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The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.

The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intended for primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components – glenophere, baseplate, and fixation component (screw or post). All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

The subject submission seeks to gain clearance for design modifications to the existing device components.

The provided FDA 510(k) clearance letter for the JARVIS Glenoid Reverse Shoulder Prosthesis does not contain any information regarding clinical studies, acceptance criteria for an AI/CADe device, or performance data related to AI assistance.

The document describes a traditional medical device (a shoulder prosthesis), not an artificial intelligence (AI) or computer-assisted detection/diagnosis (CADe/CADx) device. Therefore, it lacks the specific details requested in your prompt, such as:

• Table of acceptance criteria and reported device performance for an AI/CADe system.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Ground truth types and methods for establishing ground truth.
• Training set sample size and ground truth establishment for AI.

The "Performance Testing" section explicitly states: "Engineering analysis was conducted on the modified locking screws and concluded that the compressive force of the subject screws is equivalent to that of the predicate and therefore locking capabilities are equivalent. Therefore, all previous performance testing and validations are still applicable and no additional testing is necessary." This refers to mechanical testing of the physical implant components, not performance of an AI algorithm.

In summary, the provided text is for a physical medical implant, not an AI-based or software-as-a-medical-device (SaMD) product that would require the kind of data and studies you are asking about.

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The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

• Severe arthropathy with a grossly deficient rotator cuff;
• Previously failed joint replacement with a grossly deficient rotator cuff;
• Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
• Bone defect in proximal humerus;
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
• Inflammatory arthritis including rheumatoid arthritis;
• Correction of functional deformity.

The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures.

All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

This 510(k) submission proposes updated Surgical Technique within labeling, to reflect alternative reaming method to prepare the glenoid surface for the AltiVate Reverse Glenoid wedge baseplate. The alternative technique does not replace the original technique; it adds a secondary method for the user. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced.

This 510(k) clearance letter is for a medical device (AltiVate Reverse® Glenoid), specifically a shoulder joint prosthesis, not an AI/ML-based device. The provided text details the regulatory clearance for the device itself and a minor update to its surgical technique within labeling.

Therefore, the input does not contain the information necessary to describe acceptance criteria and a study proving an AI/ML device meets them as requested in the prompt. The document describes a physical device, not a software or AI algorithm.

Here's why the prompt cannot be answered with the provided text:

• No mention of AI/ML or Software: The entire document refers to a "shoulder joint metal/polymer semi-constrained cemented prosthesis," a physical implant. There is no mention of algorithms, artificial intelligence, machine learning, image analysis, diagnostics, or any other software-based function.
• Performance Testing: The "Performance Testing" section states, "Design Control and Verification and Validation Activities performed, demonstrates substantial equivalence between the subject and predicate devices and did not raise different questions of safety and effectiveness." This refers to traditional engineering and biomechanical testing for a physical implant, not the evaluation of an AI model's performance on data.
• Acceptance Criteria for AI: The prompt specifically asks for acceptance criteria related to AI performance (e.g., sensitivity, specificity, AUC) and details about a study evaluating an AI model (test set size, ground truth, expert review, MRMC studies). None of this information is relevant or present in the provided 510(k) letter for a physical orthopedic implant.

In summary, the provided FDA 510(k) letter is for a physical medical device and does not contain any information about the acceptance criteria or study data for an AI/ML-based device.

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The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi-arthroplasty is determined by the surgeon to be the preferred method of treatment.

• The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation.
• The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
• The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
• Humeral Heads are intended for use in cemented and press-fit applications.

Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:

The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The proposed Equinoxe Activit-E Reverse Humeral Liners are humeral liners intended to be used in reverse total shoulder arthroplasty (rTSA) as a part of the Equinoxe® Shoulder System. The proposed devices are constructed of highly crosslinked UHMWPE containing vitamin E referred to as Activit-E. There are no proposed geometric or compatibility changes as compared to the predicate humeral liner devices cleared in K223833.

The provided document is a 510(k) clearance letter and summary for a medical device, the Equinoxe® Shoulder System. This document focuses on the substantial equivalence of a new version of the device (specifically, the Humeral Liners made from Activit-E material) to a previously cleared predicate device.

The FDA 510(k) clearance process is primarily focused on demonstrating substantial equivalence, not necessarily on proving that a device meets specific "acceptance criteria" in the same way one might for a diagnostic AI algorithm. Therefore, the information typically requested in an acceptance criteria study (like sample sizes for test and training sets, expert qualifications, ground truth establishment for AI, MRMC studies, or standalone algorithm performance) is not directly present in this regulatory submission for a physical orthopedic implant.

However, I will extract the closest available information related to performance and testing, as well as explicitly state where the requested information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific medical device (Equinoxe® Shoulder System - Humeral Liners), the "acceptance criteria" are not reported as numerical thresholds like accuracy or sensitivity. Instead, the acceptance criteria are implicitly met by demonstrating that the new device performs "as intended" and is "substantially equivalent" to the predicate device through various non-clinical tests. The performance is assessed by confirming that the new Activit-E material does not negatively impact the mechanical integrity and biological interaction compared to the conventional UHMWPE.

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

This information is typically not included in a 510(k) summary for a physical implant. The "test sets" here refer to the samples of the device components used for mechanical and biological testing.

• Sample Size for Test Set: Not specified in the provided document (e.g., number of liners tested for fatigue, wear). These would be standard engineering test sample sizes as per relevant ASTM/ISO standards.
• Data Provenance: Not specified. Non-clinical bench testing is typically performed in a controlled laboratory environment. Retrospective/prospective data or country of origin are not applicable in the same way as for clinical studies or AI algorithms.

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

This information is not applicable and therefore not provided. For a physical implant like a shoulder system, "ground truth" is established through engineering specifications, material properties, and performance standards, not through expert consensus on interpretations like with medical images.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical data (e.g., radiological images) to establish ground truth, which is not relevant for the bench testing of mechanical implants.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not applicable and therefore not provided. MRMC studies are used to assess the impact of a diagnostic aid (e.g., an AI algorithm) on human reader performance, which is not relevant for the clearance of an orthopedic implant.

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

This information is not applicable and therefore not provided. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Equinoxe® Shoulder System Humeral Liners is established through industry-recognized performance standards (ASTM and ISO standards) and engineering specifications. These standards define acceptable limits for wear, fatigue, biocompatibility, and other mechanical and biological properties. Compliance with these standards, along with demonstration of equivalence to the predicate device, forms the basis of the safety and effectiveness claims.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical implant, not an AI algorithm that requires a training set.

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

This information is not applicable and therefore not provided.

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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 SMR TT 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.

In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

The subject SMR Reverse HP Shoulder System is a line extension to the predicate SMR Shoulder System (K223876) consisting of Reverse HP crosslinked UHMWPE glenospheres and Co-Cr-Mo liners. The components are available in one diameter with various options to accommodate varying patient anatomy.

Based on the provided FDA 510(k) clearance letter for the SMR Reverse HP Shoulder System, here's an analysis of the acceptance criteria and the study proving the device meets them:

It's important to note that this document is a 510(k) clearance, which is primarily a declaration of substantial equivalence to a previously cleared predicate device, rather than a full, de novo approval that would detail extensive clinical performance studies with specific statistical acceptance criteria for novel claims. The focus here is on demonstrating that the new device (SMR Reverse HP Shoulder System) is as safe and effective as existing legally marketed devices, rather than proving a new level of clinical efficacy.

Therefore, many of the specific details you've asked for, such as precise quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or effect size for AI assistance), adjudication methods, or detailed expert qualifications for ground truth establishment, are typically not found in a 510(k) summary, as they are not generally required for demonstrating substantial equivalence for an orthopedic implant.

The "acceptance criteria" for a 510(k) device primarily revolve around demonstrating that the new device performs as intended and is as safe and effective as its predicate. This is primarily done through non-clinical (mechanical) testing and reference to the predicate's established clinical history.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SMR Reverse HP Shoulder System are implicit in the demonstration of substantial equivalence to its predicate devices. The performance testing aims to show that the new components function equivalently to, or better than, the predicate components within the intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study described is primarily a non-clinical performance study combined with a post-market clinical data review for demonstrating substantial equivalence.

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

• Test Set (Non-clinical): The document states "Mechanical testing was performed on worst case components or constructs." This implies a limited sample size based on engineering principles (e.g., statistical power calculations for specific test types or industry standards for mechanical testing). Specific numbers are not provided, as is typical for 510(k) engineering tests.
• Data Provenance (Clinical): "Post-market clinical data from outside the United States on the subject and predicate device were provided in this submission." This indicates a retrospective collection of data from clinical use, not a prospective, controlled clinical trial specifically designed for this submission. The exact country of origin within "outside the United States" is not specified, nor is the specific sample size, though it is described as "patient-level radiographs, outcome measures, and safety data."

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

• Non-clinical: Ground truth is established by engineering standards and specifications (e.g., ISO, ASTM). The "experts" would be the engineers and technicians performing and assessing the mechanical tests against these predefined standards. Their qualifications are implicit in their ability to conduct and interpret these tests, but not explicitly stated in terms terms like "mechanical engineer with 10 years experience."
• Clinical: For the post-market clinical data, the "ground truth" refers to patient outcomes and safety information. This data is observed in real-world clinical practice, typically by treating physicians. There is no mention of a separate panel of experts specifically adjudicating this post-market data for "ground truth" purposes in the context described.

4. Adjudication Method for the Test Set:

• Non-clinical: The "adjudication" is against the pre-defined engineering standards and performance specifications for each mechanical test. This is typically a pass/fail determination based on quantitative measurements. No human-expert consensus "adjudication method" (like 2+1, 3+1) is described or typically applicable to component mechanical testing.
• Clinical: For the post-market clinical data, there's no mention of an adjudication method by external experts. The data would have been collected as part of routine clinical care or existing registries, and then compiled and analyzed by the manufacturer for the submission.

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 an orthopedic implant, not a diagnostic imaging AI algorithm. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not applicable to the SMR Reverse HP Shoulder System.

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

• Not applicable. As stated above, this is an orthopedic implant, not an AI algorithm.

7. The Type of Ground Truth Used:

• Non-clinical: The ground truth for mechanical testing is based on established engineering principles and international standards (ISO, ASTM) for orthopedic implants. These standards define the expected performance and limits for various mechanical properties.
• Clinical: The "ground truth" for the clinical data is real-world patient outcomes, safety events, and radiographic assessments collected during post-market use of the predicate device and the subject device (where applicable) outside the US. These are actual clinical observations rather than expert consensus on a test set.

8. The Sample Size for the Training Set:

• Not applicable for a 510(k) orthopedic implant. Training sets are relevant for machine learning algorithms. The design and validation of this mechanical implant do not involve "training sets" in this context. The "training" for the device would be the iterative design and development process, informed by biomechanical principles and material science, leading up to the final testing.

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

• Not applicable. See point 8.

In summary, the FDA 510(k) clearance for the SMR Reverse HP Shoulder System relies heavily on demonstrating engineering equivalence and material compliance through non-clinical testing, supplemented by a review of existing post-market clinical data for the predicate and related devices. It is a process focused on showing that the new device is "substantially equivalent" to an already cleared device, rather than a de novo approval process that would require extensive novel clinical efficacy studies with sophisticated statistical methodologies often seen for new drug or AI algorithm approvals.

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The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The restor3d rTSA System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid component with porous surface is indicated for uncemented biological fixation application only. The restor3d rTSA System glenoid baseplate components are intended for cementless application with the addition of screw fixation.

Humeral components with porous surface are indicated for either cemented or uncemented applications.

The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws).

The provided text is a 510(k) clearance letter for a medical device: the restor3d Reverse Total Shoulder Arthroplasty System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states, "The restor3d Reverse Total Shoulder Arthroplasty System was subject to the following non-clinical performance tests to support the assertion of substantial equivalence."

Therefore, the document describes engineering and material performance testing, not a clinical study involving human patients or analysis of clinical images/data using an AI algorithm. The questions posed in your prompt (e.g., acceptance criteria for device performance/accuracy, sample size for test set/training set, number of experts for ground truth, MRMC study, standalone performance) are typically relevant for AI/ML-enabled medical devices or devices requiring clinical performance studies.

Since the provided text does not describe an AI/ML-enabled device or a clinical study that would generate "device performance" in terms of accuracy, sensitivity, specificity, etc., against a clinical ground truth, I cannot fill out the requested table or answer most of the specific questions.

Here's an explanation based on the provided text, highlighting why the requested information isn't present:

Context from the document:

• Device Type: Reverse Total Shoulder Arthroplasty System (a physical implant)
• Regulatory Pathway: 510(k) (seeking substantial equivalence to a legally marketed predicate)
• Testing Described: "Non-Clinical Testing" which includes:
  • Glenoid Baseplate Loosening per ASTM F2028
  • Glenoid Baseplate Fatigue and corrosion analysis
  • Morse Taper Disassembly Strength per ASTM F2009
  • Humeral Stem Fatigue and corrosion analysis
  • Bone Screw Testing per ASTM F543
  • Poly Liner Performance Tests per ASTM F1820
  • Range of Motion Analysis per ASTM F1378
  • Wear Analysis

These are all benchtop, mechanical, and material science tests designed to show that the new device performs similarly from an engineering standpoint to the predicate and meets established ASTM standards for orthopedic implants. They do not involve "device performance" in terms of clinical accuracy or an AI algorithm's predictive capability.

Therefore, I cannot fulfill your request as it pertains to acceptance criteria and studies typically associated with AI/ML or diagnostic devices that produce "performance" metrics against clinical ground truth.

However, if we interpret "acceptance criteria" and "device performance" within the context of mechanical/material testing as presented in the document, here's what could be inferred, though it won't directly answer your specific table columns:

The "acceptance criteria" for this device would be implicit in meeting the requirements of the cited ASTM standards, such as surviving a certain number of fatigue cycles at a given load, or meeting specific wear rates, or exhibiting particular disassembly strengths. The "reported device performance" would be the results from these bench tests, demonstrating that the device did indeed meet those standard specifications.

To directly address your prompts based on the absence of the requested information in the provided document:

Description of Acceptance Criteria and Study to Prove the Device Meets Them (Based on provided document)

The provided FDA 510(k) clearance letter for the restor3d Reverse Total Shoulder Arthroplasty System primarily relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device. This submission does not describe a clinical study of diagnostic or predictive performance, nor does it discuss AI model performance. Therefore, the requested information regarding AI/ML-specific acceptance criteria, test set details, expert involvement for ground truth, or MRMC studies is not present in this document.

The "acceptance criteria" for this device are implicitly tied to its ability to meet the performance requirements of established ASTM (American Society for Testing and Materials) standards for orthopedic implants, and to demonstrate comparable mechanical and material characteristics to its predicate device. The "study that proves the device meets the acceptance criteria" refers to a series of non-clinical benchtop tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The provided 510(k) summary only lists the types of tests performed and states they support substantial equivalence. It does not provide the specific numerical acceptance thresholds or the detailed numerical results from these non-clinical tests. This level of detail would typically be found in the full 510(k) submission not in the public clearance letter summary.

Regarding other specific questions (not applicable based on the document's content):

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

• Not applicable. The "test set" here refers to physical implant samples subjected to bench testing, not a dataset of clinical cases for an AI algorithm. The document does not specify the number of physical samples used for each test. Data provenance (country, retrospective/prospective) is not relevant for bench testing of a physical implant.

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

• Not applicable. Ground truth in this context is established by engineering standards (e.g., ASTM specifications, material properties) and physical measurements on the device, not by expert medical review of clinical data.

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

• Not applicable. This method applies to expert review of clinical cases, not mechanical testing.

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. An MRMC study is for evaluating human performance (often with or without AI assistance) in interpreting clinical data. This document describes a physical 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 refers to AI algorithm performance. No AI algorithm is described.

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

• Not applicable in the clinical sense. Ground truth for this device is based on engineering standards (ASTM), material specifications, and physical measurements demonstrating the device's mechanical and material properties are equivalent to the predicate and meet safety requirements.

8. The sample size for the training set:

• Not applicable. This refers to AI model training data. No AI model is described.

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

• Not applicable. This refers to AI model training data. No AI model is described.

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AltiVate Reverse® Shoulder System, Reverse® Shoulder Prosthesis (RSP®), SMR Shoulder System, PRIMA Humeral System, and PRIMA Glenoid System are intended for various forms of partial or total, primary or revision shoulder joint replacement. Specific indications depend on the system and configuration (modular, monoblock, anatomic, reverse), addressing conditions such as:

• Grossly rotator cuff deficient shoulder joint with severe arthropathy
• Previously failed joint replacement with a grossly rotator cuff deficient shoulder joint
• Functional deltoid muscle is necessary to use the device
• 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)
• Bone defect in proximal humerus
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid
• Inflammatory arthritis including rheumatoid arthritis
• Correction of functional deformity
• Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods
• Revision of a failed primary implant (if sufficient bone stock remains)
• Cuff tear arthropathy (CTA Heads only)
• Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only)
• Massive irreparable rotator cuff tear

The patient's joint must be anatomically and structurally suited to receive the selected implant(s). Some components are intended for cemented and/or cementless application, often with the addition of screws for fixation. Revision surgery can include conversion from anatomic to reverse arthroplasty if the stem is stable, well positioned, and tissue integrated.

This 510(k) submission proposes updated labeling to reflect additional compatibility between previously cleared shoulder systems from Encore Medical, L.P. (AltiVate Reverse® Shoulder System) and LimaCorporate S.p.A. (SMR and PRIMA Shoulder Systems). The update allows for cross-system use of humeral and glenoid components for reverse total shoulder arthroplasty, where compatible sizes exist. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced. The proposed configurations include using an AltiVate Reverse® humeral stem and insert with SMR or PRIMA glenoid components, and vice versa.

It appears there might be a misunderstanding of the provided FDA 510(k) clearance letter. The document, K251184, is for orthopedic implants (shoulder prostheses, specifically reverse shoulder systems and related components), not for an AI/software as a medical device (SaMD) or diagnostic device that would typically have acceptance criteria, performance studies involving human readers, and ground truth establishment in the way described in your request.

The letter explicitly states:

• "Trade/Device Name: AltiVate Reverse® Shoulder System; Reverse® Shoulder Prosthesis (RSP®); SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System"
• "Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis"
• "Device Description: This 510(k) submission proposes updated labeling to reflect additional compatibility between previously cleared shoulder systems... The update allows for cross-system use of humeral and glenoid components for reverse total shoulder arthroplasty, where compatible sizes exist. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced."
• "Performance testing: Performance testing, including Wear Testing and Range of Motion Analysis, demonstrates substantial equivalence between the subject and predicate devices and did not raise different questions of safety and effectiveness."

This means the "device" in question is a physical medical implant, and the 510(k) is about demonstrating "substantial equivalence" to previously cleared implants, primarily regarding material compatibility and mechanical performance (wear, range of motion).

Therefore, the requested information about acceptance criteria for an AI/diagnostic device, sample sizes for test sets in medical imaging, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set details are not applicable to this specific 510(k) clearance letter. The testing mentioned ("Wear Testing and Range of Motion Analysis") would involve mechanical engineering and biomechanical testing, not clinical studies with human readers or AI performance metrics.

To answer your request based on the provided document would require fabricating information not present in the letter. If you have an FDA 510(k) clearance letter for an AI/SaMD or diagnostic device, I would be happy to analyze it against your criteria.

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The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.

The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intendedfor primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components - glenophere, baseplate, and fixation component (screw or post) . All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

This document is an FDA 510(k) summary for the JARVIS Glenoid Reverse Shoulder Prosthesis. It does not contain information about an AI/ML medical device. Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device.

The provided text describes a traditional medical device (shoulder prosthesis) and its mechanical and biocompatibility testing, which are standard for such devices to demonstrate substantial equivalence to legally marketed predicates.

To answer your specific questions about an AI/ML device, the input document would need to describe such a device, its intended use, and the performance studies conducted to support its claims.

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The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Blueprint® is a medical device for surgeons.

Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery. Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format. Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. Blueprint® allows surgeons to design patient specific components (patient-specific instruments and Shoulder iD™ Primary Reversed Glenoid*) based on the pre-surgical plan.

Blueprint® leads to the generation of a planning report.

Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.

Note: Measures and patient specific guide design are provided depending on the case profiles. *Only if patient-specific instruments or Shoulder iD™ Primary Reversed Glenoid are available in your geography.

The Shoulder iD™ Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

· Rheumatoid arthritis

• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• · Revision of glenohumeral joint if sufficient native glenoid bone remains

All components are single use.

The Shoulder iD™ Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation.

Note: A CT Scan is used to create the Shoulder iD™ Primary Reversed Glenoid implant

BLUEPRINT™ Patient Specific Instrumentation
Blueprint Patient Specific Instrumentation is composed of two components: Blueprint Glenoid Guides (hardware) and Blueprint Planning Software (software)

Blueprint™ Glenoid Guides
The Blueprint Glenoid Guides are patients specially designed to facilitate the implantation of Wright-Tornier glenoid prostheses.

The Blueprint Glenoid Guides are designed and manufactured based on a pre-operated only by the software Blueprint Planning Software.

Blueprint™ Planning Software
Blueprint Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer and is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed).

It is intended to help to plan an operation by allowing surgeons to:

• · Plan for shoulder arthroplasty cases
• · Position and select glenoid and humeral implants,
• · Simulate the prosthetic range of motion,
• · Interact with implants and different computed measurements
• · Generate information required to design a patient-specific glenoid component when appropriate.

Shoulder iD™ Primary Reversed Glenoid
The Shoulder iD Primary Reversed Glenoid implant (Shoulder iD) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis.

The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

This FDA 510(k) clearance letter and its accompanying summary focus on demonstrating substantial equivalence to predicate devices for two components: "Blueprint Patient-Specific Instrumentation" (software and hardware) and "Shoulder iD Primary Reversed Glenoid" (implant). The document primarily addresses the comparison of indications for use and technological characteristics, and broadly mentions performance testing.

Crucially, the provided text does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria in the format requested. The document mentions "performance testing" and "verification and validation evaluations" but does not elaborate on the specific metrics, results, or methodologies used.

Therefore, I cannot populate the table or answer most of the questions directly. However, I can extract what is implied or stated generally:

Implicit information from the FDA 510(k) context:

• Acceptance Criteria (Implied): For a 510(k) clearance, the primary acceptance criterion is substantial equivalence to existing legally marketed devices. This means demonstrating that the new device is as safe and effective as the predicate, and does not raise new questions of safety or effectiveness. For the software, this typically involves demonstrating accuracy, reliability, and functionality consistent with its intended use (pre-surgical planning). For the hardware (guides) and the implant, this involves demonstrating appropriate mechanical properties, fit, and biocompatibility.
• Study Type (Implied): Given it's a 510(k) without clinical studies, the studies would primarily be non-clinical performance testing (e.g., mechanical testing, dimensional accuracy, software verification and validation).

Here's what can be extracted and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing specific details:

• Quantitative acceptance thresholds (e.g., accuracy +/- X mm, specific mechanical test results).
• Detailed breakdown of results for each criterion.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not specified. The document mentions "cadaveric test" for the guides and "Non-clinical Reverse Glenoid Loosening testing" for the implant, but no sample sizes are given for these tests. For software verification and validation, typically a set of test cases is used, but the size or nature of these cases is not described.
• Data Provenance: The company (Stryker Corporation (Tornier, S.A.S.)) is based in France. The letter does not specify the country of origin of the test data. The studies are non-clinical (e.g., benchtop, cadaveric, software testing), not clinical trials on patients, therefore the retrospective/prospective distinction for patient data does not directly apply in the usual sense.

3. Number of Experts and Qualifications for Ground Truth:

• Not specified. Given that no clinical studies were performed, and the emphasis is on substantial equivalence through non-clinical testing and software V&V, the "ground truth" would likely be established through engineering specifications, validated simulation models, or anatomical measurements rather than expert clinical consensus on patient data.
• If expert review was involved in the software V&V or cadaveric studies (e.g., assessing anatomical landmark identification), their number and qualifications are not mentioned.

4. Adjudication Method for the Test Set:

• Not applicable / Not specified. Without details on how ground truth was established by experts on a test set (e.g., image annotations), an adjudication method cannot be inferred.

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

• No, not specified. The document explicitly states: "No clinical studies were performed." MRMC studies typically involve human readers interpreting medical images, usually in a clinical context, which wasn't part of this submission for demonstrating substantial equivalence. The device is a planning software and instrumentation, not primarily one for diagnostic interpretation by human readers.

6. Standalone (Algorithm-Only) Performance:

• Implicitly yes, for software verification and validation. The document states that "Technological differences between the subject and predicate software are supported with verification and validation evaluations." This suggests testing of the software's algorithms and functionalities independently. However, specific standalone performance metrics (e.g., accuracy of measurements, success rate of planning) are not detailed. The software is described as a "pre-surgical planner" that allows surgeons to "visualize, measure, reconstruct, and annotate anatomic data" and "design patient-specific components." The V&V would assess these capabilities.

7. Type of Ground Truth Used:

• For the hardware (guides): Likely dimensional measurements (engineering specifications) and anatomical landmarks/fit in cadaveric models.
• For the software: Likely engineering specifications, validated computational models, known anatomical dimensions from source CT data, and consistency checks against surgeon input/expectations during planning scenarios.
• For the implant: Mechanical testing standards and measurements (e.g., loosening, fatigue strength) compared against predicate performance.

8. Sample Size for the Training Set:

• Not specified. The document describes a "Blueprint Planning Software" but does not explicitly state it's an AI/machine learning model that requires a "training set" in the sense of supervised learning. It's described as software that allows surgeons to perform planning functions, implying it might be a rule-based system or an advanced visualization and measurement tool, rather than a learning algorithm. If there is an AI component, the training set size is not provided.

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

• Not specified and not directly applicable unless the "Blueprint Planning Software" incorporates machine learning and has a distinct "training set." If it does, and assuming the software assists in identifying anatomical landmarks or making measurements, the ground truth for training data would typically be established by expert radiologists or orthopedic surgeons annotating CT scans.

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The Equinoxe Shoulder System is indicated for use individuals with degenerative diseases or fractures of the glenolumeral joint where total or hemi-arthroplasty is determined by the preferred method of treatment.

• The cemented primary humeral stem, longrevision stems, and all Equinoxe glenoids are intended for cemented fixation.
• The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the surgeon.
• . The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
• . Humeral Heads are intended for use in cemented and press-fit applications.
  Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
• Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
• Congenital abnormalities in the skeletally mature
• Primary and secondary necrosis of the humeral head.
• Humeral head fracture with displacement of the tuberosities
• Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
• Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
• Displaced three-part and four-part upper humeral fractures
• Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
• Revision of failed previous reconstructions when distal anchorage is required
• To restore mobility from previous procedures (e.g. previous fusion)
  The Equinoxe Reverse Shoulder System is in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
  The Equinoxe Platform Fracture Stem is in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures (hemi-athroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximation with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superil head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The Central Screw Baseplate System is comprised of devices that will be included as part of the Exactech Equinoxe® Shoulder System for reverse total shoulder arthroplasty (rTSA). The Central Screw Baseplate System includes Glenoid Baseplates, Central Compression Screws, a Locking Plate, a Locking Nut, and a Glenosphere Locking Screw. Previously cleared components used with the Central Screw Baseplate System include Peripheral Screws and Glenoid components. The design of the proposed Central Screw Baseplate System is based on the existing foundation and principles of the currently marketed Equinoxe Standard and Small Reverse Baseplates.

The provided text is a 510(k) summary for the Exactech Equinoxe® Central Screw Baseplate System. It describes the device, its intended use, comparison to predicate devices, and a summary of non-clinical testing.

However, it does not contain information about a study proving that the device meets acceptance criteria related to an AI/ML component, human reader performance, or ground truth establishment based on expert consensus, pathology, or outcomes data. The provided document is for a medical implant (shoulder prosthesis) and focuses on mechanical, material, and biocompatibility testing, not software or AI performance.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device based on this document. The prompt asks for information pertaining to a study for an "AI device," which this product is not.

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The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: Severe arthropathy with a grossly deficient rotator cuff; Previously failed joint replacement with a grossly deficient rotator cuff; Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; Bone defect in proximal humerus; Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; Inflammatory arthritis including rheumatoid arthritis; Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

The AltiVate Reverse® Glenoid is a line extension to the existing RSP Glenoid System consisting of additional size offerings, modularity, and augment/revision offerings for varying glenoid morphologies for use in reverse Total Shoulder Arthroplasty (TSA) applications. The new implants consist of modular neutral and augmented baseplates, Torx peripheral screws, porous coated pegs, and additional offsets of glenospheres. All of the subject device implants are manufactured from Ti-6Al-4V except the glenospheres, which are manufactured from CoCrMo. New device specific accessories/instruments have been developed and are intended to facilitate proper implantation of the glenoid shoulder system.

The provided text is an FDA 510(k) clearance letter for a medical device called the AltiVate Reverse® Glenoid. It explicitly states that "Clinical data was not required." This means that the device was cleared based on non-clinical performance testing and comparison to predicate devices, rather than through a clinical study involving human patients.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, as no such clinical study was conducted or required for this 510(k) submission.

However, I can extract the information provided about the non-clinical performance testing and the basis for substantial equivalence.

Based on the provided document:

Accepted Basis for Clearance (Non-Clinical/Bench Testing):

Regarding the other requested information (which is not applicable to a non-clinical 510(k) clearance):

1. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set was used. The performance testing was non-clinical (bench testing).
2. Number of experts used to establish the ground truth... and qualifications: Not applicable, as no human expert-driven ground truth was established from clinical data.
3. Adjudication method for the test set: Not applicable, as no clinical test set was used.
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: Not applicable. This device is a physical medical implant, not an AI or imaging diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical implant, not an AI or imaging diagnostic tool.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical testing, the "ground truth" was established by adherence to ASTM standards and demonstrated mechanical/material equivalence to the predicate device.
7. The sample size for the training set: Not applicable, as no clinical training set was used.
8. How the ground truth for the training set was established: Not applicable, as no clinical training set was used.

Conclusion stated in the document: "All testing and evaluations demonstrate that the subject device is substantially equivalent to the predicate device identified." This means the device met the acceptance criteria by demonstrating equivalence to a legally marketed predicate device through non-clinical performance testing.

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