Search Results

Anatomic Applications

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of functional deformity.
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Reverse Applications
The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is neeessary.

Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The proposed device is an orthopaedic total joint intended to replace the damaged or diseased natural shoulder joint in shoulder arthroplasty to provide pain relief and restore function. It is modular in design, consisting of a baseplate held to the bone with bone screws and a modular liner. The device is designed to be implanted as the glenoid component of an anatomic total shoulder with the option to convert to a reverse shoulder configuration without removal of the metal components.

The current submission is to expand the product offering by the addition of a liner manufactured from Vivacit-E Vitamin E Highly Crosslinked Polyethylene (VEHXPE).

This document is a 510(k) premarket notification for a medical device (shoulder prosthesis) and as such, it focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing the kind of extensive performance study data that would be typical for a novel device or a clinical trial.

Therefore, the document does not contain the detailed information required to answer many of your specific questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information can be extracted:

• No "Acceptance Criteria Table" or "Reported Device Performance": The 510(k) process for this type of device (a new material liner for an existing, cleared system) primarily relies on demonstrating that the new material (Vivacit-E Liner) performs equivalently to existing materials in relevant non-clinical tests (e.g., mechanical tests). Clinical studies with specific performance metrics and acceptance criteria are generally not required for substantial equivalence for this type of modification.
• No "Study that proves the device meets the acceptance criteria" in the sense of a clinical trial: The "Summary of Performance Data" explicitly states "Clinical Tests: None provided." This means there was no multi-reader, multi-case study, no human-in-the-loop performance measurement, and no standalone algorithm performance assessment. This device is a passive implant, not an AI or diagnostic tool.

Based on the provided text, here's what can be answered or inferred:

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

• Not Applicable in the traditional sense. This submission is for a material change (Vivacit-E Liner) to an existing device. The performance data listed are non-clinical tests designed to show that the new liner material performs equivalently to existing cleared materials/devices.
• Types of Non-Clinical Tests Conducted:
  • Dissociation Testing
  • Shear Testing
  • Insertion Testing
  • Biocompatibility Assessment
  • Packaging Assessment
• "Acceptance Criteria" for these tests: While not explicitly stated with numerical values, the acceptance criterion for a 510(k) submission is that the performance of the new device (Vivacit-E Liner) is "as safe and effective as the legally marketed predicate devices" and that "any differences do not raise new questions of safety and effectiveness." This implies that the results of these non-clinical tests must fall within expected ranges or demonstrate equivalence to the predicate device for each test. Specific numerical thresholds or ranges are not provided in this summary.

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

• Sample Size: Not specified for the non-clinical tests. For mechanical testing of medical devices, sample sizes are typically determined by engineering standards (e.g., ISO, ASTM) and statistical power requirements to demonstrate equivalence or meet specified performance criteria.
• Data Provenance: Not specified, but given it's a submission by Biomet Manufacturing Corp. (a US company) to the FDA, the testing would typically be conducted according to internationally recognized standards in controlled laboratory environments. The data would be specific to components manufactured by the applicant. This is not patient data.

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 or ground truth establishment in the clinical image interpretation sense. The "ground truth" for mechanical testing is the physical property being measured (e.g., force, displacement, material degradation) against defined engineering specifications.

4. Adjudication method for the test set

• Not Applicable. No human adjudication is involved in the non-clinical mechanical testing of an implantable device like this.

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

• No. The "Summary of Performance Data" explicitly states: "Clinical Tests: None provided." This device is a passive implant, not a diagnostic or AI-powered device that would involve human readers or image interpretation.

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

• No. As above, this is a physical implant, not a software algorithm.

7. The type of ground truth used

• For Non-Clinical Tests: The "ground truth" would be engineering specifications and material properties as defined by relevant standards (e.g., ISO, ASTM) and internal design requirements. For example, for "Shear Testing," the ground truth would be the measured shear strength compared to the designed minimum shear strength or the shear strength of the predicate device.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set" for the device itself.

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

• Not Applicable. As there is no training set for the device, this question is irrelevant.

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• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• 5. Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

The Alliance Monoblock Glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

The Alliance Glenoid is a series of glenoid components which includes monoblock polyethylene glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs glenoids. All glenoid types are available in various sizes. The central posts of the modular glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium substrate with Porous Plasma Spray (PPS) coating.

The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.

This regulatory submission for the "Alliance Glenoid" device (K191814) does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of an AI/ML medical device.

The document describes a medical device, specifically shoulder glenoid components for total shoulder replacement. The "Summary of Performance Data" section lists various non-clinical tests performed (e.g., accelerated corrosion, fatigue, glenoid loosening, range of motion, wear analysis, porous structure characterization, MR Evaluation). It explicitly states "Clinical Tests: None provided."

Therefore, I cannot fulfill your request as the provided text does not describe an AI/ML device or its associated performance study with acceptance criteria.

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The SMR Modular Glenoid and liner is intended for use in total primary or revision shoulder joint replacement with the SMR Anatomic Shoulder System.

The SMR Anatomic Shoulder System is indicated for patients suffering from disability due to:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; .
• Inflammatory degenerative joint disease such as rheumatoid arthritis; .
• Treatment of acute fractures of the humeral head that cannot be treated with other fracture . fixation methods:
• Revision of a failed primary implant; .
• . Cuff tear arthropathy (CTA Heads only).

The SMR Metal Backed Glenoid/Liner construct when used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.

The L1 6mm liners are a line extension of the existing SMR Glenoid liners that are used with the SMR Modular Glenoid and SMR TT Metal Back Glenoid. These components are used in anatomic total shoulder replacements as part of the SMR Anatomic Shoulder System. When used for SMR anatomic shoulder replacement, the SMR Modular Glenoid and SMR TT Metal Back Glenoid are intended to be used with bone cement.

The L1 6mm liners are manufactured from UHMWPE (ISO 5834-2 - ASTM F648) and are available in four sizes (Small-R, Small, Standard and Large).

A snap-fit mechanism is used to attach the liner to the glenoid metal back component. Four protrusions on the upper surface of the metal-back glenoid and the conformity between the spherical shaped upper surface of the metal-back and back-side surface of the liner help ensure stability of the coupling.

The articulating surface has a radius of curvature greater than the corresponding humeral head allowing translation in the superior/inferior and anterior/posterior directions. The liners are intended to articulate with all Limacorporate SMR standard and CTA humeral heads. There is no restriction in regard to the pairing of different sizes of humeral heads and glenoid components and each humeral head size can be combined with each glenoid size.

This document is a 510(k) premarket notification from the FDA for a medical device called the "SMR Modular Glenoid." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through an independent study. Therefore, robust clinical study details in the context of AI/ML performance metrics are not present here.

However, based on the non-clinical testing section, we can infer some information relevant to the device's performance and the "study" conducted.

Here's the breakdown based on the provided text, while acknowledging that it's not a study proving AI/ML performance:

1. Table of acceptance criteria and the reported device performance:

Note: The specific numerical acceptance criteria (e.g., maximum shear force, number of cycles for dynamic testing) are not provided in this document.

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

• Sample size: Not explicitly stated for either static shear or dynamic testing. Typically, mechanical testing involves a small number of samples (e.g., n=3 or n=5) per test condition.
• Data provenance: The tests were conducted by Limacorporate S.p.A., the manufacturer, in Italy. These are non-clinical (laboratory/mechanical) tests.

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

This information is not applicable as this document describes mechanical testing of a physical implant device, not diagnostic performance of an AI/ML system. Ground truth in this context would refer to material properties and engineering specifications, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting diagnostic data, which is not relevant to mechanical device testing.

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 is not applicable. This document describes an orthopedic implant, not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or AI assistance was involved.

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

This is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For mechanical testing, the "ground truth" is typically defined by:

• Engineering specifications and design requirements.
• Established material properties (e.g., ISO 5834-2 - ASTM F648 for UHMWPE).
• Industry standards for mechanical strength and fatigue testing.
• Performance of predicate devices under similar test conditions.

8. The sample size for the training set:

This is not applicable. As a physical device, there is no "training set" in the context of machine learning. The design and manufacturing process involves iterative development and testing, but not in the sense of an ML model training.

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

This is not applicable. As there is no training set in the AI/ML sense, there is no ground truth established for it. The design criteria for the device are based on biomechanical principles, clinical needs, and predicate device performance.

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• 1. Non-inflammatory degenerative ioint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Revision where other devices or treatments have failed.
• 4. Correction of functional deformity.
• 5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• 6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Humeral components with a MacroBond surface coating are indicated for either cemented or uncemented press-fit applications.

Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).

Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular Shoulder Stems, the glenoid components of the Bio-Modular Shoulder System, and the glenoid components of the Comprehensive Shoulder System.

The Titanium Versa-Dial Humeral Head Prosthesis are indicated for patients with suspected cobalt allov sensitivity. The wear properties of Titanium and Titanium allovs are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Titanium Versa-Dial™ Humeral Head Prosthesis consists of a series of various-sized modular humeral heads with variable offset between 0.5mm and 4.5mm. The humeral heads consist of a shell head and a taper adaptor. The taper adaptor is impacted into the head in a certain position to achieve the desired amount of offset. The system can be used with Biomet's Comprehensive® Shoulder System or Biomet's BioModular® Shoulder System.

The document does not describe the acceptance criteria for a medical device in terms of performance metrics like accuracy, sensitivity, or specificity, nor does it detail a study proving the device meets such criteria. This document is a 510(k) premarket notification summary for the "Titanium Versa-Dial™ Humeral Head Prosthesis."

Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical testing and engineering evaluations, rather than a clinical performance study with acceptance criteria.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance:

The document does not present a table like this because it's not a study reporting performance against specific clinical acceptance criteria. The acceptance refers to engineering criteria for mechanical performance.

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

• Test set sample size: Not specified. The testing mentioned is non-clinical (torsional separation, axial disassembly, engineering analysis of wear), not involving patient data. The "test set" would refer to physical device samples or theoretical models for these non-clinical evaluations.
• Data provenance: Not applicable in terms of patient data. The non-clinical testing would have been conducted by Biomet Manufacturing Corp. or their contracted labs.

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

• Not applicable. The ground truth for engineering tests is based on established engineering principles and measurement techniques, not expert consensus on clinical findings.

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

• Not applicable. This concept is relevant for clinical studies where multiple human readers interpret data, typically in diagnostic imaging or pathology. For non-clinical engineering tests, the results are objectively measured.

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:

• No. This is a medical device for orthopedic surgery (humeral head prosthesis), not an AI diagnostic or assistance tool. Therefore, MRMC studies involving human readers and AI are not relevant.

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

• No. This is a physical implantable device, not a software algorithm.

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

• For the non-clinical tests, the "ground truth" is based on:
  • Objective physical measurements: For torsional separation and axial disassembly strength.
  • Engineering analysis and scientific principles: For wear behavior comparison, likely relying on material science, biomechanics, and simulation or established wear models.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI-based device, so there is no training set in that context. The device design and materials are based on established engineering knowledge and previous predicate device designs.

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

• Not applicable for the reasons mentioned above.

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The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

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

Titanium olenospheres are intended for patients with colbalt alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A cobalt alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the Macro Bond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The device is a single-use implant.

The Titanium Alloy Glenosphere Prosthesis consists of a series of various sized modular glenospheres with variable offset between 0.5mm and 4.5 mm. Titanium alloy material has been selected to provide the surgeon with an alternate material to treat patients with nickel allergies. Each modular glenosphere consists of a "head" and a taper adaptor. The taper adaptor is impacted into the head in a certain position to achieve the desired amount of offset. The system can be used with Biomet's Comprehensive® Reverse Shoulder System or Biomet's BioModular® Reverse Shoulder System.

This document is a 510(k) premarket notification for a medical device, specifically the Comprehensive® Reverse Shoulder - Titanium Glenosphere. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving that the device meets specific acceptance criteria based on performance data.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and performance metrics (like sample size for test sets, expert ground truth, effect size, etc.) are not applicable or not provided in this type of regulatory submission. The document explicitly states "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence."

However, I can extract the relevant information that is present:

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

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly defined by the characteristics and performance of the predicate devices. The performance reported here is primarily related to non-clinical bench testing.

Detailed Study Information (Not applicable/Not provided in this document type):

As noted, this document is a 510(k) summary demonstrating substantial equivalence, not a clinical study report with detailed performance data against specific acceptance criteria. Therefore, the following information is not present:

2. Sample sizes used for the test set and the data provenance: Not provided for this type of submission which relies on non-clinical testing for substantial equivalence. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no clinical test set requiring expert ground truth for this submission.
4. Adjudication method for the test set: Not applicable, as there was no clinical test set.
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 device is an orthopedic implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an orthopedic implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "No clinical data submitted." For non-clinical tests (like torsional separation), the "ground truth" would be engineering specifications and predicate device performance.
8. The sample size for the training set: Not applicable. This device is an orthopedic implant, not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Correction of functional deformity
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

The Modular Hybrid Glenoid is intended to be inserted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

The Modular Hybrid Glenoid consists of a base and optional pegs. The polyethylene base has a concave articulating surface. The back side of the base has three outer polyethylene pegs for cement fixation and a central threaded titanium insert for the attachment of a central peg. The device may be used with or without a central peg.

The polyethylene peg has circumferential flanges. A titanium rod is molded within the peg to provide a threaded connection with the base.

The porous titanium peg provides the surgeon with an option for potential tissue ingrowth fixation. The peg is circular in design and tiered. Similar to the polvethylene peg, the porous titanium peg has a central titanium rod to provide a threaded connection.

The provided document is a 510(k) summary for the Biomet Orthopedics, Inc. Modular Hybrid Glenoid device. It describes the device, its indications for use, and a comparison to predicate devices, but does not contain information about studies proving the device meets acceptance criteria in the way a diagnostic AI/ML device would be evaluated.

This document pertains to a medical device, not an AI/ML diagnostic algorithm. Therefore, the specific criteria for evaluating AI/ML algorithms (such as sensitivity, specificity, AUC, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not relevant to this submission.

Instead, the acceptance criteria for this type of medical device are generally based on non-clinical mechanical testing and establishing substantial equivalence to existing legally marketed devices.

Here's how the provided information relates to acceptance criteria for this specific medical device:

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

Since this is a mechanical orthopedic implant, the "acceptance criteria" are not reported as specific performance metrics like sensitivity or specificity. Instead, the document states:

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 Test Set: Not applicable. The "testing" here refers to mechanical engineering tests of the device itself, not a clinical study on patients or an evaluation of an algorithm on a dataset.
• Data Provenance: Not applicable for clinical data. The mechanical tests would have been performed in a laboratory setting.

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

• Not applicable. "Ground truth" in the context of an AI/ML algorithm evaluation (e.g., radiologist diagnoses) is not relevant for this device's mechanical testing. The "ground truth" for mechanical testing is established by engineering standards and measurement techniques.

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

• Not applicable. This refers to consensus methods for interpreting medical images or data, which is not relevant for mechanical device testing.

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:

• No. This type of study is specifically for evaluating diagnostic AI/ML algorithms used in conjunction with human readers. This document explicitly states: "Clinical Testing: None provided."

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

• Not applicable. This refers to the performance of an AI/ML algorithm by itself.

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

• Not applicable in the context of clinical "ground truth." For mechanical tests, the "ground truth" is derived from established engineering principles, material science, and testing methodology to ensure the device meets specified strength, fatigue, and other performance parameters.

8. The sample size for the training set:

• Not applicable. The concept of a "training set" is for AI/ML models. This is a physical medical device.

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

• Not applicable. (See #8)

Summary regarding AI/ML evaluation:

The provided document details a 510(k) submission for an orthopedic implant. It specifically states "Clinical Testing: None provided." The acceptance criteria and "study" are based on non-clinical mechanical testing and a demonstration of substantial equivalence to predicate devices, which is a different regulatory pathway and set of evaluation criteria than those used for AI/ML diagnostic devices.

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The Copeland™ Extended Articulating Surface (EAS) Resurfacing Heads are indicated for hemi- or total shoulder replacement in patients with massive, irreparable rotator cuff tears and arthritis. Specific indications Include:

1. Cuff tear arthropathy.
2. Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
   Implants with Interlok®/hydroxyapatite coating are cleared for uncemented applications. Implants with MacroBond® and MacroBond® coating with hydroxyapatite are cleared for cemented and uncemented applications; however, cement should only be applied to the surfaces that do not contain hydroxyapatite coating (i.e. stem).

These devices are intended for use in patients with an irreparable rotator cuff as a shoulder replacement system that requires minimal bone resection. The Co-Cr-Mo Copeland™ EAS Resurfacing Heads can be used in hemi- or total shoulder replacement surgical procedures in patients experiencing pain and disability of the gleno-humeral joint. By preserving the bone stock, this device gives a patient an alternative to other total shoulder devices where more bone is removed. This device can easily be revised to a longer stemmed prosthesis, if necessary, due to the initial bone preservation.
The humeral head components are available in eight (8) sizes (1-8). The Copeland™ EAS Resurfacing Heads have a variable spherical radii that range fro 20mm to 27mm. The stem is tapered and fluted to provide maximum stability in the humerus.
The most notable landmark on the Copeland™ EAS Humeral Resurfacing Head is the addition of material to the superior-lateral side of the resurfacing head. This material is added to keep the implant surface in contact with the acromion longer, reducing pain and increasing the amount that the arm can be raised in patients with rotator cuff deficiency.

This document is a 510(k) premarket notification for the Copeland™ EAS Humeral Resurfacing Heads. It is not a study reporting on the performance of an AI-powered device. Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device performance.

The document discusses the substantial equivalence of a medical device (a humeral resurfacing head) to previously marketed predicate devices, focusing on its design, indications for use, and a statement that "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." It also explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."

In summary, there is no information in this document about: AI acceptance criteria, AI device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

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Indications For Use:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Revision where other devices or treatments have failed.
• 4. Correction of functional deformity.
• 5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• 6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
• Humeral components with a Macrobond® surface coating are indicated for either cemented or uncemented press-fit applications.
• Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).
• Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation).
• Humeral components with a non-coated (Interlok") surface are indicated for cemented application only.
• Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

The Comprehensive Humeral Fracture Stem is intended for use with the Bio-Modular® humeral heads and glenoid components.

The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive Humeral Fracture Stem and the glenoid components of the Bio-Modular® Shoulder System.

The Bio-Modular® Shoulder System is a set of components intended for total or hemi shoulder arthroplasty. It consists of humeral stems, humeral heads, and glenoid components. The only change to this system proposed by this submission is the addition of Hydroxyapatite (HA) coating to the glenoid components that utilize metal backs and are intended for biological fixation with optional screw fixation. The HA coated glenoid components are intended only for total shoulder arthroplasty.

This 510(k) premarket notification (K043100) for the Bio-Modular® Shoulder System - Hydroxyapatite Coated Glenoid Components does not contain acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for an AI/ML medical device.

This submission is for a medical implant (shoulder prosthesis) and asserts substantial equivalence to a predicate device based on material, design, and functional characteristics, not on a performance evaluation like an AI/ML algorithm. Therefore, the requested information elements related to AI/ML device testing (sample sizes, expert ground truth, MRMC studies, standalone performance, training data) are not applicable to this document.

Here's a breakdown based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/ML device. For this orthopedic implant, the "acceptance criteria" are generally related to demonstrating substantial equivalence in mechanical properties, biocompatibility, and manufacturing processes compared to a predicate device. The document states:

"The Bio-Modular Shoulder System with the Hydroxyapatite coated glenoid components has the same intended use, the same mechanical design, the same functional characteristics, and is made of the same titanium alloy as the predicate device."

This statement serves as the core performance claim for substantial equivalence. No specific quantitative performance metrics (like accuracy, sensitivity, specificity) with pre-defined acceptance thresholds are provided, as this is not an AI/ML diagnostic or prognostic device.

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

Not applicable. No "test set" in the AI/ML sense was used. The submission relies on non-clinical testing (presumably mechanical and material testing) to demonstrate equivalence.

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

Not applicable. No medical expert ground truth was established for the purpose of evaluating an AI/ML algorithm.

4. Adjudication Method for the Test Set

Not applicable.

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

No. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a shoulder prosthesis submission.

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

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

Not applicable. For this device, the "ground truth" would be established through established engineering and biocompatibility standards, mechanical testing, and material characterization, rather than clinical outcomes or expert consensus in an AI/ML context.

8. The Sample Size for the Training Set

Not applicable. No AI/ML model was trained.

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

Not applicable.

Summary of Device-Specific Information for K043100:

• Device Name: Bio-Modular® Shoulder System - Hydroxyapatite Coated Glenoid Components
• Predicate Device: Bio-Modular® Shoulder System (K030710) – Biomet Inc.
• Basis for Substantial Equivalence: New device has the "same intended use, the same mechanical design, the same functional characteristics, and is made of the same titanium alloy" as the predicate device, with the addition of Hydroxyapatite (HA) coating to glenoid components.
• "Study" (Non-Clinical Testing): "Non-Clinical Testing: The modified devices were found to be substantially equivalent to the predicate devices." (Details of this non-clinical testing are not provided in the 510(k) summary itself, but would have been part of the full submission).
• Clinical Testing: "No clinical testing was provided as a basis for substantial equivalence."

In conclusion, this 510(k) document is for an orthopedic implant and does not involve AI/ML technology. Therefore, the specific criteria for evaluating AI/ML devices outlined in your request are not present or applicable here.

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The components of Bi-Anqular® Shoulder System included in this submission are intended for hemi- or total shoulder joint arthroplasty. Indications for use include:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Correction of functional deformity
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene components are indicated for cemented application only.

The Bi-Anqular® Shoulder System is composed of a titanium alloy humeral stem with a modular humeral head which is designed to articulate with an all polyethylene qlenoid component or the natural glenoid bone in a hemi-shoulder configuration. There is no linkage across the joint.

The proximally tapered, collarless stem follows the natural contours of the humeral canal thus promoting evenly distributed stress off-loading. Cylindrical distal stems fill the humeral canal. Proximal fins contribute to rotational stability while suture holes in the fins allow for proximal reconstruction of complex humeral fractures. Durinq insertion, a K-wire can be placed into the version hole in the medial calcar region of the stem to allow exact version control of the component referencing off the patient's forearm.

Proximal porous coating on the humeral stem provides for biological fixation when used without bone cement. Non-porous humeral stems are available for cemented use.

The humeral component utilizes a modular head which is taper-fit onto the stem at the time of surgery.

The all polyethylene glenoid component has an angled triangular shaped keel which can be trimmed during surgery.

The presented document is a 510(k) premarket notification for a medical device, the Bi-Angular® Shoulder System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics.

Therefore, the document explicitly states: "Clinical Testing: None provided."

Based on this, it's not possible to provide the requested information regarding acceptance criteria and performance studies because no clinical studies were conducted or provided in this 510(k) submission. The FDA's determination was based on substantial equivalence to existing predicate devices and non-clinical mechanical testing, not on clinical performance against specific acceptance criteria.

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