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This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis,collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device system is designed for cement use only.

The Prolixus™ Cruciate Retaining (CR) Total Knee System consists of three primary components: Cruciate Retaining (CR) Femoral Component, Cruciate Retaining (CR) Tibial Insert, Patellar component and Tibial base plate.

The Prolixus™ CR components are described below:

PROLIXUSTMTotal Knee Cruciate Retaining (CR) Femoral Component

Prolixus™ Total Knee Cruciate Retaining (CR) Femoral Component is fabricated from cast cobalt-chromium-molybdenum alloy, and is intended for cemented application to replace the articulating surface of the distal femur. This cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.

The Cruciate Retaining (CR) Femoral Component is available in right and left configurations, and six proportional sizes (sizes A to F) to accommodate differences in patient anatomy. The interior surface of the component is grit-blasted to increase surface roughness - this is intended to promote interdigitation of the polymethylmethacrylate (PMMA) bone cement with the surface texture and the apposing bone. This femoral component features cast-in pegs to help in femoral component placement, and to provide rotational stability.

PROLIXUS™ Cruciate Retaining (CR) Tibial Insert

The Cruciate Retaining (CR) Tibial Insert is neutral in configuration, and is available in six proportional sizes (sizes 1 to 6) and varying thicknesses (10mm, 12mm,14mm, 16mm, 18mm and 20 mm). The insert is fabricated from ultra high molecular weight polyethylene(medical grade PUR 1020 UHMPE) .The tibial insert is designed to accommodate the posterior cruciate ligament if it is present. There is a relief on the anterior aspect of the tibial insert to accommodate the patellar tendon and patellar fat pad.

PROLIXUS™ Tibial base plate

Stem tibial baseplate components (tibial baseplate) are made from Ti-The angled 6Al-4V titanium alloy. Tibial baseplates are available in 6 sizes (1 to 6).

PROLIXUS™ | Patellar components

patellar component is made from ultra high molecular weight The polyethylene(medical grade PUR 1020 UHMPE). The patella is available in five diameters, 26mm, 29mm, 32mm, 35mm and 38mm, which permit optimal bone coverage and surgical options.

The provided text describes a 510(k) premarket notification for the "PROLIXUS™ TOTAL KNEE SYSTEM". This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through bench testing comparing the new device's mechanical properties, materials, and design to established standards and predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The "studies" described are primarily bench tests conducted on physical device components.

• Fatigue Test (Tibial base plate): 5 tibial trays.
• Knee Constraint Test: Specific number not explicitly stated for each measurement, but implied to be multiple units as "mean" and "StdDev" are reported.
• Knee Tibia and Inserter Component Interlock Strength:
  • Disassembly Test by Anterior/Posterior Loading: 6 specimens for assembly, 6 specimens for disassembly.
  • Disassembly Test by Medial/Lateral Loading: 2 specimens (one for medial-lateral, one for lateral-medial).
  • Disassembly Test by Pull-off Loading: Not explicitly stated, but statistical data suggests multiple specimens.
  • Assembly Test in anteriorposterior direction: 5 specimens.
  • Disassembly Test in anteriorposterior direction and lateral direction: 5 specimens.
• Knee Femoral and Tibial insert contact area/pressure distribution test: Not explicitly stated, but compared to an "EndoLab database (n=19 test series)."
• Knee Geometry and Surfaces:
  • Femoral component: 5 components.
  • Tibia base component: 5 tibial trays.
  • Tibia insert component: Not explicitly stated, but discussed for "each insert" and statistical data provided.
  • Patella component: 6 patella components.
• Bacterial Endotoxins Test (BET/LAL): Not explicitly stated, but validation testing was performed.

Data Provenance: The studies were conducted by "EndoLab Mechanical Engineering GmbH" (likely Germany) and "Greenpia Technology, South Korea" (South Korea). The data is retrospective in the sense that it's laboratory bench testing of the manufactured device components, not data collected from patients. There is no mention of patient data or country of origin for such data.

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

Not applicable. These are bench tests against engineering standards and internal databases, not clinical studies requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" for these tests is the specified ISO standard (e.g., ISO 21536, ISO 7207-2) or established engineering principles.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring adjudication of expert readings. Test results are quantitative measurements against defined criteria.

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

No. This document does not pertain to an AI or diagnostic imaging device. It describes a total knee replacement system, a physical medical device. MRMC studies are not relevant here.

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

No. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth used for these bench tests included:

• International Standards: e.g., ISO 21536 for fatigue strength and minimum thickness, ISO 7207-2 for surface roughness, ISO 7207-1 for geometric dimensions.
• Internal Databases/Predicate Device Data: For contact area/pressure distribution, the device performance was compared to an "EndoLab database (n=19 test series)" which contained data from predicate devices.
• Engineering Specifications: Implied acceptable ranges for mechanical loads, torques, and material properties.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical implant, not a machine learning model. There is no "training set." The design and manufacturing processes are likely informed by prior engineering knowledge and predicate device designs.

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

Not applicable, as there is no training set for a machine learning model. The "ground truth" for the design and testing of a knee implant is based on established biomechanical principles, material science, clinical needs, and performance of existing devices (predicates).

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The MultiFit Total Hip System is intended to be cemented stem or uncemented stem use. The MultiFit Total Hip System is to replace a defective hip joint in the following cases: 1) Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. 2) Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis 3) Patients suffering from disability due to previous fusion 4) Patients with acute femoral neck fractures.

The MultiFit™ Total Hip System is total hip joint prosthesis which consists of stems, acetabular system, bipolar system and femoral head. Stems are available with two femoral designs. One is manufactured from Ti6A14V alloy which intended for non-cemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. All implant devices are designed for single use only and provided with separated sterilized package. Various sizes are available for each component. Femoral stems - Cementless stem (sizes 130 mm to 150 mm) and cement collared stem (sizes 110 mm to 128 mm) are intended to be used with the other components of the The MultiFit™ Total Hip Metal femoral heads - Metal femoral heads (22 mm and 28 mm in diameter) which is fabricated from Cobalt Chromium Molybdenum (CoCrMo) are intended to be used in conjunction with the commercially available press-fit Ti6Al4V or Co-Cr-Mo alloy Hip Stems cement type and cementless. Acetabular cups and UHMWPE liners - Acetabular cup is manufactured from Ti-6Al-4V ELI and Liner is manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE). The UHMWPE insert (sizes 22 mm and 28 mm) are intended to be used in conjunction with MultiFit™ Total Hip System acetabular cups (sizes 42 mm to 60 mm in 2 mm increments) in cementless applications. UHMWPE liners are available in two types of Flat and 10° elevated. Bipolar cups and liners - Bipolar cup is made of Cobalt Chromium Molybdenum (CoCrMo) and liner is made of Ultra-High Molecular Weight Polyethylene (UHMWPE) same as acetabular liner. Bipolar cups (sizes 42 mm to 55 mm 1 mm increments) are intended to be used with the bipolar liners (22 mm and 28 mm in diameter) of the MultiFitTM Total Hip System.

The provided text describes a medical device, the "MultiFit™ Total Hip System," a total hip joint prosthesis. It outlines the device's components, indications for use, and a list of bench tests conducted to demonstrate substantial equivalence to predicate devices.

However, the provided document does not describe an AI medical device or a study involving AI technology. Therefore, it is impossible to extract information related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details as requested in your prompt.

The document is a 510(k) summary for a physical medical implant (hip prosthesis), focusing on mechanical testing and material equivalence, not AI/software performance.

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The ULC spinal pedicle screw systems are intended for posterior and noncervical pedicle fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the ULC is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The ULC spinal pedicle screw system is one touch single unitary locking cap, posterior spinal fixation system which consists of pedicle screws (monoaxial screw & poly-axial screw), rod and locking cap.

The ULC system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Components of the ULC system are supplied non-sterile and single use.

The ULC system is fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the ULC Spinal pedicle screw systems.

The provided text is a 510(k) Summary for the ULC spinal pedicle screw system. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way a clinical performance study would.

Instead, the document states: "Bench testing as listed in Section 14 and Appendix D. was conducted in accordance with ASTM F1717. It demonstrates substantial equivalence to the above listed predicate devices in terms of materials, design, indications for use and operational principles."

This refers to mechanical and material testing, not a clinical study involving human or even animal subjects to assess performance metrics like sensitivity, specificity, or reader agreement. Therefore, most of the requested information regarding acceptance criteria and studies (like sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in the provided text.

Based on the provided text, here's what can be answered:

1. A table of acceptance criteria and the reported device performance:
   The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy. It refers generally to "bench testing as listed in Section 14 and Appendix D... conducted in accordance with ASTM F1717." ASTM F1717 is a standard for in vitro static and fatigue testing of spinal implant constructs in a corpectomy model. The "reported device performance" would be the results of these mechanical tests demonstrating the device's ability to withstand certain static and fatigue loads, but these specific results are not included in this summary.

   Acceptance Criterion	Reported Device Performance
   Not specified for clinical performance or accuracy. However, the device met the requirements of ASTM F1717 for mechanical performance.	Specific results not provided in this summary. It states: "demonstrates substantial equivalence to the above listed predicate devices in terms of materials, design, indications for use and operational principles."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not applicable. The document refers to "bench testing" (mechanical testing) not a clinical study with a test set of data/patients.

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, as this was not a clinical or diagnostic study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as this was not a clinical or diagnostic study.

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. The device is a spinal pedicle screw system, not an AI/imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. The device is a spinal pedicle screw system, not an AI/imaging diagnostic device. The "standalone" performance would refer to the mechanical performance of the physical implant itself in bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For mechanical testing (ASTM F1717), the "ground truth" would be the engineering specifications and performance limits defined by the standard.

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

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

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