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The patient-specific BC Reflex Unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:

· joint impairment due to osteoarthritis or traumatic arthritis of the knee,

· varus deformitv of the knee, and

· as an alternative to tibial osteotomy in patients with unicompartmental OA.

The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

The BC Reflex Uni™ Knee System is a patient-specific unicompartmental knee system that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial implants and single-use instruments are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BC Reflex Uni™ is for cemented use only and is sterilized to a SAL of 10-6.

The primary reasons for this 510(k) notification are to notify the FDA: (1) that the tibial insert will be manufactured from vitamin E stabilized and 100 kGy crosslinked UHMWPE (Vit-E HXLPE), (2) that a 5 mm thick tibial insert was added as a thickness option, and (3) of minor design updates to the implants and single use instruments.

Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (ASTM F1537-11) for the femoral component, wrought Titanium-6Aluminum-4Vanadium ELI Alloy (Ti6AI4V ELI; ASTM F136-13) for the tibial baseplate and locking pin, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the tibial insert.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The text describes a 510(k) premarket notification for a knee system, detailing its features, intended use, and comparison to predicate devices, along with performance data related to material properties and wear testing. However, it does not specify any acceptance criteria in numerical or qualitative terms, nor does it present a study designed to demonstrate performance against such criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study details.
6. Stand-alone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Total knee components are indicated for:

1. Rheumatoid arthritis.

2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

4. The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.

The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.

The subject Porous Patella is designed to be implanted with or without the use of bone cement for a total knee replacement. The Porous Patella will be made of UHMWPE and Ti-6Al-4V. The metal bone contacting surface and 3 pegs will be made from Ti-6Al-4V, which will be porous, and the bearing surface will be UHMWPE. The bone contacting porous structure will be made of CONCELOC, a material formerly cleared as part of the REDAPT CONCELOC Fully Porous Cup, K1813266. The UHMWPE will be direct compression molded on to the Ti-6AI-4V metal back. The subject Porous Patella will be designed as oval and round resurfacing patellae. The subject device will be press fit into the bone with 3 pegs for initial fixation and provided in various sizes, 26mm-41mm. As a reference, the bearing surface profile of this subject Porous Patella is identical to the Smith & Nephew Genesis II Patella, which was cleared under K042515.

The subject Porous Tibia Baseplate is designed to be implanted with or without the use of bone cement. The Porous Tibia Baseplate is made of Ti-6AI-4V and includes a porous ingrowth surface on the distal face of the implant. The proximal face of the implant includes locking mechanism, dimensions, and size options identical to Smith & Nephew's Journey cemented tibial implant cleared under K121443. The distal side of the implant has a central stem, two large posterior-directed fins, and two smaller anterior-directed fins. There are also two tibial lugs on the anterior half of the implant, one on each of the medial and lateral side of the stem. The subject device includes the same stem length for all sizes, though the fin sizes and locations of the lugs vary between sizes. The subject tibia baseplate includes multiple sizes in both left and right hand versions.

The provided document is a 510(k) premarket notification for a medical device (Porous Patella and Porous Tibia Baseplate). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials or developing complex AI algorithms. Therefore, much of the information requested about AI performance, human reader studies, and ground truth establishment in typical AI/ML medical device submissions is not applicable to this document.

Here's a breakdown of the available information based on your request:

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

The document describes performance testing used to establish substantial equivalence. The acceptance criteria are implicit in meeting the performance characteristics of the predicate devices.

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

• Sample size: The document does not specify a "test set" in the context of clinical data or AI model evaluation. The tests performed are benchtop mechanical and material characterization tests. The specific number of samples for each test (e.g., number of patellae for tensile strength, number of tibia baseplates for fatigue testing) is not provided in this summary.
• Data provenance: Not applicable in the sense of patient data. The provenance for the benchtop tests would be internal laboratory testing by Smith & Nephew.

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 device is a mechanical implant, and its performance is evaluated through engineering and material science benchtop tests, not clinical expert review or AI ground truth establishment.

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

• This is not applicable. Adjudication methods are relevant for clinical trials or expert review of diagnostic results. This submission relies on benchtop 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:

• This is not applicable. This is a submission for a mechanical implant, not an AI-powered diagnostic device.

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

• This is not applicable. The device is a mechanical implant, 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 by engineering and material science standards and benchmarks, generally derived from similar predicate devices and relevant industry standards (e.g., for mechanical properties, material composition, and manufacturing processes).

8. The sample size for the training set:

• This is not applicable. There is no "training set" as this is not an AI/ML device.

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

• This is not applicable. There is no "training set" or "ground truth" in the context of AI/ML for this device.

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The patient-specific BC Reflex Unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:

· joint impairment due to osteoarthritis or traumatic arthritis of the knee,

· varus deformity of the knee, and

· as an alternative to tibial osteotomy in patients with unicompartmental OA.

The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

The BC Reflex Uni™ Knee System is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patientspecific femoral and tibial components and single-use cutting guides are manufactured from CAD and CAM files generated from Bodycad and off the shelf software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BC Reflex Uni™ is for cemented use only and is sterilized by gamma radiation.

The subject of this 510(k) is an updated / new design of the femoral component and instruments for implantation, relative to the femoral component described in K163700 and K181302 for the predicate BUKS.

Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6A4V ELI; ASTM F136-13) for the tibial baseplate and locking pin, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.

The provided text is a 510(k) summary for the BC Reflex Uni™ Knee System, a medical device for unicompartmental knee arthroplasty. It describes the device, its intended use, and the performance data that supports its substantial equivalence to predicate devices. However, the document does not contain information about an AI/ML-based device, nor does it detail acceptance criteria or a study with human-in-the-loop or standalone AI performance, ground truth establishment, or expert involvement in a way that aligns with the questions posed in the prompt.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment from the provided document. The document discusses the substantial equivalence of the knee system based on mechanical testing and cadaver surgeries, not on the performance of a diagnostic AI system.

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The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
• Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty
• As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis.

The femoral component and tibial tray are intented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.

The Engage™ Partial Knee System is a unicompartmental knee system comprised of tibial trays, tibial inserts, tibial anchors, and femoral components. The implant geometry is optimized for the medial compartment. The Engage™ Partial Knee System permits all sizes of femur to be interchangeable with all sizes of tibial trays and associated tibial insert combinations. The tibial anchor are composed of Ti-6AI-4V alloy, the tibial insert is composed of UHMWPE, and the femoral component is composed of CoCrMo alloy. The tibial tray includes pegs and an engineered porous surface, while the femoral component includes pegs and a sintered porous coating; both of which are intended for biological fixation when used without bone cement and to enhance fixation when used with PMMA bone cement. The Engage™ Partial Knee System is intended for cemented or uncemented replacement of the medial compartment of the knee. The tibial anchors provide for supplemental fixation of the tibial tray when implanted without bone cement. The tibial anchor is not used when the tibial tray is implanted with bone cement.

Based on the provided text, the document is a 510(k) Premarket Notification for a medical device called "The Engage™ Partial Knee System." This document primarily focuses on demonstrating the substantial equivalence of this knee implant system to previously cleared predicate devices.

It does NOT describe an AI/ML-driven device or study that proves an AI device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria for an AI device, sample sizes for a test set, ground truth establishment by experts, MRMC studies, or training sets. The document details performance testing for a physical orthopedic implant device, not an AI algorithm.

The "Performance Data" section (F. PERFORMANCE DATA) lists pre-clinical performance testing conducted for the physical knee system, adhering to FDA guidance and ASTM/ISO standards. These tests are about the mechanical, biological, and material properties of the implant itself, such as:

• Tibial baseplate fatigue strength
• Range of Motion (ROM), contact pressure, and area of tibiofemoral articulation of UHMWPE inserts
• Constraint testing
• Resistance to dislodgement of the tibial insert
• Biomechanical evaluation under cyclic loading
• Evaluation of porous fixation surfaces
• Validation of additive manufacturing process
• Validation of packaging and shelf life
• Bacterial endotoxins test
• Validation of reusable instrument reprocessing parameters

These are tests for a physical medical device, not an AI/ML algorithm.

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The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
· joint impairment due to osteoarthritis or traumatic arthritis of the knee.
· varus deformity of the knee, and
· as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended fixation. A Bodycad screw must be used for fixation of the femoral component.

The Bodycad Unicompartmental Knee System (BUKS) is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial components and single-use cutting quides are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BUKS is for cemented use only and is sterilized by gamma radiation.
The subject of this 510(k) notification is a line extension and design update that includes a new tibial baseplate that is compatible with the BUKS system (K163700, K181302) and instruments that are compatible with the new tibial baseplate.
Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component and screw, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6Al4V ELI; ASTM F136-13) for the tibial baseplate, locking pin, and screw, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.

The provided text is a 510(k) summary for the Bodycad Unicompartmental Knee System. This document is a regulatory submission for a medical device and describes its intended use, technological characteristics, and a comparison to predicate devices to demonstrate substantial equivalence.

Based on the content, the document does NOT describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device. This document is for a physical medical implant (a knee system) and the performance data presented relates to mechanical testing and surgeon-user validation for the physical device, not an AI or software algorithm.

Therefore, I cannot extract the requested information regarding AI/algorithm performance, acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies.

The document primarily focuses on demonstrating the substantial equivalence of a physical knee implant (Bodycad Unicompartmental Knee System) to previously cleared predicate devices through design comparison and mechanical performance testing, not on the performance of a software algorithm or AI.

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The MOTO™ Lateral Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The MOTO™ Lateral Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

MOTO™ Lateral Partial Knee System design is characterized by:

• a femoral component designed to anatomically fit the lateral femoral condyle
• a tibia component, designed to anatomically fit the lateral tibial condyle
• a fixed tibia insert, with a flat articulating surface with rounded border

MOTO™ Lateral Partial Knee System has been designed in cemented version only. The femoral component is made of cobalt-chromium-molybdenum (Co-Cr-Mo per ISO 5832-4), and the tibial component consists of an ultra-high molecular weight polyethylene (UHMWPE per ISO 5834-2 Type 1) insert, and a metal baseplate component (Ti-6Al-4V per ISO 5832-3). The MOTO™ Lateral Partial Knee System implants are offered sterile (via gamma irradiation for the femoral and tibial tray components and ethylene oxide for the tibial insert components), are intended for single use only, and may not be re-sterilized

The Lateral Femoral Component (cemented) is symmetrically shaped (suitable for both left and right side) and designed with two (2) fixation pegs for all the sizes. It is available in seven (7) sizes (1 - 7).

The Lateral Fixed Tibial Insert has a fixed design, is symmetrically shaped (suitable for both left and right side) and is available in eight (8) sizes (1 – 8). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm). It is fixed through a snapping mechanism with baseplate.

The Lateral Fixed Tibial Tray (cemented) has a fixed bearing design with one (1) triangular keel and two (2) 'mushroom' shaped pegs to ensure primary stability. Available in eight (8) sizes (1 - 8), the Lateral Fixed Tibial Tray is offered in both Right Lateral (RL) and Left Lateral (LL) options for each size.

This document is a 510(k) Premarket Notification for the MOTO™ Lateral Partial Knee System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the context of AI/ML device performance. Therefore, most of the requested information regarding AI/ML device performance is not applicable or available in this document.

However, I can extract the information related to the device's performance testing and general acceptance criteria as presented in the document.

Acceptance Criteria and Device Performance for Mechanical Testing:

The document states: "Testing was conducted according to written protocols with acceptance criteria that were based on standards." However, the specific quantitative acceptance criteria and the numerical reported device performance are not explicitly detailed in the summary tables provided. Instead, the document lists the types of tests performed.

Detailed Information as per Request:

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

   • As noted above, specific numerical acceptance criteria and reported performance values are not explicitly stated in this 510(k) summary. The document mentions that "acceptance criteria... were based on standards" and lists the types of tests conducted. The conclusion of substantial equivalence implies that these criteria were met.

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

   • For mechanical/non-clinical studies, sample sizes are not specified. The document mentions a "Cadaveric Workshop" for design validation, implying prospective testing on cadaveric specimens, but details on the number of specimens are absent.
   • The document mentions "EndoLab Report IL test 167.180320.20.838 rev.0, dated 03.May.2018," which might contain sample size information in the full report, but it's not present in this summary.
   • Data provenance (country of origin for test data) is not explicitly stated, though the manufacturer, Medacta International SA, is based in Switzerland, and test reports mention "EndoLab" (likely a testing lab).

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 question is not applicable as the document is for a medical device (knee system), not an AI/ML diagnostic or predictive device that would typically involve expert ground truth establishment for a test set. The validation involves mechanical and design testing.

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

   • Not applicable for this type of mechanical device submission. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human 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:

   • Not applicable. This device is a knee implant, not an AI-assisted diagnostic tool. No MRMC studies were performed or relevant.

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

   • Not applicable. This is a physical medical device (knee implant), not an algorithm.

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

   • For mechanical testing, the "ground truth" refers to established engineering standards (e.g., ASTM, ISO), mechanical properties of materials, and design specifications.
   • Biocompatibility was supported by previous testing on predicate devices using similar materials.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set. The design and manufacturing process involves engineering principles and material science, not machine learning training.

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

   • Not applicable. See point 8.

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The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer Patient Specific Instruments System is to be used with Zimmer Unicompartmental High Flex Knee System prostheses families only.

The Zimmer Patient Specific Instruments are intended for single use only.

The Zimmer Patient Specific Instruments System consists of a software component, Zimmer Patient Specific Instruments Planner and a hardware component, Zimmer Patient Specific Instruments and is designed to assist the surgeon in the placement of unicompartmental knee replacement components for Unicompartmental High Flex Knee System prosthesis.

The provided text describes a 510(k) summary for the Zimmer Patient Specific Instruments System, outlining its intended use, technological characteristics, and performance data. However, it does not contain specific acceptance criteria with numerical targets, nor does it detail a study that explicitly proves the device meets such criteria in a quantitative manner as typically requested for AI/ML device evaluations.

Instead, the performance data section generally states that "Software validation and accuracy performance testing by means of saw bone models, cadaveric trials and guide deformation verification after sterilization were performed to assess the safety and effectiveness of the device." And "These tests verified that the accuracy and performance of the device is adequate to perform as intended."

This suggests a general validation rather than a study with defined acceptance criteria and corresponding quantitative results. The submission predates modern requirements that would typically necessitate detailed quantitative performance metrics for AI/ML components.

Given the information provided, I cannot populate the table or answer all requested questions with specific quantitative details. I will indicate where the information is not available in the provided text.

Here's an attempt to answer the questions based on the available text:

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

No specific numerical acceptance criteria or quantitative performance metrics are provided in the document. The performance data section broadly states: "These tests verified that the accuracy and performance of the device is adequate to perform as intended."

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

The text mentions "saw bone models" and "cadaveric trials" as part of non-clinical tests.

• Sample size: Not specified.
• Data provenance: "Saw bone models" and "cadaveric trials" imply laboratory-based testing, not clinical data from patients. The country of origin for this testing is not specified. It is inherently prospective in the context of the testing (i.e., conducted specifically for the submission).

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. The performance testing described (saw bone models, cadaveric trials, guide deformation) does not involve expert-established ground truth in the context of diagnostic interpretation or clinical decision-making. It's a physical or software accuracy validation.

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

Not applicable. This device is not an AI/ML diagnostic interpretation system that would typically require expert adjudication for ground truth. The validation relies on measurements from physical models and cadavers.

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 not mentioned. The device assists surgeons in positioning knee replacement components and guiding cuts, rather than providing interpretations for human readers to evaluate.

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

The device explicitly includes a "human-in-the-loop" step: "The software is then used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan." Therefore, a standalone (algorithm only) performance, separate from the surgeon's review and approval, is not described or indicated as being evaluated as such. The system is designed to be used with a surgeon's oversight.

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

For the non-clinical tests:

• For software validation and accuracy testing: Likely engineering specifications, direct measurements on saw bone models or cadavers (e.g., comparing planned cuts/positions to actual cuts/positions, or anatomical landmarks), and measurements related to guide deformation.
• The text states "These tests verified that the accuracy and performance of the device is adequate to perform as intended," implying comparison against an established engineering or anatomical ground truth, even if not explicitly detailed.

8. The sample size for the training set

Not applicable. The description does not indicate an Artificial Intelligence/Machine Learning (AI/ML) component that would typically require a "training set" in the modern sense. The "Zimmer Patient Specific Instruments Planner" is described as a "software component" that "generates a pre-surgical plan based on MRI imaging data." This sounds like rule-based software or traditional image processing, not a machine learning model that undergoes a distinct training phase.

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

Not applicable, as there is no indication of an AI/ML component requiring a training set with established ground truth in the context of machine learning.

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The Journey Unicondylar Femoral Implant components are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
2. Correction of functional deformity;
3. Revision procedures where other treatments or devices have failed; and
4. Treatment of fractures that are unmanageable using other techniques.

The Journey Unicondylar Femoral Implant components are single use only and are intended for implantation only with bone cement.

The Journey Unicondylar Femoral Implant components will consist of various size and hand femoral implants for medial and lateral tibiofemoral compartment replacement. The femoral implants are anatomically shaped and are available in right and left, medial-lateral hand configurations (LL/RM and RL/LM). The femoral implants are offered in sizes 1-7.

I am sorry, but the provided text is a 510(k) summary for a medical device (Smith & Nephew Journey Unicondylar Femoral Implants). This document does not contain information about acceptance criteria, device performance metrics, or details of a study involving AI, human readers, or ground truth establishment.

The document primarily focuses on:

• Intended Use: What the device is for.
• Device Description: What the device is made of and its types.
• Substantial Equivalence: Comparing the new device to previously approved devices.
• Regulatory Information: FDA approval letter, classification, and contact information.

Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about acceptance criteria, study details, sample sizes, or expert qualifications from this document.

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The ConforMIS™ Unicondylar Knee System is intended for use in Patients with:

• joint impairment due to osteoarthritis or traumatic arthritis of the knee
• Previous tibial condyle or plateau fracture, creating loss of function
• valgus or varus deformity of the knee
  The ConforMIS™ Unicondylar Knee System is for use with cement.

The ConforMIS Unicondylar Knee System is a device developed from patient CT scans to replace one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and allows internal/external rotation between the femoral and tibial components. Movement is limited by the ligaments and other soft tissues surrounding the device. The device is designed to conform to the patient's anatomy as closely as possible based on the CT scans.

The provided document describes the ConforMIS™ Unicondylar Knee Repair System, a custom-designed knee implant. However, it does not contain specific acceptance criteria, performance data from a clinical study, or details about the methodology of such a study.

Here's an breakdown of the information that is available and what is missing based on your request:

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

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: Not reported in the document. The document states: "Performance Data: Non-clinical Performance and Conclusions: Testing completed as part of the design verification procedure for the ConforMIS Unicondylar Knee System found this device to be as safe and effective as the predicate devices, further confirming substantial equivalence. Clinical Performance: Clinical data and conclusions are not necessary to demonstrate substantial equivalence."

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. No clinical test set data is provided.

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. No clinical test set data is provided, and therefore no ground truth establishment based on expert review.

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

• Not Applicable. No clinical test set data is provided.

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 physical knee implant, not an AI/software device intended for diagnostic interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. No clinical study involving ground truth establishment is described.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. It is "developed from patient CT scans to replace one compartment of the knee condyles" and "designed to conform to the patient's anatomy as closely as possible based on the CT scans." While patient CT scans are used for designing the individualized implant, this is not a "training set" in the context of an AI algorithm, and no sample size for such a set is mentioned.

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

• Not Applicable. As above, there is no "training set" in the AI sense for which ground truth would be established. The "ground truth" for the device design is the individual patient's anatomy derived from their CT scans.

Summary of the Study (as described in the document):

The document explicitly states: "Clinical data and conclusions are not necessary to demonstrate substantial equivalence." Instead, the submission relies on:

• Non-clinical Performance and Conclusions: "Testing completed as part of the design verification procedure for the ConforMIS Unicondylar Knee System found this device to be as safe and effective as the predicate devices, further confirming substantial equivalence." This refers to non-clinical (e.g., bench, mechanical) testing, but no specific results or acceptance criteria for this testing are provided.
• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through a comparison to legally marketed predicate devices (K033242, K033363, K033769). The ConforMIS™ Unicondylar Knee System is deemed substantially equivalent in terms of technological characteristics (design, production process, materials) and intended use.

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