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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

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

The patient's joint must be anatomically and structurally 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. The humeral stems are intended for cemented or cementless use.

The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

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 and structurally 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. The humeral short stem is intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

The MSS - Humeral reverse liners extension is a Medacta Shoulder System line extension aiming to include the following new implants:

• Humeral reverse liners made of Vitamin E Highly Crosslinked polyethylene (E-Cross); and
• Humeral reverse constrained liners available both in Highly Crosslinked Polyethylene (HCPE) and Vitamin E Highly Crosslinked polyethylene (E-Cross).

The MSS - Humeral reverse liners extension implants are intended to be used in the reverse configuration only, in order to replace the humeral side of the gleno-humeral joint. They are available in 4 articular surface diameters and 3 heights. The subject MSS - Humeral reverse liners have been designed to be coupled with Medacta Shoulder System humeral reverse metaphysis and to provide an articular surface for the glenosphere.

The subject liners are implantable devices provided individually packed, sterile and single-use.

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The prostheses from FH Industrie are designed for specific indications such as:

SIMPLE HUMERAL PROSTHESIS

• Humeral head necrosis without injury to the glenoid cavity.
• Extensive humeral head cartilage damage without injury to the glenoid cavity
• Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
• Rheumatoid polyarthritis with thin rotator cuff.
• Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH PEGS)

• Centred glenohumeral osteoarthritis with functional rotator cuff
• Rheumatoid polyarthritis with functional rotator cuff
• Post-traumatic sequela, functional rotator cuff with glenoid injury.

TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)

• Centred glenohumeral osteoarthritis
• Rheumatoid polyarthritis
• Post-traumatic sequela with glenoid injury
• Revision for glenoid loosening
• Glenoid bone loss, where bone graft is needed

A functional rotator cuff is necessary to use this device

REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)
The ARROW and JARVIS Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.

For all types of prosthesis, the glenoid baseplate (porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem and diaphyseal stem) is intended for cementless use.

At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.

The JARVIS Diaphyseal Stem Standard is an extension of humeral stem range of the Arrow prosthesis. The JARVIS Diaphyseal Stem Standard is intended to be used with the Metaphyseal component of the modular ARROW Short Stem device (K202024). The JARVIS Diaphyseal Stem Standard is offered in various sizes to accommodate patient anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3.

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The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.

The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intended for primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components – glenophere, baseplate, and fixation component (screw or post). All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

The subject submission seeks to gain clearance for design modifications to the existing device components.

The provided FDA 510(k) clearance letter for the JARVIS Glenoid Reverse Shoulder Prosthesis does not contain any information regarding clinical studies, acceptance criteria for an AI/CADe device, or performance data related to AI assistance.

The document describes a traditional medical device (a shoulder prosthesis), not an artificial intelligence (AI) or computer-assisted detection/diagnosis (CADe/CADx) device. Therefore, it lacks the specific details requested in your prompt, such as:

• Table of acceptance criteria and reported device performance for an AI/CADe system.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Ground truth types and methods for establishing ground truth.
• Training set sample size and ground truth establishment for AI.

The "Performance Testing" section explicitly states: "Engineering analysis was conducted on the modified locking screws and concluded that the compressive force of the subject screws is equivalent to that of the predicate and therefore locking capabilities are equivalent. Therefore, all previous performance testing and validations are still applicable and no additional testing is necessary." This refers to mechanical testing of the physical implant components, not performance of an AI algorithm.

In summary, the provided text is for a physical medical implant, not an AI-based or software-as-a-medical-device (SaMD) product that would require the kind of data and studies you are asking about.

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The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

• Severe arthropathy with a grossly deficient rotator cuff;
• Previously failed joint replacement with a grossly deficient rotator cuff;
• Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
• Bone defect in proximal humerus;
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
• Inflammatory arthritis including rheumatoid arthritis;
• Correction of functional deformity.

The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures.

All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

This 510(k) submission proposes updated Surgical Technique within labeling, to reflect alternative reaming method to prepare the glenoid surface for the AltiVate Reverse Glenoid wedge baseplate. The alternative technique does not replace the original technique; it adds a secondary method for the user. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced.

This 510(k) clearance letter is for a medical device (AltiVate Reverse® Glenoid), specifically a shoulder joint prosthesis, not an AI/ML-based device. The provided text details the regulatory clearance for the device itself and a minor update to its surgical technique within labeling.

Therefore, the input does not contain the information necessary to describe acceptance criteria and a study proving an AI/ML device meets them as requested in the prompt. The document describes a physical device, not a software or AI algorithm.

Here's why the prompt cannot be answered with the provided text:

• No mention of AI/ML or Software: The entire document refers to a "shoulder joint metal/polymer semi-constrained cemented prosthesis," a physical implant. There is no mention of algorithms, artificial intelligence, machine learning, image analysis, diagnostics, or any other software-based function.
• Performance Testing: The "Performance Testing" section states, "Design Control and Verification and Validation Activities performed, demonstrates substantial equivalence between the subject and predicate devices and did not raise different questions of safety and effectiveness." This refers to traditional engineering and biomechanical testing for a physical implant, not the evaluation of an AI model's performance on data.
• Acceptance Criteria for AI: The prompt specifically asks for acceptance criteria related to AI performance (e.g., sensitivity, specificity, AUC) and details about a study evaluating an AI model (test set size, ground truth, expert review, MRMC studies). None of this information is relevant or present in the provided 510(k) letter for a physical orthopedic implant.

In summary, the provided FDA 510(k) letter is for a physical medical device and does not contain any information about the acceptance criteria or study data for an AI/ML-based device.

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The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi-arthroplasty is determined by the surgeon to be the preferred method of treatment.

• The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation.
• The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
• The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
• Humeral Heads are intended for use in cemented and press-fit applications.

Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:

The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The proposed Equinoxe Activit-E Reverse Humeral Liners are humeral liners intended to be used in reverse total shoulder arthroplasty (rTSA) as a part of the Equinoxe® Shoulder System. The proposed devices are constructed of highly crosslinked UHMWPE containing vitamin E referred to as Activit-E. There are no proposed geometric or compatibility changes as compared to the predicate humeral liner devices cleared in K223833.

The provided document is a 510(k) clearance letter and summary for a medical device, the Equinoxe® Shoulder System. This document focuses on the substantial equivalence of a new version of the device (specifically, the Humeral Liners made from Activit-E material) to a previously cleared predicate device.

The FDA 510(k) clearance process is primarily focused on demonstrating substantial equivalence, not necessarily on proving that a device meets specific "acceptance criteria" in the same way one might for a diagnostic AI algorithm. Therefore, the information typically requested in an acceptance criteria study (like sample sizes for test and training sets, expert qualifications, ground truth establishment for AI, MRMC studies, or standalone algorithm performance) is not directly present in this regulatory submission for a physical orthopedic implant.

However, I will extract the closest available information related to performance and testing, as well as explicitly state where the requested information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific medical device (Equinoxe® Shoulder System - Humeral Liners), the "acceptance criteria" are not reported as numerical thresholds like accuracy or sensitivity. Instead, the acceptance criteria are implicitly met by demonstrating that the new device performs "as intended" and is "substantially equivalent" to the predicate device through various non-clinical tests. The performance is assessed by confirming that the new Activit-E material does not negatively impact the mechanical integrity and biological interaction compared to the conventional UHMWPE.

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

This information is typically not included in a 510(k) summary for a physical implant. The "test sets" here refer to the samples of the device components used for mechanical and biological testing.

• Sample Size for Test Set: Not specified in the provided document (e.g., number of liners tested for fatigue, wear). These would be standard engineering test sample sizes as per relevant ASTM/ISO standards.
• Data Provenance: Not specified. Non-clinical bench testing is typically performed in a controlled laboratory environment. Retrospective/prospective data or country of origin are not applicable in the same way as for clinical studies or AI algorithms.

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

This information is not applicable and therefore not provided. For a physical implant like a shoulder system, "ground truth" is established through engineering specifications, material properties, and performance standards, not through expert consensus on interpretations like with medical images.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical data (e.g., radiological images) to establish ground truth, which is not relevant for the bench testing of mechanical implants.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not applicable and therefore not provided. MRMC studies are used to assess the impact of a diagnostic aid (e.g., an AI algorithm) on human reader performance, which is not relevant for the clearance of an orthopedic implant.

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

This information is not applicable and therefore not provided. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Equinoxe® Shoulder System Humeral Liners is established through industry-recognized performance standards (ASTM and ISO standards) and engineering specifications. These standards define acceptable limits for wear, fatigue, biocompatibility, and other mechanical and biological properties. Compliance with these standards, along with demonstration of equivalence to the predicate device, forms the basis of the safety and effectiveness claims.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical implant, not an AI algorithm that requires a training set.

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

This information is not applicable and therefore not provided.

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The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

The subject SMR Reverse HP Shoulder System is a line extension to the predicate SMR Shoulder System (K223876) consisting of Reverse HP crosslinked UHMWPE glenospheres and Co-Cr-Mo liners. The components are available in one diameter with various options to accommodate varying patient anatomy.

Based on the provided FDA 510(k) clearance letter for the SMR Reverse HP Shoulder System, here's an analysis of the acceptance criteria and the study proving the device meets them:

It's important to note that this document is a 510(k) clearance, which is primarily a declaration of substantial equivalence to a previously cleared predicate device, rather than a full, de novo approval that would detail extensive clinical performance studies with specific statistical acceptance criteria for novel claims. The focus here is on demonstrating that the new device (SMR Reverse HP Shoulder System) is as safe and effective as existing legally marketed devices, rather than proving a new level of clinical efficacy.

Therefore, many of the specific details you've asked for, such as precise quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or effect size for AI assistance), adjudication methods, or detailed expert qualifications for ground truth establishment, are typically not found in a 510(k) summary, as they are not generally required for demonstrating substantial equivalence for an orthopedic implant.

The "acceptance criteria" for a 510(k) device primarily revolve around demonstrating that the new device performs as intended and is as safe and effective as its predicate. This is primarily done through non-clinical (mechanical) testing and reference to the predicate's established clinical history.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SMR Reverse HP Shoulder System are implicit in the demonstration of substantial equivalence to its predicate devices. The performance testing aims to show that the new components function equivalently to, or better than, the predicate components within the intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study described is primarily a non-clinical performance study combined with a post-market clinical data review for demonstrating substantial equivalence.

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

• Test Set (Non-clinical): The document states "Mechanical testing was performed on worst case components or constructs." This implies a limited sample size based on engineering principles (e.g., statistical power calculations for specific test types or industry standards for mechanical testing). Specific numbers are not provided, as is typical for 510(k) engineering tests.
• Data Provenance (Clinical): "Post-market clinical data from outside the United States on the subject and predicate device were provided in this submission." This indicates a retrospective collection of data from clinical use, not a prospective, controlled clinical trial specifically designed for this submission. The exact country of origin within "outside the United States" is not specified, nor is the specific sample size, though it is described as "patient-level radiographs, outcome measures, and safety data."

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

• Non-clinical: Ground truth is established by engineering standards and specifications (e.g., ISO, ASTM). The "experts" would be the engineers and technicians performing and assessing the mechanical tests against these predefined standards. Their qualifications are implicit in their ability to conduct and interpret these tests, but not explicitly stated in terms terms like "mechanical engineer with 10 years experience."
• Clinical: For the post-market clinical data, the "ground truth" refers to patient outcomes and safety information. This data is observed in real-world clinical practice, typically by treating physicians. There is no mention of a separate panel of experts specifically adjudicating this post-market data for "ground truth" purposes in the context described.

4. Adjudication Method for the Test Set:

• Non-clinical: The "adjudication" is against the pre-defined engineering standards and performance specifications for each mechanical test. This is typically a pass/fail determination based on quantitative measurements. No human-expert consensus "adjudication method" (like 2+1, 3+1) is described or typically applicable to component mechanical testing.
• Clinical: For the post-market clinical data, there's no mention of an adjudication method by external experts. The data would have been collected as part of routine clinical care or existing registries, and then compiled and analyzed by the manufacturer for the submission.

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. This device is an orthopedic implant, not a diagnostic imaging AI algorithm. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not applicable to the SMR Reverse HP Shoulder System.

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

• Not applicable. As stated above, this is an orthopedic implant, not an AI algorithm.

7. The Type of Ground Truth Used:

• Non-clinical: The ground truth for mechanical testing is based on established engineering principles and international standards (ISO, ASTM) for orthopedic implants. These standards define the expected performance and limits for various mechanical properties.
• Clinical: The "ground truth" for the clinical data is real-world patient outcomes, safety events, and radiographic assessments collected during post-market use of the predicate device and the subject device (where applicable) outside the US. These are actual clinical observations rather than expert consensus on a test set.

8. The Sample Size for the Training Set:

• Not applicable for a 510(k) orthopedic implant. Training sets are relevant for machine learning algorithms. The design and validation of this mechanical implant do not involve "training sets" in this context. The "training" for the device would be the iterative design and development process, informed by biomechanical principles and material science, leading up to the final testing.

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

• Not applicable. See point 8.

In summary, the FDA 510(k) clearance for the SMR Reverse HP Shoulder System relies heavily on demonstrating engineering equivalence and material compliance through non-clinical testing, supplemented by a review of existing post-market clinical data for the predicate and related devices. It is a process focused on showing that the new device is "substantially equivalent" to an already cleared device, rather than a de novo approval process that would require extensive novel clinical efficacy studies with sophisticated statistical methodologies often seen for new drug or AI algorithm approvals.

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