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Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries.

Mpact 3D Metal Augments are indicated in cases of:

• Acetabular dysplasia;
• Acetabular fractures;
• Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.

The Mpact 3D Metal Augment II is an acetabular implant intended to be used in Total Hip Arthroplasty cemented to its Medacta compatible Acetabular Shell. It is provided sterile and individually packaged to the end user.

The devices subject of this submission are:

• Mpact 3D Metal Augments II from size Ø46 to Ø80, made of Ti6Al4V according to ASTM F2924;
• Double Augment Technique Screw, made of Ti6Al4V according to ISO 5832-3.

The Mpact 3D Metal Augments II represent the second generation of the Mpact 3D Metal Augments cleared within K171966.

This FDA 510(k) clearance letter pertains to a medical device, specifically the Mpact 3D Metal Augments II, which are implants for hip replacement surgeries. The document focuses on establishing substantial equivalence to existing predicate devices based on design and performance testing. However, it does not describe a clinical study in the traditional sense, especially not one that involves human subjects or assesses AI performance.

The provided text details non-clinical performance data and validations to support the device's substantial equivalence to its predicate. It does not contain information about acceptance criteria for AI performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, many of the requested sections (including specific tables for acceptance criteria and device performance based on AI metrics, details about test sets, ground truth establishment for AI, MRMC studies, and standalone performance) cannot be filled from the provided document.

Here's a breakdown of the information that is available:

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

The document describes performance testing as "Fatigue testing in single and double augment configurations" and "Rationale of comparison – EBM Additive Manufacturing Technology." It also mentions "Design Validation on Mpact 3D metal Augments II." However, it does not disclose specific acceptance criteria or quantitative performance results for these tests. It only states that "testing activities were conducted to written protocols" and these validations are "provided in support of the substantial equivalence determination." This is typical for a 510(k) summary, which generally summarizes the data rather than providing all raw or detailed results.

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

This information is not provided in the document. The "tests" here refer to non-clinical laboratory and material tests, not clinical studies involving 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)

This is not applicable to the type of device and study described. There's no "ground truth" to be established by experts in the context of material fatigue or design validation for an orthopedic implant as presented here.

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

This is not applicable to the type of device and study described. Adjudication methods are typically used in clinical trials or studies involving expert review of medical images or outcomes.

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

There is no MRMC or comparative effectiveness study mentioned, as this is a physical medical device (hip augments), not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is an orthopedic implant, not an algorithm.

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

This is not applicable in the sense of medical diagnosis or AI performance. The "truth" for these non-clinical tests would be the physical properties and performance characteristics determined by established engineering and materials testing standards.

8. The sample size for the training set

This is not applicable, as there is no "training set" for an AI algorithm mentioned in this document.

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

This is not applicable, as there is no "training set" or "ground truth" for it in the context of AI.

Summary of what the document does provide regarding the study/testing:

The document describes non-clinical testing and validations performed to demonstrate the substantial equivalence of the Mpact 3D Metal Augments II to its predicate devices. These tests include:

• Design Validation: Performed on Mpact 3D Metal Augments II (details not provided).
• Performance Testing:
  • Fatigue testing in single and double augment configurations.
  • Rationale of comparison – EBM Additive Manufacturing Technology.
• Pyrogenicity: Control validated using bacterial endotoxin test (LAL test) per ISO11737-3 and European Pharmacopoeia §2.6.14, and in-vivo evaluation in rabbits per USP .
• Biocompatibility assessment.
• Shelf-life evaluation.

The document states that Medacta International S.A., based in Switzerland, submitted this 510(k). The tests are non-clinical, so data provenance regarding country of origin or retrospective/prospective does not apply in the same way as for clinical data. The studies are laboratory-based and conducted according to written protocols to ensure materials and design meet safety and performance standards for orthopedic implants.

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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 MyShoulder guides are intended to be used as guides specifically designed for the anatomy of a single patient. The humeral guide is used to define the level and orientation of the humeral head resection cut. The glenoidal guide is used to position and orient the K-wire that will subsequently guide the glenoidal reaming.

Both anatomical and reverse total joint configurations are acceptable.

Both humeral and glenoid guides are suitable for a delto-pectoral approach only.

MyShoulder Patient-Matched Guides are intended for use with Medacta Shoulder System and its cleared indications for use.

MyShoulder Patient-Matched Guides are intended for single use only.

The MyShoulder" Placement Guides are patient specific surgical instruments that allow for guided shoulder implants placement of both Medacta Shoulder Reverse System (K170452) and Medacta Anatomic Shoulder Prosthesis (K170910) and the additional products cleared under K181826 (Glenoid Polyaxial Non-locking screws), K180089 (Short Humeral Stem) and K171058 (Threaded Glenoid Baseplate).

The MyShoulder™ Placement guides uses the patient's CT Scan to perform a 3D planning of the glenohumeral joint replacement surgery. Then, following this planning the humeral and glenoidal guides are created. The MyShoulder™ Placement guides are anatomical guides for a single patient anatomy.

The MyShoulder™ Placement guides subject of this submission are comprised of the following products:

• 1. MyShoulder™ humeral guide: it will allow to perform an accurate humeral resection
• 2. MyShoulder™ glenoidal guide: it will provide a precise alignment reference that will guide the glenoidal reaming and final implant positioning.

The MyShoulder™ Placement guides are manufactured from medical grade nylon for sintering (Polyamide PA 12) which is identical to Medacta reference device MySpine Pedicle Screw Placement Guides (132788). The MyShoulder™ Placement guides are single use, external communicating devices with limited (

The provided text does not contain detailed acceptance criteria or the full study that explicitly demonstrates the device meets specific numerical acceptance criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone performance study with detailed acceptance criteria and results.

However, I can extract information related to the performance data provided to support substantial equivalence.

Here's a breakdown of the available information, addressing each point as much as possible:

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

The document does not explicitly state numerical acceptance criteria for various performance metrics, nor does it provide a table of reported device performance against such criteria. It mentions "testing was conducted according to written protocols with acceptance criteria," but these specific criteria and their corresponding results are not detailed in this summary.

The "Performance Data" section lists several non-clinical studies:

• Characterization Tests:
  • Cadaver Lab Test Report 1
  • Surgical Evaluation Test Report 2
  • MyShoulder accuracy and positioning variability cadaver test Test Report 4
  • MyShoulder accuracy test Test Report 5
• Performance Tests:
  • Effects of the Sterilization on the geometry of the MyShoulder Glenoidal Guide -Test Report 3
  • Wear Test, according to RPO-01.028.009

Without access to these specific test reports (numbers 1-5 and RPO-01.028.009), the detailed acceptance criteria and reported performance cannot be provided. The general statement is that "Risks were identified based on the proposed design and testing was conducted to mitigate those risks."

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 mentions "Cadaver Lab Test Report" and "MyShoulder accuracy and positioning variability cadaver test." This indicates the use of cadaveric samples for testing. The number of cadavers or individual samples used in these tests is not specified.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective in a clinical sense, as no clinical studies were performed. The "cadaver" tests would be considered prospective for the device evaluation.

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

This information is not provided in the document. The studies listed are non-clinical (cadaver and performance tests). While surgeons might have been involved in the "Surgical Evaluation Test Report" or "Cadaver Lab Test Report," their number and qualifications are not mentioned.

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

This information is not applicable/provided as the studies are non-clinical performance and characterization tests on cadavers and materials, not diagnostic interpretation or clinical outcome studies requiring adjudication.

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 MRMC study was done. The device is "MyShoulder™ Placement Guides," which are patient-specific surgical instruments for guiding shoulder implant placement. This is not an AI-based diagnostic tool for interpretation by human readers, so an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

The device itself is a physical surgical guide. The "planning" step involves using a patient's CT scan to perform a 3D planning of the joint replacement surgery, and then the guides are created based on this planning. This implies a human-in-the-loop process for surgical planning, followed by the physical device. The listed non-clinical studies evaluate the accuracy and performance of these physical guides. Therefore, a "standalone algorithm only" performance is not directly applicable to this type of device in the typical sense of AI algorithms. The accuracy tests (e.g., "MyShoulder accuracy test") would be evaluating the performance of the guide itself in achieving its intended surgical goal based on the planning.

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

For the "MyShoulder accuracy and positioning variability cadaver test" and "MyShoulder accuracy test," the ground truth would likely be established by precise measurements of the actual resection planes, K-wire positioning, or implant placement relative to the pre-operative 3D plan on the cadaveric specimens. This would typically involve physical measurements using highly accurate instruments, compared against the pre-operative 3D plan. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

The document states that the "MyShoulder™ Placement guides uses the patient's CT Scan to perform a 3D planning of the glenohumeral joint replacement surgery." This suggests that each guide is patient-specific and generated individually. There is no mention of a "training set" in the context of an algorithm learning from a large dataset. The customization is based on an individual patient's CT scan. If there are underlying algorithms or software used for the 3D planning itself, the training data for that specific software is not detailed in this submission.

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

As there is no "training set" described in the context of a machine learning algorithm for the device itself, this question is not applicable as presented. The process involves creating a custom guide for each patient based on their individual CT scan and a 3D planning process.

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