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General Indications:
The MobileLink Acetabular Cup System is indicated for mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• Primary and secondary osteoarthritis
• Rheumatoid arthritis
• Correction of functional deformities
• Avascular necrosis
• Femoral neck fractures
• Revision after implant loosening dependent on bone mass and quality

Dual Mobility Insert (in addition to the indications and general indications):

• Dislocation risk

The MobileLink Acetabular Shells are intended for cementless fixation.

The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

Additional indications specific to the TrabecuLink Augments:

• Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system.

MobileLink PlasmaLink and TiCaP Shells: The MobileLink System consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either titanium plasma sprayed (TPS) coating (brand name: PlasmaLink) or a double coating consisting of titanium plasma spray coating plus calcium phosphate (CaP) coating (brand name: TiCaP). The MobileLink PlasmaLink and TiCaP Shells are compatible with polyethylene liners (K182321, K241636), acetabular bone screws (K192559), Dual Mobility Inserts (K200607) with BiMobile Dual Mobility Liners (K171273, K190535), Shell/Insert Adapters ("Face Changers", K200607), and TrabecuLink Augments (K241636).

This FDA 510(k) clearance letter is for a medical device called the "MobileLink Acetabular Cup System - inhouse coatings." It does not involve AI software and therefore does not have the acceptance criteria and study information typically associated with AI/ML-based devices.

The submission is specifically for a change in the coating supplier for an existing device from an external vendor to an in-house process. This means the core design and function of the acetabular cup system are already established and cleared.

Therefore, the requested information elements (acceptance criteria table, sample size for test set, experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, how training ground truth was established) are not applicable to this specific 510(k) submission.

Here's why and what information is provided:

• Device Type: This is a physical orthopedic implant (hip replacement component), not an AI/ML software device.
• Reason for Submission: The primary reason for this 510(k) is to notify the FDA of a change in the manufacturing process (in-house coating application instead of external). This is a manufacturing/materials change, not a new device with new performance claims requiring extensive clinical or AI performance studies.
• Performance Testing: The document states:
  • "Non-clinical performance testing and analysis were provided, including: Characterization of the TPS and TiCaP inhouse coatings."
  • "Biocompatibility evaluation."
  • "The results of non-clinical performance testing demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent."
  • "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

This means the acceptance criteria and supporting studies were focused on material characterization and biocompatibility to ensure the new in-house coating process yields a product that is equivalent to the predicate device in terms of safety and performance (e.g., adhesion, wear resistance, biological response), rather than diagnostic accuracy or human-AI interaction.

In summary, there is no information in this document to answer the questions about acceptance criteria related to AI/ML performance studies, as this is not an AI/ML device submission.

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The MobileLink Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• 1. Primary and secondary osteoarthritis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformities
• 4. Avascular necrosis
• 5. Femoral neck fractures
• 6. Revision after implant loosening dependent on bone mass and quality

The MobileLink Dual Mobility Insert is additionally indicated for:
7) Dislocation risks

Additional indications specific to the TrabecuLink Augments:
Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Shells are intended for cementless fixation. The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. This 510k adds several system components to the MobileLink Acetabular Cup System previously cleared in K182321, K192559, K200607, and K222066.

X-LINKed Inserts: The X-LINKed Inserts are manufactured from highly crosslinked polyethylene material. The inserts are available in the same sizes and designs as the previously cleared E-Dur inserts (K182321). The design variants include a neutral variant with or without offset, a shouldered variant with or without offset and 10° and 20° inclining variants with an offset. The inserts are fixed using a clamping system consisting of a combination of snap mechanism and conical clamping. Notches (tabs/recesses) at the rim further contribute to the rotational stability of the PE inserts.

TrabecuLink Augments: The TrabecuLink Metal Acetabular Augments are wedgeshaped components that conform to the shape of the acetabular shell. They are additively manufactured Ti6A14V alloy per ISO 5832-3 (chemistry and mechanical properties) and feature a porous structure (TrabecuLink) on the bone interfacing surface. They mate with the same MobileLink (TrabecuLink) Shells as previously cleared in K182321 and K222066 and they can be used with the same 6.5mm diameter bone screws cleared in K192559, or with new smaller diameter (4.5mm) bone screws introduced in this submission.

Bone Screws: The MobileLink Bone Screws are Ø 4.5mm in lengths from 15 -60mm (by 5mm increments). They feature the same head size/design as the previously cleared Ø 6.5mm screws and are made of the same wrought Ti6A14V alloy per ISO 5832-3 and ASTM F136 as the previously cleared Ø 6.5mm screws.

This document is a 510(k) Premarket Notification from Waldemar Link GmbH & Co. KG for their MobileLink Acetabular Cup System - Line Extension (Multiple). It's a submission to the FDA regarding new components for an existing hip replacement system.

The document does not describe a study involving acceptance criteria for a device's performance in a diagnostic or AI context. Instead, it is a regulatory filing for a medical device (hip replacement components). The "performance testing" section refers to non-clinical tests to ensure the mechanical and material integrity of the new components are comparable to existing, cleared devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as it is not relevant to the type of device or study described.

Here's an attempt to fill in the table and address the relevant points based on the provided text, while noting where information is not applicable or available:

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance:
See the table above. The acceptance criteria essentially boil down to demonstrating "substantial equivalence" to predicate devices through various non-clinical performance tests. The reported performance for each test is that "The results... demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent." Specific numerical thresholds for acceptance are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The tests are non-clinical, likely bench testing on prototypes or manufactured samples, not patient data.

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. This is a non-clinical device performance study, not a diagnostic study requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a non-clinical device performance study, not a diagnostic study requiring adjudication.

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 not an AI/Software device, nor is it a diagnostic device where MRMC studies would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/Software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical performance tests, the "ground truth" would be the established engineering standards, material specifications (e.g., ISO 5832-3, ASTM F136, ASTM F543), and the performance characteristics of the predicate devices. The new components are tested to meet these established benchmarks.

8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device.

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General Indications:
The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.
Indications:
Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically and structurally suited to receive the implants.
The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws.
The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation.
The Humeral Stems Standard without CaP (HX) are intended for cemented or cementless fixation.
The Humeral Fracture Stems and Proximal Bodies are intended for cemented or cementless fixation.
The Modular Stems 75mm are intended for cemented or cementless fixation.
The Modular Stems, fully corundum blasted, are intended for cementless fixation.
The Modular Stems, fully polished, are intended for cemented fixation.

This Line Extension portfolio includes:

• Smaller 25 mm Ø Reverse Glenoid Baseplates (RGBs) in neutral designs and in wedged (10°, 15° and 20°) and lateralized variants (+3mm and +6mm). The new 25mm Ø RGB components include new peripheral 4.5mm Ø cortical screws in lengths of 20-60mm with a reduced head diameter as compared with the predicate 4.5mm Ø cortical screws cleared in K200368. The screws are available in standard and angle-stable/locking versions.
• Glenospheres in sizes 36mm, 39mm and 42mm diameter with +3mm and +6mm lateralization.
• Humeral Reverse Tray in a neutral (concentric) version with extended +5mm height.

The provided document is a 510(k) summary for a medical device called the "LINK Embrace Shoulder System - Reverse Configuration." It is a premarket notification to the FDA for a new component (25mm diameter reverse glenoid baseplates, glenospheres, and a humeral reverse tray) to an existing shoulder replacement system.

Based on the information provided in the document, here's a breakdown of the requested points:

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

The document does not present quantitative acceptance criteria or specific numerical performance results in a table format for this specific device modification. The performance testing section states:

The tests performed were:

• Range of Motion analysis (ASTM F1378)
• Bone screw testing
• Wear testing rationale for no new worst case
• Glenoid fretting fatigue rationale for no new worst case
• Humeral fatigue test rationale for no new worst case
• Micromotion test (ASTM F2028)
• Biocompatibility Evaluation

It's important to note that this 510(k) is for an addition/modification to an already cleared device, and the evaluation relies heavily on demonstrating "substantial equivalence" to existing predicate devices through non-clinical testing and rationales, rather than establishing entirely new performance benchmarks.

2. Sample size used for the test set and the data provenance

The document explicitly states: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." Therefore, there was no clinical "test set" in the sense of human patient data. The "test set" consisted of components tested in laboratory/benchtop settings. The document does not specify the sample sizes (e.g., number of screws tested, number of components for micromotion) for each of the non-clinical tests.

Data Provenance: The testing was non-clinical (laboratory/benchtop). The manufacturer, Waldemar Link GmbH & Co. KG, is based in Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Since no clinical testing was performed, there was no human "ground truth" to establish for a clinical test set. The "truth" for the non-clinical tests is derived from engineering and materials science principles, and standards (e.g., ASTM).

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

Not applicable. No clinical test set requiring expert adjudication was used.

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 physical implantable medical device (shoulder replacement components), not an AI/software device that assists human readers.

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

Not applicable. This is a physical implantable medical device.

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

For the non-clinical testing, the "ground truth" is based on:

• Engineering design specifications
• Performance requirements outlined in relevant ASTM standards (e.g., ASTM F1378 for Range of Motion, ASTM F2028 for Micromotion)
• Material properties and biocompatibility standards.
• Comparisons to the performance characteristics of predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

Not applicable. As above, this device does not utilize a training set or machine learning.

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General indications: Mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. Indications: 1) Primary and secondary osteoarthritis 2) Rheumatoid arthritis 3) Correction of functional deformities 4) Avascular necrosis 5) Femoral neck fractures 6) Revision after implant loosening dependent on bone mass and quality The MobileLink Dual Mobility Insert is additionally indicated for: 7) Dislocation risks The MobileLink Acetabular Shells are intended for cementless fixation.

This 510k adds MobileLink TrabecuLink Acetabular Shells to the MobileLink Acetabular Cup System previously cleared in K182321, K192559, K200607. These shells are additively manufactured from Ti6Al4V alloy per ISO 5832-3 and feature a porous structure (TrabecuLink) on the bone interfacing surface for biologic fixation. The shells come in cluster-hole and in multi-hole patterns. mate with the same UHMWPE liners (in conventional PE and highly-crosslinked vitamin E PE) as previously cleared in K182321, and with the same Dual Mobility Inserts and Shell/Insert Adapters previously cleared in K200607. They can be used with the same bone screws cleared in K192559.

I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) premarket notification clearance letter from the FDA for a medical device (LINK MobileLink Acetabular Cup System). It discusses the device's substantial equivalence to predicate devices and lists non-clinical performance testing that was performed (e.g., acetabular deformation, fatigue testing, biocompatibility).

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, number or qualifications of experts, or adjudication methods for test sets.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Details about standalone algorithm performance.
• The type of ground truth used, training set sample size, or how ground truth for the training set was established.

The document explicitly states: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." This suggests that the clearance was based on non-clinical testing and comparison to predicate devices, rather than a clinical study with the detailed criteria you're asking for.

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General Indications:
The LinkSymphoKnee is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions.
This device is intended for cemented use only unless a cementless modular stem is indicated for use.

Indications:

• Primary degenerative arthritis / osteoarthritis
• Secondary arthritis resulting from rheumatoid arthritis
• Fracture

The LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is available in cPE and E-Dur. In cases of good joint stability, where the ligaments and capsule are intact the FB UC version is available. This configuration is provided for PCL retaining joint reconstruction or if the posterior cruciate ligament is sacrificed.

The Fixed Bearing Ultracongruent (FB UC) Articulating Surface is compatible with the already cleared LinkSymphoKnee (K202924). The LinkSymphoKnee is available in multiple versions with different applications, characteristics, and materials.

This document does not describe an AI/ML device but rather a knee joint prosthetic. Therefore, many of the requested fields and information are not relevant or present in the provided text.

Based on the information provided for the LinkSymphoKnee - Fixed Bearing Ultracongruent (FB UC) Articulating Surface:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not applicable/Provided. The performance testing described is for a medical device (knee implant), not an AI/ML system. The testing likely involved mechanical testing of device samples.
• Data provenance: Not explicitly stated, but the testing was non-clinical performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is not an AI/ML system requiring expert-established ground truth. Performance was evaluated through non-clinical mechanical testing standards.

4. Adjudication method for the test set:

• Not applicable. Performance was evaluated through non-clinical mechanical testing standards, not expert adjudication.

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 not an AI-assisted device.

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

• Not applicable. This is not an AI-driven algorithm.

7. The type of ground truth used:

• For mechanical performance testing, the "ground truth" would be established physical and engineering standards (e.g., ISO 14243-1, ISO 17853, ASTM F1877, ASTM F1223-20) and benchmark data from predicate devices.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML system, so there is no training set in the context of machine learning.

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

• Not applicable. There is no training set.

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The SP-CL Hip Stem and LCU Hip System are indicated for patients with mobility-limiting hip diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.

The hip systems are indicated for the following conditions:

• Primary and secondary coxarthrosis
• Osteoarthritis
• Necrosis of the femoral head
• Femoral neck fractures

The stems are indicated for cementless use only.

The submission includes a straight stem, LCU Hip Sytem, and an anatomically curved stem, SP-CL Hip Stem. Both stems are comprised of titanium alloy (Ti6A14V acc. to ISO 5832-3, ASTM F136) available with HX (CaP) (ASTM F1609) coating. The stems are available in a range of sizes, lengths, and offsets. In total hip replacement, the SP-CL Hip Stem and LCU Hip System are combined with a corresponding prosthesis head and the acetabular implant components manufactured by Waldemar Link. The change that is subject of this 510(k) is to add calcium phosphate coating (CaP) done by Waldemar Link inhouse to the above listed systems. The devices are already commercially available with CaP coating applied by an external vendor. There is no change to the fundamental scientific technology of the referenced hip systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufactured. All components are sterile and for single use only.

This document is a 510(k) Premarket Notification for a medical device (SP-CL Hip Stem and LCU Hip System) and is primarily focused on demonstrating substantial equivalence to a predicate device rather than undergoing a new, rigorous clinical performance study with predefined acceptance criteria for a novel AI/software device.

Therefore, the information requested in your prompt regarding acceptance criteria for device performance, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this type of FDA submission. This submission is for a physical orthopedic implant seeking to demonstrate that a change in manufacturing (applying a coating in-house instead of by an external vendor) does not alter its safety or efficacy compared to an already cleared device.

However, I can extract the relevant information that is available in the document:

1. A table of (implied) acceptance criteria and the reported device performance

Since this is a 510(k) for an orthopedic implant and not a novel AI device, the "acceptance criteria" are not about AI performance metrics (like sensitivity, specificity, AUC). Instead, the acceptance criteria are met by demonstrating that the modifications (in-house CaP coating) do not negatively impact the physical and chemical properties of the hip stems compared to the predicate device.

The study that "proves the device meets the acceptance criteria" is the non-clinical performance testing conducted by the manufacturer. The conclusion is that "The results of non-clinical performance testing demonstrate that the device is suitable for its intended purpose and substantially equivalent to the predicates."

The remaining points (2-9) are largely not applicable to this type of 510(k) submission for a physical implant with a manufacturing change.

• 2. Sample size used for the test set and the data provenance: Not applicable. Testing involved material samples of the implants, not a "test set" of patient data for an AI algorithm.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. The "truth" is established by adherence to ASTM standards for material testing.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. The "ground truth" for this device's performance is derived from its adherence to established material and mechanical testing standards (e.g., ASTM F1044-05 for shear testing, ASTM F1609-08 for elemental analysis).
• 8. The sample size for the training set: Not applicable. This is not an AI device.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

In summary, this 510(k) submission relies on non-clinical engineering and material science testing to demonstrate substantial equivalence, rather than clinical studies or evaluations of AI performance.

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Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Femoral neck fractures.

Correction of functional deformities.

The Vario-Cup System consists of an UHMWPE component encased in an ultra-smooth polished EndoDur (CoCrMo) outer metal casing, for articulation in the bony acetabulum. It is to be used in conjunction with femoral components of the LINK Total Hip Systems. The 22 mm inner diameter Vario-Cup Prostheses are available in outer diameters ranging from 39-43 mm in 1 mm increments. Vario-Cups are self-centering which provides for a functional view of their position in post-op X-rays. An anti-luxation feature resists dislocation: an UHMWPE Safety Ring is placed in a groove at the entrance of the polyethylene insert after assembly of Vario-Cup and femoral components.

This FDA submission focuses on a medical device, the Vario-Cup System, and does not involve AI/ML performance evaluation. Therefore, the requested information about acceptance criteria for AI models, study design for AI models, and related AI-specific details cannot be extracted from the provided text.

The document primarily addresses the substantial equivalence of the Vario-Cup System to predicate devices based on non-clinical performance data, material characterization, and design similarities. It explicitly states that no clinical performance testing was required for this device.

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The BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects of hip joint or proximal femur, which cannot be treated by conservative or osteosynthetic procedures.

The BiMobile Dual Mobility System is indicated for the following conditions:

• · Primary and secondary coxarthrosis
• Rheumatoid arthritis
• · Correction of functional deformities
• · Avascular Necrosis
• · Femoral neck fractures
• · Revision after implant loosening dependent on bone mass and quality
• · Dislocation risks

The device is intended for cemented and cementless use.

The BiMobile instruments are considered a line extension to the instrument system cleared in 510(k) K171273 and K190535 with the BiMobile Dual Mobility System. Like the original instruments, the additional BiMobile instruments are manual orthopedic surgical reusable instruments offered to aid the implantation of the BiMobile Dual Mobility System (K171273 and K190535). The BiMobile Instruments incorporate design changes for simplicity of use. The modifications do not significantly alter the surgical workflow or technique, the intended use, or involve any change in technology.

The provided text is a 510(k) summary for the BiMobile Instruments (for use with Dual Mobility System), an accessory to hip joint prostheses. This document describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

This document does not describe a study involving an AI/Machine Learning device or an algorithm-only standalone performance study.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or training set details, as these are not relevant to the content of the provided 510(k) summary.

The document discusses the substantial equivalence of modified accessory instruments to predicate instruments based on non-clinical testing and evaluations. These evaluations are focused on ensuring the modified instruments function as intended and are safe, not on the performance of a diagnostic or predictive algorithm.

The listed "non-clinical testing and evaluations" are:

• Simulated transport testing
• Biocompatibility assessment
• Interface analysis, functional testing, biolab evaluation, application risk analysis
• Durability testing
• Validation of reprocessing and sterilization instructions

These tests are standard for mechanical medical devices and accessories to ensure their physical integrity, material safety, and functional reliability. They do not involve "device performance" in the sense of accuracy, sensitivity, or specificity as would be relevant for an AI/ML diagnostic.

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General Indications LINK Endo-Model EVO Knee System: The LINK Endo-Model EVO Knee System is intended for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or os- teosynthetic procedures. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: All LINK Endo-Model EVO components: - · Primary and secondary osteoarthritis. - Rheumatoid arthritis. - · Revision after primary or revision total knee replacement. - · Bone necroses which won't compromise the successful implantation of a hinged total knee endoprosthesis. - · Varus and valgus deformity with contracture or laxity of the medial or lateral stabilizers. The LINK Endo-Model EVO Pure Hinge is additionally indicated for: · Extreme cases of varus/valgus deformities (20-30°), theumatoid arthritis, muscular deficiency and any kind of genu laxum. · Oncological and revision surgery in lower limb (in conjunction with the Endo- Model EVO -W and the Megasystem-C) The LINK Endo-Model EVO Rotating Hinge is additionally indicated for: · Oncological and revision surgery in lower limb (in conjunction with the Endo- Model EVO - W and the Megasystem-C) General Indications Link OptiStems: The Link OptiStems are for use with the following LINK knee femoral components, both intracondylar and distal femoral replacement versions: LINK Endo-Model SL. LINK Endo-Model EVO-M. and LINK Endo-Model EVO-W and are indicated for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures. The Link OptiStems cemented are intended for cemented use only. The Link OptiStems cementless are intended for cementless use only. Indications: · Revision arthroplasty due to juxta-articular bone defects. - · Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture. - · Bone deficiencies, e.g. due to tumors, as well as in large post-revision and posttrauma segmental bone defects. · Oncological and revision surgery in the area of the distal femur (in conjunction with Endo-Model SL Rotational and Hinge Knee Prostheses or LINK Endo-Model EVO - M/ - W).

The LINK Endo-Model EVO Knee System is available in multiple versions with different applications, characteristics, and materials. The LINK Endo-Model EVO is a constrained total knee prosthesis, which is based on the previously cleared LINK Endo-Model Knee System (K143179, K152431, K212742), and is considered an evolution ('EVO') of the previous designs. The Knee System is available in two different hinge designs - Rotating Hinge and Non- rotating (Pure) Hinge. Also like the previously cleared system, the subject LINK Endo- Model EVO is available in two versions - LINK Endo-Model EVO Standard and LINK Endo-Model EVO - Modular. The femoral and tibial components of the standard version have fixed stems while the femoral and tibial components of the modular system are available with stems having a taper connection. The modular system includes femoral components with either a male taper or a female taper, and are designated as LINK Endo-Model EVO-M (male taper) and Endo-Model EVO-W ("weiblich" = female taper). The LINK Endo-Model EVO - Standard consists of a cemented monoblock femoral component made from CoCrMo and cPE and a cemented monoblock tibial component made from CoCrMo and an articulating surface made from cPE. The Standard System is available in Rotating Hinge or Pure Hinge. The LINK Endo-Model EVO – M consists of a cemented modular femoral component made from CoCrMo, Ti6A14V (Tilastan) and cPE and a cemented modular tibial component made from CoCrMo, Ti6Al4V (Tilastan) and an articulating surface made from cPE and with modular stems, cemented made from CoCrMo or cementless made from Ti6Al4V (Tilastan). The Modular System is available in Rotating Hinge or Pure Hinge. The LINK Endo-Model EVO – W intracondylar and condylar replacements consists of a cemented modular femoral component made from CoCrMo, Ti6Al4V (Tilastan) and cPE and a cemented modular tibial component made from CoCrMo, Ti6Al4V (Tilastan) and an articulating surface made from cPE and with modular stems, cemented made from CoCrMo or cementless made from Ti6Al4V (Tilastan). The Modular System is available in Rotating Hinge or Pure Hinge. The femoral components can be used with distal and femoral (straight and L-shaped) segments made from Ti6A14V (Tilastan). The modular tibial components can be used with tibial spacers made from Ti6Al4V (Tilastan). The femoral and tibial components Rotating Hinge versions are also available in LINK PorEx (TiNbN) coated version. Additionally a 3-peg patella can be used with the LINK Endo-Model EVO Knee System. It is made from cPE. The LINK Endo-Model EVO Knee System femoral and tibial components are compatible with the previously cleared LINK Endo-Model Knee System (K143179, K152431 and K212742). The femoral components of the LINK Endo-Model EVO – W are compatible with the previously cleared LINK MEGASYSTEM-C (K151008). The LINK Endo-Model EVO Knee System is compatible with previously cleared Tibial and Femoral Cones of Waldemar Link GmbH & Co. KG (K200113 and K201364). The Link OptiStems are an expansion of the modular stem portfolio. The Link OptiStems consist of a modular stem, adapter and fixation screw. The Link OptiStems come in cemented and cementless version. The Link OptiStems have to be joined and implanted in combination with the Femoral Components of LINK Endo-Model SL (K151008) or LINK Endo-Model EVO – M / -W.

The provided text is a 510(k) summary for the LINK Endo-Model EVO Knee System. It details the device description, indications for use, and a comparison to predicate devices, along with performance testing.

However, this document does not describe the acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML-enabled medical device.

The document states:

• "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." This explicitly indicates that a clinical study, which would typically involve human subjects and the type of performance evaluation (e.g., accuracy, sensitivity, specificity) relevant to AI/ML devices, was not performed.
• The "Performance Testing" section lists non-clinical tests such as "Range of Motion analysis," "Wear analysis," "Particle analysis," "Tibial baseplate component fatigue testing," "Contact area/stress analysis," and "Fretting / Corrosion." These are mechanical and material performance tests typically done for orthopedic implants, not software or AI algorithm performance.

Therefore, I cannot provide the requested information based on the given text. The details about acceptance criteria, test set size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set, and ground truth establishment are not present in this regulatory submission for a knee implant.

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The MP Reconstruction System is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The MP Reconstruction System is indicated for the following conditions:

1. Revision arthroplasty due to juxta-articular bone defects.

2. Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone.

3. Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture.

4. Deformed proximal femur due to fractures or osteotomies.

5. Correction of bone deficiencies, e.g. due to tumors.

6. Large post-revision and post-trauma segmental bone defects.

The MP Reconstruction System is for cementless use. Only cemented labeled modular stems are indicated for cemented use.

This 510k adds Cemented Stems to the MP Reconstruction System. The MP Reconstruction System is a modular hip prosthesis system and consists of Prosthesis Heads, Stems, Neck Segments, Proximal Spacers, and Expansion Bolts. The modular components are interchangeable allowing for independent positioning. The Prosthesis Stems are available in a variety of diameters and lengths. Neck Segments are available in a variety of CCD angles and sizes. Proximal Spacers are available in two different heights and can be used independently or combined to add leg length. Expansion Bolts are used to secure the Neck Segments and Proximal Spacers, when used, to the Prosthesis Stems.

The cementless prosthesis stems are tapered with a microporous surface, and include longitudinal fluting. The cemented prosthesis stems have a rounded triangular shape with an anatomic bow at the distal tip.

The MP Reconstruction Prosthesis Stems (cementless) and Neck Segments are produced of Titanium Aluminum Vanadium alloy (Ti-6Al-4V). Cemented Stems, Proximal Spacers and Expansion Bolts are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials.

This document pertains to the 510(k) premarket notification for the MP Reconstruction System, specifically focusing on the addition of cemented stems.

Here's an analysis of the provided information regarding acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document primarily describes non-clinical performance testing (mechanical testing). Therefore, the concept of a "test set" in the context of clinical data or patient samples is not applicable here.

• Sample Size: Not applicable. The testing refers to physical specimens of the femoral stems. The number of specimens tested for femoral stem fatigue (ISO 7206-4) is not explicitly stated but would be defined by the ISO standard for such tests.
• Data Provenance: Not applicable in the context of patient data. The testing involves laboratory-controlled mechanical tests of device components.

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

Not applicable. For non-clinical mechanical testing, "ground truth" is established by the specifications of engineering standards (e.g., ISO 7206-4) and the physical properties of the materials and design. The evaluation is performed by engineers and technicians against these established standards.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based evaluations involving human interpretation. This submission relies on objective mechanical test results.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "There was no clinical performance testing required for this device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a medical device (hip prosthesis), not an AI algorithm or software device.

7. The Type of Ground Truth Used:

The "ground truth" for this medical device's performance is established through compliance with recognized international standards (e.g., ISO 7206-4) for mechanical properties, and comparison to the characteristics and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the conventional sense.

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

Not applicable for the same reason as above.

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