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Hemi- or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for:
• Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis if bone stock is adequate.
• Avascular necrosis.
• Conditions consequent to earlier operations.
• Optional use in revision: in some medical conditions (e.g. early revision when adequate bone stock exits), the surgeon may opt to use primary implants in a revision procedure).
The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System
• The Anatomical Shoulder Reverse System and the ASHCOM Shoulder system are indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
• 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 Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.
Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi- and fracture shoulder arthroplasty in treatment of the following:
• Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment.
• Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment.
• Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment.
• Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus.
• Posttraumatic necrosis of the humeral head.
• Posttraumatic arthrosis after humeral head fracture.
The Humeral Fracture Stems are intended for either cemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented are intended for cemented use only.
Anatomical Shoulder Combined System
Advanced destruction of the shoulder joint resulting from:
• Omarthrosis
• Rheumatoid arthritis
• Post-traumatic arthritis
• Avascular necrosis of the humeral head
• Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)
• Conditions following earlier operations
The Anatomical Shoulder Combined System is intended for cemented or cementless use.
When used with the following humeral stems the Anatomical System is intended for cemented use.
• Anatomical Shoulder Standard Cemented Humeral Stem
• Anatomical Shoulder Long Stem
When used with the following humeral stem the Anatomical System is intended for cementless use:
• Anatomical Shoulder Standard Uncemented Stem.
When used with the following humeral stems the Anatomical System is intended for cemented or cementless use:
• Anatomical Shoulder Fracture Stem.
• Anatomical Shoulder Fracture Long Stem.
When used with the following glenoids the Anatomical System is intended for cemented use:
• Bigliani/Flatow Glenoid (pegged and keeled).
• Trabecular Metal™ Glenoid.

The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision (Reverse Shoulder Arthroplasty), total or hemi- shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
The proposed Anatomical Shoulder System is comprised of the following families of products:
Anatomical Shoulder Humeral Stems (Cemented, Uncemented)
Anatomical Shoulder Reverse System (Cups, PE-inlays, Glenoid Fixation, Screws, Glenospheres)
Anatomical Shoulder Fracture System (Stems, Heads)
Anatomical Shoulder Combined system (Bigliani / Flatow® Adaptors)
Anaverse™ Anatomical Shoulder Pegged Glenoid
Anatomical Shoulder Domelock® System (Heads, Dome Centric, T-Domes)
Anatomical Shoulder ASHCOM® Shoulder System (ASHCOM Shoulder AC-Connector)

This document is a 510(k) premarket notification for the Zimmer GmbH Anatomical Shoulder System. It details the device, its indications for use, and its substantial equivalence to previously cleared predicate devices.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present explicit "acceptance criteria" in a quantitative table for a new device's diagnostic performance, as this is a medical device (shoulder prosthesis) rather than an AI/diagnostic software. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various non-clinical performance tests.

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

• Test Set (Non-clinical Performance Data): The document does not specify a "sample size" in the context of patients or clinical cases for a test set. The tests performed are non-clinical (MR compatibility, mechanical integrity of instruments, packaging performance).
  • For MR compatibility, it states "MR compatibility evaluation on the Anatomical Shoulder™ System," but no specific number of implants or tests is given. It clarifies that no new MRI performance testing or simulations were completed for the implant devices, but existing reports were reviewed.
  • For Mechanical integrity and resistance, it states testing was performed "for instrument groups of mechanically loaded devices." No specific number of instruments or tests is provided.
  • For Packaging performance, it states "Packaging Configuration testing was conducted by representative worst-case products." No specific number of packages or products is provided.
• Data Provenance: Not applicable in the traditional sense of patient data. The provenance for the non-clinical tests would be Zimmer GmbH's internal testing facilities or contracted labs.

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

• Not applicable. This is not a study requiring expert readers to establish ground truth from medical images or clinical data. The "ground truth" for non-clinical tests is established by objective engineering and material science standards (e.g., ISO standards for packaging, mechanical test specifications).

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

• Not applicable. This is not a study requiring adjudication of expert readings.

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:

• Not applicable. This is an application for a shoulder prosthesis, not an AI-assisted diagnostic device. No MRMC study was performed.

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

• Not applicable. This is a physical medical device (shoulder prosthesis), not a standalone algorithm.

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

• For the non-clinical performance tests, the "ground truth" is defined by established engineering and material science standards (e.g., ISO 11607-1:2006, ISO 11607-2:2006 for packaging, relevant mechanical testing standards for device integrity, and MRI compatibility standards).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. No training set for an algorithm was used.

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Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for

• · Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
• · Avascular necrosis.
• · Conditions consequent to earlier operations.
• · Omarthrosis.
• · Rheumatoid arthritis.
• · Revision of shoulder prosthesis.

The Humeral Stems Cemented are intented for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intented use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

Reverse Application of the Anatomical Shoulder System
· The Anatomical Shoulder Inverse/Reverse System is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
· 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 Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.

Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasts in treatment of the following:

• · Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment
• · Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
• · Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment
• Fracture instability after osteosynthesis of 3- and 4-part fragments of the proximal humerus
• · Posttraumatic necrosis of the humeral head
• · Posttraumatic arthrosis after humeral head fracture

The Humeral Fracture Stems are intended for either cemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.

The Anatomical Shoulder System is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi shoulder arthroplasty.

Anatomical Shoulder Humeral Stems are available as either cemented or uncemented designs. Cemented stems are available in longer designs to support revision cases. The Anatomical Shoulder Fracture Stem is available as a slim and standard version, with longer stems available for revision surgery. They may be used with or without bone cement where appropriate fixation using cement or via a press-fit is achieved using the correct choice of rasp size. All Humeral Stems possess a female oval taper geometry, which is the basis for all modularity with compatible mating components. The stems can be combined with the Anatomical Shoulder Domelock Head or the Anatomical Shoulder Ball-taper Humeral Head. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component of the Anatomical Shoulder System for total arthroplasty. Alternatively, the Legacy Biomet Bio-Modular Keeled all-polyethylene Glenoid or Modular Hybrid Glenoids are proposed as compatible glenoid components.

The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.

The provided document is a 510(k) premarket notification from Zimmer GmbH to the FDA for the Anatomical Shoulder™ System, Anatomical Shoulder Domelock® System, and Anatomical Shoulder™ Fracture System.

It describes the device and its intended use, but it does NOT describe an AI/ML-based medical device performance study, nor does it contain information about acceptance criteria or performance against such criteria for an AI/ML device.

The document states:
"The devices are not modified as compared to their predicates. Instead, the compatibility of the Anatomical Shoulder Humeral Heads is extended to allow articulation against the legally marketed Bio-Modular Keeled all-polyethylene Glenoid and the Modular Hybrid Glenoid. The indications for use/intended use are unchanged. The articulating materials remain the same with the new compatibility and therefore the fundamental technology is unchanged."

And for Performance Data:
"The results of non-clinical performance testing and analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance analyses included:

1. Range of Motion Analysis (ASTM F1378-12)
2. Radial Mismatch Analysis
   Clinical Performance and Conclusions: Clinical data and conclusions were not needed to demonstrate substantial equivalence."

Therefore, I cannot answer your specific questions regarding acceptance criteria for an AI/ML device and its study, as the provided text pertains to a traditional orthopedic implant (shoulder prosthesis) and not an AI/ML-based medical device.

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Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System

The Anatomical Shoulder Humeral Stems and Domelock System are indicated for

• · Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
• · Avascular necrosis.
• · Conditions consequent to earlier operations.
• · Omarthrosis.
• · Rheumatoid arthritis.
• Revision of shoulder prosthesis.

The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.

Reverse Application of the Anatomical Shoulder System

· The Anatomical Shoulder Inverse/Reverse System is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

· 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 Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.

Fracture Application of the Anatomical Shoulder Fracture System

The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following: • Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment

• Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment

• Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment

· Fracture instability after osteosynthesis of 3- and 4part fracture fragments of the proximal humerus

• · Posttraumatic necrosis of the humeral head
• Posttraumatic arthrosis after humeral head fracture

The Humeral Fracture Stems are intended for either cemented or uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.

The Anatomical Shoulder System is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi shoulder arthroplasty.

Anatomical Shoulder Humeral Stems are available as either cemented or uncemented designs. Cemented stems are available in longer designs to support revision cases. All Humeral Stems possess a female oval taper geometry, which is the basis for all modularity with compatible mating components. For a hemi or total arthroplasty application, the stems can be combined with the proposed Anatomical Shoulder Domelock System, the existing Anatomical Shoulder Ball-taper Humeral Head System or the existing Anatomical Shoulder Bigliani/Flatow Adaptor. For a reverse application the stems are combined with the existing Anatomical Shoulder Inverse/Reverse components.

The Anatomical Shoulder Domelock System consists of a Humeral Head which is connected to the Anatomical Shoulder Stems using either an adjustable Domelock Dome centric including a Ball-taper and Expansion-pin, or a series of fixed-angle T-Domes. The Domelock Dome and T-Domes are used to set the orientation of the Domelock Humeral Heads. The male oval cone taper of the Domelock component is compatible with all Humeral Stems of the Anatomical Shoulder System. The assembled humeral component may be used alone for hemiarthroplasty or combined with the existing glenoid component of the Anatomical Shoulder System for total arthroplasty.

The Anatomical Shoulder Fracture System consists of a Humeral Fracture Stem and a Humeral Head Fracture including a Fracture Baseplate and a Looking Screw. The Anatomical Shoulder Fracture Stem is available as a slim and standard version, with longer stems available for revision surgery. They may be used with or without bone cement where appropriate fixation using cement or via a press-fit is achieved using the correct choice of rasp size. The Anatomical Shoulder Humeral Head Fracture offers right and left side-specific versions. The assembled Anatomical Shoulder Fracture humeral component may be used alone for hemiarthroplasty or combined with the glenoid component of the Anatomical Shoulder System for total arthroplasty. The Anatomical Shoulder Fracture Stem is also designed to accept the existing Anatomical Shoulder Inverse/Reverse components and the existing Anatomical Shoulder Bigliani/Flatow Adaptor.

The Humeral Stems and Baseplates are made from Protasul-100 (Ti6Al7Nb. ASTM F1295-11). The Domelock Humeral Heads, the Fracture Heads and the Fracture Screw are made from Protasul-21WF (Co28Cr6Mo, ASTM F1537-11). The Domelock head locking mechanism is made from Protasul-100 and Protasul-64WF (Ti6A14V, ASTM F136-13). The materials are anticipated to have permanent contact. All components are provided sterile (gamma irradiated) for use implantation in a hospital.

The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the Anatomical Shoulder™ System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in numerical terms (e.g., minimum tensile strength of X MPa). Instead, it lists the types of performance data collected and implicitly assumes that the results of these tests demonstrate safety and effectiveness, and substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these various tests.

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

• Sample Size for Test Set: This information is not provided in the document. The studies listed are "non-clinical performance testing and analyses," which typically involve a limited number of physical prototypes or virtual models, rather than a large patient-specific test set.
• Data Provenance: Not applicable in the context of non-clinical, in-vitro/computational testing. These are laboratory-based tests of the device itself.

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

• Number of Experts: Not applicable. These are physical and mechanical tests/analyses, using engineering standards (ASTM F1378-12, ASTM F2009-00), not expert-derived ground truth based on clinical data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human interpretation or subjective assessment of clinical data that would require adjudication. The tests likely follow predefined protocols and acceptance criteria within the referenced ASTM standards.

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

• Was an MRMC study done? No.
• Effect Size of human reader improvement: Not applicable, as no MRMC study was conducted. The submission specifically states: "Clinical data and conclusions were not needed to demonstrate substantial equivalence."

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

• Was a standalone study done? Not applicable. This device is a total shoulder joint prosthesis (mechanical implant), not an algorithm or AI system. The "performance data" refers to the mechanical and material characteristics of the implant components.

7. Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical tests, the "ground truth" is defined by the objective physical and mechanical properties measured against established engineering standards (ASTM F1378-12, ASTM F2009-00) and design specifications. This is engineering/physical measurement data and compliance with established standards.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As this is a mechanical medical device, there is no "training set" in the context of an AI or algorithm. The design and manufacturing processes are refined through engineering principles, material science, and iterative testing, not machine learning training.

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

• How Ground Truth Was Established: Not applicable. There is no "training set" with associated ground truth for this type of device submission. The design and development process for such an implant relies on established biomechanical principles, material science knowledge, manufacturing standards, and pre-clinical testing data to ensure safety and effectiveness.

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