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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 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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