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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® TRULIANT® Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The TRULIANT Cemented Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only. The TRULIANT Porous Femoral Components are indicated for cemented or cementless use. The TRULIANT Porous Tibial Trays are indicated for cemented or cementless use.

The Exactech® Truliant® Knee System is a total knee replacement system comprised of femoral, tibial, and patellar implants. The proposed Porous Tibias are additional tibial tray implant variants intended for use with the Truliant Knee System. This submission proposes Truliant Porous Tibial Trays made from titanium alloy consolidated via direct metal laser sintering (DMLS). This submission additionally proposes a Porous Tibial Tray variant without screw holes, additional intermediate tray sizes, and minor geometric change(s) to the predicate Porous Tibial Tray design.

This document is a 510(k) Premarket Notification from the FDA regarding the Exactech® TRULIANT® Knee System. It does not describe an AI/ML device and therefore does not contain the specific information requested in the prompt about acceptance criteria for an AI model, such as performance metrics like sensitivity/specificity, AI model training/test sets, expert adjudication, or MRMC studies.

The document discusses the substantial equivalence of a medical device (a knee replacement system) to a legally marketed predicate device. The performance data presented relates to engineering and biocompatibility testing for a physical implant, not an AI algorithm.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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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 Vantage Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Vantage Total Ankle System is indicated for cemented use only.

The Vantage® Total Ankle System is a fixed-bearing total ankle replacement device that is comprised of four components (Tibial Plate, Liner, Talar Component and Locking Component).

The predicate Vantage Fixed Bearing Liners are constructed of compression-molded UHMWPE. This submission proposes Vantage Fixed Bearing Liners made from UHMWPE containing vitamin E. This submission additionally proposes minor geometric change(s) to all Fixed Bearing Liners as well as additional Fixed Bearing Liner thickness options.

The provided text is a 510(k) summary for a medical device, the Vantage® Total Ankle System, specifically an orthopedic implant for ankle replacement. It does not describe an AI/ML-driven medical device or a study involving human readers or ground truth for image analysis. Therefore, it is impossible to extract the information requested in the prompt, as those details relate to the validation of AI/ML systems, which is not the subject of this document.

The document focuses on demonstrating substantial equivalence of a new version of the ankle system (with vitamin E-containing UHMWPE liners and minor geometric changes) to a previously cleared predicate device. It relies on non-clinical testing and engineering analyses (material characterization, wear, range of motion, stability, disassembly, biocompatibility, bacterial endotoxins) to show that the changes do not adversely affect safety or effectiveness.

Thus, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML, nor details about sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set information, as this document is not about an AI/ML medical device.

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The Vantage Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Vantage Total Ankle System is indicated for cemented use only.

Vantage Total Ankle Flat Cut Talar Components are for use in resurfacing talar bone as one of the four components of the Exactech Vantage Total Ankle System (including tibial plate, tibial insert, locking component and talar component) intended for use in total ankle arthroplasty.

The proposed Vantage Flat Cut Talar Components represent modifications to the Vantage Total Ankle Talar Components cleared per 510(k) K152217. The proposed Vantage Total Ankle Flat Cut Talar Components are equivalent to the previously cleared talar components, but utilize one additional fixation structure and flat cut geometry on devices' bone-contacting surface rather than a curved underlying surface featured in the cleared, predicate talar components.

The proposed and predicate devices share the same fundamental scientific technology, have the same intended use, indications for use, and similar design features, employ the same materials of construction and manufacturing processes, are offered in the same product size scope, are implanted using similar surgical techniques and instrumentation, work with the same compatible Vantage Total ankle tibial plates and locking components, and, size for size, are compatible with the same tibial inserts from the previously cleared Exactech Vantage Total Ankle System.

The provided text is a 510(k) summary for a medical device, the Exactech® Vantage® Total Ankle Flat Cut Talar Components. It describes the device, its intended use, and substantial equivalence to a predicate device, focusing on non-clinical testing.

However, the document does not provide information about the acceptance criteria or a study that uses those criteria to evaluate a device's performance in the context of an AI/ML algorithm. The product described is a physical implant for ankle replacement, not a software or AI/ML-driven diagnostic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML or algorithm performance.

The non-clinical testing mentioned (Sizing Studies, Cadaveric Study, Bone Stability Testing, Range of Motion Study, Comparative Analysis, Finite Element Analysis, Pyrogen testing) are typical for physical orthopedic implants, demonstrating biological safety, mechanical integrity, and surgical fit, rather than diagnostic accuracy or algorithmic performance against a ground truth.

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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 Exactech Equinoxe Small Reverse Shoulder System is a reverse shoulder system that provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Reverse Shoulder System; these geometry modifications are the entire basis for the proposed Exactech Equinoxe Small Reverse Shoulder System.

This document is a 510(k) premarket notification for a medical device called the "Exactech® Equinoxe® Small Reverse Shoulder System." It describes the device, its intended use, and provides evidence of its substantial equivalence to previously cleared predicate devices.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for performance metrics that would typically be expected for a diagnostic or AI-driven device. Instead, the "acceptance criteria" for this implantable device are demonstrated through mechanical and biological testing to show it performs as intended and is substantially equivalent to predicate devices. The "reported device performance" is essentially the successful outcome of these tests.

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

The document describes non-clinical laboratory testing (mechanical and pyrogen testing) rather than a test set of patient data. Therefore, this information is not applicable in the context of typical AI/diagnostic device studies using patient data. The "sample size" refers to the number of test articles (implants) used in the mechanical and pyrogen tests. The document does not specify exact numbers of test articles, but it does reference specific ASTM and USP standards for these tests, which would dictate appropriate sample sizes.

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

This information is not applicable. The device is an implantable shoulder system, not a diagnostic or AI-enabled device requiring expert interpretation of results for ground truth establishment. The "ground truth" for this device's performance is established through standardized engineering and biological tests conducted by qualified laboratory personnel following established protocols.

4. Adjudication method for the test set

This information is not applicable as there is no test set in the sense of a collection of patient cases requiring expert adjudication. The "adjudication" of the device's performance is based on meeting the quantitative criteria specified by the referenced ASTM and USP standards during laboratory testing.

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

This information is not applicable. This device is an implantable medical device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or would be relevant for this type of device.

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

This information is not applicable. There is no algorithm or AI component in this device, so no standalone algorithm performance study was done.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily mechanical performance data against industry standards and biological safety data (pyrogenicity). This means:

• Mechanical Ground Truth: Adherence to the specified mechanical properties (e.g., strength, range of motion) as defined by ASTM F2028 and ASTM F1378.
• Biological Ground Truth: Absence of pyrogens within specified limits as defined by USP <161>, USP <85>, and ANSI/AAMI ST72.

8. The sample size for the training set

This information is not applicable. There is no AI component in this device, and thus no training set was used.

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

This information is not applicable. As there is no training set for an AI/algorithm, no ground truth needed to be established in this context.

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

Clinical indications for anatomic total shoulder arthroplasty are as follows:

• Osteoarthritis, osteonecrosis or post-traumatic degenerative problems
• Congenital abnormalities in the skeletally mature
• Primary and secondary necrosis of the humeral head.
• 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)
• To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.

The Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.

The Equinoxe Stemless Shoulder is intended to be used with Exactech glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The Equinoxe Stemless Shoulder includes humeral components and humeral heads. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V, and have porous regions. The Equinoxe Stemless Humeral Heads are manufactured from Cobalt Chrome. The Equinoxe Stemless Humeral Components are available in two types, Caged and Non-Caged, with each type available in three sizes, with lengths between 17mm and 24mm. The Equinoxe Stemless Humeral Heads are available in 12 sizes, with diameters between 38mm and 53mm and two height options (Extra Short, Short).

This FDA 510(k) premarket notification for the Exactech® Equinoxe® Stemless Shoulder device does not describe an AI/ML-based medical device. Therefore, the questions related to acceptance criteria, AI/ML study design, ground truth, and sample sizes for training/testing sets are not applicable in this context.

This submission is for a medical implant (a shoulder prosthesis) and focuses on demonstrating substantial equivalence to previously approved predicate devices through non-clinical (mechanical) testing, material comparisons, and similar indications for use.

Instead of AI/ML performance metrics, the document presents mechanical performance criteria.

Here's a breakdown of the relevant information provided:

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

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 for AI/ML device. The "test set" here refers to mechanical test samples, not clinical data for an algorithm. The document does not specify the number of mechanical samples used for each test. Data provenance is not relevant as it's mechanical testing of a physical device.

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 for AI/ML device. Ground truth, in the context of AI/ML, refers to labels or diagnoses. For a physical implant, ground truth would be established through engineering specifications and standards.

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

• Not applicable for AI/ML device. Adjudication methods are used to resolve disagreements in expert labeling for AI/ML ground truth.

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

• Not applicable. This is not an AI/ML device, so no MRMC studies or human reader improvement with AI assistance were performed.

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

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

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

• Not applicable for AI/ML device. For this physical device, "ground truth" equates to the established engineering specifications, performance standards (e.g., ISO, ASTM for fatigue, pull-out strength), and material properties that the device must meet to function safely and effectively.

8. The sample size for the training set:

• Not applicable for AI/ML device. There is no training set for a physical implant.

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

• Not applicable for AI/ML device. There is no ground truth or training set in the AI/ML sense for this device.

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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Exactech Alteon HA femoral stems are intended for press-fit fixation.

The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V with a polished neck region, grit blast surface and HA coating on the stem body. The stem has a 12/14 taper. The Alteon HA Femoral Stems Femoral Stems are available in various lengths with standard and extended neck offset configurations, and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces.

The Alteon HA Femoral Stems are intended for press-fit applications and are not intended for use with bone cement.

This FDA 510(k) summary for the Exactech® Alteon® HA Femoral Stem focuses on demonstrating substantial equivalence to an existing predicate device (Exactech Novation Element Press-Fit Femoral Stem), rather than proving the device meets specific performance criteria through a clinical study or an AI-driven evaluation.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance is not included in this document. This type of information is typically associated with the evaluation of artificial intelligence/machine learning (AI/ML) devices, diagnostics, or other devices requiring direct performance validation against clinical outcomes or expert labels.

The provided document describes a traditional 510(k) submission for a Class II medical device (hip joint prosthesis). For such medical devices, "acceptance criteria" primarily relate to:

• Mechanical performance: Ensuring the device can withstand physiological loads and wear over time.
• Biocompatibility: Confirming the materials are safe for implantation.
• Sterility: Verifying the device is sterile when packaged.
• Design and manufacturing controls: Ensuring consistent quality.

The "study that proves the device meets the acceptance criteria" in this context refers to benchtop engineering testing, not clinical trials or diagnostic performance studies involving human subjects' data interpretation.

Summary of what is present in the document related to "acceptance criteria" and "proof":

Acceptance Criteria and Proof (as per this 510(k) document)

The document outlines engineering analyses conducted to prove the device's mechanical properties. These are the de facto acceptance criteria for this type of device in a 510(k) submission seeking substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states "Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Exactech Alteon HA Femoral Stems are substantially equivalent to the cleared Exactech Novation Element Press-Fit Femoral Stem." This implies that the performance in these tests was comparable to or better than the predicate device, thus meeting the unstated acceptance thresholds for substantial equivalence.

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

• Test Set Sample Size: Not specified for the engineering tests. For mechanical testing, this typically refers to the number of physical samples of the device tested, not patient data.
• Data Provenance: The tests are inherently prospective as they are specifically conducted for the regulatory submission. The "data" are generated in a laboratory setting (benchtop testing), not from patient populations. Country of origin for data is not applicable in the sense of patient demographics; the tests would be performed in a controlled environment.

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

• Not Applicable. Ground truth in the context of diagnostic AI/ML algorithms relies on human expert consensus or clinical outcomes. For this mechanical device, "ground truth" is established by standard engineering principles, test methodologies (e.g., ISO standards, ASTM standards), and regulatory guidelines. The "experts" would be the engineers and technicians conducting the tests and the regulatory specialists evaluating the data.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication is relevant for conflicting interpretations of clinical data, especially in image-based diagnostics. For mechanical engineering tests, results are typically quantitative and objective measurements (e.g., cycles to failure, deflection, etc.).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

• No. An MRMC study is specific to evaluating the diagnostic performance of human readers, often comparing performance with and without AI assistance. This device is a mechanical implant, not a diagnostic tool, so such a study is not relevant.

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

• No. This refers to the standalone performance of an AI algorithm. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

• Engineering Standards and Predicate Device Performance. The "ground truth" for this submission is established by demonstrating that the new device performs mechanically at least as well as the legally marketed predicate device when tested according to recognized engineering standards and methods. It's a comparative performance, not a clinical outcome or pathological diagnosis.

8. The Sample Size for the Training Set:

• Not Applicable. "Training set" refers to data used to train AI/ML algorithms. This is a traditional medical device, not an AI/ML product.

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

• Not Applicable. See point 8.

In conclusion, this document demonstrates that the Exactech® Alteon® HA Femoral Stem meets the requirements for substantial equivalence for a 510(k) submission based on benchtop engineering testing, not clinical study data for diagnostic performance.

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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 <161>, USP <85>, 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 Equinoxe Humeral Reconstruction 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 Humeral Reconstruction Prosthesis System can be used in either primary or revision arthroplasty procedures.

The Equinoxe Humeral Reconstruction 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 irreplaceable and grossly deficient, and a functional deltoid muscle is present.

In the USA, the Equinoxe Humeral Reconstruction Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.

The Equinoxe Humeral Reconstruction Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Humeral Reconstruction Prosthesis Distal Stem Collars are only for uncemented, press-fit use.

The proposed Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies represent a modification of the predicate Exactech Equinoxe Humeral Reconstruction Prosthesis Proximal Bodies cleared in K143659. Both the predicate and proposed devices have the same intended use, general design features and basic fundamental scientific technology. The only difference between the predicate and the proposed device is a decreased tuberosity thickness.

Based on the provided text, the device in question is the Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies, which is a type of shoulder joint prosthesis. The document is a 510(k) premarket notification summary submitted to the FDA.

It is crucial to understand that a 510(k) submission for this type of device (a Class II orthopedic implant) focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, primarily through engineering analysis and mechanical testing, rather than clinical performance (like an AI/software device would). This means the type of acceptance criteria and supporting studies are very different from what one would expect for an AI/ML medical device.

Therefore, many of the requested points regarding AI/ML device performance (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) are NOT applicable to this document as it describes a hardware orthopedic implant, not an AI/ML software.

Here's an analysis based on the provided text, addressing the relevant points:

Acceptance Criteria and Study for Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies

The document describes the acceptance criteria and study to demonstrate substantial equivalence of a modified orthopedic implant to a predicate device. The focus is on mechanical and material integrity, not clinical effectiveness of an AI/ML algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not applicable in the context of clinical trial or AI/ML test sets. The "sample size" here refers to the number of test articles/specimens used for the mechanical tests. The exact number of specimens tested for each mechanical test (e.g., how many constructs were subjected to fatigue testing) is not explicitly stated in this summary document.
• Data Provenance: The tests are described as "engineering analysis" and "pyrogen testing" conducted by the manufacturer, Exactech Inc., in Gainesville, Florida, USA. These are laboratory studies, not retrospective or prospective patient data studies.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. This submission focuses on the safety and performance of a physical implant through engineering tests, not on diagnostic accuracy requiring expert image interpretation or clinical outcomes. Ground truth for mechanical properties is established by engineering standards and measurements, not expert consensus from medical professionals.

4. Adjudication Method for Test Set

• Not applicable. There is no "test set" in the sense of patient data requiring adjudication for diagnosis or outcomes. The "test set" consists of physical specimens undergoing standardized mechanical tests.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human readers for diagnostic tasks (e.g., interpreting medical images). This document describes a physical orthopedic implant and its mechanical properties.

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

• Not applicable. This is not an AI/ML algorithm. The "performance" is the mechanical integrity of the implant itself.

7. Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on engineering standards and regulatory limits for mechanical properties (e.g., material strength, fatigue life, pull-off force) and biocompatibility (e.g., pyrogen levels). It's essentially "performance against established engineering specifications and predicate device performance."

8. Sample Size for Training Set

• Not applicable. There is no AI/ML model being "trained" here.

9. How Ground Truth for Training Set was Established

• Not applicable. (See #8)

Summary of Relevant Information from the Document:

The acceptance criteria for the Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies are primarily functional and material-based, demonstrating that the modified device performs similarly to or better than the predicate device under specific mechanical challenges and meets biocompatibility standards. The study proving this involved engineering analyses and mechanical bench testing, focusing on parameters like taper, suture abrasion, axial pull-off, fatigue, and torsion, along with pyrogen testing. The ultimate "acceptance" is the FDA's determination of substantial equivalence to the predicate device K143659.

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