncoated femoral components (CR and PS) and uncoated tibial baseplates (pegged, pegless, and holed) are made from cast CoCr alloy (ASTM F75), and are intended for cemented use only. The tibial inserts (CR and PS) and all-poly patellar components (oval and round) are made from UHMWPE (ASTM F648) or VitalitE (ASTM F2695). The PS2 tibial baseplate employs a modular keel, which is compatible with the previously cleared Consensus Revision Knee System (CRKS) stem and taper plug made from Titanium alloy (ASTM F1472). The PS2 holed baseplate is compatible with the previously cleared Consensus Knee System (CKS) 6.5mm cancellous bone screw made from Titanium alloy (ASTM F136). The PS2 baseplate is supplied with four preassembled cement dams made from UHMWPE and supplied with a distal plug made from UHMWPE intended for assembly in the operating room when stems are not desired.

The provided document describes the PS2 Knee System, a medical device, and its substantial equivalence to legally marketed predicate devices, rather than detailing the acceptance criteria and the study proving it meets those criteria in the context of an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, or MRMC comparative effectiveness studies because this document is for a traditional medical device (knee prosthesis), not an AI/ML device.

The document discusses:

• Indications for Use: What the device is intended for.
• Substantial Equivalence: How the device is similar to previously cleared devices.
• Non-Clinical Performance Data: Bench testing performed on the device's components to ensure safety and effectiveness, following various ASTM standards and FDA guidance for traditional medical devices. This includes topics like fatigue testing, joint stability, contact characteristics, locking mechanisms, and wear testing.

This information is typical for a 510(k) submission for a non-AI/ML device where the primary pathway to market is demonstrating substantial equivalence to a predicate device based on material properties, design, and mechanical performance.

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The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

The indications for use are:

• 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.

The Consensus Knee System (CKS) modular tibial baseplate is a non-porous (uncoated), anatomic, fixed-bearing design made from cast CoCrMo (ASTM F75). Its boss-and-fin type keel employs a modular 12/14 female taper for assembly with Consensus Revision Knee System (RKS) stems or the RKS taper plug. The CKS modular baseplate is offered in pegged, pegless, and holed configurations. Holed configurations are supplied with preassembled cement dams manufactured from UHMWPE (ASTM F648). All configurations are supplied with a distal plug intended for assembly in the operating room when stems are not desired. Distal plugs are manufactured from UHMWPE (ASTM F648). Other components compatible with the CKS modular baseplate include all CKS tibial inserts, femoral components, and patella components; all RKS femoral components; and the 6.5mm cancellous bone screw used with CKS holed baseplates.

This document is a 510(k) premarket notification for the "Consensus Knee System Modular Tibial Baseplate." It demonstrates the device's substantial equivalence to previously marketed devices rather than providing a study demonstrating the device meets a set of acceptance criteria in the typical sense of a clinical trial for an AI/CAD product.

Therefore, the requested information elements related to AI/CAD system performance (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this regulatory submission.

However, I can extract the closest analogous information regarding the evaluation of this medical device.

1. A table of Acceptance Criteria and the Reported Device Performance:

The document describes non-clinical performance data (bench testing) to verify the device's safety and effectiveness. The "acceptance criteria" are implied by the standards used for testing (ASTM F1800-12) and the stated objective to ensure no failure or involuntary dislocation.

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

• Sample Size: Not specified in terms of clinical cases or patient data, as this is bench testing. For bench testing, "sample size" would refer to the number of device components tested, which is not detailed in this summary.
• Data Provenance: Non-clinical bench testing. The country of origin of testing is not specified, but the device is manufactured by a US-based company (Consensus Orthopedics, Inc., El Dorado Hills, California).
• Retrospective/Prospective: Not applicable. This is non-clinical bench testing.

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):

Not applicable. Ground truth in this context refers to the physical properties and performance of the device component itself, evaluated through engineering tests, not interpretation by medical experts.

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

Not applicable. This refers to the adjudication of clinical outcomes or diagnostic interpretations, not bench testing results.

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. This is a conventional medical device, not an AI/CAD system.

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

Not applicable. This is a conventional medical device, not an AI/CAD system.

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

The "ground truth" for this device's evaluation is derived from engineering specifications and the established performance standards of ASTM F1800-12 for fatigue testing, as well as functional testing for the distal plug's retention and operability.

8. The sample size for the training set:

Not applicable. This is a conventional medical device, not an AI/CAD system.

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

Not applicable. This is a conventional medical device, not an AI/CAD system.

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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

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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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

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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The VitalitE Acetabular Insert for the Consensus CS2™ Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, CS2 Hip System, or UNISYN™ Hip System for the following indications:
A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C) Proximal femoral fractures.
D) Avascular necrosis of the femoral head.
E) Non-union of proximal femoral neck fractures.
F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities
Acetabular components are indicated for cemented and cementless use.
Consensus femoral stems are indicated for cemented and cementless use.
UniSyn, TaperSet, and CS2 femoral stems are indicated for cementless use only.
HA coated implants are indicated for cementless use only.

The Consensus CS2™ Acetabular Cup System consists of a titanium alloy shell (ASTM F620 or F136) and a polyethylene liner (ASTM F648). The system is compatible with the femoral components of all cleared hip systems manufactured by Consensus Orthopedics, Inc.: Consensus Hip System (CHS), TaperSet Hip System (THS), CS2 Hip System (CS2HS), and UniSyn Hip System (UniSyn). The CS2 Acetabular Cup System can be used with the CoCr, zirconia, or Biolox delta femoral heads currently marketed by Consensus and with 22mm, 32mm, and 36mm inner diameters. The liners are available in either neutral or hooded versions and with either standard or lateral offsets. The shell is designed for uncemented press-fit or cemented use to the prepared acetabulum, and is designed to mate with the insert via secure insert/shell locking mechanism. The shell comes with or without holes for additional screw fixation. The new acetabular liners will be made from UHMPWE that contains vitamin E (a-tocopherol).

The provided text describes the 510(k) premarket notification for the VitalitE Acetabular Insert for the CS2™ Acetabular Cup System. The submission primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the VitalitE Acetabular Insert to be evaluated against in a clinical study. Instead, the submission relies on the concept of "substantial equivalence" to predicate devices. The performance data is primarily "Non-Clinical Performance Data."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a clinical study with a "test set" of patient data. The "testing" mentioned is entirely non-clinical (bench testing, material characterization, and biocompatibility). Therefore, there is no sample size for a test set or data provenance (country of origin, retrospective/prospective) related to patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Since no clinical study involving patient data was conducted to establish ground truth, no experts were used for this purpose.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not a diagnostic device requiring interpretation by human readers. It is a medical implant, and the submission focuses on its physical and material properties.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not a software algorithm device. It is a physical medical device (an acetabular insert).

7. Type of Ground Truth Used:

Ground truth in the typical sense of clinical outcomes or expert consensus for patient data is not used in this submission. The "ground truth" here is established through:

• Material properties: Chemical composition and physical characteristics of the UHMWPE.
• Design specifications: Geometric and structural adherence to established designs.
• Bench test results: Mechanical performance (wear, push-out, torque-out) measured against engineering standards or comparison to predicate device performance under similar test conditions.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set was used.

Summary of the Study:

The "study" described in K130652 is a non-clinical substantial equivalence submission. It relies on:

• Comparison of material properties: The vitamin E polyethylene is stated to be "identical" to material in already cleared devices.
• Comparison of design: The new insert's design is "identical" to previously cleared inserts.
• Bench testing: Wear testing of the "worst-case acetabular insert" and disassembly testing (push-out, torque-out) were performed. The results are not detailed but are stated to "indicate that the VitalitE Acetabular Insert is substantially equivalent to devices currently marketed."
• Biocompatibility testing: Mentioned as part of the non-clinical data.

The "study" concludes that based on these non-clinical evaluations, the device is "as safe, as effective, and performs at least as safely and effectively as legally marketed predicates." This approach is typical for 510(k) clearances when a new device is fundamentally similar to existing, legally marketed devices.

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The CS2TM Hip System is 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.
• B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• C. Proximal femoral fractures.
• D. Avascular necrosis of the femoral head.
• E. Non-union of proximal femoral neck fractures.
• F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural. abnormalities

This CS2TM hip stem is indicated for cementless use.

Indications for Use of the CONSENSUS® BIPOLAR or UNIPOLAR:

• A. Primary replacement of the femoral head and neck with very little if any acetabular degradation noted.
• B. Rheumatoid, osteo, and post traumatic arthritis.
• C. Proximal femoral fractures.
• D. Avascular necrosis of the femoral head.
• E. Non-unions of proximal femoral neck fractures.
• F. Revision of failed total hip arthroplasty.
• G. Treatment of malunion or nonunion acetabular fractures.

The CONSENSUS® BIPOLAR or UNIPOLAR are intended for cementless use.

The Consensus CS2TM Hip System (CS2HS) is a monolithic; titanium alloy fit & fill hip stem design with a proximal, plasma sprayed, porous CPTi coating. The stem has a cylindrical geometry with a bullet tip and is available in sizes designated as 10 mm to 22 mm. The stems feature a neck shaft angle of 128° and a 12/14. Morse taper trumilon. The stems are available with, or without a collar. The CS2 Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is. compatible with previously cleared CoCr heads, zirconia heads, Biolox delta heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.

This 510(k) summary describes a submission for a new hip stem design, the CS2™ Hip System, and primarily focuses on demonstrating its substantial equivalence to previously cleared devices through non-clinical performance data. As such, it does not detail acceptance criteria and a study proving those criteria are met in the same way a clinical trial or a performance study for an AI/ML device would.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like hip stems, "acceptance criteria" are typically related to mechanical properties, material integrity, and biological compatibility, which are demonstrated through bench testing and characterization, not performance metrics like accuracy or AUC. The "reported device performance" refers to the results of these non-clinical tests.

• Distal fatigue testing
• Proximal fatigue testing of the worst-case stem.
  These tests were conducted "consistent with the 'Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses'." (The specific quantitative results or pass/fail thresholds are not detailed in this summary.) |
  | Porous Coating Characteristics (e.g., porosity) | CPT plasma sprayed coating characterization "meets the definition of porosity per 21 CFR 888.3358." (Specific quantitative porosity values are not detailed.) |
  | Material Characterization | Based on "material, characterization data, geometry and mechanical testing" (Specific characterization data is not detailed.) |
  | Substantial Equivalence to Predicate Devices | "All of the observed results indicate that the CS2 Hip System is substantially equivalent to devices currently marketed. Therefore, the device is as effective, and performs at least as safely and effectively as legally marketed predicates." |

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary, as it describes non-clinical bench testing. The "test set" would be the physical samples of the hip stem components subjected to mechanical and material characterization tests. The number of samples for each specific test (e.g., how many stems for fatigue testing) is not specified.
• Data Provenance: The data comes from "Non-clinical Performance Data" and "bench testing." This implies internal laboratory testing conducted by Consensus Orthopedics, Inc. (the sponsor). There is no mention of country of origin of the data as it's not patient data, nor is it retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This is not applicable for this type of submission. Ground truth, in the sense of expert consensus on diagnostic images or clinical outcomes, is not relevant to non-clinical bench testing of a hip implant's mechanical properties. The "ground truth" here is established by engineering standards and regulatory requirements for medical device performance.

4. Adjudication Method for the Test Set

• Not applicable as there is no "adjudication" of expert opinions for a test set. Non-clinical tests follow established protocols, and results are measured objectively against predefined engineering specifications or regulatory guidance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve interpretation by human readers (e.g., radiologists, pathologists) and often for AI/ML-assisted diagnostic tools. This 510(k) pertains to a hip implant's physical and mechanical properties.

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

• No, a standalone performance study as described is not applicable. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" is based on:
  • Engineering Standards and Specifications: The mechanical tests (fatigue testing) were conducted "consistent with the 'Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses'." This guidance provides the framework and methodologies for evaluating the safety and effectiveness of such devices.
  • Regulatory Definitions: The coating characterization "meets the definition of porosity per 21 CFR 888.3358."
  • Essentially, the "ground truth" is adherence to established industry-specific test methods and regulatory requirements for proving the safety and effectiveness of a hip prosthesis.

8. The Sample Size for the Training Set

• Not applicable. There is no training set for a physical hip implant. Training sets are typically associated with machine learning algorithms.

9. How the Ground Truth for the Training Set was Established

• Not applicable for the reason stated above.

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Significantly impaired joints resulting from rheumatoid, 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 UniSyn Hip System was originally cleared as a modular hip system for Hayes Medical under the name "Triton", modifications to the system were cleared in a subsequent submission by Hayes under the UniSyn name. Hayes Medical changed its name to Consensus Orthopedics in 2008. This system consists of three primary components: the neck, the body, and the stem. This submission is to addition of a set of modified ("Plus") stems.
These minor modifications in body thickness are designed to allow for better contact between the implant and the inner surface of the medullary canal during revision surgery. The sizes of stems offered with the modified design are within the ranges previously cleared for the UniSyn system. The Plus stems are offered in neutral or +1 mm styles, short or long, in 10 to 20 mm diameters, and lengths from 110 to 210 mm. There is no change to the manufacturing, packaging, or sterilization processes. This change will not affect the indications for use nor any of the labeling.

The provided text describes a 510(k) premarket notification for the UNISYN Plus stem, which is part of the UNISYN Hip System. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing new safety and effectiveness through a comprehensive study with acceptance criteria and performance metrics in the way a novel device might.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

For this type of 510(k) submission, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating that the modified device (UNISYN Plus stem) maintains the same fundamental characteristics and performance as its predicate devices. The document does not present a table with specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity) and corresponding performance results. Instead, it relies on the concept of substantial equivalence.

The key "criteria" for this submission are that the new "Plus" stems for the UniSyn hip systems employ the:

• Same materials
• Basic design features
• Manufacturing processes
• Packaging
• Indications as the predicate stems for the UHS.

The "reported device performance" is implicitly that these criteria are met, leading to the conclusion of substantial equivalence.

Specific Performance Data Mentioned:

• Distal fatigue performance: "Distal fatigue performance of the UniSyn Plus grit blasted stem was evaluated per ISO 7206-4 on a worst case example."
  • Acceptance Criteria (Implied): The fatigue performance must be equivalent to, or better than, the predicate device and meet the standards set by ISO 7206-4.
  • Reported Performance: Not explicitly stated with a numerical result, but the conclusion is that "No other nonclinical bench testing was deemed necessary over that used in support of the predicates based on identical design and materials," implying satisfactory performance.

2. Sample Size for Test Set and Data Provenance:

• Sample Size for Test Set: The document explicitly states "a worst case example" was evaluated for distal fatigue performance. This means the sample size for this specific test was very small, likely N=1 or a limited number of test articles representing the worst-case scenario. It is a bench test, not a clinical test involving human subjects.
• Data Provenance: The data comes from non-clinical bench testing conducted by the manufacturer (Consensus Orthopedics, Inc.). It is not from human subjects, so concepts like "country of origin" or "retrospective/prospective" do not apply.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:

Not applicable. The "ground truth" for a device like a hip stem is typically established through engineering specifications, material science standards, and established biomechanical performance criteria (e.g., ISO standards). There are no "experts" in the sense of clinicians establishing a diagnostic ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. This is a non-clinical bench test, not a clinical study involving human assessment or adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is typically done for diagnostic imaging devices or AI-assisted diagnostic tools. The UNISYN Plus stem is a physical orthopedic implant, making an MRMC study irrelevant. There is no human reader improvement with AI assistance discussed as there is no AI component.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. There is no algorithm or AI component in the UNISYN Plus stem. Performance assessment is based on physical material and design testing.

7. Type of Ground Truth Used:

The ground truth used for evaluating the UNISYN Plus stem's performance relies on engineering specifications, material properties, and adherence to recognized international standards such as ISO 7206-4 for fatigue testing. It is not expert consensus, pathology, or outcomes data in the clinical sense, but rather a demonstration of compliance with established biomechanical and material science criteria.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its development and testing are based on traditional engineering design and physical performance verification.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set. The "ground truth" for the overall design and performance of the hip system is established through a combination of biomechanical design principles, material science knowledge, and adherence to relevant ISO standards, accumulated over years of orthopedic implant development.

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The TaperSet™ Hip System is 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.
• B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• C. Proximal femoral fractures.
• D. Avascular necrosis of the femoral head.
• E. Non-union of proximal femoral neck fractures.
• F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
  The TaperSet™ hip stem is indicated for cementless use.

The TaperSet Hip System (THS) is a monolithic, titanium alloy tapered hip stem design with a proximal, plasma sprayed, porous CP Ti coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes currently designated as 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. The TaperSet Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is compatible with previously cleared CoCr heads, zirconia or Biolox delta ceramic heads, unipolar heads, bipolar heads. UHMWPE inserts and acetabular cups. The modification addressed here is the addition of two stems in sizes 5mm and 6mm.
The new stems are manufactured from forged titanium alloy (Ti-6AI-4V ELI, ASTM F620) and the proximal portion of the femoral stem component is plasma sprayed with commercially pure titanium (C. P. Ti. ASTM F1580). The new femoral stems are available in both standard and 7mm lateralized options and have the identical neck and taper design, and porous coating as the predicate TaperSet stems cleared under K102399 in design and indications.

The provided FDA 510(k) summary (K121935) describes the TaperSet Hip System Small Stems, which are orthopedic implants, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and study design are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the non-clinical study that demonstrates the device's performance based on mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document refers to testing of a "worst-case example," specifically "the 5mm lateral femoral stem." This implies that at least one of these stems was tested. The document also states "The stems were to achieve...", suggesting that multiple stems may have been tested to confirm consistency, but the exact number isn't specified beyond "the 5mm lateral femoral stem was determined to be the worst-case example per analysis report (R11-007)." The study is a non-clinical, laboratory-based mechanical test.
• Data Provenance: This is not applicable in the context of clinical data for a mechanical test. The testing was performed on newly manufactured devices to evaluate their mechanical properties.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This is not applicable as the study involves mechanical testing of an orthopedic implant, not the evaluation of a device by human experts or the establishment of a ground truth for diagnostic purposes. The "ground truth" here is the physical performance of the device under specific loading conditions, measured by engineering standards.

4. Adjudication Method for the Test Set

This is not applicable for a non-clinical mechanical test. The test results are determined by instrumentation and adherence to engineering standards, not through human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is not an AI/ML device or a device that requires human interpretation of outputs.

6. If a Standalone Performance (i.e. algorithm only without human-in-the-loop performance) was Done

No. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this study is defined by established biomechanical and engineering standards for hip prostheses:

• ASTM F2068-2009 (Standard Specification for Femoral Prostheses – Mechanical Performance)
• ISO 7206-4:2010(E) (Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components)

The acceptance criteria (5 million cycles at 517 lbs/2300 N without failure) are directly derived from these standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device.

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