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Software: The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit presurgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels.

Hardware: The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection. The Precision AI Guides and Biomodels are indicated for single use only. The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only. The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components: Enovis and Lima.

The Precision AI Surgical Planning System is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific guides and models to transfer the plan to surgery. The subject device is a system composed of the following: The Precision AI Surgical Planning System Software will create a 3D construct/render of the patient's shoulder joint for the surgeon to plan the operatively then create a physical Patient Specific Instrument (or Guide), using 3D printing by selective laser sintering. The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm. The surgeon can visualise the deformity of the diseased joint, on this 3D render and CT scan images, and determine the inherent deformity of the joint. They are then able to virtually place the artificial implants in an optimal position to correct the measured deformity for that specific patient. The Precision AI Guides, which are a patient-specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery.

The provided text is an FDA 510(k) summary for the Precision AI Surgical Planning System (PAI-SPS). It describes the device and its intended use, but it does NOT contain specific acceptance criteria, detailed study designs, or performance results in terms of metrics like sensitivity, specificity, accuracy, or effect sizes for human reader improvement.

The document states that "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' This includes verification against defined requirements and validation against user needs." It also mentions that "Design verification and validation testing demonstrated that the PAI-SPS meets all design requirements and is as safe and effective as its predicate device (K233992)."

However, it does not explicitly lay out the acceptance criteria (e.g., "model must achieve 90% accuracy") or the results against those criteria. It focuses more on demonstrating substantial equivalence to a predicate device (PAI-SPS K233992) by showing that the technology and intended use are similar, with the main differences being the addition of compatibility with more implant systems.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I will provide information based on what is available and indicate where information is missing.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

Based on the provided FDA 510(k) summary, the PAI-SPS device is being cleared primarily through demonstrating substantial equivalence to an already cleared predicate device (PAI-SPS, K233992). The key claim for equivalence rests on similar intended use, fundamental scientific technology, design, functionality, operating principles, and materials, with the primary difference being expanded compatibility with additional implant systems.

The document implicitly suggests that the "acceptance criteria" are tied to demonstrating that these technological differences "do not raise any different questions of safety and effectiveness." The studies cited are primarily focused on software verification and validation, ensuring the new compatible implant systems do not negatively impact the established safety and effectiveness.

Here is a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy percentages, specific error bounds) or detailed performance metrics. The performance is largely framed as demonstrating that the device "meets all design requirements and is as safe and effective as its predicate device."

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

• The document does not specify the sample size for any test set (e.g., for software validation or hardware accuracy).
• Data Provenance: Not explicitly stated for specific test sets. Given the company is "Precision AI Pty Ltd" in Australia, and the document discusses "previous cadaver testing and composite bone model testing," it's likely a mix of lab-based/simulated data and potentially some retrospective clinical imaging data for initial AI development/testing, but this is not detailed. The document implies that new testing was not extensively conducted for this submission, relying heavily on the predicate device's prior validation and the minor changes to compatibility.

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

• The document does not specify the number of experts or their qualifications used to establish ground truth for any test set.
• It mentions that the software allows a "qualified surgeon" to approve pre-surgical plan data, implying that expert surgical review is part of the workflow.

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results.

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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The focus of this 510(k) is substantial equivalence based on technological similarity and expanded compatibility, not a comparative study against human readers or performance improvement with AI assistance.

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

• The document states that the AI algorithm performs "auto segmentation via a locked, or static, artificial intelligence algorithm." While this indicates a standalone AI component, the document does not provide standalone performance metrics for this AI segmentation. The overall system is described as a "pre-surgical planner" where the surgeon can "visualize, measure, reconstruct, annotate and edit pre-surgical plan data," suggesting a human-in-the-loop workflow.

7. The Type of Ground Truth Used

• For software, the implicit ground truth appears to be expert consensus or approved surgical plans for judging the accuracy of the software's representations and planning capabilities. The document states "The software allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data."
• For hardware, "previous cadaver testing and composite bone model testing" were used, implying physical measurements against a known standard or "true" position established in these models.

8. The Sample Size for the Training Set

• The document does not specify the sample size used for the training set for the AI segmentation algorithm.

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

• The document does not specify how the ground truth for the AI training set was established. It only mentions that the AI algorithm for auto-segmentation is "locked, or static," implying it was trained previously.

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant;
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

The SMR Connectors are used to couple the glenosphere to the metal-backed glenoid. Connectors are made from Ti6Al4V alloy (ASTM F1472 - ISO 5832-3) and are characterized by a double male taper. To increase the solidity of the system, a screw is used to link the glenosphere to the glenoid component. No.5 additional sizes (Lateralized connectors) are available in both Small-STD and Small-R configuration to allow lateralization of Center of Rotation.

The provided document is a 510(k) premarket notification for a medical device called "SMR Lateralized Connectors with screws". This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than proving efficacy or safety through extensive clinical trials. Therefore, much of the information requested about acceptance criteria and detailed study designs (especially relating to AI or expert adjudication) is not applicable or present in this document.

However, I can extract the relevant information regarding the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown of the available information:

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

The document does not provide a specific table of numerical acceptance criteria or reported device performance in the format typically seen for novel device performance claims. Instead, it states that mechanical tests "demonstrated device performances fulfill the intended use and are substantially equivalent to the predicate devices." This implies that the performance met predefined internal criteria for equivalence, but these criteria are not explicitly detailed.

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

The document mentions "Mechanical testing was performed on worst case components or constructs." It does not specify the exact sample size for these mechanical tests. The data provenance is internal to Limacorporate S.p.A. and the tests are non-clinical (experimental/lab-based), not derived from patient data.

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

This is not applicable as the study described is non-clinical mechanical testing, not a study involving human interpretation or ground truth establishment by experts for diagnostic or prognostic purposes.

4. Adjudication method for the test set

This is not applicable for the same reason as point 3.

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 study was not done. The device is a mechanical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

No, a standalone AI algorithm performance study was not done. The device is a mechanical implant.

7. The type of ground truth used

For the non-clinical mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks derived from the predicate devices and relevant ASTM/ISO standards (e.g., ASTM F2028-18). The device's performance was compared against these established standards and predicate device characteristics to demonstrate substantial equivalence.

8. The sample size for the training set

This is not applicable as there is no AI algorithm being trained.

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

This is not applicable as there is no AI algorithm being trained.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical structure for AI/diagnostic device evaluation, it does provide clear information about the type of acceptance criteria and study performed for this medical device:

• Acceptance Criteria (Implied): Substantial equivalence to predicate devices, fulfilling intended use, and meeting relevant mechanical testing standards (e.g., ASTM F2028-18 for dynamic evaluation of glenoid loosening and dissociation, and standards for fatigue-fretting behavior and endurance stability of taper connections).
• Study Type: Non-clinical mechanical testing.
• Specific Tests Mentioned:
  • Dynamic evaluation of glenoid loosening and dissociation per ASTM F2028-18.
  • Fatigue-fretting behavior.
  • Endurance stability of the taper connection, followed by evaluation for corrosion.
• Sample Size for Testing: "worst case components or constructs" (specific number not provided).
• Data Provenance: Laboratory testing (non-clinical).
• Ground Truth for Testing: Engineering specifications, performance benchmarks of predicate devices, and relevant international standards (ASTM, ISO).
• Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of SMR Connectors to the predicate devices."

The document primarily focuses on demonstrating that the new SMR Lateralized Connectors with screws are safe and effective because their design, materials, and mechanical performance are equivalent to predicate devices already cleared for market, negating the need for novel clinical data.

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The AltiVate Anatomic™ to Reverse Conversion Module is indicated for revision surgeries in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The conversion module is only indicated for use with a well fixed AltiVate Anatomic Humeral Stem.
Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

In cases of revision surgeries to a well fixed AltiVate Humeral Stem, a reverse conversion module can be mated with the AltiVate stem to convert to a reverse shoulder application.
The currently cleared AltiVate™ Anatomic humeral stem will a conversion module to provide an option to revise a failed traditional total shoulder arthroplasty to a reverse shoulder arthroplasty without the need to remove a well fixed humeral stem.

The provided text describes a 510(k) premarket notification for the "AltiVate Anatomic to Reverse Conversion Module," a medical device. The document states that clinical testing was not required or performed for this submission. Therefore, it does not contain information regarding acceptance criteria, device performance from clinical studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on non-clinical testing and substantial equivalence to predicate devices.

Here's a breakdown of the available information based on the provided input and the limitations due to the absence of clinical testing:

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

• No clinical acceptance criteria or reported clinical device performance are provided as clinical testing was not performed.
• Non-clinical testing: FEA analysis for stress analysis was conducted, determining the subject device is similar to the evaluated predicate device. Bacterial endotoxin testing was also conducted and met expected limits. However, specific numerical acceptance criteria or performance metrics for these non-clinical tests are not detailed in the provided text.

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

• Not applicable as no clinical test set was used.

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

• Not applicable as no clinical test set was used.

4. Adjudication method for the test set:

• Not applicable as no clinical test set was used.

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 MRMC study was done. This device is a medical implant, not an AI diagnostic tool.

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

• Not applicable. This device is a medical implant, not an AI algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" would be engineering specifications and established standards for mechanical performance and sterility (endotoxin levels). The document states the FEA analysis found the device "similar to the evaluated predicate device" and endotoxin testing "met the expected endotoxin limits."

8. The sample size for the training set:

• Not applicable as this is not an AI/algorithmic device and no clinical "training set" was used.

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

• Not applicable as this is not an AI/algorithmic device and no clinical "training set" was used.

In summary, the FDA cleared this device based on non-clinical testing (FEA analysis, endotoxin assessment) and demonstration of substantial equivalence to predicate devices, without requiring or performing clinical trials.

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Cemented Aequalis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Uncemented Aequalis Reversed prosthesis:

It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aegualis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to relieve pain. The reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification consists in the addition of glenoid base plates with central threaded post and a new coating.

Here's an analysis of the provided text regarding the Aequalis Reversed Shoulder Prosthesis, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) Premarket Notification summary for a modification to an already cleared device ("Aequalis Reversed II glenoid base plate"). Therefore, the studies are primarily aimed at demonstrating substantial equivalence of the new components to the previously cleared ones, rather than establishing de novo safety and effectiveness for a completely new device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission for a modification, the "acceptance criteria" are framed around demonstrating equivalence to previously cleared predicate devices, particularly concerns about the new glenoid base plate's anchorage.

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

• Pull-out Testing (E1586):
  • Sample Size: Not explicitly stated as a number. The text mentions "Posts of glenoid base plate (pending and cleared) are impacted in the same foam bloc in several configurations." This implies a comparative test with multiple specimens/configurations for both the new and cleared devices.
  • Data Provenance: The study was "conducted on the new Aequalis Reversed II glenoid base plate and the cleared Aequalis Reversed II glenoid base plate." This indicates controlled laboratory testing, not human patient data.
• Cadaver Testing:
  • Sample Size: Not explicitly stated (e.g., number of cadavers).
  • Data Provenance: "Cadaver testing was performed." This is prospective testing on biological tissue from cadavers, likely conducted in a laboratory or simulated surgical environment.

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

For the engineering tests (pull-out) and cadaver testing described, "ground truth" is typically established by objective physical measurements (e.g., force required for pull-out, visual inspection for fractures/complications) rather than expert consensus on interpretive data.

• No information is provided about the number or qualifications of experts for establishing ground truth in these non-clinical tests. This type of testing relies on engineering and biomechanical principles, not clinical interpretation.

4. Adjudication Method for the Test Set

Given the non-clinical, objective nature of the tests (pull-out force, observational findings during cadaver surgery), formal adjudication methods like 2+1 or 3+1 (common in diagnostic imaging studies) are not applicable or described. The results would be based on direct measurement and observation by the testing personnel.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• This submission pertains to a medical implant (shoulder prosthesis modification), not a diagnostic device or a system involving human interpretation of data. Therefore, the concept of human readers or AI assistance in the context of an MRMC study does not apply here.

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

• No, a standalone algorithm-only performance study was not done.
• This is an implantable medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Pull-out Testing: The ground truth used was objective physical measurement of the force required to pull out the glenoid base plate from a foam block. The "truth" was the measured load/resistance.
• Cadaver Testing: The ground truth was based on direct observation and qualitative assessment of surgical outcomes, specifically whether "primary fixation has been achieved without scapular fracture or other major peri-operative complications." This involved visual inspection, palpation, and potentially other assessments during and after the simulated surgical procedure.

8. The Sample Size for the Training Set

• Not applicable. This is a medical implant, not a machine learning algorithm. There is no concept of a "training set" in this context. The device's design is based on engineering principles and previous device iterations, not data-driven machine learning.

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

• Not applicable, as there is no training set for this type of device.

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The Titan™ Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The glenoid base plate is intended for cementless application with the addition of screws for fixation.
The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

The Integra TITAN Reverse Shoulder System is a modular shoulder prosthesis system. The humeral components consist of humeral stems, varying heights of reverse bodies, and humeral poly liners. The poly liners are available in varying thicknesses and constraints to achieve stability and offset of the glenohumeral joint. The variable length reverse bodies and proximally-filling shape are designed to accommodate the natural humeral geometry, providing stable fixation as well as proximal bone loading. The glenoid components are composed of a baseplate secured by a central compression screw and 4 peripheral screws, two of which can be locked. A glenosphere is attached to the baseplate via taper lock. Glenospheres are available in varying offsets and lateralizations.

The provided document describes the Integra TITAN Reverse Shoulder System, a medical device. The information details nonclinical testing performed to establish substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical or AI-assisted diagnostic context.

Therefore, the following information, as requested in the prompt, is not available in the provided text:

• A table of acceptance criteria and reported device performance (in a diagnostic context)
• Sample size used for the test set and data provenance (for diagnostic performance)
• Number of experts used to establish ground truth for the test set
• Qualifications of those experts
• Adjudication method
• If a multi reader multi case (MRMC) comparative effectiveness study was done
• Effect size of human readers improving with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a diagnostic algorithm
• The sample size for the training set (for a diagnostic algorithm)
• How the ground truth for the training set was established (for a diagnostic algorithm)

However, I can extract information regarding the nonclinical performance testing that was conducted for the device. The document explicitly states: "Clinical performance data were not necessary to support substantial equivalence." This means no human clinical trials (as one might expect a diagnostic AI to undergo) were presented for this 510(k) submission.

Here's what can be extracted about the device's nonclinical performance:

Nonclinical Testing and Acceptance Criteria:

The Integra TITAN Reverse Shoulder System underwent several nonclinical performance tests to confirm its ability to perform under expected clinical conditions. The acceptance criteria for each test are implicitly met as the summary states the "System met all acceptance criteria" or "is acceptable" for each respective test.

Additional Notes:

• Sample Size (for nonclinical tests): The document does not specify the exact sample sizes (number of units tested) for each nonclinical test, but refers to "worst-case components or constructs" being tested.
• Data Provenance (for nonclinical tests): These are laboratory-based engineering tests, not clinical data from patients or a specific country.
• Ground Truth (for nonclinical tests): The ground truth for these tests is based on established engineering principles, biomechanical justification, industry standards (e.g., ASTM F2009-00(2011)), and FDA guidance documents.
• Training Set (for nonclinical tests): This concept does not apply to the nonclinical testing described. These are physical performance assessments against predefined engineering parameters.

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The Reverse Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:

• . In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.
• In cases of bone defect in proximal humerus. .

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

The Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff. failed hemi or total shoulder arthroplasty with irreparable rotator cuff, and for fracture in which the tuberosity and rotator cuff are irreparable. The RSP is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup attached to the humeral stem. The components included in this system are a glenoid head, a humeral socket, a humeral stem, a glenoid baseplate, and baseplate screws.

The Monoblock design consists of:

• . a non-modular stem designed by joining the humeral socket with the humeral stem (sizes 6, 7, 8, 10 and 12);
• . humeral inserts in size 44 semi-constrained UHMWPe and +4 offset inserts in sizes 32, 36, 40 and 44 (standard and semi-constrained UHMWPe). Currently cleared sizes of inserts (32, 36, 40, and 44 in standard poly and size 32, 36, and 40 semi-constrained UHMWPe) are also compatible with the monoblock design.
• . glenoid components will be the same as currently cleared under K 100741, K092873, K051075, and K041066

Here's an analysis of the provided text regarding the Reverse® Shoulder Prosthesis Monoblock, focusing on the requested acceptance criteria and study information:

Based on the provided text, the device is a medical implant (shoulder prosthesis), and the information is from an FDA 510(k) clearance document. For this type of device, "acceptance criteria" and "device performance" are typically related to mechanical and material properties, biocompatibility, and functional integrity under simulated physiological conditions. The document does NOT describe the acceptance criteria or reported device performance for a software-based AI/ML device. The questions about AI-specific criteria (sample size, experts, adjudication, MRMC, standalone performance, training data) are not applicable to this medical device submission.

Here's a breakdown of what is available in the document related to testing, rephrased to fit the structure of your request where possible, and indicating where information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical medical implant and not a software AI/ML device, the table below reflects the type of information that would be relevant for such a device. The provided text does not include specific numerical acceptance criteria or detailed reported performance values for the device's mechanical properties, as these studies were already completed for previous versions.

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

• Sample Size: Not explicitly stated for specific mechanical tests in this document. The document refers to "prior non-clinical testing" performed for previously cleared components (K100741, K092873, K051075, and K041066). The current submission states no additional testing was necessary.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. For mechanical testing, this typically refers to the lab where the tests were conducted, which is not detailed here.

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

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth from data.

4. Adjudication method for the test set

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool that requires adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool. The document explicitly states "Clinical Testing: None provided."

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

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm.

7. The type of ground truth used

• This question is not applicable in the context of AI/ML ground truth from expert consensus, pathology, or outcomes data. For a mechanical device, "ground truth" would be the known mechanical properties of materials, validated engineering models, and the performance of predicate devices against established standards during non-clinical testing.

8. The sample size for the training set

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm.

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

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm. The "ground truth" for mechanical testing is established through standardized engineering test methods and material science principles.

Summary of Device-Specific Information from the Text:

The document concerns the "Reverse® Shoulder Prosthesis Monoblock," an update to an existing shoulder implant. The submission is for a 510(k) clearance, indicating it is a "substantially equivalent" device to a predicate (K082120 - Tornier Aequalis@-Reversed Fracture prosthesis).

The key takeaway regarding testing is:

• Non-Clinical Testing: "After completing review of prior non-clinical testing conducted for this system and submitted under K100741, K092873, K051075, and K041066, it was concluded that additional testing was not necessary to support equivalence." This means the current device leverages prior testing data for its components or overall system design, implying that component-level mechanical, material, and biocompatibility requirements were met previously and are assumed to hold for the new configuration due to design similarities to the predicate and previously cleared components.
• Clinical Testing: "None provided." This is common for 510(k) submissions, especially for modifications of existing devices or when non-clinical testing is deemed sufficient to establish substantial equivalence.

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For treatment of patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

The modification consists of creating a monoblock device by joining the humeral socket with the humeral stem and to add additional humeral insert sizes. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission. This includes no changes to packaging or sterilization.

This document is a 510(k) premarket notification for a medical device called the "Reverse Shoulder Prosthesis". It states that no clinical testing was performed. The submission relies on non-clinical mechanical testing and a comparison to predicate devices to demonstrate substantial equivalence.

Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria, specifically concerning performance with human data, cannot be extracted from this document.

The document does provide information relevant to a non-clinical study, which is included below for completeness:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Test Set Sample Size: Not applicable, as this was non-clinical testing. The "test set" consisted of physical prototypes and design specifications for mechanical analysis.
• Data Provenance: Not applicable for clinical data. The data originates from internal engineering analysis and mechanical testing performed by the manufacturer (Encore Medical, L.P. / DJO Surgical).

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

• Not applicable as this was non-clinical mechanical and design equivalence testing, not clinical human performance evaluation. The "ground truth" was established by engineering specifications, material science standards, and accepted biomechanical testing methodologies.

4. Adjudication method for the test set

• Not applicable as this was non-clinical testing. Verification activities were performed, implying internal review and assessment against design specifications and predicate device characteristics.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This was a non-clinical submission for a shoulder prosthesis, not an AI-based diagnostic or treatment device involving human readers.

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

• No. This was a non-clinical submission for a shoulder prosthesis, not an algorithm.

7. The type of ground truth used

• For the non-clinical testing, the "ground truth" was based on:
  • Engineering design specifications.
  • Material property standards.
  • Biomechanical principles and accepted testing methodologies (e.g., for socket lever out strength, stress analysis).
  • Characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. There was no machine learning or AI involved requiring a training set.

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

• Not applicable. There was no machine learning or AI involved requiring a training set.

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The Encore Reverse Shoulder Prosthesis (RSP) is intended for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

During primary surgery, after the humerus is prepared for the RSP humeral stem, if the glenoid bone stock appears "insufficient" to bear the load of the glenoid baseplate, a RSP humeral stem adapter can be used to convert the RSP humeral stem to a hemiarthroplasty prosthesis. During revision surgery of an RSP, if the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device; a RSP Humeral Stem Adapter is used to convert the RSP device to a hemiarthroplasty prosthesis.

The Encore Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff, failed hemi or total shoulder arthroplasty with irreparable rotator cuff, and for fracture in which the tuberosity and rotator cuff are irreparable. Unlike traditional total shoulders, the RSP is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup attached to the humeral stem. The RSP Humeral Stem Adapter is used to convert the RSP to a hemiarthroplasty when the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission.

The provided text describes a medical device, the Encore Reverse Shoulder Prosthesis (RSP), and its approval via a 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, rather than a clinical trial proving specific performance acceptance criteria. The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." and "The modified Encore RSP is similar in design, materials, and intended use to the previously cleared Encore RSP devices, K041066 and K051075."

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your specific questions, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document does not describe specific performance criteria or a study that measures the device against them.
2. Sample sized used for the test set and the data provenance: Not available. No "test set" in the context of performance evaluation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
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 a shoulder prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available. The approval is based on substantial equivalence to predicate devices, not on direct performance against a "ground truth" as might be seen for diagnostic devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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The Encore Reverse Shoulder Prosthesis® (RSP) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

The Encore Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff, failed hemi or total shoulder arthroplasty with irreparable rotator cuff, in operation our, half, half hand rotator cuff are irreparable. Unlike traditional total shoulders, the RSP is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup attached to the humeral stem. buooplate, and this system are a glenoid head, a humeral socket, a humeral stem, a glenoid baseplate, and baseplate screws. The glenoid baseplate is intended for cementless a glondia baouplate, and bon of screws for fixation. The humeral stem is intended for cemented use only. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission.

The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is primarily a 510(k) summary and an FDA clearance letter for the Encore Reverse Shoulder Prosthesis (RSP), stating its indications for use and substantial equivalence to a previously cleared device.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details. The information about the device's technical specifications and the regulatory clearance process is present, but not the performance evaluation data you're asking for.

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