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The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. It is indical for any medical condition in which the use of stereotaxtic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as:

• · Pedicle Screw Placement (Thoracic and Lumbosacral spine)
• Iliosacral Screw Placement
  The NextAR Spine platform is intended to be used in combination with NextAR™M Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning software is used preoperatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

The NextARTM Spine Platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:

• Navigation software which displays information to the surgeon; ●
• Augmented Reality glasses; ●
• Optical tracking system; ●
• PC based hardware platform; ●
• Fiducial Block: ●
• Adaptor for sensor:
• Spine attachment instruments ●
• Reusable surgical instruments for spine surgery procedures. ●
  The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block, and a group of pins and drills are provided sterile.
  The NextAR™ Spine Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time on a screen monitor.
  The NextAR Spine system is a surgical navigation platform which uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D-CArm scan in order to register the spine to navigation elements.
  The registration can be performed with one of the following approaches:
• Direct 3D: based on the use of an intra-operative 3D-CArm scan ●
• . 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D-CArm scan
  The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating numerical acceptance criteria for clinical performance. However, based on the performance data section, the device's accuracy was a key performance metric evaluated. The acceptance criteria for accuracy are not explicitly stated in numerical terms in this document, but the study described aimed to confirm its performance comparable to the predicate.

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

The document mentions a "Cadaver study" as part of the performance testing.

• Sample Size: The exact number of cadavers used is not specified in the provided text.
• Data Provenance: The study was a "Cadaver study," indicating it was conducted on human cadavers. This is a form of retrospective data in terms of patient-specific outcomes, as the cadavers represent once-living individuals, but the experimental setup is controlled like a prospective study. The country of origin is not specified.

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

The document does not provide details on the number of experts or their specific qualifications (e.g., radiologists with X years of experience) used to establish ground truth within the cadaver study. It states the system is intended to aid surgical placement, implying the ground truth would typically be related to the accuracy of instrument placement or trajectory relative to anatomical landmarks, ideally verified by expert assessment or post-procedure imaging analysis.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1) for the test set (cadaver study).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size regarding human readers improving with AI vs. without AI assistance. The device is a navigation platform for surgeons, implying human-in-the-loop assistance, but a formal MRMC study as typically performed for diagnostic AI is not described.

6. Standalone (Algorithm Only) Performance:

The document does not explicitly describe a standalone (algorithm only without human-in-the-loop performance) study. The device is designed as a "surgical navigation platform" to "aid the surgeon" and display information "in real-time on a screen monitor," indicating an inherent human-in-the-loop design.

7. Type of Ground Truth Used:

For the "Accuracy test" and "Cadaver study" related to placement, the ground truth would likely involve:

• Precise measurements of instrument tip position or trajectory relative to anatomical landmarks.
• Verification using high-resolution imaging (e.g., CT scan) of the cadaver after "screw placement" to assess deviation from planned trajectories or ideal anatomical placement.
  The document does not explicitly state the method for establishing ground truth, but for a navigation system, it would generally be based on anatomic truth verified by imaging or detailed measurements.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. As a substantial equivalence determination, the focus is on performance testing and comparison to predicates, not on the details of algorithmic training. The "Dedicated algorithm" is mentioned as a technological characteristic, implying machine learning components, but its training details are not disclosed here.

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

Since there is no information on a training set, the document does not provide details on how its ground truth was established.

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The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.

Total Hip Arthroplasty with the Mpres stem is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia.
· Avascular necrosis of the femoral head.

• · Acute traumatic fracture of the femoral head.
• Failure of previous hip surgery:
  o Conservative hip surgery,
  o Internal fixation,
  o Arthrodesis,
  o Hip resurfacing replacement.

Partial hip arthroplasty with the Mpres stem is indicated in the following cases:

• · Acute traumatic fracture of the femoral head.
• · Avascular necrosis of the femoral head.
  · Primary pathology involving the femoral head but with a non-deformed acetabulum.

The Mpres Neck Preserving Stem is a cementless short femoral stem intended to be used in total or partial hip arthroplasty for primary or revision surgery with minimally invasive hip replacement techniques. The Mpres Neck Preserving Stem is made of titanium alloy (Ti6Al7Nb) according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite in compliance with ASTM F1185. It is available in 12 sizes (sizes 3-14) for each neck variation configuration: a standard 130° CCD angle or an high offset 123° CCD angle.

This document is a 510(k) Premarket Notification from the FDA regarding the "Mpres Neck Preserving Stem" hip prosthesis. This type of document is generally about establishing substantial equivalence to an existing predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel AI diagnostic would.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or reader improvement with AI assistance, does not directly apply to this document's content.

The document focuses on demonstrating that the Mpres Neck Preserving Stem is substantially equivalent to legally marketed predicate devices based on technological characteristics and non-clinical performance data. It explicitly states that "No clinical studies were conducted."

However, I can extract information related to the performance data and the types of studies that were conducted to support the substantial equivalence claim.

Here's an adaptation of the requested information based on the provided text, highlighting what is available and what is not:

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

Since this is a substantial equivalence submission for a mechanical implant, performance is demonstrated through biomechanical testing and material characterization against established standards, rather than clinical performance metrics typically associated with diagnostic devices. The acceptance criteria are implicit in meeting the requirements of the cited ISO/ASTM standards.

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 in terms of specific numbers of devices tested for each non-clinical study. The reports cited (e.g., "Endolab Test Report," "CeramTec AG Test Reports," "Accentus Test Report") would contain this detail, but it's not present in this summary. For "cadaveric evaluation," the number of cadavers is not given.
• Data Provenance: The testing appears to have been conducted by various external and internal labs (e.g., EndoLab, CeramTec AG, Accentus). The company, Medacta International SA, is based in Switzerland, and Medacta USA is in Tennessee, USA. The standards cited are international (ISO, ASTM, EN) and US (USP, European Pharmacopoeia). This indicates a varied provenance tied to international standards for medical device testing.
• Retrospective or Prospective: These non-clinical performance tests are "prospective" in the sense that they are specifically performed for the purpose of this submission and validate the current design. They are not observational studies on existing 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 concept does not apply to this type of device submission. There is no "ground truth" established by experts in the context of diagnosing or interpreting images, as this is a hip implant, not an AI diagnostic device. The "ground truth" for these tests is the adherence to established engineering and material science standards.

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

This concept does not apply. Adjudication methods are relevant for clinical studies or studies involving expert interpretation, which were not performed here.

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 multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is designed for AI diagnostic aids, not for a hip implant. The document explicitly states: "No clinical studies were conducted."

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

This concept does not apply. A hip implant is a physical device, not an algorithm.

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

The "ground truth" here is the performance against established engineering and material science standards (e.g., ISO, ASTM, EN, USP). For example, a fatigue test must demonstrate that the device can withstand a certain number of cycles at a specific load without failure, as defined by the standard.

8. The sample size for the training set

This concept does not apply. 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 concept does not apply.

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Medacta Shoulder System - Reverse

Reverse Shoulder Prosthesis

The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint, severe arthropathy failed joint replacement and a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application of screws for primary stability.

Short Humeral Diaphysis

The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Medacta Shoulder System - Anatomic

Anatomic Shoulder Prosthesis

The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

Short Humeral Diaphysis

The Medacta Anatomic Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

The Medacta Shoulder Systems are modular systems intended to be used for shoulder arthroplasty (anatomical or reverse). System components were previously cleared by the FDA under K170910 (anatomic shoulder prosthesis) and K170452 (reverse shoulder prosthesis).

The Long Humeral Diaphysis implants, subject of this 510(k), are implantable devices used to replace the humeral side of the gleno-humeral joint. The product is intended to be used with the Medacta Shoulder System components as an alternative to the Standard Humeral Diaphysis components provided with those systems.

The Medacta Shoulder System Long Humeral Diaphysis couples with the Humeral Reverse Metaphysis (K170452) in the reverse configuration and the cemented and cementless Humeral Anatomic Metaphysis (K170910) in the anatomic configuration. The long humeral diaphysis, provided in 160 mm and 200 mm length options, may be used when additional distal stability in the humeral canal is needed.

The subject devices are manufactured from titanium alloy (Ti6A17Nb) and are provided sterile in 11 sizes per length option.

This device is a medical implant, not an AI/ML device, therefore, the requested information regarding acceptance criteria and study details related to AI/ML performance is not applicable. The provided text is an FDA 510(k) clearance letter and summary for a physical medical device: the Medacta Shoulder System. This document focuses on demonstrating substantial equivalence to a predicate device through material, design, and performance testing, which are different from the criteria typically found in AI/ML device evaluations.

However, I can provide a summary of the performance data that was provided in support of the substantial equivalence determination for this medical device, as described in the document.

Performance Data Provided:

The 510(k) summary lists the following performance data:

• Sterilization Validation: Per UNI EN ISO 11137-1:2015 and AAMI/ANSI/ISO 11137-2:2013. This ensures the device can be properly sterilized for safe use.
• Fatigue Testing: Per ASTM F1378-17. This evaluates the device's mechanical durability and its ability to withstand repeated stress over time, simulating conditions within the human body.
• Cadaver Studies: These studies typically assess surgical technique, implant fit, and preliminary biomechanical performance within an anatomical context.

Please note that none of the specific AI/ML related questions (sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) are relevant to the information presented in this 510(k) summary for the Medacta Shoulder System.

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The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

MectaLIF Transforaminal lumbar intervertebral body fusion device is characterized by different sizes of PEEK-OPTIMA LT1 (Polyetheretherketone) implants that can be applied with a TLIF procedure (Transforaminal Lumbar Intervertebral Fusion). Mectal IF Transforaminal is used to replace a degenerative disc in order to restore the height of the spinal column structure. They are made of PEEK-OPTIMA LT1 and contain Tantalum Markers as well as a titanium gear which enables the surgeon to alter the angle of the MectaLIF Transforaminal in situ in 15° increments and to reposition during surgery without switching instrumentation. MectaLIF Transforaminal is intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft. The dimensions of MectaLIF Transforaminal are within the following range: Length 30-34mm; Height 8-15mm; Width 12-14mm; Lordosis 5°. The materials of the components of MectaLIF Transforaminal are as follows: Implant: PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026), Gear: Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136), and Marker: Tantalum (ISO 13782 / ASTM F 560).

This document describes the premarket notification (510(k)) for the MectaLIF Transforaminal intervertebral body fusion device.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MectaLIF Transforaminal device are implicitly based on comparison to legally marketed predicate devices, demonstrating substantial equivalence in terms of performance characteristics. The document states that the device has "similar performance testing as the predicates." While specific quantitative acceptance criteria or pass/fail thresholds are not explicitly stated for each test, the successful completion of these tests and the determination of substantial equivalence indicates that the device met the necessary performance benchmarks.

2. Sample Size and Data Provenance:

The provided document describes the mechanical testing conducted for the MectaLIF Transforaminal device. For this type of device, "sample size" typically refers to the number of devices tested in the mechanical studies. However, the document does not specify the exact sample sizes used for each of the performance tests (Static Axial Compression, Dynamic Axial Compression, Static Compression/Shear, Dynamic Compression/Shear, Subsidence Resistance).

The data provenance for these mechanical tests would be from laboratory testing performed on the physical devices. The document does not specify the country of origin where the testing was physically conducted, but the applicant, Medacta International SA, is based in Switzerland, and Medacta USA (contact person) is in the USA. The testing is assumed to be prospective laboratory testing for regulatory submission rather than retrospective or prospective clinical data.

3. Number of Experts and Qualifications for Ground Truth:

This submission is for a medical device (intervertebral body fusion device) primarily supported by mechanical testing and substantial equivalence to predicate devices, not an AI/ML software device. Therefore, the concept of "ground truth" derived from expert consensus, typically used for assessing diagnostic or prognostic AI/ML algorithms, does not apply in this context. The "ground truth" for the performance of this device is established by its physical and mechanical properties as measured by the specified ASTM standards.

4. Adjudication Method:

Since no human "experts" were used to establish a diagnostic or prognostic ground truth for a test set (as this is not an AI/ML device), there was no adjudication method used in the sense of reconciling expert opinions. The performance is based on objective laboratory measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of medical device submission. MRMC studies are typically used to evaluate the impact of AI on human reader performance in diagnostic imaging. This submission focuses on the mechanical and material equivalence of an implantable device. The submission does not refer to human readers or AI assistance.

6. Standalone Performance (Algorithm Only):

This section is not applicable as the MectaLIF Transforaminal is a physical medical device, not an algorithm or software. Its performance is inherent to its physical properties and design, not an algorithm's output.

7. Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria is based on objective mechanical and material property testing performed according to recognized industry standards (ASTM F2077, ASTM F2267). This is a form of engineering or laboratory "ground truth" rather than clinical or expert consensus ground truth. The comparison to predicates also establishes substantial equivalence based on previously cleared devices meeting these same standards.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this type of device submission. Training sets are used in the development of AI/ML algorithms. This submission pertains to a physical medical implant.

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

As there is no "training set" for this physical device, this question is not applicable.

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The GMK® Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

• · Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis.
• · Avascular necrosis of femoral condyle.
• · Post traumatic loss of joint configuration.
• · Primary implantation failure.

The tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.

This modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System is a line extension to include the GMK® Revision SC (Semiconstrained) liners. The GMK® Revision SC liners work with components from the GMK® Total Knee System and from the GMK® Revision, a previously cleared Special 510(k) to the GMK® Total Knee System.

The GMK® Revision SC Liners, the subject of this 510(k), are a set of tibial inserts which work with the GMK® Revision femoral PS components and the GMK® tibial baseplates. These liners provide the surgeon with an additional option. The GMK® Revision SC Liners are offered in six sizes with seven thicknesses from 10 mm to 26 mm. The GMK® Revision SC Liners are attached to the GMK® tibial baseplates of the same size from the GMK® Total Knee System using a support peg made of CoCrMo. The device is used to replace the articular surface of the tibial plateau in the knee joint by limiting the movement of the prosthetic femoral component in translation and rotation. The GMK® Revision SC Liners attached to the GMK® tibial baseplates can also be combined with an extension stem, an offset connector and tibial wedges.

The provided text describes a 510(k) submission for a medical device (GMK® Total Knee System- Revision Semi-Constrained Liners), focusing on proving substantial equivalence to a predicate device rather than a standalone performance study with a defined acceptance criteria for diagnostic accuracy. Therefore, several of the requested sections (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC study) are not applicable or cannot be extracted from this document, as they relate to studies typically conducted for devices that perform a measurement or diagnostic function.

However, I can provide information based on the performance testing conducted to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states "The testing was conducted on the worst case component size and option/design based on engineering analysis." This implies a limited physical sample size, likely representative units for specific configurations, rather than a large statistical sample of clinical data.
• Data Provenance: The testing was conducted by the manufacturer (Medacta International SA), likely in their own or contracted testing facilities. This is a retrospective analysis of the device's mechanical and functional properties against established engineering and regulatory benchmarks, not clinical data provenance.

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

Not applicable. This document describes mechanical performance testing of a knee implant component, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions. The "ground truth" for these tests would be the established engineering standards and design specifications.

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 is a medical device (implantable knee component), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (implantable knee component), not an algorithm. The "standalone" performance here refers to the device's mechanical integrity and function.

7. The type of ground truth used

The ground truth used for this type of submission is based on:

• Established standards (e.g., ISO, ASTM for medical devices, though not explicitly stated which ones).
• FDA guidance documents for knee prostheses.
• Comparison to the predicate device system (GMK® Total Knee System, K090988), meaning the performance of the new device should be within the established parameters or comparable to the predicate.
• Design specifications and risk analysis outcomes defined by the manufacturer.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable.

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The Medacta Total Hip Prosthesis System – Quadra C Femoral Stems are intended for cemented use in total or partial hip arthroplasty and in primary or revision surgery. Hip replacement is indicated in the following cases: Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia; Avascular necrosis of the femoral head; Acute traumatic fracture of the femoral head or neck; Failure of previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. Size 0 implants should not be implanted in patients with a mass of 65 kg or greater.

This modification to the original Medacta Total Hip Prosthesis System -Quadra C femoral stems is a line extension to include the AMIStem C femoral stems and Quadra C Short Neck (SN) femoral stems. AMIStem C femoral stems are based on the design of the Quadra C femoral stems in the original submission. The AMIStem C femoral stems differ from the Quadra C femoral stems by a decreased length of 15% and a reduced shoulder. The Quadra C short neck femoral stems are the same design femoral stems as the Quadra C femoral stems in the original submission but the length of the neck that is 5 mm shorter. Like the Quadra C femoral stems, the AMIStem C femoral stems and the Quadra C SN femoral stems are highly polished, collarless femoral components manufactured from forged stainless steel according to ISO 5832-9. The AMIStem C femoral stems and the Quadra C SN femoral stems are straight quadratic stems with a triple taper shape. The proximal portion of the stem has a standard 12/14 taper for mechanical attachment to cleared Medacta International metallic or ceramic femoral heads. Like the Quadra C femoral stems, two different caput-collum-diaphyseal angles (CCD) are available for the AMIStem C femoral stems and the Quadra C Short neck femoral stems: 135° for the standard offset and 127° for the lateralized offset. The Quadra C short neck femoral stems come in eight sizes with a standard offset and seven sizes with a lateral offset. The AMIStem C femoral stems come in eight sizes with a standard offset and seven sizes with a lateral offset. There are no short neck versions for the AMIStem C femoral stems. The AMIStem C femoral stems and the Quadra C short neck femoral stems provide additional femoral stem options to the surgeon for use with the Medacta Total Hip Prosthesis System.

This document describes the Medacta Total Hip Prosthesis System - AMIStem C and Quadra C SN femoral stems. As a 510(k) summary, the focus is on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics against specific acceptance criteria.

The information provided does not include:

• A specific table of acceptance criteria and reported device performance.
• Details on sample sizes used for test sets, training sets, or data provenance.
• Information on the number or qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used or how it was established for training sets.

Instead, the document states that performance testing was conducted according to various standards and FDA guidance documents, with predefined acceptance criteria based on these standards. The conclusion is that all acceptance criteria were met, verifying the performance and supporting substantial equivalence.

Here's a summary of the available information and a structured table for acceptance criteria, acknowledging the lack of specific numerical performance data within this summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This document describes bench testing for a medical device rather than a clinical study involving human data. The testing was conducted on "worst case based on engineering analysis."

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

Not applicable. Ground truth, in the context of this device, refers to meeting established engineering and material standards for the implant, not to expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human judgment (e.g., image interpretation), which is not the nature of this submission. The "adjudication" here would be the verification against predefined engineering acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a 510(k) submission for a hip prosthesis, focusing on substantial equivalence through bench testing, not a clinical effectiveness study involving human readers or AI.

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

Yes, in a sense. The "performance testing" described is for the device itself (the femoral stem), without human interaction in its functional evaluation. The testing verifies the physical and mechanical properties of the implant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is adherence to established engineering standards and FDA guidance documents for hip prostheses, covering aspects like material properties, mechanical strength, endurance, and design specifications. This ensures the device is mechanically sound and safe for its intended use.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in that context. The "training" for such a device would involve its design and manufacturing processes, which are guided by established engineering principles and standards.

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

Not applicable, as there is no "training set" in the AI/ML sense. The design and manufacturing of the device are based on long-standing medical device engineering principles, material science, biomechanics, and ISO standards (e.g., ISO 5832-9 mentioned for stainless steel). The "ground truth" here is derived from scientific and engineering knowledge accumulated over time regarding safe and effective hip prostheses.

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The GMK® Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
• avascular necrosis of femoral condyle .
• post traumatic loss of joint configuration .
• primary implantation failure. .

The tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

The modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System is a line extension to include the GMK® Revision femoral components (STD and PS), extension stems with offset adaptors, distal and posterior femoral wedges and tibial wedges.

GMK® Revision femoral components are based on the design of the GMK® Primary femoral components in the original 510(k) submission K090988. The GMK® Revision differs from GMK® Primary by an internal box that allows attachment of the extension stem and the femoral pegs are replaced by two threaded holes to attach femoral wedges.

GMK® Revision femoral components are available in two versions, standard and posterior stabilized femurs, left and right from size 1 to 6. The femoral posterior wedges include sizes 1- 6 with a thickness of 5mm and 10mm while the femoral distal wedges are available in the same size range (1- 6), in thicknesses of 4mm, 8mm and 12mm. Distal and posterior wedge screws are offered in 4mm, 8mm, and 12mm. GMK® Revision femoral components work with the same Tibial baseplates, UC tibial inserts, posterior stabilized tibial inserts and patellas cleared under the original GMK® Total Knee System, K090988.

The offset adaptors are available in 3mm and the associated extension stems are offered in diameters of 11mm, 16mm, 19mm and 20mm with each being 65mm, 105mm or 150mm in length. The tibial wedges are available in size 1- 6 at a thickness of 5mm or 10mm.

The provided text describes a 510(k) submission for a medical device, the GMK® Total Knee System - Revision. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the performance testing conducted to show that the revised device is as safe and effective as its predicate.

Here's an analysis of the provided information:

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

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 as a number of devices. The document mentions "worst case component size and option/design" for mechanical testing, implying a limited, targeted selection of components for physical evaluation. This is typical for mechanical testing of orthopedic implants, where physical samples are manufactured and subjected to rigorous testing.
• Data Provenance: The testing was conducted by or on behalf of MEDACTA International SA, based in Castel San Pietro, Switzerland. The tests were performed to FDA guidance and international standards (e.g., ASTM, ISO), which are globally recognized. The data is prospective in the sense that the tests were performed specifically for this 510(k) 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)

• This information is not applicable to this type of submission. For a 510(k) for an orthopedic implant, "ground truth" is established through engineering and material science principles, based on recognized standards (ASTM, ISO) and laboratory testing. There are no clinical images or diagnostic cases requiring expert review for ground truth in this submission.

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

• This information is not applicable as the evaluation of this device involves mechanical and material testing against predefined engineering standards, not human interpretation of clinical data. The "adjudication" is met by the test results falling within the accepted parameters specified by the 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

• This information is not applicable as this is a physical orthopedic implant, not a diagnostic imaging device or an AI-powered system designed to assist human readers.

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

• This information is not applicable as this is a physical orthopedic implant, not a software algorithm.

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

• The "ground truth" for this device's performance testing is established through recognized engineering standards (ASTM, ISO) and the physical properties of the materials and design. The acceptance criteria for mechanical integrity (e.g., surviving 10 million cycles under physiological loads, acceptable torsional forces) are derived from these established standards and real-world physiological demands on implants.

8. The sample size for the training set

• This information is not applicable. There is no "training set" in the context of mechanical performance testing for a physical orthopedic implant. This term is relevant for AI/machine learning models or statistical models that learn from data.

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 device submission.

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MyKnee Cutting Blocks are intended to be used as anatomical cutting blocks specific for a single patient anatomy to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of hone before cutting.

MyKnee Cutting Blocks are intended for use with GMK Total Knee System and its cleared indications for use.

MyKnee Cutting Blocks are intended for single use only.

MyKnee Cutting Blocks are designed and manufactured from patient imaging data so that the cutting blocks match the patient's anatomy. The MvKnee Cutting blocks for the patient are used with Medacta's existing GMK Total Knee System.

This 510(k) summary for the MyKnee Cutting Blocks describes performance testing; however, it does not provide detailed acceptance criteria or a specific study designed to "prove" the device meets acceptance criteria in the way one might expect for a software or AI/ML device.

Instead, the documentation focuses on demonstrating substantial equivalence to predicate devices through a combination of non-clinical testing and design validation. Given the nature of the device (patient-matched cutting blocks for total knee replacement), the "acceptance criteria" discussed are largely related to manufacturing quality, material properties, and dimensional accuracy, rather than clinical efficacy as might be assessed with AI.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "MyKnee Cutting Blocks were tested as part of design verification to written protocols with pre-defined acceptance criteria. The testing met all acceptance criteria..." However, the specific acceptance criteria and their corresponding reported performance values are not detailed in this summary.

Based on the text, the following types of performance were evaluated, implying associated acceptance criteria existed:

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

The document mentions "a cadaver laboratory" for design validation. This implies the use of human cadavers as a test set. However:

• Sample Size: The exact number of cadavers used is not specified.
• Data Provenance: This would be from cadaveric studies, likely performed in a laboratory setting. It is retrospective in the sense that the cadavers were not living patients undergoing surgery, but rather preserved specimens. The country of origin is not specified but would typically be the country where the manufacturing or validation studies were performed (likely Switzerland where Medacta is based, or potentially the US if outsourced).

3. Number of Experts and Qualifications

This information is not provided in the summary. While the study involved surgical tools, there is no mention of experts establishing a ground truth for a test set in the context of diagnostic performance.

4. Adjudication Method

This information is not provided in the summary. This type of adjudication is typically relevant for studies involving human interpretation (e.g., radiologists reviewing images), which doesn't appear to be the primary focus of the performance testing described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done with human readers and AI assistance. This device is a physical cutting block, not an AI diagnostic or assistive tool in that traditional sense. The "patient-matched" aspect refers to the manufacturing process creating a custom physical tool from patient imaging data, not an AI providing clinical interpretations.

6. Standalone (Algorithm Only) Performance

The closest analog to "standalone performance" for this device would be the accuracy and precision of the MyKnee Cutting Blocks themselves in matching the patient's anatomy and guiding cuts. This was part of the "dimensional accuracy and precision" testing, and "software tools used to manufacture the MyKnee Cutting Blocks were validated for their intended use." However, it's not an algorithm only in the sense of a standalone AI model; it's the accuracy of the manufactured physical product derived from digital data. No specific performance metrics are given.

7. Type of Ground Truth Used

For the cadaver laboratory design validation, the ground truth would likely involve:

• Physical measurements: Direct measurements of the bone cuts and component positioning on the cadaveric knees after using the MyKnee Cutting Blocks, compared against surgical plans derived from the patient imaging data.
• Expert surgical assessment: Evaluation by surgeons to confirm if the blocks facilitate accurate and appropriate resections as intended.

8. Sample Size for the Training Set

The phrase "training set" is typically used for machine learning models. For this device, the "training" for the manufacturing process comes from the engineering design, material science, and manufacturing protocols. There isn't a "training set" of data in the AI/ML sense. The "patient imaging data" for each individual patient is used to design their specific cutting blocks, not to train a general model.

9. How Ground Truth for Training Set Was Established

Given that there is no "training set" in the AI/ML sense, this question is not applicable to the MyKnee Cutting Blocks device as described. The "ground truth" for the overall design and manufacturing process would be established through engineering specifications, material properties testing, and verification of the manufacturing process (as implied by process reproducibility and software validation).

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The iMNS Medacta Navigation System is intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, instrument and implant positioning during joint replacement.

The iMNS Medacta Navigation System provides computer assistance to the surgeon based on anatomical landmarks and other specific data obtained intra-operatively that are used to place surgical instruments.

Examples of some surgical procedures include but are not limited to: Total Knee Replacement Minimally Invasive Total Knee Replacement

The iMNS Medacta Navigation System is a device for computer aided navigation of surgical instruments used in total knee replacement surgery. The system works on the common principle of stereotaxic technology in which passive markers are securely mounted on the patient's bones and an infrared camera is used to monitor the spatial location of those markers. This information is used to locate the anatomical landmarks such as centers of rotation of the femur head, knee and ankle intraoperatively. These measurements are displayed on a computer screen in real time. The instruments are then outfitted with the passive markers to improve the positioning of the cutting guides. The information from the system with the "navigated" instruments assists the surgeon in conducting the bone resections and positioning of the orthopedic surgical implants. The surgeon maintains control of the surgery and makes any decisions required with regard to bone resections and implant positioning but the iMNS Medacta Navigation System provides real time support and information throughout the surgery.

The iMNS Medacta Navigation System consists of the following kev components:

• · An acquisition system composed of two infrared cameras equipped . with infrared light emitting diodes (LED) to track the position of the passive markers.
• . A computer running the proprietary Medacta software and a monitor,
• . Interface devices of a keyboard, foot pedal and optional mouse to control the system, and
• Manual reusable surgical instruments. .

The software application called GMK v4.2.2 is designed to work with Medacta's GMK Total Knee System, cleared under K090988. The manual reusable surgical instruments include instruments specifically designed for navigated surgery and other standard surgical instruments needed to conduct total knee replacement.

The Medacta iMNS Navigation System (GMK v4.2.2) is a computer-aided navigation system for total knee replacement surgery. The device was tested through a series of "design verification and validation" protocols with predefined acceptance criteria. These tests were conducted as part of the Special 510(k) submission (K100314) to demonstrate substantial equivalence to its predicate device (iMNS Medacta Navigation System v4.0, K083872).

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

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

The document states that "The iMNS Medacta Navigation System was tested as part of design verification and validation to written protocols with pre-defined acceptance criteria. The testing met all acceptance criteria." However, specific numerical acceptance criteria (e.g., accuracy thresholds) and their corresponding reported device performance values are not detailed in the provided text. The tables list the Protocol IDs, Report IDs, and Titles of the verification and validation activities.

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

The document primarily describes internal design verification and validation activities. It mentions "Design validation was conducted on the iMNS Medacta Navigation System in a simulated user setting by a surgeon". It does not specify a sample size for a test set (e.g., number of patients or cases), nor does it provide information on data provenance (country of origin, retrospective/prospective). The testing appears to be conducted in a simulated environment rather than on patient 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)

The design validation was conducted "by a surgeon". The specific number of surgeons, their qualifications, or how they established "ground truth" (e.g., in a simulated environment for measurement accuracy) is not detailed beyond the mention of "a surgeon."

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

The document does not describe any adjudication method for the test set results. The validation was conducted by "a surgeon," implying a single expert evaluation for the simulated user setting.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is a surgical navigation system, not an AI diagnostic tool for human readers. It assists the surgeon directly in instrument positioning.

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

The document implies that "standalone" testing (algorithm only performance) was inherently part of the design verification and validation activities, particularly for functionalities related to "res resection planning," "single point acquisition," and "mechanical axis and sagittal plane reconstruction." These would evaluate the accuracy and functionality of the software's calculations and measurements independent of the surgeon's real-time input, though the text does not explicitly use the term "standalone performance." The "simulated user setting" test with a surgeon would combine both algorithm and human-in-the-loop.

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

Given the nature of the device (surgical navigation), the "ground truth" for the verification and validation activities likely involved predefined geometric or anatomical targets and measurements within the simulated environment. For example, for "resection planning," the system's output for bone cuts would be compared against the ideal planned cuts. For "mechanical axis and sagittal plane reconstruction," the system's computed axes would be compared against known or calculated true axes. The document does not explicitly state the type of ground truth in terms such as "expert consensus," "pathology," or "outcomes data."

8. The sample size for the training set

The document does not mention a training set or its sample size. This type of 510(k) submission generally focuses on design verification and validation of a defined software version, not on the developmental process involving a training set for machine learning. The system's core principle is "stereotaxic technology," implying pre-programmed algorithms rather than machine learning models requiring training data.

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

Since a training set is not mentioned, there is no information on how its ground truth would have been established.

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The Versafitcup™ Double Mobility Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of: - Severely painful and/or disabled joint as a result of osteoarthritis, post traumatic arthritis, rheumatoid arthritis, or psoriactic arthritis, - Congenital hip dysplasia - Ankylosing spondylitis - Avascular necrosis of the femoral head - Acute traumatic fracture of the femoral head or neck - Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. - Dislocation risks

The Versafitcup™ Double Mobility Highcross® HXUHMWPE liners are a modification of the polyethylene liners to be made of a highly crosslinked ultra high molecular weight polyethylene. The liners are identical in sizes, dimensions and functionality as the standard UHMWPE liners which were cleared as part of the original 510(k) submission. The Highcross® UHMWPE liners are manufactured from UHMWPE that has been crosslinked by controlled exposure to radiation followed by a stabilizing heat treatment prior to machining of the liners. The crosslinked UHMWPE has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to wear. The Highcross® highly crosslinked UHMWPE meets all of the specifications of ASTM F648. There is no change to the metal acetabular cup of the Versafitcup™ Double Mobility system. The polyethylene double mobility liner is designed to articulate freely within the metal acetabular cup. The Versafitcup™ Double Mobility acetabular cup has a highly polished inner surface to facilitate this articulation. The Versafitcup™ Double Mobility Family including the new highly crosslinked UHMWPE liners are designed to be used with the Medacta Total Hip Prosthesis' Quadra Stems and ball heads (K072857, K073337, K080885, K082792).

This document describes the premarket notification (510(k)) for the Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners, a hip joint prosthesis component. The focus of the submission is on demonstrating substantial equivalence to a predicate device, which is primarily achieved through performance testing and comparison of material properties and design.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table detailing "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might expect for software or diagnostic devices. Instead, it states that:

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

• Sample Size: The document states that "testing was conducted on the worst case component size and option/design." No specific numerical sample size is provided for the performance testing.
• Data Provenance: The data is generated from in vitro performance testing (e.g., "simulator wear data") conducted by the manufacturer, Medacta International SA. It is not patient or clinical data. The country of origin of the data would be where Medacta International SA performed the testing, which is Switzerland. The data is retrospective in the sense that it describes the performance of the manufactured product under test conditions, not prospective clinical outcomes.

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

This criterion is not applicable in the traditional sense for this type of device and submission. The "ground truth" for the device's performance is established through objective engineering and material science testing against predefined standards and specifications, not through expert consensus on medical images or diagnoses. There's no mention of experts establishing ground truth for the test set.

4. Adjudication Method for the Test Set

This criterion is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases (e.g., radiology reads) to establish a consensus ground truth. The performance testing for this orthopedic implant relies on objective measurements from instruments and 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 criterion is not applicable. The device is an orthopedic implant (hip liner), not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or assessment of AI assistance improvement for human readers was performed or is relevant.

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

This criterion is not applicable. The device itself is a physical medical device. There is no "algorithm" to be tested in a standalone manner without human-in-the-loop performance. The testing performed is on the physical properties and wear characteristics of the implant material.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the device's performance is based on:

• Material Specifications and Standards: Compliance with ASTM F648 for highly crosslinked UHMWPE.
• Engineering Performance Benchmarks: Comparison of physical and mechanical properties to standard UHMWPE and demonstration of increased wear resistance through simulator testing.
• Design and Manufacturing Consistency: Ensuring the new liners maintain the same design, sizes, dimensions, functionality, and manufacturing methods as the predicate device.

8. The Sample Size for the Training Set

This criterion is not applicable. There is no "training set" in the context of an AI/machine learning model. The device is a physical product, and its development and validation rely on engineering design, material science, and physical testing.

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

This criterion is not applicable as there is no training set for an AI/machine learning model.

In summary: The provided document describes the regulatory submission for a physical medical device (hip joint liner). The performance testing and acceptance criteria are rooted in material science, engineering standards, and direct comparison to a predicate device's established characteristics, rather than clinical efficacy studies, expert consensus on images, or AI algorithm validation methods.

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