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Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched 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 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 Patient-Matched Glenoid implant is anchored to the bone with screws and is for non-cemented fixation. Note: A CT Scan is used to create the Tornier Perform Patient-Matched Primary Reversed Glenoid implant.

BLUEPRINT™ Patient Specific Instrumentation:
BLUEPRINT ™ Glenoid Guides: The BLUEPRINT™ Glenoid Guides are intended to be used as surgical instruments 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™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a medical device for surgeons. BLUEPRINT™ 3D Planning Software is intended to be used as a pre-surgical planner for shoulder replacement surgerv. BLUEPRINT™ 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format. BLUEPRINT™ 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINT™ 3D Planning Software allows surgeons to design patient specific components (Patient-Specific instruments and Tornier Perform™ Patient-Matched Primary Reversed Glenoid*) based on the pre-surgical plan. BLUEPRINT™ 3D Planning Software leads to the generation of a planning report. BLUEPRINT™ 3D Planning Software 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 Tornier Perform™ Patient-Matched Primary Reversed Glenoid are available in your geography.

Tornier Perform™ Patient-Matched Primary Reversed Glenoid: The Tornier Perform™ Patient-Matched Primary Reversed Glenoid implant (Patient-Matched Glenoid) 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.

BLUEPRINT™ Patient Specific Instrumentation: BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the BLUEPRINT™ Glenoid Guides and BLUEPRINT™ 3D Planning Software is the responsibility of Tornier is the legal manufacturer for the hardware and the software.
BLUEPRINT ™ Glenoid Guides: The BLUEPRINT ™ Glenoid Guides are patient-specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D Planning Software.
BLUEPRINT™ 3D Planning Software: BLUEPRINT™ 3D Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer 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.

This document, K211359, is a 510(k) premarket notification for the Tornier Perform™ Patient-Matched Primary Reversed Glenoid (implant) and BLUEPRINT™ Patient Specific Instrumentation (hardware and software). The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through clinical trials. As such, the information provided focuses on non-clinical performance and verification/validation, largely relying on the predicate device's established safety and effectiveness.

Therefore, the following information, which typically applies to AI/software as a medical device (SaMD) clearances involving complex algorithms and clinical performance studies, is largely not present in this 510(k) summary. The provided text explicitly states that "No clinical studies were performed." This indicates that the device's performance was not evaluated through a study comparing it to an established ground truth in the way a traditional AI/SaMD clinical study would.

Here is a breakdown based on the provided document and the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing for both the implant and the instrumentation. These are engineering/material specifications rather than clinical performance metrics for an AI algorithm.

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

• Test Set Sample Size: Not applicable in the context of a clinical performance test for an AI algorithm. The tests described are non-clinical engineering/materials tests (e.g., pullout, fatigue). For the software, "verification and validation evaluations" were performed, but no specific number of cases or data provenance is detailed, as it's a conformity assessment to the predicate's operating principle.
• Data Provenance: Not applicable for an AI algorithm evaluation in this context. The document mentions "cadaveric test performed on the subject device" for the hardware, which would be test data, but not a "test set" in the sense of clinical images for an AI.

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 study or AI algorithm evaluation with human expert ground truth was performed.

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

• Not applicable as no clinical study or AI algorithm evaluation with adjudicated ground truth was performed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." Therefore, there is no effect size on human reader improvement with AI assistance.

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

• For the BLUEPRINT™ 3D Planning Software, "verification and validation evaluations" were performed. While these evaluations assess the algorithm's functionality, they are not presented as a standalone performance study in a clinical context (e.g., measuring diagnostic accuracy against a ground truth dataset). The software is a planning tool, not a diagnostic AI.

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

• For the non-clinical tests (implant): Engineering specifications, material properties, and established consensus standards serve as the "ground truth" for the physical device's performance.
• For the software: The ground truth would be the accuracy and correctness of the planning outputs and measurements generated by the software, compared to expected or designed values. This is typically assessed through software verification and validation against a golden standard or internal reference data, not clinical ground truth like pathology or outcomes.

8. The sample size for the training set:

• Not applicable, as this is a 510(k) for an orthopedic implant and a planning software, not a deep learning AI model that requires a "training set" in the same sense. The software's design and programming are based on established anatomical and biomechanical principles.

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

• Not applicable, as no external "training set" with established ground truth, typical for AI model development, is mentioned.

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Biomet Comprehensive Reverse Shoulder products are 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 Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

This submission is for manufacturing of an alternate version of exiting Comprehensive Standard and Mini Baseplates components with the porous plasma spray (PPS) coating applied by an outside vendor and the addition of Zimmer's Calcicoat coating. There is no change to the design to these existing products.

The new Comprehensive Reverse Augmented Baseplate has an augmented backside while retaining the existing Comprehensive Reverse baseplate geometry. The device will be available with three augment sizes, Small, Medium and Large. The new variant will be manufactured with PPS coating applied by a vendor and Zimmer Calcicoat coating.

This document is a 510(k) Summary for the Zimmer Biomet Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, and Comprehensive Mini Baseplate. It describes the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of a medical device submission for substantial equivalence to predicates, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the information provided in this document.

The acceptance criteria and device performance are described in terms of engineering and material characteristics for orthopedic implants.

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the non-clinical tests performed to demonstrate substantial equivalence. These are not performance metrics in the sense of accuracy, sensitivity, or specificity as would be the case for AI/ML models, but rather engineering and material properties.

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

This is an orthopedic implant 510(k) submission, not a study of an AI/ML device. Therefore, the concept of a "test set" in the machine learning sense, or data provenance in terms of patient data origin and retrospectivity/prospectivity, is not applicable. The documentation refers to mechanical and material testing, which would have specific sample sizes for engineering tests (e.g., number of specimens tested for shear strength, porosity), but these details are not provided in this summary document.

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

Not applicable. This is not an AI/ML device that requires human expert review for establishing ground truth on image data or similar. The "ground truth" here refers to established engineering standards and material specifications.

4. Adjudication Method for the Test Set

Not applicable. Ground truth establishment for AI/ML model test sets.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done

Not applicable. This is not an AI/ML device where human readers interact with AI assistance.

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

Not applicable. This is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to:

• Engineering Standards and Material Specifications: The device's performance against established industry standards for orthopedic implants, including mechanical strength, durability, material composition (e.g., PPS and HA/TCP coating properties), and resistance to loosening/disassociation.
• Predicate Device Performance: The comparison of the proposed device's characteristics to those of legally marketed predicate devices, demonstrating that any differences "do not raise new questions of safety and effectiveness."

8. The Sample Size for the Training Set

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

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

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

Summary of Device and Performance Aspects from the Document:

• Device Name: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
• Purpose: Manufacturing of alternate versions of existing Comprehensive Standard and Mini Baseplates with a different porous plasma spray (PPS) coating vendor and the addition of Zimmer's Calcicoat coating. Also includes a new Comprehensive Reverse Augmented Baseplate with an augmented backside.
• Basis for Substantial Equivalence:
  • Intended Use & Indications for Use: Identical to predicate devices.
  • Materials: Substrate and porous coating are the same as the predicate; Calcicoat® coating has been previously cleared.
  • Design Features: Identical or similar to predicates.
  • Sterilization: Identical assurance level and validation methods to predicate (new vendor).
• Performance Data Provided: Non-clinical tests were conducted. These included assessments of PPS and HA/TCP Coating Pore Size and Porosity, Glenoid Loosening/Disassociation Test Method, and Shear testing justification. No clinical tests were provided.
• Conclusion: The proposed devices are deemed substantially equivalent because they have the same intended use and indications for use, similar technological characteristics, and the differences do not raise new questions of safety and effectiveness, meaning they are at least as safe and effective as the legally marketed predicate devices.

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The ExactechGPS is intended for use during preoperative planning and during stereotaxic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

The ExactechGPS Total Shoulder Application is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.

The ExactechGPS Total Shoulder Application is a modification of the Exactech GPS stereotactic navigation system designed to help guide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure.

Like predicate Exactech GPS system software dedicated to use with total knee arthroplasty procedures, the ExactechGPS Total Shoulder Application works with Exactech GPS hardware trackers that communicate intraoperative data to the Exactech GPS hardware station to provide surgeons with real-time information on the position of patient anatomical structures and of instrumentation used to prepare patient bone during stereotaxic surgery.

The ExactechGPS Total Shoulder Application adds a preoperative planning feature, where surgeons use CT-scan images of patient bone with software models of Exactech Equinoxe implants to preoperatively plan procedures in a virtual environment prior to surgery.

The ExactechGPS Total Shoulder Application is used with the same ExactechGPS V2 station, trackers, and disposable kit hardware as the predicate ExactechGPS. This submission includes new surgical instruments dedicated to total shoulder arthroplasty.

The provided text describes a 510(k) premarket notification for the ExactechGPS® Total Shoulder Application. It outlines the device's indications for use, its description, and references non-clinical testing performed to establish substantial equivalence. However, it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document lacks specific quantitative acceptance criteria for accuracy, precision, or other performance metrics. It also does not detail a specific human-in-the-loop (MRMC) study or a standalone algorithm study with defined ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods for the test set.

Based on the provided text, here's what can be extracted and what is missing:

Missing Information:

• A table of specific numerical acceptance criteria (e.g., accuracy +/- X mm, precision +/- Y degrees).
• Reported device performance against those specific numerical criteria.
• Sample sizes for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth for the test set.
• Qualifications of those experts.
• Adjudication method for the test set.
• Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and if so, the effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for quantitative performance evaluation.
• The sample size for the training set.
• How the ground truth for the training set was established.

Information that can be extracted from the provided text:

1. Acceptance Criteria & Reported Device Performance:

The document broadly states that "Software verification testing to ensure all design outputs meet all specified requirements" and "Software validation to ensure software specifications conform to user needs and intended uses, and that the particular requiremented through software can be consistently fulfilled" were performed.

Regarding device performance, it mentions:

• "System accuracy verification via bench testing to ensure the ExactechGPS Total Shoulder Application works with Exactech GPS hardware to display information to surgeons as intended"
• "System accuracy verification via comparison of system outputs to CT-scan data collected during simulated use via evaluation with cadaveric specimens"
• "Overall system validation through simulated use via evaluation with cadaveric specimens"

However, the specific numerical acceptance criteria for accuracy (e.g., in mm or degrees) and the quantitative results of these tests are NOT provided in this document. It implies that certain accuracy thresholds were met, but the specific values are absent.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: Not specified. The phrase "evaluation with cadaveric specimens" is used, implying multiple specimens, but the exact number is not given.
• Data Provenance: The cadaveric specimens imply real anatomical data. The company is based in France ("6 Allée de Bethléem 38610 Gières France"), so it's reasonable to assume the studies were conducted there or in collaboration with institutions in other countries, but the specific country of origin for the cadaveric data is not stated. The studies were likely performed retrospectively on collected cadaveric data, not prospectively in a clinical setting.

3. Number and Qualifications of Experts:

• Number of experts: Not specified.
• Qualifications of experts: Not specified. The testing involves "surgeons" in a simulated use context, but their experience or specific role in establishing ground truth is not detailed.

4. Adjudication Method:

• Not specified. Given the nature of the "system accuracy verification" tests, it's more likely that the "ground truth" was established through physical measurements on the cadaveric specimens and/or comparison to the source CT data, rather than through expert image review adjudication.

5. MRMC Comparative Effectiveness Study:

• No specific MRMC comparative effectiveness study is mentioned in the provided text. The testing described focuses on system accuracy and validation, not on how human readers/surgeons improve with the AI vs. without AI assistance. This device is a navigation system aiding a surgeon during a procedure, not primarily an AI algorithm for diagnostic image interpretation.

6. Standalone Performance (Algorithm Only):

• No specific standalone performance study is explicitly described in terms of an algorithm working without human interaction for a diagnostic or predictive task. The mentioned "System accuracy verification via comparison of system outputs to CT-scan data" relates to the device's ability to display information accurately based on CT data, which is a component of its overall function, but not typically reported as a "standalone algorithm" performance in the context of diagnostic AI. The device is intended for human-in-the-loop use (surgeon guidance).

7. Type of Ground Truth Used:

• For the "System accuracy verification via comparison of system outputs to CT-scan data collected during simulated use via evaluation with cadaveric specimens," the ground truth was likely established by:
  • High-resolution CT-scan data: Used as the reference for anatomical structures.
  • Physical measurements/known geometries: For bench testing and potentially for certain structures on the cadaveric specimens.
  • Simulated surgical outcomes: Comparing the system's guidance to a desired anatomical alignment.
  • It is not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic AI.

8. Sample Size for Training Set:

• Not specified. The document does not describe the specific development of an AI algorithm with a training set. The device is a "stereotaxic navigation system" and "preoperative planning tool," which suggests a more traditional software engineering approach (rules-based, image processing, 3D reconstruction) rather than a deep learning model requiring vast training datasets and associated ground truth.

9. How Ground Truth for Training Set was Established:

• Not applicable / not specified. As above, the text doesn't describe a machine learning model that would require a "training set" with established ground truth in the typical AI sense. The "ground truth" here refers to the accuracy of the system's displayed information relative to real anatomy or CT data.

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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 proposed Exactech Equinoxe Reverse Shoulder Compression Screws. Glenosphere Locking Screw, and Locking Cap devices represent a modification of the predicate Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap (K063569 and K110708) used in reverse shoulder arthroplasty. All devices were cleared via 510(k) K063569 except the 50mm and 54mm Equinoxe Reverse Shoulder Compression Screws. These sizes were cleared via 510(k) K110708. The only difference between the proposed Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap and predicate Equinoxe Compression Screws, Glenosphere Locking Screw, and Locking Cap is the sterilization method. The predicate compression screws, glenosphere locking screw, and locking cap are provided sterile via gamma radiation. The modified compression screws, glenosphere locking screw, and locking cap will be supplied non-sterile and must be sterilized by steam sterilization in a separately provided re-usable sterilization container prior to implantation. Cleaning and sterilization instructions are provided in the package insert for the Equinoxe Reverse Shoulder System Screw Components.

This document describes a Special 510(k) submission for modifications to the Exactech® Equinoxe® Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices, primarily focusing on a change in sterilization method.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Preamble Information:

The document is a letter from the FDA regarding a K162325 submission for Exactech Inc. for the devices mentioned. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a test set in the traditional sense of a clinical or imaging study. The "testing" primarily refers to bench testing related to the new sterilization method.

The data provenance is for engineering studies and pyrogen testing which focus on materials, design, and sterilization. There's no indication of human or animal data being used for this particular submission's testing. The devices are orthopedic implants, and the context of the submission is a modification to a previously cleared device.

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

This information is not provided in the document. The studies referenced are engineering and pyrogenicity tests, which typically rely on standardized protocols and laboratory analysis rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the engineering and pyrogenicity testing described.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on a modification to an existing device (change in sterilization method), and the testing described is limited to demonstrating the safety and effectiveness of this specific modification through engineering studies and pyrogen testing.

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

This question is not applicable as the device is a physical orthopedic implant (reverse shoulder system components) and not an algorithm or AI-powered device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through:

• Engineering specifications and standards: For material properties, dimensions, design features, and device compatibility, ensuring they remain the same as the predicate.
• Standardized testing protocols: For cleaning, sterilization effectiveness, and pyrogenicity (e.g., USP , USP , ANSI/AAMI ST72). The "ground truth" here is compliance with these predefined standards and the associated recommended limits.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that would have a training set. The "training" for this device would refer to the historical data and experience with the predicate devices, which are already marketed.

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

This information is not applicable for the same reasons as point 8.

In summary:

The provided document describes a Special 510(k) where the primary "study" proving the device meets acceptance criteria revolves around demonstrating that a change in sterilization method (from gamma radiation to steam sterilization) for components of an already cleared reverse shoulder system does not alter the fundamental characteristics, performance, safety, or effectiveness of the device. The acceptance criteria are met by proving that the modified components maintain the same indications for use, intended use, materials, design, dimensions, and compatibility as their predicate versions, and that the new sterilization method is effective and meets pyrogenicity standards through engineering and laboratory testing. This is a technical (bench) evaluation, not a clinical study involving human subjects, experts for ground truth, or statistical sample sizes in the context of clinical outcomes.

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The Aequalis PerFORM Reversed & Aequalis PerFORM+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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 the devices if sufficient bone stock remains.

The Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed Glenoid are intended to replace the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis. Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed glenoid component assembly must be used in association with a Tornier humeral component:

• Humeral implants Aequalis Reversed, Aequalis Reversed Fracture or Aequalis Adjustable ● Reversed Shoulder
• . or Humeral implants Aequalis Ascend Flex Shoulder System in reverse configuration
• or humeral implants Aequalis Reversed FX2 ●

The glenoid component assembly includes a modular system including a baseplate with central screw or press-fit post, peripheral anchoring screws and a glenosphere. The baseplates are available in various design configurations including: standard, lateralized, half-wedge augment and full-wedge augment. The glenospheres are available in various design configurations including: standard, lateralized and eccentric. The press-fit post may be used with the standard baseplate in lieu of the central anchoring screw. The baseplates and the press-fit posts are manufactured using additive manufacturing technology.

The document provided does not describe an acceptance criteria or study that proves the device meets specific performance metrics in the way a clinical or standalone study for an AI/algorithm-based device would.

Instead, this is an FDA 510(k) Premarket Notification for a medical device (Aequalis PerFORM Reversed and Aequalis PerFORM+ Reversed Glenoid – a shoulder prosthesis). The purpose of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to meet pre-defined performance acceptance criteria as would be typical for a diagnostic or AI device.

Here's how the information provided relates to your request, with an emphasis on what's not relevant for a typical AI/algorithm acceptance criteria study:

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

• Acceptance Criteria: Not explicitly stated as pass/fail numeric targets for performance metrics like sensitivity, specificity, or AUC, as these are not relevant for a mechanical prosthesis 510(k). The "acceptance criteria" here is that the device is "substantially equivalent" to predicate devices, meaning it is as safe and effective.
• Reported Device Performance: The document lists "Performance Data" which consists of a series of non-clinical bench tests (mechanical testing). These demonstrate the physical properties and durability of the prosthesis. Examples include:
  • Compressive Strength and Elastic Modulus Testing of Titanium Porous Metal Verification
  • Titanium Porous Structure Stereological Evaluation
  • Titanium Porous Structure Mechanical Verification
  • PerFORM Reversed Fixation Pull-out Test
  • Fatigue Test
  • Range of Motion Analysis
  • PerFORM Reversed Taper Pull-Off Test
  • Glenoid Loosening Test (100,000 cycles)
  • PerFORM+ Reversed Augment Baseplate compared to the Exactech Equinoxe Reverse Augmented Baseplate Analysis
  • PerFORM Reversed Lateralization Comparison
  • PerFORM Reversed and PerFORM+ Reversed Peripheral Screw Angulation
  • Direct Metal Laser Sintering (DMLS) Process Validation
  • Endotoxin (

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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 hemiarthroplasty 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 g 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 wellfixed/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:
  | P | L | F | Indications |
  |---|---|---|---|
  | √ | √ | | 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) |
  | √ | √ | √ | Rotator cuff tear arthropathy |
  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 (hemiarthroplasty), 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 Superior/Posterior Augment Reverse Shoulder Glenoid Baseplates are modifications to augmented Equinoxe reverse shoulder glenoid baseplate devices cleared through premarket notification #K110708.
This submission proposes the following design changes:

• 1. The proposed device combines a 10° superior augment and an 8° posterior augment previously provided as separate options in the scope of the cited predicate devices
• 2. The cage peg length is increased to 21.5mm as compared to 17mm for the predicate 10° superior augment glenoid baseplate and 15.7mm for the predicate 8º posterior augment glenoid

This document is a marketing approval letter from the FDA for a medical device, the Exactech® Equinoxe® Reverse Shoulder System. It does not contain acceptance criteria or study results that prove the device meets acceptance criteria.

The letter acknowledges that the device is "substantially equivalent" to legally marketed predicate devices, which means it has the same intended use and technological characteristics as a device already on the market. This type of submission (510(k)) generally relies on demonstrating equivalence rather than providing new clinical data to prove safety and effectiveness.

The section titled "Non-Clinical Performance Data" mentions "Fixation assessment" and "Cyclic abduction loosening testing" but only provides the type of evaluation, not the acceptance criteria for these tests nor the results. Therefore, I cannot extract the requested information from this document.

To answer your request, I would need a different type of document that details the specific acceptance criteria for a device, the methodology of a study designed to meet those criteria, and the reported performance results of that study. This document only confirms the device's substantial equivalence to a previous version and lists its indications for use.

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