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The b-ONE Total Knee System is intended for total knee arthroplasty due to the following conditions:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis,

· Post-traumatic loss of knee joint configuration and function.

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Revision of previous unsuccessful knee replacement or other procedure.

• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture- management techniques.
  Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components:

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.

• · Absent or nonfunctioning posterior cruciate ligament.

• · Severe anteroposterior instability of the knee joint.

The b-ONE Total Knee System is intended for implantation with bone cement only. b-ONE Total Knee System components are not intended for use with other knee systems.

The b-ONE Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device type and includes two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.

The System includes left and right femoral components manufactured from cast cobalt chrome. The system includes 30 sizes. Sizes 1-10 are provided in right and left versions. Sizes 3-7 are provided in both standard and narrow configurations, with the narrow sizes having a relatively smaller aspect ratio of the medial-lateral to anterior-posterior widths when compared to the standard sizes. Optional modular distal pegs are included in the system.

The system includes a Patella Component offered in seven sizes of variable diameter and thicknesses. The bone fixation surface incorporates three fixation pegs. The Patella Components are made from Conventional UHMWPE.

The system includes Tibial Inserts which are offered in 40 sizes, size A/1-4 through HJ/7-10 with 8 thicknesses and 48 sizes for PS+ inserts, size A1-2+ through HJ/7-10+ with 8 thicknesses. The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.

The system includes Tibial Baseplates offered in 9 sizes ranging from A-J. Tibial Baseplates are manufactured from forged titanium alloy.

All system components are supplied sterile and are single use devices.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the b-ONE Total Knee System. This type of document is used to demonstrate that a new device is "substantially equivalent" to an existing, legally marketed device (predicate device) and therefore does not require a full Pre-Market Approval (PMA).

It is important to understand that a 510(k) summary for a prosthetic joint like a knee replacement does NOT involve clinical studies or "acceptance criteria" related to diagnostic performance as would be found in AI/ML medical devices.

Instead, the "acceptance criteria" for a knee replacement relate to the performance of the physical components (e.g., strength, fatigue life) and their biocompatibility, demonstrating that the new device functions as safely and effectively as the predicate devices. The "study that proves the device meets the acceptance criteria" refers to non-clinical (bench) tests of the device's materials, design, and mechanical properties.

Therefore, the requested information elements related to AI/ML device evaluations (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

Here's a breakdown of the applicable information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Not Applicable. This is a physical medical device (knee implant), not a diagnostic algorithm. The "test sets" refer to individual device components or representative samples subjected to specific engineering tests, not patient data sets. The data provenance would be laboratory testing results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. "Ground truth" in this context refers to established engineering standards, material specifications, and mechanical performance criteria, not expert consensus on medical images or diagnoses. These tests are conducted by engineers and technicians.

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

• Not Applicable. Adjudication methods are relevant for subjective interpretations of data, typically in clinical evaluations or AI/ML ground truth establishment. These are objective engineering tests.

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 is a physical knee implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant.

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

• No. This is a physical knee implant, not an AI/ML algorithm.

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

• The "ground truth" for the non-clinical tests is based on established engineering standards, material specifications, mechanical performance criteria, and comparison to the predicate devices' known performance and specifications.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing processes are developed through engineering and materials science principles.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" for the device's design and manufacturing is established through adherence to recognized industry standards, regulatory requirements, and engineering principles.

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The LOSPA Modular Knee System is intended for the treatment of diseases as follows:

· Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;

· Post-traumatic loss of knee joint configuration and function;

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;

· Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.

The LOSPA Knee System is intended for cemented application only.

The LOSPA Modular Knee System components are similar to "LOSPA Total Knee System" cleared under K110404, K121037 & K130673 which consists of Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and related Instrumentation and are Patella Femoral Tibial Knee Prosthesis Systems, intended for cemented total knee arthroplasty, and all have same indications for use. The subject components, is a line extension to include extension stems with stem plugs and offset adaptors, distal and posterior femoral augments.

The provided text describes a 510(k) premarket notification for the LOSPA Modular Knee System. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in relation to an AI system.

The document is a clearance letter from the FDA, a 510(k) summary, and indications for use for a medical device (a knee replacement system). The "Performance Testing - Bench" section describes mechanical tests performed on the physical knee implant components to demonstrate substantial equivalence to predicate devices, not performance criteria for an AI system.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets those criteria from this document.

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The intended use of the modified device [LOSPA Tibial Base Plate] has not changed as a result of the modification of the predicate device cleared under Lospa Total Knee System, K110404.

The LOSPA Tibial Base Plate which is a component of LOSPA Total Knee System is intended for use in total knee arthroplasty surgery for the following indications:
•Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative Joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;
•Post-traumatic loss of knee joint configuration and function;
·Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
· Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.

The LOSPA Tibial Base Plate is intended for cemented use only.

The LOSPA Tibial Base Plate is a component of "LOSPA Total Knee System" cleared under K110404 which consists of Femoral Components. Tibial Base plate, Tibial Insert, Patellar Components and Instrumentation - LOSPA Total Knee Instrumentation for use with the system implant components

The current premarket notification is related to the modification of LOSPA Tibial Base Plate design. The modification is specific to the KEEL and the design is similar to predicate device in K110404 and other approved device such as Stryker Scorpio 'NRG' Knee (K030978). Similar to predicate device the tibial base plates (or trays), are available in nine (9) sizes to provide optimal tibial coverage. The tibial base plates are designed for use in either the left or right side, and with either CR or PS femoral components or corresponding tibial inserts.

All tibial base plate components are manufactured from cobalt-chromium-molybdenum alloy conforming to ASTM F75, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075).

The AP width ranges from 36 mm, and the ML width ranges from 55 mm to 84 mm. The underside of the base plate features a central keel and stem; the length of the stem is either 35 mm or 40 mm. The stem with keel design is intended to improve the initial stability. In addition, the posterior slope of the keel and stem helps to increase rotational resistance. The base plate is designed to fully capture and lock the polyethylene insert. The surface of the tibial base plate that interfaces with the polyethylene insert includes a ground finish to minimize back side wear of tibial inserts.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the LOSPA Tibial Base Plate:

It's important to note that the provided document is a 510(k) summary for a Special 510(k) submission, which focuses on device modification and demonstrating substantial equivalence to a predicate device. Therefore, it does not contain the typical acceptance criteria and detailed study data found in submissions for novel devices or comprehensive clinical trials. Instead, the performance testing described is primarily to demonstrate that the modified device performs similarly to the predicate device and does not raise new safety or efficacy concerns.

Here's a breakdown based on your requested information, with acknowledgements of what is not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criterion	Reported Device Performance
   Fatigue/Endurance (Mechanical)	Performed similar to the predicate device (K110404) based on ASTM F1800/ISO14879-1 and ISO 21536 standards.
   Modified Instrument Validation (Tibial Keel Punch)	Tested and validated.
   Substantial Equivalence (Overall)	Demonstrated based on similar intended use, fundamental scientific technology, operating principles, and materials compared to predicate devices (K110404 and K030978). No new issues of safety or efficacy raised.

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

   • Sample Size for Test Set: Not explicitly stated. For mechanical testing, sample sizes are typically determined by the relevant ASTM/ISO standards (e.g., a certain number of samples for fatigue testing). The exact number is not provided in this summary.
   • Data Provenance: Not specified, but mechanical testing is typically performed in a laboratory setting, not on patient data.
   • Retrospective or Prospective: Not applicable, as this refers to mechanical bench testing, not clinical 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. "Ground truth" in this context would refer to expert medical diagnoses or outcomes in a clinical study. The performance testing here is mechanical in nature, comparing the physical properties of the device to established engineering standards and a predicate device.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., imaging reads). This submission describes mechanical bench testing.

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 study is a clinical study involving human readers (e.g., radiologists) interpreting cases, often with and without AI assistance. This document describes a mechanical device and its bench testing.

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

   • Not applicable. This is a physical medical device (a tibial base plate), not a software algorithm.

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

   • The "ground truth" for the mechanical testing is based on established engineering standards (ASTM F1800, ISO14879-1, ISO 21536) and the performance characteristics of the legally marketed predicate device (K110404). The goal is to show that the modified device's mechanical properties are equivalent or better and meet these standards.

8. The sample size for the training set

   • Not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. Training sets are relevant for machine learning algorithms.

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

   • Not applicable, as there is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is primarily a mechanical performance study designed to demonstrate substantial equivalence of the modified LOSPA Tibial Base Plate to its predicate device (Lospa Total Knee System, K110404) and another approved device (Stryker Scorpio 'NRG' Knee, K030978).

The key components of this study included:

• Mechanical Testing: Specifically, fatigue (endurance) testing was performed on the tibial base plate.
• Standards: The testing was carried out using methods described in recognized international and national standards:
  • ASTM F1800 (Standard Practice for Cyclical Fatigue Testing of Static and Articulated Internal Spinal Fixation Devices) / ISO14879-1 (Implants for surgery — Knee joint prostheses — Part 1: Determination of endurance properties of knee tibial trays)
  • ISO 21536 (Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint prostheses)
• Comparison: The results of the mechanical testing showed that the LOSPA Tibial Base Plate "performed similar to the predicate device submitted under K110404." This similarity in performance, along with shared design principles, materials, and intended use, formed the basis for the substantial equivalence determination.
• Instrument Validation: The modified instrument, the tibial keel punch, was also "tested and validated." The specific methods or acceptance criteria for this validation are not detailed but imply functional verification.

The underlying "acceptance criteria" not explicitly listed in a bolded table (as would be typical for a clinical study) are implicitly met by demonstrating compliance with the referenced ASTM/ISO standards and achieving performance levels similar to the predicate device. This approach is standard for Special 510(k) submissions focusing on modifications that do not fundamentally alter the device's mechanism of action or safety/efficacy profile, thus relying on established performance benchmarks for similar devices.

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The Scorpio® NRG® Knee System is a sterile, single-use device intended for total knee arthroplasty.

The Scorpio® NRG® Knee System components are for use in total knee arthroplasty as a result of:

• Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis
• . Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability;
• Revision of previous unsuccessful knee replacement or other procedure; .

Additional Indications for Posterior Stabilized Components:

• . Ligamentous instability requiring implant bearing surface geometries with increased constraint
• . Absent or non-functioning posterior cruciate ligament

These components are single use only and are intended for implantation with bone cement.

The Scorpio® NRG® Knee System comprises a series of femoral and tibial insert components. The subject Scorpio® NRG® X3® inserts are available in cruciate retaining (CR) and posterior stabilized (PS) designs and are used for the replacement of the bearing/articulating surfaces of the proximal tibia. The modification to the subject devices is the sequentially crosslinked and annealed X3® UHMWPE material process.

This document is a 510(k) summary for the Scorpio® NRG® Knee System, which is a total knee joint replacement prosthesis. The document states that the device is substantially equivalent to a previously cleared device. Therefore, no studies are provided to prove the device meets acceptance criteria. Only the indications for use and general device description are provided.

Here's the breakdown of why the requested information cannot be provided from the given text:

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

• Not available. The document is a 510(k) summary for a substantial equivalence determination, not a clinical trial report. It asserts equivalence to a predicate device rather than presenting new performance data against specific acceptance criteria.

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

• Not available. No new test data is presented in this 510(k) summary. The submission relies on demonstrating equivalence to existing, legally marketed 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):

• Not available. No test set or ground truth establishment process is described.

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

• Not available. No test set or adjudication method is described.

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 device is a total knee joint replacement prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• Not available. No new studies or ground truth establishment are reported in this 510(k) summary.

8. The sample size for the training set:

• Not applicable. This device is a physical implant, not a machine learning model.

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

• Not applicable. This device is a physical implant, not a machine learning model.

Summary of what is available:

• Device: Scorpio® NRG® Knee System (Total Knee Joint Replacement Prosthesis)
• Approval Type: 510(k) clearance based on substantial equivalence.
• Predicate Device: Scorpio NRG Knee System (K042343 and K030978).
• Modification: Sequentially crosslinked and annealed X3® UHMWPE material process for the inserts.
• Basis for Equivalence: Identical intended use and indications for use, and similar design to the predicate devices.
• Indications for Use: (Provided in the original text) Painful, disabling joint disease (degenerative, rheumatoid, post-traumatic arthritis), post-traumatic loss of knee joint configuration, moderate deformities where ligaments can be stabilized, revision of previous procedures. For PS components: ligamentous instability, absent or non-functioning posterior cruciate ligament.
• Intended Use: Sterile, single-use device intended for total knee arthroplasty, for implantation with bone cement.

In essence, the document serves as a regulatory submission demonstrating that the modified device is as safe and effective as a previously approved device, thus it does not include new performance studies or data against specific acceptance criteria.

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