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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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The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The ORTHOLOC™ SPS Shoulder Plating System is designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws. The plates are available in three designs: Standard, Posterior, and Greater Tuberosity (GT) and are manufactured from stainless steel per ASTM F138. The system also includes locking screws manufactured from stainless steel per ASTM F2229 and non-locking screws manufactured from stainless steel per ASTM F138 or ASTM F2229. The system is provided non-sterile and requires steam sterilization prior to use.

The provided text is a 510(k) premarket notification for a medical device called the ORTHOLOC™ SPS Shoulder Plating System. This type of document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than presenting a study proving a device meets specific clinical performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance studies are not available within this document because clinical studies were not performed.

Here's what can be extracted and what cannot:

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

Note: The specific numerical acceptance criteria from ASTM F543-17 are not detailed in this document, only that the device met them and they were the same as the predicate device.

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

• Sample Size for Test Set: Not specified for the bench testing. The document states "No clinical studies were performed."
• Data Provenance: The document refers to "non-clinical bench testing" performed to ASTM F543-17 standards. This implies laboratory-based testing, not human or animal data. No country of origin for the data is specified, but the applicant company is located in Bloomington, MN, USA. The testing is prospective for the purpose of this 510(k) submission.

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

• Not applicable. This information pertains to studies involving human interpretation or clinical outcomes. Since only non-clinical bench testing was performed, no experts were used to establish ground truth in this context. The "ground truth" for bench testing would be the physical measurements against engineering specifications.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert opinions or diagnoses. For bench testing, results are typically determined by instrumental measurements and adherence to test standards.

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. An MRMC comparative effectiveness study was not performed. This document is for a mechanical orthopedic implant, not an AI-assisted diagnostic device, and no clinical studies were performed.

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

• No. A standalone performance study was not performed. This device is a mechanical implant, not an algorithm or AI system.

7. The type of ground truth used:

• For the non-clinical bench testing, the "ground truth" would be engineering specifications and the established performance criteria within ASTM F543-17. There is no pathology or outcomes data mentioned.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned as no clinical studies or AI/machine learning development were discussed. The device itself (the implant) does not have a "training set."

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

• Not applicable. As there is no training set, there is no ground truth for one.

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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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The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

ORTHOLOC™ SPS is a plating system designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws. The plates are available in three designs: Standard, Posterior, and Greater Tuberosity (GT) and are manufactured from stainless steel per ASTM F138. The system also includes locking cortical and cancellous screws manufactured from stainless steel per ASTM F2229 and non-locking cortical screws manufactured from stainless steel per ASTM F138. The system is provided non-sterile and requires steam sterilization prior to use.

This document describes acceptance criteria and outlines performance testing for the ORTHOLOC™ SPS Shoulder Plating System. However, it does not describe a study involving an AI/algorithmic device or its performance against acceptance criteria. Instead, it describes non-clinical bench testing for a physical medical device (bone plating system).

Therefore, I cannot populate the requested table and answer the study-specific questions (2-9) about AI device performance, sample sizes, ground truth, experts, or MRMC studies.

Here's the information that can be extracted from the provided text regarding the physical device and its testing:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing):

Regarding the study, based on the provided text:

1. Sample size used for the test set and the data provenance: Not applicable. The testing described is non-clinical bench testing of a physical device, not an AI model.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. 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. The document explicitly states: "No clinical studies were performed."
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
6. The type of ground truth used: Not applicable for an AI device. For the physical device testing, the "ground truth" would be established engineering standards (ASTM F382-17, ASTM F543-17) and comparative physical properties with predicate devices.
7. The sample size for the training set: Not applicable. This is not an AI/algorithmic device.
8. How the ground truth for the training set was established: Not applicable.

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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:

Study Details

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

• Sample Size: Not specified for the bench tests. For mechanical testing, this typically refers to the number of components or assemblies tested.
• Data Provenance: The studies were non-clinical performance bench testing. Thus, there is no patient data provenance (country of origin, retrospective/prospective) as it involves laboratory testing of physical devices.

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. This is a physical device (Class II medical implant), and the studies described are non-clinical mechanical bench tests and an endotoxin test. There is no "ground truth" in the clinical sense established by human experts for these types of tests. Compliance is typically assessed against engineering standards and specifications by engineers and quality control personnel.

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

• Not Applicable. As mentioned above, this is non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnosis where there can be inter-reader variability.

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. An MRMC comparative effectiveness study was not done. This device is a physical total elbow arthroplasty, not an AI algorithm or a diagnostic tool that assists human readers.

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

• No. This is a physical medical device. The concept of "standalone performance" applies to AI algorithms operating independently, which is not relevant here.

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

• Not Applicable in the clinical sense. The "ground truth" for the non-clinical tests would be the established engineering specifications, material standards, and performance characteristics for mechanical strength, durability (fatigue), and biocompatibility (endotoxin levels). For the "substantial equivalence" claim, the predicate device's established performance serves as a comparative benchmark.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

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