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The Easytech® Anatomical Shoulder System is in total shoulder repacement to treat a severely painf il and/or disabled joint resulting from osteoarthritis.

The humeral stemless of the Easytech® Anatomical Shoulder is intended for cementless use only. The glencid components of the Easytech® Anatomical Shoulder System are intended for cemented use only.

The patient's joint must be anatomically suited to receive the selected implants and a functional rotator cuff is necessary to use the device.

The Easytech® Anatomical Shoulder is an anatomical shoulder prothesis designed for use in patients with a functional rotator cuff. The Easytech® humeral stemless (Anchor base) is used with a connector, a centered or offset humeral head, and a glenoid for use in an anatomical shoulder configuration.

This system is designed to articulate with a glenoid component for total shoulder arthroplasty. Subject of this submission is the cementless, stemless Humeral Anchor base that is part of the Easytech® Anatomical Shoulder System. The compatible components to complete the system have been cleared previously in K111097, K123814, and K163669.

The Easytech® Anchor base is a stemless prosthesis. The cementless Anchor base is available in diameters of 30 to 38 mm. The Anchor base has a main central post with striaes. In the periphery of the Anchor base, five retentives striaes are positioned to help with the primary fixation. The undersurface of the Anchor base, including the central post and retentive striaes, has a plasma sprayed CPTitanium and Hydroxyapatite coating without the superior surface and the female taper. The Anchor base incorporates a female taper for attachment of compatible components. This component is manufactured in Ti-6AI-4V ELI allov conforming to ISO 5832-3.

The Anchor base can be used with a straight taper connector or a centered spacer manufactured from Ti-6Al-4V ELI alloy conforming to ISO 5832-3, a centered or offset humeral head manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and a 2 pegs or 3 or 4 pegs cemented glenoid manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2 for use in an anatomical shoulder configuration.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

• Adjusted Constant Score >54 AND improved from baseline >10
• No migration or subsidence
• No radiolucencies of the humeral or glenoid components
• Implant integrity maintained
• No revision surgery
• No serious adverse device event | 91.7% (with a lower two-sided 90% confidence bound of 87.3%).
  This is compared to a performance goal for the predicate device of 92.3% and a reference margin of 10%. The lower bound (87.3%) being greater than (92.3% - 10% = 82.3%) indicated success. |
  | Adjusted Constant Score Improvement: Clinically significant improvement in Adjusted Constant Score from preoperative baseline. | Average Month 24+ Adjusted Constant Score: 99.14 (SD 18.73).
  Clinically significant improvement (p

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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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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 ASHCOM Shoulder System is intended for reverse shoulder arthroplasty.

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 and the Biomet all-polyethylene Keeled Glenoid are intended for cemented 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 Inverse/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 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.

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 (including revision shoulder arthroplasty).

The Anatomical Shoulder Combined System is intended for cemented or cementless use.

When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use:
• Anatomical Shoulder Standard Cemented Humeral Stem.
• Anatomical Shoulder Revision Stem.

When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use:
• Anatomical Shoulder Standard Uncemented Stem.

When used with the following humeral stems the Anatomical Shoulder Combined 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 Shoulder Combined System is intended for cemented use:
• Bigliani/Flatow Glenoid (pegged and keeled).
• Trabecular Metal™ Glenoid.

The ASHCOM Shoulder AC-Connector is a double tapered Adaptor that allows the combination of the Anatomical Shoulder Humeral Stems with the Comprehensive Trays. The male oval cone taper of the ASHCOM Shoulder AC-Connector is compatible with the cemented, uncemented and fracture humeral stems of the Anatomical Shoulder System. The female round taper is compatible with the Comprehensive Reverse Trays. In combination with compatible Zimmer Biomet reverse glenoid the implant is intended for a reverse application. The existing Anatomical Shoulder System, for which MR conditional labeling is proposed, is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi shoulder arthroplasty. The existing Anatomical Shoulder Combined System, for which MR conditional labeling is proposed, allows the combination of a Bigliani/Flatow® Head with any Anatomical Shoulder Humeral Stem.

The provided text does not contain detailed acceptance criteria for a medical device or a comprehensive study demonstrating that the device meets these criteria. The document is primarily a 510(k) premarket notification for shoulder prosthetic systems (ASHCOM™ Shoulder System, Anatomical Shoulder™ System, Anatomical Shoulder™ Combined System), aiming to establish substantial equivalence to previously cleared predicate devices.

Instead, the document focuses on:

• Indications for Use: What conditions the devices are intended to treat.
• Device Description: The components and general design of the prosthetic systems.
• Comparison to Predicate Device: How the new devices are similar to existing, legally marketed devices.
• Performance Data (Nonclinical): A list of non-clinical tests performed to support safety and effectiveness, particularly for the ASHCOM Shoulder System and the MRI compatibility of the Anatomical Shoulder systems.

Here's an analysis based on the information provided, highlighting what's present and what's explicitly absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific quantitative targets and corresponding device performance data to demonstrate compliance.

Instead, it lists the types of non-clinical tests performed to show safety and equivalence:

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

For the non-clinical tests listed, the document does not specify sample sizes (e.g., number of prostheses tested) or data provenance (e.g., country of origin, retrospective/prospective). These details would typically be found within the full test reports, which are not included in this summary.

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

This section is not applicable as the document describes non-clinical performance testing of physical devices (implants), not a study involving evaluation by medical experts to establish ground truth for a diagnostic or AI-driven system.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3.

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

This section is not applicable. The device is an orthopedic implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI assistance was conducted or mentioned.

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

This section is not applicable. The device is an orthopedic implant and does not involve an algorithm.

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

For the non-clinical performance tests, "ground truth" would not be established by expert consensus, pathology, or outcomes data in the traditional sense. Instead, the "ground truth" or reference state is defined by engineering specifications, material properties, and regulatory standards (e.g., ASTM F2009 for taper connection testing). The tests aim to demonstrate that the physical properties and performance of the device meet these predefined engineering and safety criteria.

8. The sample size for the training set

This section is not applicable. The device is an orthopedic implant, and there is no mention of an algorithm or AI model that would require a training set.

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

This section is not applicable for the same reasons as point 8.

Summary of what the document does indicate regarding device performance and acceptance:

The submission relies on non-clinical performance testing and analysis to demonstrate the safety and effectiveness of the ASHCOM Shoulder System and the existing Anatomical Shoulder systems (for MRI compatibility labeling) and establish their substantial equivalence to predicate devices. The listed tests (FEA, cyclic fatigue, corrosion fatigue, static taper connection) are standard for orthopedic implants to assess mechanical integrity, durability, and material performance. For MRI compatibility, the evaluation followed FDA guidance, suggesting a series of tests to confirm the "MR Conditional" status.

The statement "Results of non-clinical performance testing and analyses demonstrate that the ASHCOM Shoulder System is safe and effective and substantially equivalent to the predicate devices" serves as the overall conclusion regarding acceptance based on the conducted studies, without detailing the specific quantitative acceptance criteria or results in this summary. The FDA's clearance (K170711) indicates that they found the provided non-clinical data sufficient to establish substantial equivalence.

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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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ARROW® Indications for Use: The anatomical shoulder system, depending on the components used, is designed for:

Simple humeral prosthesis:

• Fracture dislocation or complex four part fracture of the proximal humerus
• Humeral head necrosis without injury to the glenoid cavity.
• Extensive humeral head cartilage damage without injury to the glenoid cavity
• Centered osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
• Rheumatoid polyarthritis with thin rotator cuff.
• Off-centered osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

Total anatomical prosthesis (cemented glenoid implant with 4 pegs)
AND/OR

• Centered glenohumeral osteoarthritis with functional rotator cuff
• Rheumatoid polyarthritis with functional rotator cuff
• Fracture sequela, functional rotator cuff with glenoid injury.

The ARROW® anatomical shoulder system is a modular shoulder prosthesis, composed of the following elements:

• humeral stems,
• humeral heads (centred or off-centred),
• cemented glenoids.

The ARROW® anatomical shoulder system is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

The provided document is a 510(k) Premarket Notification for the ARROW® anatomical shoulder system, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical outcomes through human studies with strict acceptance criteria based on metrics like sensitivity or specificity.

Therefore, many of the typical acceptance criteria and study design elements requested in the prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device submission. The "acceptance criteria" here are related to demonstrating mechanical performance and biocompatibility sufficient to show equivalence.

However, I can extract the information that is present and indicate where the requested information is not provided or applicable given the nature of a 510(k) for a shoulder prosthesis.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

• ASTM F1738-05 (Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Forgings for Surgical Implants)
• ASTM F1829-98 (Standard Specification for Universal Metallic Extension Fixation Systems)
• ASTM F2028-05 (Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants) for the glenoid components. |
  | Performance Conclusion: Performance determined to be substantially equivalent to predicate devices. | After testing, it was determined that the ARROW® anatomical shoulder system performances were substantially equivalent to those of the selected predicate devices. |
  | Risk Mitigation: Risks to health addressed through specified materials, processing, quality, and compliance. | Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations. |

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

• Sample Size for Test Set: Not applicable in the context of device performance testing for substantial equivalence for a shoulder prosthesis. The testing was mechanical/material specific based on ASTM standards, not a clinical test set with patient data.
• Data Provenance: Not applicable. The "test set" here refers to physical components of the device undergoing mechanical testing, not a dataset of patient information.

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

• Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on clinical findings, is not established for this type of mechanical testing. The "ground truth" for the mechanical tests would be the accepted parameters defined by the ASTM standards.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this 510(k) submission.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a shoulder prosthesis, and this type of study is typically performed for diagnostic devices (e.g., AI for radiology interpretation).
• Effect Size: Not applicable as no MRMC study was performed.

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

• Standalone Performance Study: Not applicable. This device is a physical shoulder prosthesis, not a software algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the mechanical performance "testing," the "ground truth" is defined by the established ASTM (American Society for Testing and Materials) standards (ASTM F1738-05, ASTM F1829-98, and ASTM F2028-05). Compliance with these standards demonstrates acceptable mechanical properties and material performance.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of a physical medical device like a shoulder prosthesis. The design and manufacturing processes are developed through engineering and materials science, not machine learning training.

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

• Ground Truth for Training Set: Not applicable. As there is no training set, there is no ground truth established in this manner. The "ground truth" for the device's design and material selection would be established through established engineering principles, biomechanical understanding, and regulatory requirements, which are inherent to the development of such an implant.

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