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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant; in case of SMR Short Stems only if sufficient bone stock remains);
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

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 Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. 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 Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

The PRIMA Glenoid 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 PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.

The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patients. 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 PRIMA Short Stem and PRIMA Short Stem Plus are intended for use in cementless and cemented applications, at the discretion of the surgeon.

The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to:

• Non-inflammatory degenerative joint disease (i.e. osteoarthritis),
• Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis,
• Avascular necrosis of the humeral head,
• Traumatic/post-traumatic arthritis,
• Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains,
• Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains,
• Cuff tear arthropathy (CTA Heads only).

The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).

Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses.

The PRIMA reverse implant is indicated for patients suffering from pain and disability due to:

• Rotator cuff tear arthropathy,
• Osteoarthritis with rotator cuff tear,
• Rheumatoid arthritis with rotator cuff tear,
• Massive irreparable rotator cuff tear,
• Avascular necrosis of the humeral head,
• Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains,
• Fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains.

The subject devices consist of a line extension of the SMR Shoulder System and the PRIMA Shoulder System. The new devices introduced with this 510(k) are SMR and PRIMA Glenospheres with diam. 40 and 44mm made of Vitamin E crosslinked UHMWPE (LimaVit) and corresponding CoCrMo humeral liners.

The PRIMA Humeral System consists of the following single use components:

• Anatomic configuration:
  • Stem
  • adaptor for humeral heads.
• Reverse configuration:
  • stem
  • reverse tray and polyethylene reverse insert, or
  • metallic reverse insert.

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The InSet Reverse Total Shoulder System should be used in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or 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 InSet Reverse Total Shoulder System is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Glenoid Baseplate is intended for cementless application with the addition of screw fixation. The Humeral Stem may be implanted by press-fit or cement fixation.

N22 EZ Glenosphere made of Titanium is indicated for patients with a suspected sensitivity to the constituents of CoCr alloy that complies with ASTM F75. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Cobalt Alloy Glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to the constituents of CoCr alloy.

The proposed N22 EZ Glenosphere is manufactured from titanium alloy (Ti-6Al-4V) per F136 featuring a nitrogen ion implantation surface hardening treatment. It is designed for use with the InSet™ Reverse Total Shoulder System components cleared under K210533, maintaining the same dimensional specifications as the cleared CoCr Glenospheres (K210533), with modifications including increased articular surface roughness and a radiused distal end on the male Morse taper. The glenosphere-baseplate construct and humeral assembly mirror those of the predicate device, utilizing a central compression screw with peripheral screws for baseplate fixation and compatible humeral stems (K173824), which allow for press-fit or cemented use. All associated components (humeral stem, tray, baseplate, screws) are made from Ti-6Al-4V per ASTM F136, with porous titanium coating (ASTM F67) on the humeral stem and baseplate.

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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.

The AltiVate Reverse® ADLC Glenosphere is a line extension to the existing Reverse Shoulder Prosthesis® (RSP) Glenosphere for use in reverse Total Shoulder Arthroplasty (TSA) applications. The new implants consist of glenospheres manufactured from titanium alloy (Ti-6Al-4V) and coated on the articulating surface with amorphous diamond-like carbon (ADLC).

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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.

At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation. Metaphyseal stems and diaphyseal stems are intended for use without cement. The glenoid bases (metal-back or porous) are intended for cementless use with the addition of cortical and cancellous bone screws.

The JARVIS Metaphyseal Stem is modification to the metaphysis component of the Arrow Short Stem prosthesis (K202024). The Metaphyseal Stem is intended to be used with the diaphyseal component of the modular ARROW Short Stem device (K202024), including the JARVIS Diaphyseal Stem Standard (K253345). The subject modifications include optimized leading edges as well as the inclusion of suture holes for soft tissue reattachment. The JARVIS Metaphyseal Stem 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 with a pure titanium plasma spray coating per ASTM F1580.

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The Tornier Perform™ Reversed MonoPost Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of glenohumeral joint if native glenoid bone remains

All components are single use.

The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation

The Tornier Perform™ Reversed MonoPost Glenoid (Perform Mono) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis.

The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

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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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