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The ELEOSTM/ELEOSx™ Limb Salvage System is indicated for resection and replacement of the proximal femur, intercalary portion of the femur, total femur, distal femur. and proximal tibia in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, traumatic arthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed: and. 5) Treatment of fractures that are unmanageable using other techniques. The ELEOS™/ELEOSx™ Limb Salvage System is also indicated for procedures where resection and replacement of the proximal femur, intercalary portion of the femur, total femur, distal femur, and proximal tibia is required with the following conditions: 1) Patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision hip or knee arthroplasties, and/or Oncology indications. 3) Metastatic diseases. The ELEOSx™ MDPB coating, where applied, is intended to reduce bacterial contamination prior to implantation resulting from deposition in the operating room on the surface of the device components. The clinical impact associated with the MDPB coating, including prevention of infection or reduction of infection risk in patients, has not been evaluated in human clinical trials. The MDPB coating is not intended to treat existing infections and does not act within or on the body.

The Onkos Surgical ELEOSx™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The systems include components manufactured from cobalt-chrome alloy (CoCr), titanium alloy (TAV), and ultra-high molecular weight polyethylene (UHMWPE). Non-articulating CoCr component surfaces are coated with 12-Methacryloyloxydodecyl Pyridinium Bromide (MDPB), which is intended to reduce bacterial contamination on the surface of the device components prior to implantation resulting from deposition in the operating room. Based on in vitro testing, this coating may result in immobilization and/or lysis of some challenge organisms. The MDPB coated CoCr stems are for cemented use in the reconstruction/replacement of the lower limb. The reconstruction applications are proximal femur, intercalary portion of the femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS™ Limb Salvage components are femoral head, proximal femur, female stem, mid-section, stem, distal femur, tibial hinge component, axial pin. tibial poly spacer, tibial baseplate, malemale mid-section, resurfacing femur, proximal tibia, tapered screws, patella, stem extension, tibial wedges, and augments. Instruments included in the Onkos ELEOSx™ Limb Salvage System are used in implantation and removal of the system components.

The provided text describes a De Novo classification request for a medical device, the ELEOSx™ Limb Salvage System, which includes a quaternary ammonium compound coating. The document focuses on regulatory information, device description, non-clinical/bench studies, and risk assessment to support its classification.

However, the input text does not describe a study involving an AI/Machine Learning device or an "algorithm only" performance study. It details the acceptance criteria and the studies that prove the mechanical, chemical, and biological performance of a physical medical implant, specifically focusing on the MDPB coating's integrity, effects on range of motion, cement interface pull-out strength, fretting and corrosion, antimicrobial performance, and physicochemical characterization.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone algorithm performance, training set sample size, ground truth establishment) are not applicable to the information provided because the device in question is a physical implant, not an AI or algorithm-based system.

Below, I will extract the relevant information from the provided text regarding the acceptance criteria and the studies that prove the device meets these criteria, as described for this physical medical device.

Acceptance Criteria and Device Performance for ELEOSx™ Limb Salvage System

The acceptance criteria for the ELEOSx™ Limb Salvage System are defined by a series of non-clinical (bench) studies, biocompatibility evaluations, sterilization validation, and material characterization, with the overarching goal of demonstrating the device's safety and performance, particularly concerning the novel MDPB coating. The studies primarily aim to show that the MDPB coating does not negatively impact the device's mechanical integrity or biocompatibility, and that it effectively reduces bacterial contamination prior to implantation without affecting the body internally.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Sets: The document refers to various bench studies. Specific sample sizes are not detailed for each mechanical test (e.g., "stems were inserted," "proximal femurs").
• Data Provenance: The studies are described as "non-clinical/bench studies," which implies laboratory testing. The text does not specify the country of origin of the data
  (e.g., US, Europe, Asia) nor whether they were retrospective or prospective, as these terms are typically used for clinical data or AI model development. These are lab-based, controlled experiments.

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

This is not applicable. The "ground truth" for these physical device tests is based on established engineering and material science standards (e.g., ISO standards, ANSI/AAMI standards) and direct measurements/observations in controlled laboratory environments. It does not involve expert readers interpretating images or data for AI model validation.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI model validation where human interpretation and consensus are required to establish ground truth or resolve discrepancies. These bench studies rely on objective measurements and established protocols.

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:

This is not applicable. An MRMC study is designed to evaluate the impact of an AI system on human reader performance, typically in diagnostic imaging. The ELEOSx™ Limb Salvage System is a physical medical implant, not an AI or diagnostic imaging device.

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

This is not applicable. This question pertains to the performance of an AI algorithm in isolation. The ELEOSx™ Limb Salvage System is not an algorithm.

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

The "ground truth" for this device's performance is established through objective measurements and adherence to recognized international standards and test methods. For example:

• Mechanical properties: Measured against established engineering specifications and comparative data to uncoated devices.
• Biocompatibility: Demonstrated by passing standardized in vitro and in vivo (animal) tests (e.g., per ISO 10993 series).
• Sterility and Pyrogenicity: Verified through validated sterilization processes and bacterial endotoxin testing (e.g., per ISO 11137, ANSI/AAMI ST72).
• Antimicrobial Performance: Demonstrated in vitro through simulated use testing.

8. The sample size for the training set:

This is not applicable. The concept of a "training set" refers to data used to train an AI or machine learning model. This is a physical medical device. The manufacturing process and materials testing involve quality control and validation, but not machine learning training sets in the AI sense.

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

This is not applicable for the reasons stated above.

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The My3D® Personalized Pelvic Reconstruction system is indicated for use in patients requiring reconstruction of the pelvis and/or hip joint due to disease, deformity, trauma, or revision procedures where other treatments or revisions have failed. The device is a combination of single use guided osteotomy instruments, a pelvic implant, screws, and acetabular/ femoral components. The pelvic implant is intended for cementless application in individuals where bone quality or bony defect size cannot support a standard sized acetabular implant is intended to be fixed to the remaining pelvic anatomy using compatible bone screws to create a prosthetic acetabulum. The reconstructed prosthetic acetabulum is intended to be used with a compatible cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components to restore hip function.

The subject submission adds locking screw component options and associated instrumentation to the subject My3D® Personalized Pelvic Reconstruction system.

The My3D® Personalized Pelvic Reconstruction system is a patient specific combination of single use resection instruments, a pelvic implant, screws, acetabular, and femoral components. The system was developed to address conditions which require reconstruction of the acetabulum and hip joint.

This patient matched device is designed from inputs including imaging, diagnosis, and surgical approach. Together with the surgeon, these inputs are then translated via a design process to create patient specific implants and, if appropriate, instruments to reconstruct the patient's pelvis. If utilized, the patient specific instruments are used to resect the bone and allow for implantation of the patient matched pelvis. The joint is then reconstructed with a cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components.

The implants and resection instruments are single use devices. Reusable instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

This FDA 510(k) summary for the My3D® Personalized Pelvic Reconstruction device (K223348) primarily focuses on establishing substantial equivalence to a predicate device (K212815) for an addition of locking screw components and associated instrumentation. It does not describe a clinical study in the typical sense of evaluating diagnostic accuracy or clinical outcomes in human subjects with acceptance criteria.

Instead, the "acceptance criteria" and "study" are related to mechanical performance testing of the newly added locking screw components to demonstrate that they are comparable to existing, legally marketed devices and do not negatively impact the overall device's safety and effectiveness.

Here's a breakdown of the requested information based on the provided document:

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

The document does not explicitly state numerical acceptance criteria for each test or detailed performance reports with specific values. Instead, it refers to industry standards (ASTM F543-17) and implies that the device met these standards. The "reported device performance" is a general statement that the device underwent testing and a stress analysis, which supported its safety.

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of screws tested) for the mechanical tests. Mechanical testing often involves a smaller number of samples compared to clinical trials, determined by statistical considerations for materials testing.
• Data Provenance: The data provenance is from mechanical laboratory testing performed on the device components (locking screws). It is not clinical data from human subjects. The country of origin of the data is not explicitly mentioned but is likely associated with the manufacturer (Onkos Surgical, Inc., based in Parsippany, New Jersey, USA) or a third-party testing facility. This is not retrospective or prospective clinical data.

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

This information is not applicable in this context. The "ground truth" for mechanical testing is established by engineering principles and adherence to recognized industry standards (e.g., ASTM F543-17). There are no "experts" establishing a clinical ground truth for a test set in this 510(k) submission, as it focuses on mechanical equivalence.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (e.g., 2+1) are typically used in clinical or image-based studies where multiple reviewers assess data and reconcile discrepancies. Mechanical testing results are objective measurements against defined physical standards.

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, a MRMC comparative effectiveness study was not done. This device is a physical medical device (pelvic reconstruction system) and not an AI/imaging device that would involve human readers or AI assistance in interpretation.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device and does not involve a standalone algorithm in the way this question implies (e.g., a diagnostic AI algorithm).

7. The type of ground truth used

The "ground truth" for the mechanical testing is based on:

• Industry Standards: Adherence to established mechanical testing standards like ASTM F543-17.
• Engineering Rationale: Demonstrating through stress analysis that the new components do not compromise the structural integrity or safety of the overall pelvic implant.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of mechanical laboratory testing for a physical device like this. This question is typically relevant for machine learning or AI models.

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

This information is not applicable, as there is no training set for this type of submission.

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The My3D® Personalized Pelvic Reconstruction system is indicated for use in patients requiring reconstruction of the pelvis and/or hip joint due to disease, deformity, trauma, or revision procedures where other treatments or revisions have failed. The device is a combination of single use guided osteotomy instruments, a pelvic implant, screws, and acetabular/ femoral components. The pelvic implant is intended for cementless application in individuals where bone quality or bony defect size cannot support a standard sized acetabular implant is intended to be fixed to the remaining pelvic anatomy using compatible bone screws to create a prosthetic acetabulum. The reconstructed prosthetic acetabulum is intended to be used with a compatible cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components to restore hip function.

The My3D® Personalized Pelvic Reconstruction system is a patient specific combination of single use resection instruments, a pelvic implant, screws, acetabular, and femoral components. The system was developed to address conditions which require reconstruction of the acetabulum and hip joint.

This patient matched device is designed from inputs including imaging, diagnosis, and surgical approach. Together with the surgeon, these inputs are then translated via a design process to create patient specific implants and, if appropriate, instruments to reconstruct the patient's pelvis. If utilized, the patient specific instruments are used to resect the bone and allow for implantation of the patient matched pelvis. The joint is then reconstructed with a cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components.

The implants and resection instruments are single use devices. Reusable instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

I am sorry, but the provided text content does not contain enough information to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as per your request. The document is an FDA 510(k) clearance letter and summary for the My3D® Personalized Pelvic Reconstruction device, which primarily addresses substantial equivalence to a predicate device.

Specifically, the document mentions "Performance Data" and lists several types of testing performed (biocompatibility, manufacturing residuals, sterilization validation, mechanical testing of porous structure, fatigue testing, screw performance, cadaveric evaluation of design process). However, it does not provide:

1. A table of acceptance criteria and reported device performance. It only lists the types of tests.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document explicitly states: "Clinical data were not deemed necessary for the subject device." This further indicates that no human-centric validation studies (like MRMC or studies requiring expert ground truth and adjudication) were conducted or included in this submission summary. The testing mentioned appears to be primarily engineering and material performance tests.

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The ELEOS™ Limb Salvage System is indicated for resection and replacement of the proximal femur; intercalary portion of the femur, total femur, distal femur, and proximal tibia in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia;

2. Inflammatory degenerative joint disease such as rheumatoid arthritis;

3. Correction of functional deformity

4. Revision procedures where other treatments or devices have failed; and,

5. Treatment of fractures that are unmanageable using other techniques.

The ELEOS Limb Salvage System is also indicated for procedures where resection and replacement of the proximal femur, intercalary portion of the femur, distal femur, and proximal tibia is required with the following conditions:

1. Patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma, revision hip or knee arthroplasties, and/or Oncology indications.

3. Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction are proximal femur, intercalary portion of the femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, female stem, mid-section, segmental stem, distal femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial baseplate, male-male mid section, resurfacing femur, proximal tibia, patella, stem extension, and tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

The provided text is a 510(k) Summary for a medical device called the ELEOS™ Limb Salvage System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics like sensitivity, specificity, or accuracy.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not applicable or available in this type of submission.

Here's an analysis of the available information:

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

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through a risk-based evaluation and comparison of technological characteristics, rather than reporting specific performance metrics against pre-defined acceptance criteria.

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. As no new performance testing was required (see point 5.7), there was no "test set" in the context of typical AI/software performance studies. The evaluation was based on a risk assessment and comparison to existing predicate devices.

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)

This information is not provided. Since no new performance testing with a ground truth was conducted, this is not applicable.

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

This information is not provided. Not applicable for the reasons stated above.

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

This information is not provided. An MRMC comparative effectiveness study is not mentioned. The device is a "Limb Salvage System" (a physical implantable medical device), not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not provided. This concept is not applicable as the device is a physical implant, not an algorithm.

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

This information is not provided. Not applicable for the reasons stated above.

8. The sample size for the training set

This information is not provided. The device is an orthopedic implant, not an AI model that requires a "training set."

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

This information is not provided. Not applicable as there is no training set for this type of device.

Summary of what is provided regarding the "study" for substantial equivalence:

• Device: ELEOS™ Limb Salvage System (K211677)
• Purpose of Submission: To add a new indication for use (intercalary replacement) to the existing ELEOS™ Limb Salvage System, consistent with the predicate DePuy LPS System, and to introduce a female stem component.
• Predicate Devices:
  • Primary Predicate: ELEOS™ Limb Salvage System, Onkos Surgical, Inc., K161520
  • Predicate: Orthogenesis LPS System, DePuy, Inc., K003182
• Method of "Proof":
  • Technological Characteristics Comparison: The submission compares the technological characteristics of the subject device (including the new female stem) to the predicate devices. It notes that the design of the female stem utilizes the same material, segmental taper, cement flutes, and length as the primary predicate.
  • Risk-Based Evaluation: A risk-based evaluation determined that the addition of the female stem for intercalary replacement does not raise new concerns with respect to safety and/or effectiveness.
  • Conclusion of Risk Evaluation: This evaluation demonstrated "no new or increased risks related to loosening, subsidence, fatigue, dissociation, and/or fretting corrosion compared to the primary predicate device."
  • Performance Data: "additional performance testing was not required to support this submission" because the risk-based evaluation showed no new concerns.
  • Clinical Data: "Clinical data was not deemed necessary for the subject device."
• Overall Conclusion (5.9): Based on the comparisons and risk assessment, the subject device is deemed substantially equivalent to the primary predicate and predicate devices, implying that any differences do not raise new questions of safety and effectiveness, and the proposed device is at least as safe and effective as the legally marketed predicate devices.

In essence, the "study" here is a design comparison and risk assessment against an already cleared device, demonstrating that the modifications (new indication and component) do not introduce new safety or effectiveness risks compared to the predicate devices. It relies on the prior clearance information of the predicate devices.

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ELEOSTM Limb Salvage System Hip Components:

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions :

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia;

2. Inflammatory degenerative joint disease such as rheumatoid arthritis;

3. Correction of functional deformity

4. Revision procedures where other treatments or devices have failed; and,

5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and or total femur is required with the following conditions:

1. Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment:

2. Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.

• 3. Metastatic diseases
     ELEOSTM Limb Salvage System Knee Components:

Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;

2. Inflammatory degenerative joint disease including rheumatoid arthritis;

3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and

5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions:

1. Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications.

3. Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male mid-section, resurfacing hinge femur, and proximal tibia, optional components include modular collars, patella, stem extensions, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per the validated instructions stated below.

The provided text is a 510(k) summary for a medical device (ELEOS Limb Salvage System with BioGrip) seeking FDA clearance. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets those criteria in the way you've outlined for a clinical performance study of, for example, an AI algorithm.

Instead, the document details performance data provided in support of substantial equivalence to a predicate device. This data focuses on mechanical and biocompatibility testing to ensure the new device (a line extension with modular collars and porous technology) is as safe and effective as the existing, cleared predicate device.

Here's a breakdown of what is available based on your request, with an explanation of why other points are not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there isn't a direct "acceptance criteria" table with specific performance metrics (like sensitivity/specificity for an AI algorithm) that the device must meet to prove its clinical utility. Instead, the performance data provided demonstrates that the device performs similarly or better mechanically and is biocompatible compared to predicate devices, adhering to recognized standards.

Biocompatibility Testing:

Mechanical Testing:

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

This information is not applicable in the context of this 510(k) submission. The "test set" in this case refers to the physical device components subjected to laboratory testing. The document does not describe a clinical study with patients or data from medical records.

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

This information is not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, is not established for the mechanical and biocompatibility tests performed. These tests rely on standardized protocols and measurements, not expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretations of data. The performance analyses presented here are laboratory-based.

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

This information is not applicable. This submission is for a physical orthopedic implant system, not an AI algorithm. No MRMC study or AI assistance is mentioned.

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

This information is not applicable. This submission is for a physical orthopedic implant system, not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the "ground truth" is defined by the toxicological characteristics and cellular responses measured against established ISO standards.
For mechanical testing, the "ground truth" is defined by the physical limits and properties established in the ASTM and ISO standards for orthopedic implants.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device's development as it is not an AI/machine learning device. The design and testing are based on engineering principles and material science.

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

This information is not applicable for the same reasons as point 8.

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ELEOSTM Limb Salvage System with Hip Components:

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia:

2. Inflammatory degenerative joint disease such as rheumatoid arthritis;

3. Correction of functional deformity

4. Revision procedures where other treatments or devices have failed; and,

5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/ or total femur is required with the following conditions:

1. Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.

3. Metastatic diseases

ELEOS™ Limb Salvage System with Knee Components:

Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

l ) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2. Inflammatory degenerative joint disease including rheumatoid arthritis;

3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and

5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the is required with the following conditions:

1. Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications.

3. Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction applications are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, mid-section, stem, distal femur, tibial hinge component, axial pin, tibial poly spacer, tibial baseplate, male-male mid-section, resurfacing femur, proximal tibia, tapered screws, patella, stem extension, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

This is an FDA 510(k) clearance letter for the ELEOS™ Limb Salvage System. Unfortunately, the provided document does not contain the kind of detailed information about acceptance criteria, device performance, study methodology (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) that your request outlines.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based primarily on mechanical testing.

Here's what can be extracted from the document regarding performance data, and an explanation of why the other information is not present:

Acceptance Criteria and Device Performance

Study Details (Not Applicable as per document content)

The document explicitly states: "Clinical data was not deemed necessary for the subject device." This means a clinical study, as you've described with human readers, ground truth, and statistical analysis for diagnostic performance, was not performed or required for this 510(k) clearance.

Therefore, the following information is not available in the provided text:

• Sample sized used for the test set and the data provenance: Not applicable, as a clinical test set for diagnostic performance was not used.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 device is a surgical implant, not an AI diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Explanation:

The ELEOS™ Limb Salvage System is a physical medical device (orthopedic implant) used in reconstructive surgery. The FDA's 510(k) clearance pathway often relies on demonstrating substantial equivalence to an already legally marketed predicate device. For devices like this, substantial equivalence is primarily established through:

1. Technological Characteristics Comparison: Showing that the new device has similar design, materials, and intended use as the predicate.
2. Performance Data: This typically involves bench testing (mechanical, material, biocompatibility, etc.) to ensure the device performs safely and effectively as intended and is comparable to the predicate.

The type of detailed clinical study information you're asking for (sample sizes, expert ground truth, MRMC studies, AI performance metrics) is characteristic of submissions for diagnostic devices, particularly those involving artificial intelligence or image analysis, where the "performance" is about diagnostic accuracy or reader improvement. This is not applicable to a surgical implant like the ELEOS™ Limb Salvage System in the context of this 510(k) clearance.

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ELEOSTM Limb Salvage System with Hip Components:

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia:

2. Inflammatory degenerative joint disease such as rheumatoid arthritis;

3. Correction of functional deformity

4. Revision procedures where other treatments or devices have failed; and,

5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/ or total femur is required with the following conditions:

1. Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.

3. Metastatic diseases

ELEOS™ Limb Salvage System with Knee Components:

Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

l ) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2. Inflammatory degenerative joint disease including rheumatoid arthritis;

3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and

5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the is required with the following conditions:

1. Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications.

• 3. Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction applications are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male-male mid-section, resurfacing hinge femur, and proximal tibia, patella, stem extension, modular collar, tibial wedges and augments.

The ELEOS™ Limb Salvage System with BIOGRIP™ did not have specific quantitative acceptance criteria for performance metrics in a clinical or AI-assisted context. The substantial equivalence determination was based on demonstrating the safety and effectiveness of the device through biocompatibility and mechanical testing, comparing it to a predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Material Mediated Pyrogenicity
• Genotoxicity
• Chemical Characterization
• Toxicological Risk Assessment
• Endotoxin limit of 20 EU/device | "Testing was successfully performed, and it was confirmed that the subject devices meet the 20 EU/device testing limit for general medical devices that are implanted."
  "The following biocompatibility tests were performed on each material group to ensure biocompatibility." (Implies successful completion for all listed tests). |
  | Mechanical Performance | Equivalence to predicate device based on bench tests per FDA guidance and ASTM/ISO standards:
• Shear Testing of Coatings (ASTM F1044)
• Tension Testing of Coatings (ASTM F1147)
• Shear and Bending Fatigue Testing of Coatings (ASTM F1160)
• Stereological Evaluation of Porous Coatings (ASTM F1854)
• Abrasion Resistance (ASTM F1978)
• Knee Replacement Prosthesis Specification (ASTM F2083)
• Plasma sprayed unalloyed titanium coatings (ISO13179-1:2014) | "The following bench testing was completed and the results of support the subject devices are equivalent to the predicate device." (Implies successful demonstration of equivalence across all listed tests). |
  | Design Validation | Function as intended and user needs met. | "Design Validation demonstrated the subject implant and existing instruments function as intended and user needs were met." |

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

• Sample Size: Not applicable in the context of clinical testing with human subjects. The testing was primarily bench testing (biocompatibility and mechanical) and a cadaver lab for design validation. The document does not specify the number of individual test articles or specimens used in the bench tests, only the types of tests performed.
• Data Provenance: The biocompatibility and mechanical testing were conducted in a laboratory setting (bench tests), not from patient data. The design validation used a cadaver lab.

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

• Not applicable as the study did not involve human experts establishing ground truth on a test set (e.g., image interpretation for an AI device). The "ground truth" for the performance aspects was established through standardized laboratory testing protocols and design validation in a cadaver lab.

4. Adjudication Method for the Test Set (e.g., 2+1, 3+1, none)

• Not applicable. There was no expert adjudication process for a test set as the evaluation was based on laboratory testing and functional assessment in a cadaver lab rather than diagnostic interpretation.

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, an MRMC comparative effectiveness study was not done. This device is a medical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a physical medical implant (Limb Salvage System), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for demonstrating the device's acceptable performance was based on:
  • Validated laboratory testing standards (ISO and ASTM for biocompatibility and mechanical properties)
  • Direct functional assessment in a cadaver lab for design validation.
  • Comparison to a legally marketed predicate device to establish substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This document describes the clearance of a medical device (implant), not an AI algorithm that requires a training set.

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

• Not applicable. As there was no AI algorithm or training set, there was no ground truth for a training set to be established.

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The ELEOSTM Bipolar Acetabular System is indicated for the following conditions:

1. pathological fractures of the femoral neck
2. non-union of femoral neck fractures
3. aseptic necrosis of the femoral head and neck
4. primary pathology involving the femoral head or femur but with a non-deformed acetabulum.

ELEOS™ Bipolar Acetabular System is a bipolar hip implant design that features a cross-linked polyethylene bearing surface with a lock detail enhanced for strength. Historical concerns with traditional bipolar designs have included loosening of the insert, disassociation of the head from the shell, and osteolysis resulting from polyethylene wear. This system is designed to address these concerns to give surgeons greater confidence when using a bipolar implant.
There is an UHMWPE support ring inside the shell that is permanently fixed. There is also an UHMWPE locking ring that assembles above the support ring and locks into place once the head is inserted into the shell. Bipolar heads are available in a variety of diameters with corresponding internal diameters for 22, 28, 32 and 36mm femoral heads with skirts are not compatible with the bipolar shells.

The provided text is a 510(k) summary for the ELEOS™ Bipolar Acetabular System. It states that no performance data for the subject device (ELEOS™ Bipolar Acetabular System) is provided. Instead, the submission relies on the substantial equivalence principle, asserting that the subject device has the same materials, technology, and sterilization methods as the predicate device (GLADIATOR® Bipolar System, K062693).

Therefore, I cannot extract information about acceptance criteria and a study proving the device meets those criteria from this document. The document explicitly states:

"No performance data is provided. A copy of the full 510(k) for the predicate device (K062693) is provided because there are no technological differences between the subject and predicate devices."

As such, I cannot populate the table or answer the specific questions about sample size, provenance, experts, adjudication, MRMC studies, standalone performance, ground truth types, or training set details, as this information is related to performance data that is explicitly stated to be not provided for the subject device in this document.

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ELEOSTM Limb Salvage System Hip Components:

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli. and painful hip dysplasia;

2. Inflammatory degenerative joint disease such as rheumatoid arthritis;

3. Correction of functional deformity

4. Revision procedures where other treatments or devices have failed; and,

5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/ or total femur is required with the following conditions:

1. Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.

3. Metastatic diseases

ELEOSTM Limb Salvage System Knee Components:

Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

• 2. Inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. Correction of functional deformity;
• 4. Revision procedures where other treatments or devices have failed; and
• 5. Treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions:

1. Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;

2. Surgical intervention for severe trauma. revision knee arthroplasties, and/or Oncology indications.

• 3. Metastatic diseases

The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction applications are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male mid-section, resurfacing hinge femur, and proximal tibia, patella. stem extension, tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per the validated instructions stated below.

The provided text is a 510(k) summary for a medical device (ELEOS Limb Salvage System) seeking FDA clearance based on substantial equivalence to a predicate device. It does not describe a study involving acceptance criteria for a device's performance in the context of an AI/algorithm-driven system. Therefore, I cannot extract the information required to answer your questions as they pertain to AI/algorithm performance studies.

The document states:

• "No performance data is provided." (Page 7, Section VII. Performance Data)
• "A copy of the full 510(k) for the predicate device (K013035) is provided because there are no technological differences between the subject and predicate devices." (Page 7, Section VII. Performance Data)
• The conclusion is based on the subject device being "identical with respect to fit, form, function and manufacturing processes as the predicate device" (Page 7, Section VIII. Conclusions).

This indicates that the clearance for the ELEOS Limb Salvage System was based on demonstrating substantial equivalence to a previously cleared device, not on independent performance testing against specific acceptance criteria for a new, AI-driven functionality.

Therefore, questions about acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to this document.

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