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The Comprehensive® Segmental Revision System is intended for use in cases of:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Revision where other devices or treatments have failed.
• 3. Correction of functional deformity.
• 4. Oncology applications including bone loss due to tumor resection.

When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.

When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.

Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application 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 suited to receive the implants and a functional deltoid muscle is necessary. For the US and Canada only: reverse application is limited to proximal humeral replacement.

The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.

The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment Augments are not available in all markets.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the humerus up to and including the humeral side of the shoulder and elbow joints. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullary replacement of bone. The Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The provided text describes a medical device, the "Comprehensive Segmental Revision System (SRS)," and its 510(k) premarket notification to the FDA. This document is a regulatory submission for a medical device and thus does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI-powered diagnostic or predictive system.

The text does mention:

• Non-Clinical Tests/Justification: Coating Characterization, Fatigue Strength Report Flanges, Fatigue Strength Analysis Humeral Stems, Shot Peen Testing Summary, and MRI. These are engineering and material science tests relevant to the physical implant's safety and performance, not a study of an AI system's diagnostic accuracy.
• Clinical Tests: "None provided." This explicitly states that no clinical studies were performed for this specific submission to expand the indications of the device, as substantial equivalence was demonstrated through other means (comparison to predicates, engineering tests).

Therefore, based on the provided text, I cannot answer questions 1 through 9 as they relate to the performance evaluation of an AI device. The document is about a mechanical orthopedic implant, not an AI system.

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TEMA Elbow system is intended for use in cemented applications for patients suffering from disability due to:

1. Elbow joint destruction which significantly compromises the activities of daily living
2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain
4. Revision where other devices or treatments have failed.
5. Correction of severe functional deformity.
6. Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
7. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion

The unlinked, semi-constrained version is for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.

TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies.

The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly.

The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.

TEMA Elbow system - Line extension introduces two new sizes of Ulnar stems to the ulnar stem range already cleared; moreover, a design change is introduced for the axle component, ulnar body component and for the humeral body compared to the original cleared version.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the TEMA Elbow system - Line extension.

It's important to note that the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on proving that a new medical device meets specific acceptance criteria in a clinical study. The document primarily discusses non-clinical (bench) testing. Therefore, several requested categories (like ground truth, expert qualifications, adjudication, MRMC studies, training set size) are not applicable or cannot be extracted from this type of FDA submission.

Acceptance Criteria and Device Performance

The core of this submission is to demonstrate that the "TEMA Elbow system - Line extension" is substantially equivalent to the previously cleared "TEMA Elbow system (K181362)". The acceptance criteria, in this context, are not explicit pass/fail thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) but rather the demonstration that the new device's performance, particularly mechanical, is comparable or superior to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document uses terms like "demonstrated" and "substantially equivalent" rather than specific numerical performance metrics typical for software or diagnostic devices.

Study Details (Based on available information)

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

• Sample Size (Test Set): Not applicable in the context of a clinical test set from this document. The "test set" here refers to the physical samples used in bench tests. The document does not specify the number of physical components or prototypes tested for "Range of Motion," "Stability," "Fatigue," "Fretting-Corrosion," or "Wear Evaluation."
• Data Provenance: Not applicable. The document describes non-clinical (bench) testing, not human or animal data. The manufacturing company is LimaCorporate S.p.A. based in Italy.

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

• Not applicable. This was a non-clinical (bench) study. Ground truth in this context would likely be engineering specifications or established test standards, not expert clinical consensus.

4. Adjudication method for the test set

• Not applicable. As a non-clinical (bench) study, there is no mention or need for a clinical adjudication method.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical elbow prosthesis, not an AI-powered diagnostic or assistive tool.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant.

7. The type of ground truth used

• For the non-clinical (bench) tests, the "ground truth" would be established engineering standards, material properties, and performance benchmarks for orthopedic implants, typically defined in ASTM or ISO standards. The document doesn't specify these exact standards but refers to "mechanical evaluations (both bench tests and rationales)."

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

• Not applicable. No training set.

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The LATITUDE EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The LATITUDE EV™ Total Elbow Arthroplasty system is intended for cemented use only.

The LATITUDE EVI™ Total Elbow Arthroplasty system is a total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The LATITUDE EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the prosthesis is a semiconstrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.

The provided text is a summary of an FDA 510(k) premarket notification for a medical device called the LATITUDE EV™ Total Elbow Arthroplasty system. This document focuses on the regulatory approval and comparison to predicate devices, and therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning AI/algorithm performance.

The document explicitly states: "No clinical studies were performed." This indicates there was no study conducted to assess the performance of the device in a clinical setting in the context of this 510(k) submission. Furthermore, there is no mention of any AI or algorithmic component to the device.

Therefore, I cannot provide the requested information.

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TEMA Elbow System is intended for use in cemented applications for patients suffering from disability due to:

• 1. Elbow joint destruction which significantly compromises the activities of daily living
• 2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
• 3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain
• 4. Revision where other devices or treatments have failed.
• 5. Correction of severe functional deformity.
• 6. Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
• 7. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion

The unlinked, semi-constrained version is intended for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of dislocation or disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.

TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies.

The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly.

The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.

All of the system components are available in different sizes.

The modularity of the polyethylene ulnar component also allows replacement of the ulnar bearing, if needed, without removal of the humeral and ulnar assemblies. The modularity also provides an additional advantage that if replacement of the humeral and/or ulnar body is needed (e.g. due to damage from a traumatic event or due to excessive wear of the bushing of the humeral body) and the stem components are well fixed. the stems do not need to be removed and only disconnection of the humeral and ulnar bodies from the stems is required for their revision.

The provided text is a 510(k) Summary for the TEMA Elbow System. It describes the device, its indications for use, and compares it to predicate devices. However, this document does not contain information about the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

The TEMA Elbow System is a mechanical prosthetic device, and the evaluation for its substantial equivalence relies on non-clinical mechanical testing and a comparison of its design and materials to existing predicate devices.

Therefore, I cannot provide the requested information for an AI/ML device, as the document pertains to a traditional medical implant.

Specifically, the document does NOT contain information on:

• A table of acceptance criteria and reported device performance (for an AI/ML device).
• Sample sizes for a test set or data provenance (relevant to AI/ML studies).
• Number of experts or their qualifications for ground truth establishment (relevant to AI/ML studies).
• Adjudication methods (relevant to AI/ML studies).
• MRMC comparative effectiveness studies including effect sizes for human readers (relevant to AI/ML studies).
• Standalone algorithm performance (relevant to AI/ML studies).
• Type of ground truth used (relevant to AI/ML studies).
• Sample size for the training set (relevant to AI/ML studies).
• How ground truth for the training set was established (relevant to AI/ML studies).

The "Non-Clinical Testing" section mentions mechanical testing for the device's ability to perform in a substantially equivalent manner, but these are engineering tests for a physical implant, not a study of an AI/ML algorithm's diagnostic or prognostic performance. The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of TEMA Elbow System to the predicate devices."

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Coonrad/Morrey Total Elbow: Indications include: post-traumatic lesions or bone loss contributing to elbow instability; ankylosed joints, especially in cases of bilateral ankylosis from causes other than sepsis; advanced rheumatoid or degenerative arthritis with incapacitating pain: revision arthroplasty, and instability or loss of motion when the degree of joint damage precludes less radical procedures. The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patient with single joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation.

Zimmer Nexel Total Elbow: Indications for use include: Elbow joint destruction which significantly compromises the activities of daily living; Post-traumatic lesions or bone loss contributing to elbow instability; Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis; Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain; Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis; Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus; Revision arthroplasty. Caution: This device is intended for cemented use only.

The Coonrad/Morrey Total Elbow and Zimmer Nexel Total Elbow are total elbow prosthesis designed for use with bone cement. They are available in multiple sizes and in right and left configurations. The devices are designed to replace the articulating surfaces of and restore motion to the humeroulnar (elbow) joint. The implants are constrained in design and consist of a humeral component and an ulna component joined through bearings in a hinged fashion. The purpose of this submission is the addition of MR conditional language to the labeling for these products. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging or sterilization. Additionally, this submission includes minor modifications to the subject device systems.

The provided text is a 510(k) summary for the Zimmer Nexel Total Elbow and Coonrad/Morrey Total Elbow. It concerns the addition of MR conditional language to the product labeling and minor design modifications, not a study evaluating device performance against specific clinical acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document.

However, I can provide information on what was studied and the conclusions drawn related to substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present clinical acceptance criteria for the elbow prostheses themselves (e.g., pain reduction, range of motion improvement). Instead, it focuses on the performance related to MR Conditional safety. The acceptance criteria are implicit in the adherence to ASTM standards for MRI compatibility.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not applicable in the traditional sense of a clinical trial. The "test set" here refers to the Zimmer Nexel Total Elbow and Coonrad/Morrey Total Elbow implants that underwent MRI compatibility testing. The document does not specify the number of individual implants tested for these non-clinical evaluations, but it refers to the performance of "implants."
• Data Provenance: The tests were non-clinical (laboratory/engineering) as performed by Biomet (presumably the manufacturer, as Zimmer is also the manufacturer listed). The location/country of origin of the testing facility is not specified. The studies are by nature prospective in the sense that they were conducted specifically for this submission to address MRI safety.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This was a non-clinical evaluation based on adherence to engineering standards (ASTM) for MRI safety. Ground truth was established by the specified ASTM test methods. No human expert consensus was used for establishing MRI compatibility ground truth; it's a technical outcome.

4. Adjudication Method for Test Set:

Not applicable. Non-clinical engineering tests do not typically involve adjudication methods like those used in clinical image interpretation studies. The results are quantitative and determined by the test protocol.

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

• No, a MRMC comparative effectiveness study was not done. The submission is for non-clinical testing related to MRI safety and minor design modifications, not for assessing human reader performance or the clinical effectiveness of the elbow prostheses themselves.

6. Standalone Performance (Algorithm Only):

• Not applicable. This submission is for medical devices (total elbow prostheses), not a software algorithm.

7. Type of Ground Truth Used:

• For the MRI compatibility studies, the ground truth was based on established engineering standards and measurements as defined by ASTM F2503-13, F2182-11a, F2119-07, and F2052-14.
• For the minor design modifications, the ground truth was based on engineering rationale and testing to demonstrate that the modifications do not negatively impact device performance or safety.

8. Sample Size for Training Set:

• Not applicable, as this is not a machine learning or AI-based device requiring a training set.

9. How Ground Truth for Training Set Was Established:

• Not applicable.

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1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.

• 2. Tumor resections.
• 3. Revision of previously failed total joint arthroplasty.
• 4. Trauma.
     The Compress Segmental Femoral Replacement System components are intended for uncemented use.

1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.

• 2. Tumor resections.

3. Revision of previously failed total joint arthroplasty.

• 4. Trauma.
     The Compress Segmental Humeral Replacement System components are intended use.

The Compress and Mini Compress Anti-Rotation Spindles are components of the Compress Segmental Femoral Replacement System and Compress Segmental Humeral Replacement System. The Anti-Rotation Spindles attach to an anchor plug and a proximal/distal femoral/humeral component to serve as a method of fixing a segmental joint replacement to a patient's host bone. The Anti-Rotation Spindles contain several conical washers which allow a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. The Anti-Rotation Spindles also include a series of holes around the spindle collar to allow placement of pins to prevent rotation of the component. The purpose of this submission is the update of the surgical techniques associated with the Compress and Mini Compress Anti-Rotation Spindles to revise the recommended pin selection range for use with the Anti-Rotation Spindles.

This FDA 510(k) premarket notification for the "Compress and Mini Compress Anti-Rotation Spindles" describes a device that is essentially an updated component of existing segmental replacement systems. The submission centers around an update to surgical techniques and therefore does not rely on extensive clinical or performance studies in the way a novel device might.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for an update to surgical techniques for components of an existing device, and not for a new device itself, the typical "acceptance criteria" related to diagnostic performance metrics (like sensitivity, specificity, accuracy) are not applicable. Instead, the acceptance is based on demonstrating that the updated surgical technique does not adversely affect the device or its intended use, and that the devices remain substantially equivalent to predicates.

The "acceptance criteria" here implicitly relate to ensuring functional compatibility and non-inferiority in terms of mechanical properties and surgical application.

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

• Sample Size: Not applicable in the context of typical performance testing. The "test set" in this case appears to be a geometric evaluation of the components in relation to the revised surgical technique.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The geometric evaluation would be internal to the manufacturer (Biomet Inc.).

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

• Not applicable as this was a geometric evaluation, not a clinical study requiring expert ground truth for interpretation. The "ground truth" would be the engineering specifications and physical properties of the device components.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical study with a test set requiring adjudication in the traditional sense.

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

• No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not provided for the subject devices." This type of study investigates human reader performance, which is not relevant for this engineering-focused submission about surgical technique updates.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no AI component or human-in-the-loop study was involved.

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

• No, a standalone (algorithm only) performance study was not done. This device is a mechanical implant, not an algorithm or software.

7. Type of Ground Truth Used

• The implicit "ground truth" for this submission is engineering specifications and verification/validation data related to the geometric fit and function of the Anti-Rotation Spindles with the revised surgical technique, as determined by the "geometric evaluation." There is no clinical or pathology-based ground truth mentioned.

8. Sample Size for the Training Set

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design and manufacturing of the device components would follow standard engineering and quality control processes.

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

• Not applicable, as there was no training set in this context.

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The Latitude EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Latitude EV™ Total Elbow Arthroplasty system is intended for cemented use only.

The Latitude EV™ Total Elbow Arthroplasty system is a total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The Latitude EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the prosthesis is a semi-constrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.

This document is a 510(k) premarket notification for a medical device (LATITUDE EV Total Elbow Arthroplasty). It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance testing. Crucially, it explicitly states: "No clinical studies were performed."

Therefore, based on the provided text, there is no information to answer the questions regarding acceptance criteria and a study proving the device meets those criteria, as no clinical studies were conducted.

The device clearance relies on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical bench testing and process validations, not on meeting specific performance acceptance criteria derived from a clinical trial.

To reiterate the reason for not being able to provide the requested information:

• No clinical studies were performed. This means there was no study designed to prove the device meets acceptance criteria in a clinical setting.
• The acceptance criteria for this 510(k) submission were likely focused on demonstrating mechanical performance, material properties, and biological safety through bench testing, which is different from clinical performance metrics.

Therefore, I cannot populate the table or answer the specific questions about clinical study design, sample sizes, expert involvement, ground truth, or MRMC studies because such studies were not conducted for this FDA clearance.

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Indications For Use:

The Comprehensive Segmental Revision System is intended for use in cases of:

• 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. Oncology applications including bone loss due to tumor resection.

When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.

When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.

Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application 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 suited to receive the implants and a functional deltoid muscle is necessary. Reverse application is limited to proximal humeral replacement in the United States.

The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.

The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the shoulder joint. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullay replacement of bone. The components of the Comprehensive SRS system have previously been cleared for use in hemi and anatomic total shoulder replacement. The current submission is to expand the indications to include reverse shoulder applications. All components have been previously cleared.

I am sorry, but based on the provided text, I cannot provide the detailed information you requested about acceptance criteria and the study proving the device meets them.

The document is a 510(k) premarket notification letter from the FDA to Biomet Manufacturing Corp. It determines substantial equivalence for the Comprehensive Segmental Revision System (SRS) to legally marketed predicate devices.

Here's why I cannot fulfill your request based on this document:

• No specific acceptance criteria or performance metrics are listed for the device itself. The document only details the "Indications for Use" for the device, which are the medical conditions or purposes for which it is intended.
• The document states "No new testing provided" under "Non-Clinical Tests" and "None provided" under "Clinical Tests" for the current submission (K173411). This means the FDA's substantial equivalence determination for this specific submission was based on existing data from previous clearances (K111746) and comparison to the predicate device, not on new studies conducted for this K173411.
• The details about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for either training or test sets are not present in this regulatory letter. These types of details would typically be found in the comprehensive testing reports that accompany a 510(k) submission, not in the FDA's determination letter itself.

In summary, the provided text confirms the FDA's decision regarding substantial equivalence but does not contain the specific performance data, acceptance criteria, or study details you are asking for.

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The Lattude EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Latitude EVIM Total Elbow Arthroplasty system is intended for cemented use only.

The Latitude EV™ Total Elbow Arthroplasty system is a 2- or 3-part total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The Latitude EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the elbow. The prosthesis is a semi-constrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.

The Latitude EV™ humeral and ulnar stems are available in multiple sizes for primary and revision surgery and include a plasma spray coating. The optional radial implant is uncoated and is available in several sizes corresponding to the humeral and ulnar construct size selected.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Latitude EV™ Total Elbow Arthroplasty device:

Based on the provided 510(k) summary, this device is a medical implant, not an AI/software device, which explains why many of the requested AI-specific points (like MRMC studies, standalone performance, training data, etc.) are not applicable.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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The Comprehensive Segmental Revision System is intended for use in cases of:

• 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. Oncology applications including bone loss due to tumor resection.

When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.

When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.

The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.

The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral and total humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The components of the Comprehensive Segmental Revision System (SRS) components may be combined to create a proximal humeral replacement, distal humeral replacement and total humeral replacement. Previously cleared for use in conjunction with Biomet's Discovery Elbow System, the Comprehensive SRS system is being expanded to be compatible with the Zimmer Nexel Total Elbow. To accomplish this, the only component requiring modification is the Distal Humeral Body. The modified distal humeral bodies will be available in left and right configurations in three sizes 50, 60 and 70mm utilizing the same modular flange as the predicate device. The yoke geometry will match that of the humeral component in the Nexel Total Elbow System.

This document describes a 510(k) premarket notification for the "Comprehensive SRS/Nexel Elbow" device. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study demonstrating the device meets a specific set of acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/algorithm-based device is not present in the provided document.

The document details a traditional medical device submission for an elbow prosthesis. The key points from the provided text are:

1. A table of acceptance criteria and the reported device performance:
Not applicable. This document is for a medical implant (elbow prosthesis) and focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific performance metrics for an AI/algorithm. Performance is generally assumed to be equivalent to the predicate if design, materials, and intended use are similar.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No "test set" in the context of an AI/algorithm is mentioned. The submission relies on an engineering analysis to determine that modified components do not present a new worst-case condition, rather than a clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No ground truth establishment for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication method is mentioned.

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 not an AI/algorithm-based device, so an MRMC study related to AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth in the context of evaluating an AI/algorithm is mentioned.

8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device, so there is no training set.

9. How the ground truth for the training set was established:
Not applicable. There is no training set.

Summary of Device and Evidence provided in the document:

• Device Name: Comprehensive SRS/Nexel Elbow
• Purpose of Submission: K153398 is a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device.
• Predicate Device: Comprehensive Segmental Revision System (SRS) - K111746, with additional reference to Zimmer Nexel Total Elbow – K123862.
• Device Description: The Comprehensive SRS components can be combined for proximal, distal, and total humeral replacement. The current submission expands compatibility with the Zimmer Nexel Total Elbow by modifying the Distal Humeral Body to mate with the Nexel Elbow's humeral component.
• Evidence for Substantial Equivalence:
  • Intended Use: Identical to the predicate.
  • Indications for Use: Identical to the predicate.
  • Materials: Identical to the predicate.
  • Design Features: Identical to the predicate, "except that the geometry has been modified to mate with the Nexel Elbow."
  • Sterilization: Identical to the predicate.
  • Non-Clinical Tests: "None Provided. Engineering analysis and MR assessment to determine that the modified components do not present a new worst case condition."
  • Clinical Tests: "None Provided."
• Conclusion: The sponsor claims the proposed device has the same intended use and similar technological characteristics as the predicate, and that differences do not raise new questions of safety and effectiveness, making it at least as safe and effective as the predicate.

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