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The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

• Osteoarthritis
• Post-traumatic arthrosis
• Focal avascular necrosis of the humeral head
• Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Fractures of the humeral head (with Short Humeral Stems).
• Fractures of the humeral head and proximal humerus, where other methods of treatments are deemed inadequate (with Standard or Long Stems).
• Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods

The humeral stem is intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The anatomic glenoid and anatomic hybrid glenoid are intended for cemented use only. The baseplate components of the convertible glenoids are intended for cementless application with the addition of screw fixation. When a convertible glenoid liner is used, the baseplate is indicated for use with a central screw and three peripheral locking screws that are 25mm or greater in length. The peripheral non-locking screws, peripheral posts and central posts are not indicated for use with the convertible glenoid.

Reverse Total Shoulder

The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

• A severely painful, disabling, arthritic joint
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
• Revision of previously failed shoulder joint replacement

Fixation Methods

The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation. When a Peripheral Post is used, the baseplate is indicated for use with a Central Screw and two Peripheral Locking Screws that are 25mm or greater in length. The peripheral Non-Locking screws and Central Post are not indicated for use with the Peripheral Post.

The INHANCE Reverse Total Shoulder System consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-Linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), a baseplate (titanium alloy), peripheral screws (titanium alloy), a baseplate augment (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy). The purpose of this submission is to add alternate angle humeral liners to the INHANCE reverse shoulder system. The subject device is manufactured from a Cross-linked, VE UHMWPE. Size options include diameter 32mm, 36mm and 40mm with thickness +0mm or +4mm. Standard and Retentive options are available.

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The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.

The Signature™ ONE System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the Signature™ ONE System.

The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Trabecular Metal Reverse Plus® Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance® Glenoid System.

The Signature™ ONE System pre-operative planning is also compatible with the humeral components of the following shoulder implant systems in accordance with their indications and contraindications: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, and Identity™ Shoulder System.

The Signature™ ONE System Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in preoperative planning (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides and bone model) if desired in skeletally mature individuals for Total Shoulder Arthroplasty. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.

The Signature ONE Guides and Bone Models are designed and manufactured of polyamide (nylon) using additive manufacturing selective laser sintering (SLS), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provided non-sterile and sterilized at the hospital. They are used intra-operatively to assist the surgeon in reproducing the plan on the scapula. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty workflow.

The Signature™ ONE System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

The purpose of the submission is that the CT Reconstruction internal software application was updated with an improved AI/ML locked model for automatic segmentation and also retraining the model with new production grade scapula and humerus CT segmentations. The AI/ML model is used in the Segmentation step only within the CT Reconstruction internal software application prior to manual segmentation performed by the Zimmer Biomet operator. The use of AI has not changed since predicate K232425. In addition, the Landmarking step within the internal software application was updated with option to select additional configurable landmarks in the Planning application (used to determine the reference coordinate systems to provide native bone information).

The provided FDA 510(k) clearance letter for the Signature™ ONE System does not contain a detailed study with specific acceptance criteria, reported performance, or comprehensive information about the data used for testing and training. This document focuses on demonstrating substantial equivalence to a predicate device, K232425 Signature™ ONE System.

The information regarding acceptance criteria and the study that proves the device meets them is very limited in this document. The submission states that "Performance tests documented to ensure the performance of the implemented features and verify related design inputs" were conducted, but does not provide details of these tests or their results.

Here's an attempt to extract and infer the requested information based on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study for Signature™ ONE System (AI/ML Segmentation Update)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document mentions the AI/ML model was "retrained with new production grade scapula and humerus CT segmentations" and previous "humerus scans were exploratory quality." This implies a test set was used to establish the "new production grade" status, but the exact size is not provided.
• Data Provenance: Not specified. It only mentions "production grade scapula and humerus CT segmentations." The country of origin and whether the data is retrospective or prospective are not mentioned.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• Was an MRMC study done? No, the document does not mention an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The AI/ML model is described as assisting "prior to manual segmentation performed by the Zimmer Biomet operator," implying an assistive role, but no comparative study is detailed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Not explicitly stated as a standalone "study." The language "used in the Segmentation step only (...) prior to manual segmentation" suggests the AI performs segmentation independently before human review/modification, but its standalone performance metrics are not provided. The overall system is described as having manual segmentation by an operator after the AI step.

7. Type of Ground Truth Used

• Type of Ground Truth: The document refers to "new production grade scapula and humerus CT segmentations." This implies that the ground truth for segmentation was established by expert review and/or manual segmentation deemed as high quality (i.e., "production grade"). It does not specify if this was expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified. The document states the model was "retrained with new production grade scapula and humerus CT segmentations." The size of this new training set is not provided.

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

• How Ground Truth Was Established: The ground truth for the training set was established through "production grade scapula and humerus CT segmentations." This suggests that human experts (likely trained Zimmer Biomet operators or clinicians) performed manual segmentations that were then refined and verified to a high standard, serving as the ground truth for training the AI/ML model.

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• 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 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.

• Anatomic Shoulder Prosthesis

The Medacta Anatomic Shoulder Prosthesis is intended for use as a hemi or total shoulder replacement 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 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 humeral stems are intended for cemented or cementless use.

The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and 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 humeral short stem is intended for cementless use.

• Reverse Shoulder Prosthesis – monobloc stem

The reverse shoulder prosthesis using the standard monobloc stem 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 standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.

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 using the short monobloc stem 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 short monobloc stem is intended for cementless use only.

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.

• Anatomic Shoulder Prosthesis – monobloc stem

The anatomic shoulder prosthesis using the standard monobloc stem is intended for use as a hemi or total shoulder replacement. It 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 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 standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.

The anatomic shoulder prosthesis using the short monobloc stem is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and 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 short monobloc stem is intended for cementless use only.

The MSS – Monobloc stem is a Medacta Shoulder System line extension including the following implantable, individually packed, sterile and single-use devices:

• Monobloc stem, 11 sizes available in both standard and short versions. Short version has been designed, as the standard version, made of Ti6Al7Nb with Ti+HA coating, but also made from Ti6Al4V powder through an additive manufacturing process;
• Monobloc stem spacer small and large;
• Monobloc stem double eccenter small and large;
• Monobloc stem spacer/double eccenter screw;
• Distal screws with lengths from 18 to 36 in 2mm steps;
• Humeral reverse liners small and large available both in UHMWPE highcross and UHMWPE + vitamin E;
• Humeral reverse metaphysis small concentric and eccentric.

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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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Software

The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels.

Hardware

The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.

The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection.

The Precision AI Guides and Biomodels are indicated for single use only.

The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only.

The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components:

Enovis:

• AltiVate Anatomic (K162024, K173073, K193226 (CS Edge))
• AltiVate Anatomic Augmented (K213387, K222592)
• Turon Shoulder System (K111629, K080402, K123982)
• Reverse Shoulder Prosthesis (K051075, K092873, K111629, K100741, K111061, K111735, K041066, K141006)
• AltiVate Reverse (K141990, K172351, K190290)
• AltiVate Reverse Glenoid (ARG) (K233481)

Lima:

• SMR Shoulder System (K161476, K100858, K101263)
• SMR Reverse Shoulder System (K110598)
• SMR 40MM Glenosphere (K142139)
• SMR 3-Pegs Glenoid (K153722, K130642)
• SMR Modular Glenoid (K113254, K143256)
• SMR TT Metal Back Glenoid (K133349)
• SMR Hybrid Glenoid System (K163397)
• SMR Stemless Anatomic (K221758)
• SMR 140° Reverse Humeral Body (K201905)
• SMR TT Augmented Glenoid System (K191746, K200171)
• SMR Lateralized Connectors with screws (K183042)
• SMR TT Augmented 360 Baseplate (K220792)
• SMR TT Hybrid Glenoid (K220792)
• PRIMA Humeral System and SMR Glenosphere Ø42 (K212800)
• PRIMA TT Glenoid (K222427)

The Precision AI Surgical Planning System is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing patient-specific guides and models to transfer the plan to surgery. The subject device is a system composed of the following:

• The Precision AI Surgical Planning System Software will create a 3D construct/render of the patient's shoulder joint for the surgeon to plan the operation preoperatively. The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm. The surgeon can visualise the deformity of the diseased joint, on this 3D render and CT scan images, and determine the inherent deformity of the joint. They are then able to virtually place the artificial implants in an optimal position to correct the measured deformity for that specific patient. The software will create patient-specific Guide CAD file(s) if requested by the surgeon.

• The Precision AI Guides, which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guides and models will be manufactured using 3D printing by selective laser sintering if the surgeon requests patient-specific guides to transfer the plan to surgery.

The PAI-SPS generates a pre-surgical plan based on medical imaging data using the PAI-SPS Software. The software allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data, which leads to the generation of a case planning report. The PAI-SPS Software allows for the creation of a glenoid and/or humeral pre-operative plan. If requested by the surgeon, PAI-SPS Guides and Models are designed and manufactured based on the approved pre-surgical plan. PAI-SPS Guide and Models are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intraoperatively assisting the surgeon in positioning glenoid/humeral components used with total and reverse shoulder arthroplasty procedures.

The provided 510(k) clearance letter for the PAI-SPS does not contain specific acceptance criteria or details of a study proving the device meets said criteria in the format requested. The document primarily focuses on the regulatory clearance process, device description, and comparison to predicate devices, stating that clinical testing was not required to demonstrate substantial equivalence.

However, based on the information provided, we can infer some aspects and highlight what is missing.

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

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of measurable thresholds (e.g., minimum accuracy percentages, error margins). The document implies that the acceptance criteria relate to demonstrating "substantial equivalence" in safety and effectiveness compared to predicate devices.
• Reported Device Performance: No specific numerical performance metrics are reported. The document states that "Software verification and validation" and "Usability validation" were completed to demonstrate substantial equivalence.

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

• Sample Size: Not specified. The document does not mention a specific "test set" in the context of clinical or performance data using patient-specific samples.
• Data Provenance: Not specified. As clinical testing was not required for substantial equivalence, there's no mention of country of origin or whether data was retrospective or prospective.

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

• Not applicable/Not specified. The document does not describe a study involving expert-established ground truth for a test set. The validation efforts mentioned (software V&V, usability validation) do not typically involve this type of ground truth establishment.

4. Adjudication method for the test set

• Not applicable/Not specified. Since no expert-established ground truth test set is described, an adjudication method is not mentioned.

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. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence." Therefore, an MRMC comparative effectiveness study was not performed or submitted for this clearance.

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

• Yes, implicitly. The "Software verification and validation" would have involved testing the algorithm's performance in generating the 3D construct and patient-specific guide files. While specific metrics are not provided, this validation inherently assesses the algorithm's standalone capabilities. The software "auto segments via a locked, or static, artificial intelligence algorithm."

7. The type of ground truth used

• For the AI algorithm (segmentation): Implicitly, the ground truth for the segmentation algorithm would have been expert-annotated CT images or established anatomical landmarks against which the AI's segmentation accuracy is measured during its development and internal validation. The document does not specify how this ground truth was established, only that the AI algorithm is "locked, or static."
• For the overall system: The ground truth for the planning software and guides would be the "optimal position" for implant placement as determined by a qualified surgeon. The system's goal is to assist in achieving this optimal position.

8. The sample size for the training set

• Not specified. The document mentions that the AI algorithm for auto-segmentation is "locked, or static," implying it was trained on a dataset, but the size of this training set is not provided.

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

• Not specified. While it's implied that the AI for auto-segmentation was trained using data with established ground truth (likely expert-defined anatomical structures on CT images), the methodology for establishing this ground truth is not detailed in the clearance letter.

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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 Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.

ANATOMIC TOTAL SHOULDER OR HEMI-SHOULDER

The Catalyst F1x Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst F1x Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity

REVERSE TOTAL SHOULDER

The Catalyst F1x Shoulder System is a reverse total 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;
• 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

Catalyst F1x press-fit stems are intended for cementless press-fit applications.

The Catalyst F1x cemented stems are intended for cemented fixation.

The Catalyst F1x stem is compatible with the implants from the Catalyst CSR System, Catalyst EA Convertible Shoulder System and R1 Shoulder Systems.

The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. The stems can be used in conjunction with the Catalyst R1 Reverse Shoulder humeral articulating poly inserts and glenoid implants for use in reverse shoulder arthroplasty. The stems can also be used in conjunction with the Catalyst Convertible System and CSR System for use in total or hemi-shoulder arthroplasty. The design intent of the Catalyst F1x Shoulder System is to offer a unique solution for revision shoulder arthroplasty and for securing and immobilizing the greater and lesser tuberosities in the repair of proximal humerus fractures.

This submission for the Catalyst F1x Shoulder System is to add anatomic indications for the Catalyst F1x Shoulder System. This submission consists of proximal bodies, distal stems and locking screws. The fracture specific proximal bodies have asymmetric, right- and left-sided finned geometry to provide specific locations to reattach the greater and lesser tuberosities for a stable reconstruction of the proximal humerus. The proximal bodies will have a porous titanium structure on the bone engaging regions to enhance the mechanical fixation. The distal stems shall be provided in varying diameters to accommodate varying bone geometries. The distal stems will be offered in press-fit and cemented versions. The press-fit distal stems shall have a tapered, splined proximal geometry with an HA (hydroxyapatite) coating. The cemented stems shall have a smooth stem geometry. The proximal bodies and distal stems shall be secured together using a mechanical taper interface that is supplemented with a locking screw.

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