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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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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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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 Zimmer Nexel Total Elbow system includes a cemented total elbow prosthesis and instrumentation. No changes are being made to the implants, but two changes to the instrumentation are being proposed in this submission.
• The Zimmer Nexel Total Elbow surgical technique is being modified to include a back table utilization of the Ulnar Bearing Assembly Tool (UBAT).
• As a result of the surgical technique change, the subject Zimmer Nexel Total Elbow Ulnar Cement Diverter is being added as an accessory instrument to the existing Zimmer Nexel Total Elbow system. The proposed cement diverter is a sterile, single-use manual orthopedic instrument manufactured from Ultra High Molecular Weight Polyethylene in conformance with ASTM F648-14. The subject component diverts excess bone cement from the articular surfaces of the existing ulnar implant component during implantation.

This document describes the Zimmer® Nexel® Total Elbow Ulnar Cement Diverter. Based on the provided text, the device is an accessory instrument to an existing total elbow replacement system, designed to divert excess bone cement during implantation. The document does not describe a clinical study in the typical sense (e.g., no patient data, no comparison of outcomes with and without the diverter). Instead, it relies on non-clinical performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the "study" (non-clinical) that proves the device meets them:

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

The document does not explicitly state numerical acceptance criteria in the typical format of a clinical trial (e.g., "sensitivity must be > X%", "accuracy must be > Y%"). Instead, the acceptance is based on demonstrating the safety and effectiveness of the cement diverter and the updated surgical technique through non-clinical evaluations.

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: The document mentions a "Cadaveric Evaluation." While the specific number of cadavers or test instances is not explicitly stated in this summary, cadaveric studies typically involve a small number of specimens.
• Data Provenance: The study is non-clinical, involving cadavers. The country of origin for the cadavers is not specified. It is inherently a prospective evaluation in the context of the device's development and regulatory submission, even though it uses post-mortem tissue.

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)

The document does not specify the number or qualifications of experts involved in the cadaveric evaluation. While such studies would ideally involve orthopedic surgeons or biomechanical engineers, this information is not provided in the 510(k) summary. The "ground truth" for these tests would likely be the direct, observable performance of the device during simulated implantation on the cadaveric specimens, assessed by the researchers and potentially expert surgeons.

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

The document does not describe an adjudication method for the non-clinical test set. Methods like 2+1 or 3+1 are typically used in imaging studies where interpretations are subjective and require expert consensus. In a cadaveric mechanical/functional test, the assessment of "safety and effectiveness" would likely be based on direct observation and measurement, rather than a subjective interpretation requiring adjudication among multiple readers.

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

There was no MRMC comparative effectiveness study done. This device is an orthopedic instrument, not an AI or imaging diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

There was no standalone (algorithm-only) performance study done. This device is a manual orthopedic instrument, not an algorithm.

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

The ground truth for the non-clinical evaluations was primarily direct observation and functional assessment during the cadaveric evaluation and mechanical testing (Functional Relationship Analysis). For the cadaveric study, the "ground truth" was whether the cement diverter effectively diverted cement and allowed for proper implantation without compromising the ulnar component. For the FRA, the ground truth was whether the diverter physically fit and functioned correctly with the existing components.

8. The sample size for the training set

There is no training set sample size because this is a mechanical device, not a machine learning algorithm.

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

Not applicable, as there is no training set.

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Indications for use include:

• Elbow joint destruction which significantly compromises the activities of daily living ー
• 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 Zimmer Nexel total Elbow is a total elbow prosthesis designed for use with bone cement. It is available in multiple sizes and in right and left configurations.

How the Device Functions: The Zimmer Nexel Total Elbow is an implant designed to replace the articulating surfaces of and restore motion to the humeroulnar (elbow) joint. The implant is a constrained device assembly and consists of the following components: humeral component, ulnar component, humeral bearing-A, ulnar bearings-B, axle pin and humeral screws.

The Following Scientific Concepts, Design Features and Physical Properties form the Basis for the Zimmer Nexel Total Elbow: The humeral component has a humeral stem designed to be implanted with bone cement into the patient's humeral medullary canal, an anterior flange designed to accept a bone graft and limit torsional and posterior migration, a humeral yoke with rounded corners to avoid the creation of stress risers within the medial and lateral humeral supracondylar columns, and plasma spray region to enhance fixation to bone cement within the medullary canal, and to improve fatigue strength. The ulnar component has an ulnar stem designed to be implanted with bone cement into the patient's ulnar medullary canal, an ulnar eye that is both highly polished and nitrogen-enriched to limit wear of the apposing polymer bearings, and plasma spray region to enhance fixation to bone cement within the medullary canal. Bearings A and B are designed to broadly distribute joint reaction forces.

Materials Used: The humeral and ulnar components are made of a titanium alloy, the bearings A and B are made of Vitamin E highly cross-linked polyethylene, and the humeral screws and axle pin are made of a cobalt-chromium-molybdenum alloy.

Here's an analysis of the acceptance criteria and study information for the Zimmer Nexel Total Elbow, based on the provided text:

Based on the provided K123862 510(k) summary, the device is a medical implant (total elbow prosthesis) and the study conducted is non-clinical performance testing for demonstrating substantial equivalence to a predicate device, rather than a clinical study involving human readers or AI. Therefore, many of the requested fields are not applicable in this context.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This was non-clinical performance testing (e.g., fatigue, wear, durability), not a study on a test set of patient data.
• Data Provenance: Not applicable. The data came from laboratory testing of the device and its components, not from patient-derived data or specific countries.

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

• Number of Experts: Not applicable. Ground truth for non-clinical performance testing typically refers to engineering specifications, industry standards, and established test methods, rather than expert human interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there was no test set requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

• MRMC Study: No. This was non-clinical testing of a physical implant, not an AI-assisted diagnostic tool.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No. This is physical hardware, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Engineering specifications, industry standards, and established test methodologies for evaluating the mechanical properties, durability, and wear characteristics of the prosthetic components. This typically involves physical measurements against predefined limits.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This was non-clinical testing of a physical implant, not a machine learning model requiring a training set.

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

• Ground Truth Establishment: Not applicable, as there was no training set. The "ground truth" for the non-clinical testing was based on published standards, internal design specifications, and comparison to the predicate device's known performance.

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The Discovery Elbow - X-Small is intended for cemented use in patients with the following conditions:

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. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods

The Discovery™ Elbow is a total elbow prosthesis comprised of an ulnar and humeral component. Placing the humeral articulation through the ulnar articulation links the ulnar and humeral component. The humeral components are available with or without a flange. The numeral and ulnar components are avialalbe with either a smooth or roughened surface. The components contained in this submission are X-Small in size.

The provided text is a 510(k) summary for the Discovery™ Elbow - X-Small, an elbow prosthesis. It is a submission to the FDA for market clearance and discusses the device description, intended use, and comparison to a predicate device.

Based on the information provided, no acceptance criteria or a study that proves the device meets specific acceptance criteria are described in the typical format of a clinical trial or performance study for a medical device with measurable outcomes (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Discovery™ Elbow, K013042 and K051975). This is a regulatory pathway that primarily relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device.

Here's an analysis of the provided information in the context of your request:

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

• Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for performance metrics. The underlying acceptance criterion for this 510(k) submission is that the device is substantially equivalent to the predicate device. This means it must:
  • Have the same intended use.
  • Have the same technological characteristics, or have different technological characteristics that do not raise different questions of safety and effectiveness.
  • If there are different technological characteristics, data must demonstrate that the device is as safe and effective as the predicate device.
• Reported Device Performance:
  • 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." This is a very general statement and does not provide specific performance metrics, methodology, or results in a table format. It implies mechanical and material testing, but no details are given.
  • Clinical Testing: "None provided as a basis for substantial equivalence." This explicitly states that no clinical performance data was used to demonstrate substantial equivalence for this particular submission.

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

• Not applicable. There is no "test set" in the context of clinical or device performance data described in this 510(k) summary because no clinical testing was performed for this submission. Non-clinical (laboratory) testing was mentioned but no sample sizes or data provenance for that testing are provided.

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. As no clinical testing was performed and no "ground truth" for a test set was established in this submission.

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

• Not applicable. No test set or associated 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 device is an elbow prosthesis (a physical implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

• Not applicable. As above, this is a physical medical device, not an algorithm.

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

• Not applicable. No clinical ground truth data was used for this submission. The "ground truth" for substantial equivalence is effectively the performance (safety and effectiveness) of the predicate device, which is assumed to be established.

8. The sample size for the training set

• Not applicable. There is no "training set" mentioned or relevant for this type of 510(k) submission for an elbow prosthesis.

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

• Not applicable. As above, no training set is mentioned.

In summary, the provided 510(k) summary details a regulatory submission based on substantial equivalence to a predicate device, supported by non-clinical laboratory testing. It does not contain information about specific acceptance criteria for performance metrics, clinical studies, or expert-adjudicated ground truth data, as these are typically not required for this type of submission when demonstrating substantial equivalence without clinical data.

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The Acclaim™ Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, theumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.

Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives.

The Acclaim™ Total Elbow System is intended for cemented use only.

The Acclaim™ Total Elbow System replacement hinge pin assembly is designed as a replacement of a linked (constrained) elbow hinge pin assembly due to hinge pin disassociation. When the Acclaim Total Elbow System is implanted as a linked system. it is held together with the linked ulnar component and pin assembly, and is used when there is poor bone stock.

The Acclaim™ Total Elbow System replacement hinge pin assembly is comprised of a polyethylene humeral yoke and locking sleeve, with a metal locking pin, ulnar bearing, ulnar bearing screw, washer, and wire. The replacement hinge pin assembly is used in conjunction with well-fixed humeral and ulnar components.

Acclaim™ Total Elbow System replacement hinge pin assembly design includes modifications to the ulnar bearing, polyethylene sleeve, and locking pin. In addition, a washer and cross-pin locking mechanism has been included to the assembly using the same design as the Mark II Total Elbow System locking mechanism, previously cleared in K872084 dated June 25, 1987.

This document describes a 510(k) premarket notification for a medical device – the Acclaim™ Total Elbow System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with specific acceptance criteria as you've outlined.

Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance cannot be found in this document because:

• This is a 510(k) summary for a medical implant (prosthesis), not a software device or AI algorithm. The questions you've posed are typically relevant for the assessment of AI/ML-based medical devices or diagnostic tools.
• 510(k) submissions focus on substantial equivalence. The primary goal is to show the new device is as safe and effective as a predicate device already on the market, not to meet pre-defined performance metrics against a "ground truth" using statistical studies as would be done for novel devices or AI.
• The "study" referenced here is the comparison to predicate devices and conformance to voluntary performance standards, not a clinical trial or performance study against an adjudicated ground truth in the way your questions are framed.

Here's a breakdown of what the document does provide in relation to your questions, and what it does not provide:

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:

• Does NOT Provide: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, etc.) or specific device performance metrics in numerical terms. It's a regulatory submission demonstrating substantial equivalence, not a performance study report for an AI.
• Does Provide (Implicitly): The "performance" is implicitly tied to the performance and safety record of the predicate devices (Acclaim™ Total Elbow System - K992656, Mark II Elbow System - K872084). The submission states, "The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards." This implies the new device performs at least as well as the predicate devices and meets relevant industry standards, but no new empirical performance data or specific criteria are listed.

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

• Does NOT Provide: This document does not describe a "test set" in the context of evaluating an AI or diagnostic algorithm's performance on a specific dataset. Therefore, there's no mention of sample size or data provenance in that regard.
• Does Provide (Indirectly): The "test" for substantial equivalence involved comparing the new device's design, materials, sterilization, and packaging to the predicate devices. This isn't a data-driven test set as you've implied.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Does NOT Provide: Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as this is not an AI/diagnostic device.

4. Adjudication Method:

• Does NOT Provide: Not applicable. There is no adjudication method described as there's no ground truth to establish for a test set.

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

• Does NOT Provide: This is a mechanical prosthetic device, not a diagnostic imaging tool or AI. Therefore, an MRMC study is completely irrelevant to this submission and is not mentioned.

7. The Type of Ground Truth Used:

• Does NOT Provide: No "ground truth" as a reference standard (like pathology, expert consensus, or outcomes data) is used because this is an orthopedic implant, not a diagnostic tool requiring such validation. The "truth" in this context is that the device is substantially equivalent to a legally marketed predicate device.

8. Sample Size for the Training Set & 9. How Ground Truth for Training Set was Established:

• Does NOT Provide: These concepts are entirely irrelevant to a 510(k) submission for a mechanical implant. There is no AI model, no training set, and no ground truth for a training set in this context.

In summary, the provided document is a 510(k) summary for an elbow prosthesis aiming to demonstrate substantial equivalence to existing devices. It does not contain the type of AI/ML performance study information you are requesting.

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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.

The Coonrad Morrey Total Elbow is a total elbow prosthesis designed for use with bone cement. It is available in regular, small and extra small sizes, in right and left configurations.

The provided document is a 510(k) premarket notification for a medical device, the Coonrad/Morrey Total Elbow prosthesis. It is a submission for substantial equivalence to a predicate device, not a study evaluating a new AI/ML-based device. Therefore, the questions related to AI/ML device performance (acceptance criteria, sample sizes for test/training, expert ground truth, adjudication, MRMC studies, standalone performance) are not applicable to this document.

The document indicates that the modified device (modified stem lengths for ulnar assemblies) is substantially equivalent to its predicate device (Coonrad/Morrey Total Elbow, K001989).

Here's the relevant information based on your request, highlighting what is not applicable due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This is a 510(k) submission for substantial equivalence of an updated mechanical implant, not an AI/ML device with performance metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" here is the demonstration of substantial equivalence.

2. Sample Sizes used for the Test Set and Data Provenance

Not Applicable for an AI/ML context. The submission mentions "nonclinical analysis" to support substantial equivalence. This would typically involve engineering analysis, bench testing, and comparisons to the predicate device's design specifications and performance, rather than a "test set" of patient data for an algorithm. No sample sizes for testing or data provenance are specified in this document.

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

Not Applicable. No "test set" in the context of AI/ML evaluation is described. The assessment relied on engineering and design comparison.

4. Adjudication Method for the Test Set

Not Applicable.

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

Not Applicable. This study is not relevant for a mechanical elbow prosthesis.

6. Standalone Performance Study (Algorithm Only)

Not Applicable. This is not an algorithm.

7. Type of Ground Truth Used

Not Applicable for an AI/ML context. The "ground truth" for this submission would be the established safety and effectiveness of the predicate device and engineering principles ensuring the modified device meets those standards.

8. Sample Size for the Training Set

Not Applicable. This is not an AI/ML device.

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

Not Applicable.

Summary based on the document:

• Device Type: Coonrad/Morrey Total Elbow, a metal/polymer constrained elbow prosthesis.
• Submission Type: 510(k) premarket notification for substantial equivalence.
• Modification: Ulnar Assemblies of modified stem length.
• Predicate Device: Coonrad/Morrey Total Elbow (K001989).
• Performance Data: "Results of nonclinical analysis indicate that the modified device is substantially equivalent to the predicate." This suggests engineering analysis and bench testing were performed to compare the modified device's characteristics (e.g., strength, fit) to the original.
• The FDA concluded that the device is "substantially equivalent" for its stated indications for use.

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The Porous Coated Discovery™ Elbow is intended for cemented use in patients with the following conditions:

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 severe functional deformity.
5. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatments.

The Porous Coated Discovery™ Elbow is a total elbow prosthesis comprised of an unfidrar components of components. The humeral components. The humeral through the unfar anticulation into the une and ulnar components are porous coated to provide enhanced fixation.

The provided text is a 510(k) summary for the "Porous Coated Discovery™ Elbow." It describes the device, its intended use, and states that substantial equivalence is claimed to a predicate device based on non-clinical mechanical testing. Crucially, it explicitly states "Clinical Testing: None provided as a basis of substantial equivalence."

Therefore, a detailed breakdown of acceptance criteria, study design, and performance metrics as typically derived from clinical studies cannot be provided because no clinical studies were submitted.

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

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly defined in terms of specific performance metrics within the provided document. The basis for substantial equivalence is "Non-Clinical Testing: Mechanical testing was provided to demonstrate that devices ability to perform." The acceptance criteria would likely be conformity to established mechanical testing standards for this type of prosthetic, demonstrating comparable safety and effectiveness to the predicate device.
• Reported Device Performance: The document states that the mechanical testing demonstrated the device's "ability to perform." No specific performance metrics (e.g., strength, durability, wear characteristics) or their numerical results are reported in this summary.

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

• Sample Size for Test Set: Not applicable for clinical data, as no clinical testing was performed for substantial equivalence. For non-clinical mechanical testing, the sample size is not specified in this summary.
• Data Provenance: Not applicable for clinical data. For non-clinical mechanical testing, the provenance of the test articles would be from the manufacturer (Biomet Manufacturing Corp.).

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

• Not applicable as no clinical testing was performed and therefore no ground truth established by experts in a clinical context.

4. Adjudication Method for the Test Set:

• Not applicable as no clinical testing was performed.

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

• No MRMC comparative effectiveness study was done, as explicitly stated: "Clinical Testing: None provided as a basis of substantial equivalence."

6. Standalone Performance Study (Algorithm Only):

• Not applicable. This is a physical medical device (elbow prosthesis), not an AI algorithm.

7. Type of Ground Truth Used:

• For the non-clinical mechanical testing, the "ground truth" would be the engineering specifications and established performance standards for elbow prostheses. The document does not specify if these standards were internal, industry-wide, or regulatory.

8. Sample Size for the Training Set:

• Not applicable for physical device testing in this context. Training sets are relevant for machine learning algorithms.

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

• Not applicable.

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The LPS Upper Extremity is intended for use in replacement of the proximal, mid-shaft or intercalary portion, distal and/or total humerus. This system is especially designed for cases that require extensive resection and restoration. Specific diagnostic indications for use include:

• Primary bone neoplasnms (e.g., osteosarcomas, chondrosarcomas, Ewing's sarcomas) requiring extensive resection(s) and replacement(s) of the proximal and/or distal humerus;
• Metastatic bone disease and pathologic fractures with extensive bone loss or where other forms of treatment such as internal fixation are inadequate;
• Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (JD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal humerus;
• Patients suffering from congential or acquired deformity, such as post-traumatic deformity and/or arthritis;
• Communited fractures of the proximal, distal and/or humeral shaft where forms of fixation are indadequate;
• Persistent humeral fracture non-union;
• Patients suffering from severe cuff tear arthropathy that does not respond to any conservative therapy or better alternative surgical treatment;
• Revision shoulder or elbow arthroplasty cases requiring extensive resection(s) and replacements of the proximal, distal or total humerus.
• Severe trauma requiring extensive resection and replacement.
  The LPS Upper Extremity components are for CEMENTED USE ONLY.

The LPS Upper Extremity components are designed for the replacement of the mid-shaft or intercalary portion of the humerus, proximal, distal and/or total humerus. Unlike primary shoulder and elbow systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, end-stage revision). A total humeral replacement is possible in those cases where no part of the humerus can be salvaged.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study conducted to prove the device meets specific criteria. The document is a 510(k) summary for the 'LPS Upper Extremity' device, which outlines its indications for use, device description, and substantial equivalence to previously cleared devices. It does not include details on clinical trials, performance testing, sample sizes, expert ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets them based on the given information.

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