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The MedalOne Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;

• 2. inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. correction of functional deformity:

revision procedures where other treatments or devices have failed: and treatment of fractures 4) that are unmanageable using other techniques.

The MedalOne Total Knee System is for cemented use only.

The subject device, MedalOne Total Knee System, is intended for reduction or relief of pain and/or improved knee function. The subject device is a total knee replacement system composed of four different component types: MedalOne Femoral Component, MedalOne CS Tibial Insert, MedalOne Tibial Base and SoSuperior Patella.

The subject system is based on, and substantially equivalent to, the predicate EVOLUTION® MP Total Knee System in terms of size availability, geometry, nominal dimensions, manufacturing tolerances, overall device processing steps, and materials of construction. The articulation adheres to the same "Medial-Pivot" philosophy as the predicate device. The femoral components are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are offered in sizes 1-8 in left and right variants. The tibial inserts are made from standard UHMWPE conforming to ISO 5834-2 and are available in sizes 1-8 in standard and "extended" versions with thickness options of 10, 12, 14, 17, 20, and 24mm. The tibial bases are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are available in 8 standard sizes and 3 plus sizes to permit 1-up/1-down size interchangeability. The patellas are made from UHMWPE conforming to ISO 5834-2 and are offered in a tri-peg design in 4 sizes: 26, 29, 32, and 35mm. The system is intended to be used with bone cement for fixation.

The system also includes device-specific instrumentation to facilitate implantation of the subject devices. The instrument system includes new MedalOne instrumentation and is fully compatible with the predicate Evolution instrumentation.

This FDA 510(k) summary describes a new knee replacement system, the MedalOne Total Knee System, and compares it to a legally marketed predicate device. The document focuses on demonstrating substantial equivalence rather than presenting an acceptance criteria table with reported device performance against specific targets for a new AI/software device.

Here's an analysis based on the provided text, addressing your points where information is available:

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

The provided text does not contain a typical acceptance criteria table with specific performance metrics and reported values. This document is a 510(k) submission summary for a medical device (a knee replacement system), not an AI/software performance study. The "acceptance criteria" here are implicitly related to demonstrating "substantial equivalence" to a predicate device through various non-clinical tests.

Instead of a table of acceptance criteria and reported device performance in the context of an AI/software driven diagnostic, the document outlines the types of non-clinical tests performed to support the safety and effectiveness of the MedalOne Total Knee System. The "performance" is demonstrated by showing that these tests align with established standards (e.g., ISO, ASTM) and that the results are comparable to the predicate device.

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 applicable in the context of this document. The submission pertains to a physical knee implant, not a software or AI device that processes data. The "tests" mentioned are mechanical, materials, and biocompatibility evaluations of the physical components, not studies on a test set of 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)

This information is not applicable. Ground truth establishment by experts (like radiologists) is relevant for diagnostic AI/software, not for the physical and material testing of a knee implant.

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

This information is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth for diagnostic AI, neither of which is present in the context of this physical device's 510(k) summary.

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. An MRMC study is relevant for evaluating the impact of AI assistance on human diagnostic performance. The document describes a physical knee implant, not an AI system.

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

This information is not applicable. This question assesses the standalone performance of an algorithm. The document is about a physical medical device, not an algorithm.

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

This information is not applicable in the sense of ground truth for a diagnostic AI system. For the physical device, "ground truth" implicitly refers to established biomechanical principles, material science standards (e.g., ISO 5832-4 for Cobalt Chrome alloy, ISO 5834-2 for UHMWPE), and biocompatibility guidelines (ISO 10993 series). The device's performance is compared against these engineering and biological standards and the performance of the predicate device.

8. The sample size for the training set

This information is not applicable. A training set is used for machine learning models. This document is for a physical medical implant.

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

This information is not applicable. As above, there is no training set mentioned or implied as this is not an AI/ML device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document's context):

The "study" in this context refers to the non-clinical testing performed and leveraged analyses to demonstrate substantial equivalence to the predicate device, the EVOLUTION® MP Total Knee System (K093552), and other reference devices.

• Acceptance Criteria (Implicit): The implicit acceptance criteria are that the MedalOne Total Knee System must perform as safely and effectively as the predicate device(s) and conform to relevant international standards for materials, biomechanics, and biocompatibility. The differences in technological characteristics should not raise new questions of safety and effectiveness.

• Reported Device Performance (Implicit): The non-clinical performance testing results demonstrate that the device is "as safe and effective and performs as well or better than the legally marketed predicate and reference devices." Specific numerical performance values are not given in this summary, but the types of tests performed are listed.

• Non-Clinical Tests Performed:

  • Tibial baseplate fatigue strength evaluation per ISO 14789-1:2000
  • MRI safety evaluation per ASTM F2182-19 and FDA guidance (including other ASTM standards like F2182-11a, F2181-11, F2052-15, F2213-17, F2119-07)
  • Biocompatibility testing per ISO 10993-1 (2018), ISO 10993-5 (2009), ISO 10993-10 (2014), ISO 10993-11 (2017), ISO/TS 21726 (2019), and FDA Guidance.
  • Endotoxin Testing

• Analyses Leveraged from Predicate Device (due to substantial equivalence):

  • Range of motion evaluation
  • Femorotibial and patellofemoral contact area and stability evaluation
  • Component lock detail evaluation
  • UHMWPE Material Property Characterization
  • Durability of the Patellofemoral Joint
  • UHMWPE Tibial Insert Endurance and Deformation Under High Flexion
  • Fatigue Strength of Knee Femoral Components

• Justification for Omissions: Justification was provided for not completing wear testing of the tibial bearing components.

• Clinical Data: No clinical data were provided, and the submitter stated they were "not necessary to support the substantial equivalence."

In essence, the "study" for this device involved a battery of engineering, materials, and biological tests to demonstrate that its physical properties and intended function are within acceptable limits defined by established standards and are equivalent to a device already cleared for market.

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