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PRIMA Humeral System: 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 suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Stem is 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 Stem is intended as conversion surgery from anatomic to reverse, where the PRIMA 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 PRIMA Humeral System consists of the following single use components:

• Anatomic configuration:
  • stem
  • adaptor for humeral heads.
• Reverse configuration:
  • stem
  • reverse tray and
  • reverse insert.

The PRIMA Humeral System is intended to be used with all SMR glenoids implants.

SMR Glenosphere Ø42: 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 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 the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

The PRIMA Humeral System is the subject of this 510(k) and includes the SMR Glenosphere Ø42.

The PRIMA Stem is a convertible short stem component with proximal fixation with Trabecular Titanium to be used in both anatomic and reverse configurations. Depending on the configuration, the short stem component (Ti6Al4V) can be coupled with an Adaptor for the humeral heads (Ti6Al4V) in case on anatomic system and with a Reverse Tray (Ti6Al4V) and Reverse Insert (LimaVit E UHMWPE Ti6A14V ring) only in case of reverse. The PRIMA Stem is intended for use in cementless and cemented applications, at the discretion of the surgeon.

When used in reverse configuration, the PRIMA Stem is coupled with a Glenosphere through a Reverse Tray and a Reverse Insert. PRIMA Stem is compatible with already cleared SMR Glenospheres Ø36 and Ø40 (K110598, K163397). In addition, PRIMA Stem is compatible with the new SMR Glenosphere Ø42 (CoCrMo), subject of the present 510(k).

This is a 510(k) premarket notification for a medical device, not a study evaluating device performance or artificial intelligence (AI) algorithm. Therefore, the typical acceptance criteria and study design for AI algorithms are not applicable here.

The document describes a medical device, the PRIMA Humeral System and SMR Glenosphere Ø42, and seeks to demonstrate its substantial equivalence to already legally marketed predicate devices. This means the manufacturer is showing that their new device is as safe and effective as existing similar devices, without necessarily conducting efficacy studies on human subjects as might be required for new, higher-risk devices or completely novel technologies.

Here's why the requested information cannot be provided from this document:

• Acceptance Criteria for AI Performance: This device is a shoulder joint prosthesis, a physical implant. It doesn't involve any AI algorithms and therefore doesn't have acceptance criteria related to AI performance metrics like sensitivity, specificity, accuracy, or F1-score.
• Study Proving Device Meets Acceptance Criteria (in the context of AI): There are no studies here that would "prove the device meets acceptance criteria" in the way an AI algorithm's performance is evaluated. Instead, this document relies on non-clinical testing (mechanical tests, material biocompatibility, sterility) and a comparison to predicate devices to demonstrate substantial equivalence.
• Sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, ground truth type, training set size, how ground truth for training set was established: All these points are relevant to AI/ML algorithm validation. Since the PRIMA Humeral System and SMR Glenosphere Ø42 are physical orthopedic implants and not AI software, this information is not present or relevant to this 510(k) submission.

What is present in the document related to "acceptance criteria" and "study":

The "acceptance criteria" for this device, in the context of a 510(k) submission, are largely based on substantial equivalence to predicate devices. This involves demonstrating that the new device:

• Has the same intended use.
• Has similar technological characteristics (design features, materials, principles of operation).
• Is as safe and effective as the predicate device(s).

The "studies" mentioned are non-clinical tests to ensure the mechanical integrity, material compatibility, and safety of the implant. These are not clinical trials evaluating patient outcomes in the same way an AI algorithm's clinical effectiveness might be assessed.

Non-clinical testing performed (as listed in the document):

• Fretting Fatigue in anatomic and reverse configuration
• Fatigue test on polyethylene liner
• Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028)
• Coupling resistance under static load: push-out, lever-out and torque-out tests
• Wear test, as per ISO 14242 - 2 and ASTM F2003
• Biocompatibility evaluation, as per ISO 10993-1
• Endotoxin assessment, as per ANSI/AAMI ST72
• Packaging and shelf life validation as per ISO 11607-1/-2
• Sterilization validation, as per ISO 11137-1/-2/-3

The conclusion states that "Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA Humeral System and SMR Glenosphere Ø42."

Therefore, I cannot provide the requested information in the format specific to AI/ML performance evaluation because this document pertains to a traditional medical device (a physical implant) and not an AI algorithm.

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