Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device