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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 Exactech® Equinoxe® Scapula Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the scapula. Specific clinical indications for ORIF are as follows: Levy Type I, IIA, and IIB fractures, fracture dislocations, osteotomies, and non-unions of the acromion and scapular spine.

The 3.5mm diameter and 2.7mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula.

The Straight Plates of the EPIC Fracture Plate System (cleared under K172441) are also intended for use with the Exactech® Equinoxe® Scapula Fracture System for Open Reduction Internal Fixation procedures of the scapula.

The Exactech® Equinoxe® Scapula Fracture System with EPIC Screws and Straight Plates is a set of plate and screw components for use in Open Reduction Internal Fixation (ORIF) applications for fractures of the acromion and scapular spine. The Exactech® Equinoxe® Scapula Fracture System includes a range of sizes and options of scapula fracture plates and screws to accommodate varying patient anatomy and needs. Previously cleared components to be used with the Exactech® Equinoxe® Scapula Fracture System include the Exactech® EPIC Locking Screws, EPIC Non-Locking Screws, and EPIC Straight Plates. All components work together in various configurations to address scapular ORIF procedures.

The provided FDA 510(k) clearance letter for the Equinoxe® Scapula Fracture System does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity.

This 510(k) clearance is for a physical medical device (bone fixation system), not a software or AI-enabled device that would typically undergo performance testing requiring a test set, ground truth experts, or MRMC studies. The letter reviews the substantial equivalence of the Scapula Fracture System to a legally marketed predicate device.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical testing and analyses performed to demonstrate the device's functional integrity and safety as a bone fixation system.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are demonstrated through adherence to performance standards and achieving results comparable to the predicate device in specific non-clinical tests.

Study Details (Non-Clinical Testing for a Physical Device)

Since this is a physical implantable device, the questions related to AI/software performance metrics (sample size for test/training sets, experts for ground truth, adjudication, MRMC studies) are not applicable in this context.

1. Sample size used for the test set and the data provenance: Not applicable. Performance was evaluated through non-clinical laboratory testing and engineering analysis rather than a "test set" of patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical and material properties is established by recognized engineering standards (ASTM, ISO) and laboratory measurements, not expert consensus in a clinical diagnostic sense.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Laboratory testing results are objectively measured against pre-defined engineering standards.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done because this is a physical implant (bone plate and screw system), not a diagnostic algorithm or AI-enabled device that assists human readers.
   • Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used:
   • The "ground truth" for this device's performance relies on established engineering standards (ASTM F897, ASTM F543, ISO 10993-1:2018) and objective laboratory measurements of mechanical properties, biocompatibility, and corrosion resistance. It's about demonstrating that the device meets defined physical and material specifications, not about diagnostic accuracy against a clinical reference standard.
7. The sample size for the training set: Not applicable. There is no "training set" as this is not a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

In summary, the FDA 510(k) clearance document confirms that the Equinoxe® Scapula Fracture System met its "acceptance criteria" by demonstrating substantial equivalence to a predicate device through rigorous non-clinical bench testing and engineering analyses that confirm its mechanical, material, and biological safety properties are fit for its intended use in scapula fracture repair. The nature of this device means the type of "study" to prove acceptance is fundamentally different from what would be done for an AI/software medical device.

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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 Equinoxe Mega Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• · Rheumatoid arthritis
• · Revision where other devices or treatments have failed
• · Correction of functional deformity
• Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
• · Traumatic arthritis
• · Oncology applications including bone loss due to tumor resection.
• · Significant humeral resection which are unmanageable using other treatment methods

The Equinoxe Mega Prosthesis System can be used in either primary or revision arthroplasty procedures.

The Equinoxe Mega Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreparable and grossly deficient, and a functional deltoid muscle is present.

The Equinoxe Mega Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.

The Equinoxe Mega Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Mega Prosthesis Distal Fixation Rings are only for uncemented, press-fit use.

The Equinoxe Mega Prosthesis differs from conventional Total Shoulder Arthroplasty implants in that it is intended to replace both the articulating surface (humeral head) as well as the resected humerus. The modular design allows for the surgeon to construct the middle and proximal segments of the prosthesis in various lengths in order to match the length of resected bone, and to maintain the patient's natural arm length.

The prosthesis is manufactured from Ti-6A1-4V and has both Titanium Plasma Spray and HA coated regions. The proximal bodies are available in four sizes (Small, Medium, Large, Extra-Large) and two lengths (+0mm, +12.5mm). The middle segments are available in 3 lengths (25mm, 50mm, 75mm) with one diameter (20mm). The distal stems are available in 3 lengths (80mm, 120mm, 200mm) and 6 diameters (6mm, 7mm, 8mm, 9mm, 11mm, 13mm). The distal fixation rings are available in 17 diameters (17.5mm-33.5mm, 1mm increments). The distal fixation rings are intended for press-fit fixation. The proximal bodies and middle segments have suture through holes to facilitate soft tissue attachment.

This document is a 510(k) premarket notification for the Exactech Equinoxe Mega Prosthesis, which is a medical device. The primary purpose of this type of submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its effectiveness or safety through extensive clinical trials as would be required for a PMA. Therefore, the information typically requested for acceptance criteria and studies (especially those involving human subjects, ground truth, experts, and statistical analysis with sample sizes) for AI/ML devices is not explicitly detailed in this type of submission for a traditional medical implant.

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

Here's an attempt to fill in the requested table and information based on the provided document, acknowledging the limitations for a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information (Based on provided text, acknowledging this is a mechanical device, not AI/ML):

The document describes a submission for a traditional medical device (Exactech Equinoxe Mega Prosthesis), not an AI/ML device. Therefore, many of the requested categories like "test set," "training set," "ground truth," "experts," and "MRMC comparative effectiveness study" are not applicable in the context of an AI/ML diagnostic system. The evaluation here is based on non-clinical (bench and cadaveric) testing and comparison to a predicate device for substantial equivalence.

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

• Sample Size (Test Set): Not explicitly stated in the summary for each test. For mechanical tests like fatigue, torsion, pull-off, etc., sample sizes would typically be determined by relevant ASTM or ISO standards but are not reported in this summary. For the cadaveric study, the sample size (number of cadavers or specimens) is not specified.
• Data Provenance: The studies are non-clinical (bench and cadaveric). Country of origin is not specified, but the applicant (Exactech, Inc.) is based in Gainesville, Florida, USA. The studies are prospective in the sense that they were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts/Qualifications: Not applicable in the context of this traditional device submission. For a cadaveric study, surgeons might be involved in evaluating surgical technique or fit, but they are not "establishing ground truth" in the diagnostic sense. The "ground truth" for mechanical testing is derived from engineering principles and standards.

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

• Adjudication Method: Not applicable. This concept belongs to expert review of diagnostic cases, which is not the nature of these non-clinical tests.

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

• MRMC Study: No. This is a traditional medical device, not an AI/ML diagnostic.

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

• Standalone Study: Not applicable. This is a physical implant, not an algorithm.

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

• Type of Ground Truth:
  • For mechanical tests (Fatigue, Torsion, Taper, Axial Pull-Off, Suture Abrasion, Plasma Spray Characterization): The "ground truth" is adherence to established engineering standards (e.g., ASTM, ISO) and successful demonstration of mechanical integrity and performance under simulated physiological conditions.
  • For the Cadaveric Study: The "ground truth" would be the observed biomechanical performance, surgical fit, and handling characteristics within the cadaveric specimen, assessed against expected anatomical and surgical outcomes.
  • For Clinical Literature Review: The "ground truth" is established medical knowledge and previous clinical outcomes reported in peer-reviewed literature for similar devices or surgical approaches.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. There is no AI/ML model being trained. The design of the device is based on engineering principles and existing knowledge.

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

• Ground Truth Establishment (Training Set): Not applicable.

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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 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:
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 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 extra short humeral heads represent a modification to Equinoxe short humeral heads cleared per 510(k) K042021. Both predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The only differences between predicate and proposed devices are the following dimensional modifications:

1. Proposed device thickness is decreased by 3mm.
2. Proposed device female taper length is reduced by 5mm.
3. Proposed device female taper length is offset, where only 44mm and 47mm predicate devices feature offset female taper lengths.
   These modifications are proposed to provide surgeons with additional options for matching variation in patient anatomical needs.

Acceptance Criteria and Device Performance for Exactech® Equinoxe® Extra Short Humeral Heads

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Equinoxe Short Humeral Heads, K042021) rather than establishing specific, quantitative performance acceptance criteria in the classical sense (e.g., a specific accuracy threshold). Instead, the acceptance criteria are implicitly that the modified device performs comparably to or better than the predicate device in relevant engineering tests, demonstrating that the dimensional changes do not compromise safety or effectiveness.

2. Sample Size and Data Provenance

The document does not specify exact sample sizes for the mechanical tests (cyclic fatigue and axial pull-off) or the surgical evaluation/cadaveric validation.

• Test Set: Not explicitly stated. The tests are engineering analyses rather than clinical trials with patient-based test sets.
• Data Provenance: The tests are described as "engineering analyses" and "cadaveric validation," suggesting they were conducted in a laboratory or simulated environment, likely in the country where Exactech, Inc. is located (USA). The data would be prospective in the sense that these tests were specifically designed and executed for this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated for establishing ground truth for the test set.
• Qualifications of Experts: For the "surgical evaluation/cadaveric validation," the experts would be surgeons or individuals with relevant surgical expertise, likely orthopedic surgeons specializing in shoulder arthroplasty, performing the cadaveric procedures. Specific qualifications (e.g., years of experience) are not provided in the summary.

4. Adjudication Method

Not applicable. The reported studies are laboratory-based engineering tests and cadaveric validation, not clinical studies that typically involve adjudication of patient outcomes or imaging interpretations.

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

No. This is a 510(k) Special submission for a dimensional modification of an existing device. The studies conducted are non-clinical (mechanical and cadaveric) to demonstrate substantial equivalence, not a clinical MRMC study. Therefore, there is no effect size reported for human readers with or without AI assistance.

6. Standalone Performance (Algorithm Only)

No. This device is a physical medical implant (humeral head), not an algorithm or AI-powered diagnostic tool. Standalone algorithm performance is not applicable.

7. Type of Ground Truth Used

The "ground truth" for the mechanical tests would be the established engineering standards, material properties, and performance characteristics of the predicate device. For the cadaveric validation, the "ground truth" would be the successful and safe surgical handling, fit, and biomechanical interaction observed during the cadaveric procedure, as assessed by expert surgeons. It is based on engineering benchmarks and expert observation/assessment, not pathology, patient outcomes, or expert consensus in interpreting clinical data.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

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

Ask a specific question about this device

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:
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 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.

This submission proposes an increase in the angled surface from 12° to 16°, relative to the 12° posterior augment pegged glenoid devices previously cleared via 510(k) K111379. The proposed Exactech Equinoxe Posterior Augment Glenoids are intended to be used with Equinoxe shoulder system components described in #K042021, #K061454, #K093430, #K103419, and #K111379.

The provided text describes a Special 510(k) for the Exactech® Equinoxe® UHMWPE 16° Posterior Augment Pegged Glenoids™, which is a modification of a previously cleared device (Exactech Equinoxe UHMWPE 12 Degree Posterior Augment Pegged Glenoid, K111379). The primary change is an increase in the angled surface from 12° to 16°.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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 the sample size (number of devices or tests) used for the mechanical testing.
The data provenance is from non-clinical performance data (laboratory testing) conducted by the manufacturer, Exactech Inc. It is not patient data (retrospective or prospective) and thus has no country of origin in the clinical sense.

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

This information is not applicable as the study described is a non-clinical, mechanical testing study, not a clinical study involving expert interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable as there was no expert review or adjudication of clinical data. The study was mechanical testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This was a non-clinical mechanical testing study to demonstrate substantial equivalence of a modified medical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable as the device is a physical implant, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is irrelevant.

7. Type of Ground Truth Used

The "ground truth" for this study was established through recognized industry standard test methods (ASTM F2028) for evaluating the mechanical properties of glenoid components. This standard defines the criteria for what constitutes acceptable mechanical behavior.

8. Sample Size for the Training Set

This information is not applicable as the device is not an AI algorithm and therefore does not have a "training set."

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

This information is not applicable as the device is not an AI algorithm and therefore does not have a "training set" or ground truth established for one.

Ask a specific question about this device

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:
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 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.

This submission proposes an increase in the angled surface from 8° to 12°, relative to the 8º posterior augment pegged glenoid devices previously cleared via 510(k) K103419. The proposed Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids are intended to be used with Equinoxe shoulder system components described in #K042021, #K061454, #K093430, and #K103419.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™, structured according to your request.

Please note: This device is a physical medical implant, not an AI/Software as a Medical Device (SaMD). Therefore, many of your requested points regarding AI-specific studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this submission. The "study" described is a mechanical test to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the document. Mechanical tests typically involve multiple samples of the actual device component.
• Data Provenance: The study was a non-clinical mechanical test, not reliant on patient data.

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

• Not Applicable. This is a mechanical test of a physical device, not an evaluation requiring expert interpretation of clinical data or images. The "ground truth" is defined by the objective standards and measurements within the ASTM F2028 test method.

4. Adjudication Method for the Test Set

• Not Applicable. As a mechanical test, there is no adjudication of subjective expert opinions. Pass/fail criteria are based on objective measurements against the ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This is a physical medical device, not an AI/SaMD. MRMC studies are not relevant.

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

• No. This is a physical medical device, not an AI/SaMD. Standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Mechanical Performance Standards: The "ground truth" for this device's performance is adherence to the objective measurements and pass/fail criteria established by the ASTM F2028 standard for glenoid loosening or disassociation.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/SaMD. There is no "training set."

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

• Not Applicable. This is a physical medical device, not an AI/SaMD. There is no "training set" or corresponding ground truth establishment process in this context.

Summary of the Study for this Device:

The study conducted for the Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™ was a non-clinical mechanical test performed according to ASTM F2028 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation.

The purpose of this study was to demonstrate substantial equivalence to a previously cleared predicate device (Exactech Equinoxe UHMWPE 8 Degree Posterior Augment Pegged Glenoid, K103419). The primary change in the new device was an increase in the angled surface from 8° to 12°.

The acceptance criteria were that the new device's mechanical performance, specifically regarding glenoid loosening or disassociation, would meet the requirements of the ASTM F2028 standard and be comparable to the predicate device. The document explicitly states: "Test result and analyses provided in this 510(k) demonstrate Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids are substantially equivalent to the cited predicate device." This statement confirms that the device met its acceptance criteria based on the results of the mechanical testing.

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The Equinoxe Shoulder System is in skeletally manre individuals with degeneralive 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 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 (I'), 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 degeneralive 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 foss 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 humens 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 ceniented use only.

The modifications proposed by this submission describe minor geometry changes to the standard offering of Equinoxe glenospheres, glenoid plates, and compression screws; these geometry modifications are the entire basis for proposed Reverse Shoulder line extensions (expanded offset glenospheres, posterior and superior augmented glenoid plates, +10mm extended cage glenoid plate, and longer compression screws).

All proposed components are designed to interface and articulate with the Equinoxe Shoulder system and are supplied sterile.

The provided document describes a 510(k) premarket notification for the Exactech® Equinoxe® Reverse Shoulder™ Line Extensions. This document focuses on the substantial equivalence of the device to legally marketed predicate devices, not on a study to determine device performance against specific clinical acceptance criteria in terms of accuracy or efficacy in diagnosing conditions.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, and ground truth establishment, cannot be extracted from this document as it is not relevant to the type of submission provided.

The document primarily addresses the following for the "Exactech® Equinoxe® Reverse Shoulder™ Line Extensions":

• Intended Use: Total Shoulder Arthroplasty.
• Materials: Equivalent to predicate devices, conforming to industry standards.
• Dimensions: Available in equivalent size ranges to predicate devices.
• Sterilization Processes: Sterile for single use, conforming to industry standards.
• Performance Specifications: Withstand clinically relevant biomechanical loads.

Substantial Equivalence Conclusion: Based on mechanical tests, simulated-use tests, engineering analyses, and a clinical literature summary, the proposed device is substantially equivalent to predicate devices.

The evidence for this conclusion includes:

• Cadaver lab validation to demonstrate design features.
• Geometric computer analysis to evaluate the relationship between design parameters and Range of Motion (ROM), impingement, and stability.
• Dynamic test at worst-case physiological load in a polyurethane bone substitute to evaluate initial fixation, loosening, and disassociation.
• Clinical literature summary related to cuff tear arthroplasty and reverse shoulder arthroplasty.

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

The Equinoxe™ fracture adapter tray connects to the Equinoxe™ fracture humeral stems via a morse taper and a non-breakaway locking screw using a 5/16-18 thread instead of the primary adapter tray connecting to the primary/revision humeral stems via a spherical taper and a breakaway locking screw using a M6 thread

This document is a 510(k) premarket notification for a medical device called the Exactech® Equinoxe Reverse Shoulder Fracture Humeral Adapter Tray and Fracture Humeral Adapter Tray Locking Screw. The purpose of this notification is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.

The provided text does not contain a study that proves the device meets specific acceptance criteria in the format requested. Instead, it describes an engineering evaluation conducted to verify the device's performance. The acceptance criteria and "reported device performance" would typically be found within the detailed engineering evaluation report, which is not fully provided here.

However, based on the provided text, I can infer some aspects and highlight what is missing from the request.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not Available in the Provided Text for the requested items):

The provided text is a summary of a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing a clinical study with human subjects, or a standalone algorithm-only performance study. Therefore, most of the requested information for AI/imaging device studies is not applicable or not present in this type of document.

Below is a breakdown of why each point is missing or not applicable in this context:

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

• Not Applicable / Not Provided: This device is a mechanical implant (shoulder prosthesis components), not an AI algorithm or a diagnostic imaging device. The "test set" for this type of device typically refers to samples or prototypes used in mechanical engineering evaluations (e.g., fatigue testing, tensile testing) rather than a dataset of patient images or clinical outcomes. The document refers to "engineering evaluations" but does not specify the number of samples tested or their provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Not Provided: Ground truth, in the context of expert consensus, is typically established for diagnostic devices or AI algorithms where interpretation of data (e.g., images) by human experts is key. For mechanical implants, "ground truth" relates to physical properties and performance measured against engineering standards, not expert interpretation. The "experts" involved would be engineering and materials specialists designing and testing the device, and potentially orthopedic surgeons providing clinical input on requirements, but not in the sense of adjudicating a "test set" as described in the request.

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

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., radiologists' readings). This is not relevant for the engineering evaluation of a mechanical implant.

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: MRMC studies are specific to diagnostic devices, particularly in imaging, to evaluate the performance of human readers, sometimes with AI assistance. This is a mechanical implant; therefore, an MRMC study is not relevant.

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

• Not Applicable: This device is a physical implant, not an algorithm.

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

• Engineering Standards / Biomechanical Principles: For this type of device, the "ground truth" for performance would be based on established engineering standards (e.g., ISO or ASTM for orthopaedic implants), biomechanical principles derived from cadaveric studies or in-silico models, and clinical requirements for long-term implant function and durability. The summary states "Engineering evaluations were conducted to verify that the performance of the proposed components would be adequate for anticipated in vivo use." This implies performance was measured against such standards.

8. The sample size for the training set

• Not Applicable: As this is a mechanical implant and not an AI algorithm, there is no "training set" in the conventional sense of machine learning. The design and development of the device would involve iterative design, prototyping, and testing (the "engineering evaluations"), but not a data-driven training process.

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

• Not Applicable: Since there is no training set, this question is not applicable. The design "ground truth" would be established through clinical need assessment, biomechanical analysis, material science principles, and existing predicate device performance.

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The Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore function 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 failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The Equinoxe™ Reverse Shoulder System includes a reverse semi-constrained prosthesis for use in total-shoulder joint replacement procedures in cases with an irreparable or nonfunctional totator cuff. The system includes primary and revision humeral stems, various sizes and types of humeral adapter plates, glenospheres, humeral liners, and screws. The reverse shoulder System is designed to function with the Equinoxe primary press-fit, primary cemented, and long/revision humeral stems. All components are supplied sterile.

The Exactech Equinoxe™ Reverse Shoulder System is a medical device for total shoulder joint replacement. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared devices rather than providing specific acceptance criteria and a detailed study report with performance metrics for this particular device.

However, based on the information provided in the "Summary of Non-Clinical Performance Data," we can infer the types of tests conducted and what would typically serve as acceptance criteria for such a device, even if explicit numerical targets are not stated. The study focuses on mechanical testing and engineering analyses to ensure safety and effectiveness.

Here's an attempt to structure the information based on your request, with the caveat that explicit numerical acceptance criteria and a direct "performance vs. acceptance criteria" table are not present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Dynamic Loading Study:
  • Polyurethane bone substitute (TR-2006-052): Sample size for this part is not specified but it involved a "polyurethane bone substitute."
  • Cadaver (TS-2006-024): Sample size not specified, but involved "a cadaver."
• Geometric Analysis Studies (TR-2006-028, TR-2006-029) and Finite Element Analysis (TR-2006-039): These are analytical studies, not involving a "test set" in the sense of patient data or traditional biological samples. They are based on computer models and existing design principles.
• Data Provenance: The studies are non-clinical (mechanical tests, engineering analyses, simulated surgical implantations) and were conducted by Exactech, Inc. The provenance of the specific materials (e.g., cadavers) is not detailed.

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

This section is not applicable as the studies are non-clinical mechanical and engineering analyses, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication method for the test set

This section is not applicable as the studies are non-clinical mechanical and engineering analyses, not clinical studies requiring human adjudication of results.

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

This section is not applicable. This submission is for a physical medical device (reverse shoulder system), not an AI/imaging device, and therefore, no MRMC study or AI assistance evaluation was performed or required.

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

This section is not applicable. This submission is for a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply.

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

For the non-clinical studies:

• Dynamic Loading and Micromotion: The "ground truth" for comparison appears to be the performance of "Depuy Delta III and Encore RSP components when subjected to a similar loading pattern" (predicate devices).
• Glenosphere Center of Rotation: The "ground truth" for comparison is the "low reported incidence of glenoid loosening associated with the Grammont Reverse Shoulder" and the design characteristics of the Delta III.
• Geometric Analyses: "Ground truth" is based on established relationships between prosthetic design parameters and clinical failure modes, as described in literature and previous studies (e.g., Grammont Reverse Shoulder Prosthesis).
• Finite Element Analysis: "Ground truth" is derived from engineering principles and material science, demonstrating that the geometry is not subject to fracture under theoretical worst-case loads.

8. The sample size for the training set

This section is not applicable as this is a physical medical device. The "training" for the design often comes from iterative design processes, engineering calculations, and understanding of biomechanics and clinical outcomes of existing devices, rather than a quantifiable "training set" in the context of machine learning.

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

This section is not applicable as this is a physical medical device. The 'ground truth' for the design process would be established through a combination of:

• Literature review: Understanding biomechanics, materials science, and clinical performance of existing devices.
• Clinical experience: Insights from surgeons and observations of prior device performance.
• Engineering principles: Application of mechanical and material science principles to design and validate components.
• Predicate device analysis: Studying the design and performance of legally marketed predicate devices to understand successful characteristics and potential areas for improvement.

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