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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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Advanced destruction of the shoulder joint resulting from:

• Omarthrosis.
• Rheumatoid arthritis
• Post-traumatic arthritis
• Avascular necrosis of the humeral head.
• Cuff-tear arthropathy (BF 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 Anatomical Shoulder (AS) Combined System consists of the following:

• AS Humeral Stem (cemented or uncemented)
• AS Fracture Humeral Stem
• Bigliani/Flatow Head
• Bigliani/Flatow Gleniod
• Trabecular Metal (TM) Glenoid
• AS Bigliani/Flatow (AS B/F) Adaptor

The AS B/F Adaptor is a new product designed to be used with the humeral stems of the Anatomical Shoulder System and Anatomical Shoulder Fracture System and with any humeral head of the Bigliani/Flatow (BF) System in a conventional hemi or total shoulder arthroplasty procedure. The B/F humeral heads are used with existing UHMWPE B/F glenoids and TM glenoids manufactured from Trabecular Metal and UHMWPE. AS cemented humeral stems are manufactured from Protasul -1 (Co-Cr-Mo); the uncemented and fracture stems from Protasul-100 (titanium alloy). The B/F heads are manufactured from Zimaloy® (Co-Cr-Mo). Collectively, these components are identified as the Anatomical Shoulder Combined System.

The Adaptor features two taper interfaces, one connecting to the Anatomical Shoulder humeral stems and the other connecting to the Bigliani/Flatow humeral heads. The proximal taper of the adaptor (connecting to the Bigliani/Flatow heads) is identical to the male taper geometry from the predicate Bigliani/Flatow humeral stems. The distal taper of the adaptor (connecting to the Anatomical Shoulder humeral stem) is a male oval taper, identical to the oval taper of the predicate Anatomical Shoulder Ball-Taper component. Both the AS B/F Adaptor and the predicate AS Ball-Taper component are manufactured from Protasul-100, a forged titanium alloy.

The Zimmer Anatomical Shoulder™ Combined System is a medical device and, as such, the "acceptance criteria" and "device performance" are typically assessed through non-clinical (laboratory) testing to demonstrate substantial equivalence to predicate devices, rather than through sensitivity, specificity, or AUC as might be seen for diagnostic AI/ML devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For medical devices like shoulder prostheses, "acceptance criteria" are usually based on meeting established engineering standards and demonstrating equivalent or superior performance to existing predicate devices through various mechanical and material tests. The specific numerical acceptance criteria for each test (e.g., minimum load for fatigue, maximum corrosion rate) are not detailed in this summary but are implied to have been met.

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

• Sample Size for Test Set: This device underwent non-clinical (lab) performance testing and/or analyses. The document does not specify a "sample size" in the context of a clinical test set with patient data. Instead, it refers to mechanical and material tests performed on various components of the device. The "sample size" would relate to the number of physical components tested for each specific non-clinical test (e.g., number of stems tested for fatigue, number of adaptors for strength testing). These specific numbers are not provided in this summary.
• Data Provenance: The data is from non-clinical (lab) performance testing. No country of origin for this testing is explicitly stated, but the sponsor is Zimmer GmbH in Switzerland, and the contact person is in Indiana, USA. This is not retrospective or prospective patient data, but rather engineering test data.

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

• Not applicable. This is a mechanical device, and "ground truth" for a test set typically refers to clinical diagnosis or outcome, which is not relevant here. Ground truth would be defined by engineering standards and specifications.

4. Adjudication Method for the Test Set

• Not applicable. This refers to consensus among clinical experts for diagnostic decisions, not for mechanical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. Such studies are typically for diagnostic devices or AI/ML tools where human readers interpret medical images.
• Effect size of human reader improvement: Not applicable.

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

• Not applicable. This device is a shoulder prosthesis, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is established through industry-standard engineering specifications, material properties, and biomechanical principles. Performance is benchmarked against the known characteristics and successful clinical history of the predicate devices. This includes adherence to standards for loading conditions, fatigue life, fretting corrosion resistance, and assembly strength.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and prior successful device designs (predicates).

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

• Not applicable, as there is no "training set" for this type of medical device.

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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 fragments of the proximal humerus;
• Posttraumatic necrosis of the humeral head;
• Posttraumatic arthrosis after humeral head fracture.
  The Anatomical Shoulder Fracture stem is intended for cemented or cementless use.

The Anatomical Shoulder Fracture System is designed specifically to treat complex 3 or 4 part proximal humerus fractures requiring hemi- or total shoulder arthroplasty. The Anatomical Shoulder Fracture System may be used with or without bone cement. The Anatomical Shoulder Fracture System consists of four components, a stem, baseplate, screw and head. The Anatomical Shoulder Fracture System baseplate offers right and left side-specific versions in order to appropriately match the original shoulder anatomy with respect to right and left humeral anatomy. The Anatomical Shoulder Fracture System head is also designed to articulate with the glenoid components of the Anatomical Shoulder System (K030259). The Anatomical Shoulder Fracture System stem is also designed to accept the Anatomical Shoulder Inverse/Reverse humeral cup (K053274) for conversion from hemi- or total shoulder arthroplasty to an inverse/reverse shoulder arthroplasty in situations when the rotator cuff is irreparable and the patient is experiencing severe instability of the shoulder joint. The Anatomical Shoulder Fracture System stem is comparable in shape and size to stems traditionally used for hemi- and total shoulder arthroplasty. The Anatomical Shoulder Fracture System stem, however, has two features which distinguish it as a stem designed for treatment of proximal humeral fractures. The proximal surface of the humeral stem and much of the surface of the baseplate offer spikes which assist in the stable anchoring of the humeral tuberosities to the stem and allow for primary stability of the tuberosities. The Anatomical Shoulder Fracture System stem and baseplate also offer several suture holes to allow initial stable fixation of the humeral tuberosities with sutures.

The provided text is a 510(k) summary for the Zimmer Anatomical Shoulder™ Fracture System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Key takeaways regarding acceptance criteria and studies:

The document states: "Performance testing indicates that all components meet or exceed predetermined performance criteria for their intended use." However, it does not provide specific numerical acceptance criteria for the device's performance, nor does it detail the specific study designs, methodologies, or results that prove these criteria were met.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices, an approach common for 510(k) submissions. This means that the device is considered safe and effective because it is similar in intended use, design, materials, and manufacturing methods to devices already on the market.

Therefore, many of the requested details about specific acceptance criteria and detailed study information are not available in the provided text because it's a summary focused on substantial equivalence rather than a full study report with performance metrics.

Here's a breakdown of what can be inferred or stated as "not applicable/provided" based on the input:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for the test set: Not provided.
• Data provenance: Not provided. The document mentions "Performance testing" but does not specify if this involved patient data, laboratory tests, or simulation, nor does it give origin or nature (retrospective/prospective). Given it's a 510(k) for an implant, the "performance testing" likely refers to non-clinical bench testing rather than clinical patient studies.

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

• Number of experts: Not applicable/Not provided. As no clinical "test set" in the context of expert review (e.g., for image interpretation) is described, expert ground truth establishment for such a test set is not relevant here.
• Qualifications of experts: Not applicable/Not provided.

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

• Adjudication method: Not applicable/Not provided. No clinical test set requiring adjudication by experts is described.

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

• MRMC comparative effectiveness study: No. This device is an orthopedic implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.
• Effect size of human readers with/without AI: Not applicable.

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

• Standalone performance: Not applicable. This device is a physical shoulder implant, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept.

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

• Type of ground truth: Performance testing for an orthopedic device typically involves biomechanical testing or material testing against engineering standards or established performance benchmarks for similar devices. The "ground truth" would be the measurable physical properties and performance under specific simulated conditions (e.g., fatigue life, strength, range of motion, wear characteristics). The document simply states "Performance testing indicates that all components meet or exceed predetermined performance criteria," implying such testing was conducted but not detailing the 'ground truth' benchmarks.

8. The sample size for the training set

• Sample size for the training set: Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set" in the computational sense. If "training set" refers to design and testing iterations, these details are not in the summary.

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

• How ground truth for the training set was established: Not applicable/Not provided. As this is not an AI/ML device, the concept of a training set with established ground truth is not relevant here.

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