Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device