Search Results

The Skeletal Dynamics Total Wrist Arthroplasty System is intended for replacement of the painful wrist joint due to rheumatoid arthritis, osteo-arthritis, or post-traumatic arthritis.

The subject Total Wrist Arthroplasty System is a total joint replacement of the wrist. The system has four major components: a radial component, a carpal component, a poly "lunate" component, and screws which fix the carpal component to the carpus.

This document is a 510(k) premarket notification for a medical device called the "Total Wrist Arthroplasty System (TWA)." It is a submission to the FDA seeking clearance to market this device, demonstrating its substantial equivalence to a previously cleared predicate device.

The provided text does not describe:

• Acceptance criteria for an AI/software device.
• A study proving a device meets acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC).
• Any details about sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment for AI.

Instead, this document is a regulatory submission for a physical medical implant (a wrist joint replacement system). The "Performance Testing" section refers to sterilization validation and material testing (CoCr, CPTi, UHMWPE, Ti 6AL-4V ELI) as per ISO standards (ANSI/AAMI/ISO 11135 and ISO10993-7), not AI/algorithm performance.

Therefore, I cannot fulfill your request using the provided input as it pertains to an AI/software device's acceptance criteria and study data. The document describes a traditional medical device (implant) and its manufacturing/sterilization validation.

Ask a specific question about this device

The Skeletal Dynamics Total Wrist Arthroplasty System is intended for replacement of the painful wrist joint due to rheumatoid arthritis, osteo-arthritis, or post-traumatic arthritis.

The subject Total Wrist Arthroplasty System is a total joint replacement of the wrist. The system has four major components: a radial component, a carpal component, a poly "lunate" component, and screws which fix the carpal component to the carpus.

The provided text is a 510(k) summary for the Skeletal Dynamics Total Wrist Arthroplasty System (TWA). It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria, reported device performance metrics (numerical data for sensitivity, specificity, AUC, etc.), sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Performance Testing" section lists various mechanical tests conducted according to ASTM and ISO standards, but these are for evaluating the physical properties and durability of the implant components, not for assessing the performance of a software or AI-driven diagnostic device against clinical outcomes or expert ground truth.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about the study design related to AI performance, as this information is not present in the provided document.

The document indicates a physical medical device (Total Wrist Arthroplasty System), not a software or AI-based diagnostic device. The "performance testing" refers to mechanical and material testing to ensure the safety and effectiveness of the implant itself, not to the performance of an algorithm against clinical data.

Ask a specific question about this device

The Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The Freedom Wrist Arthroplasty System is intended for cemented use.

The Freedom Wrist Arthroplasty System consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint. The components are intented together as a system, not individually as hemi-arthroplasty components. The radial component is made of Cobalt Chrome Molybenum Alloy (CrCoMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal. The carpal implant is an assembly consisting of a titanium carpal plate, which is fixed into the carpal bones with a cemented central peg and locking caps. A convex Ultra-High-Molecular-Weight Polyethylene (UHMWPE) bearing is locked onto the carpal plate to articulate with the radial component.

Unfortunately, the provided text does not contain information about an AI/ML-based medical device study. The document is an FDA 510(k) clearance letter for the "Freedom Wrist Arthroplasty System," which is a physical medical device (a wrist implant).

The text primarily focuses on:

• Device Description: The components and materials of the wrist implant.
• Intended Use/Indications for Use: What the implant is designed to treat.
• Predicate Device Comparison: How it compares to previously cleared devices.
• Non-Clinical Testing: Specifically, tests related to MRI safety and compatibility (Magnetically Induced Displacement Force, Torque, RF-Induced Heating, Image Artifacts).

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or specific performance metrics for an AI/ML device, as this information is not present in the provided document.

Ask a specific question about this device

The Arthrosurface Total Wrist Arthroplasty System is indicated for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.

The device is a single-use implant intended to be used with bone cement.

The Arthrosurface Total Wrist Arthroplasty (TWA) System is a modular joint restoration system that consists of both a radial implant assembly and carpal implant assembly. The radial implant assembly is comprised of a metallic stemmed tray component and Ultra-High-Molecular-Weight-Polyethylene (UHMWPE) articular component. The carpal implant assembly consists of a taper post component, a carpal plate, an articular component and two auxiliary bone screw components, all of which are metallic. The system is designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint.

The provided text describes a 510(k) premarket notification for the Arthrosurface WristMotion Total Wrist Arthroplasty System. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a study proving the device meets specific performance criteria as would be found for a novel device.

Therefore, many of the requested details, particularly regarding acceptance criteria with reported performance, sample sizes for test and training sets, expert qualifications, and specific AI-related comparative effectiveness or standalone studies, are not applicable or not explicitly provided in this type of regulatory document.

However, based on the information given, here's what can be extracted and inferred:

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

This information is not explicitly provided in a quantified table format in the document. The submission focuses on demonstrating substantial equivalence through non-clinical tests. The "Conclusion" states: "The results have demonstrated the safety and effectiveness of the Arthrosurface Total Wrist Arthroplasty System along with substantial equivalence to the predicate devices." This implies that the device met the performance expectations for these tests, but the specific acceptance criteria (e.g., maximum torque, minimum cycles) and the reported values are not detailed.

Specific Non-Clinical Tests Conducted (without acceptance criteria or reported performance):

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: Not specified. The document mentions "non-clinical tests and/or analysis" but does not detail the number of samples used for each test.
• Data Provenance: The tests are non-clinical, likely performed in a laboratory setting, so country of origin or retrospective/prospective nature of patient data is not applicable.

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):

This information is not applicable as this submission is for a medical implant (arthroplasty system), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" for non-clinical device testing refers to engineering standards and physical measurements.

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

Not applicable for this type of non-clinical device testing. Adjudication methods are typically used in clinical studies or for interpreting ambiguous cases in AI/software performance evaluations by humans.

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 submission is for a medical implant, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This submission is for a medical implant.

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

The "ground truth" for the non-clinical tests listed would be based on engineering standards, material properties, and physical measurements performed in a laboratory. For example, for "torsion to failure," the ground truth would be the objectively measured torque at which the screw failed, compared against a pre-defined standard or predicate device performance. For the LAL test, the ground truth is whether the endotoxin level meets the specified USP and AAMI standards.

8. The sample size for the training set:

Not applicable. This submission is for a physical medical implant, not a machine learning model that requires a training set.

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

Not applicable. As above, this is for a physical implant, not an AI/ML device.

Ask a specific question about this device

The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist joints disabled by pain, deformity, and/or limited motion caused by:

1. Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease
2. Revision where other devices or treatments have failed
3. Scapholunate Advanced Collapse (SLAC)
4. Rheumatoid Arthritis
   The device is intended to be implanted with bone cement.

The KinematX Total Wrist Arthroplasty System is a semi-constrained implant system designed to replace the joints of the wrist to alleviate pain while restoring functionality and mobility of the wrist joints. The system consists of two main, modular components:

1. Radial Implant Assembly: CoCr radial stem and an ultra-high molecular weight polyethylene (UHMWPE) bearing surface that interlocks onto a CoCr tray
2. Carpal Implant Assembly: Baseplate with central peg, index metacarpal screw, hamate screw, and CoCr cap.

This FDA document, K191525, describes the KinematX Total Wrist Arthroplasty System. However, it does not include details about acceptance criteria, device performance tables, sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies. It explicitly states that "No clinical testing was performed."

Therefore, I cannot provide the requested information based on the provided text. The document focuses on establishing substantial equivalence to predicate devices through non-clinical testing (mechanical and cadaveric evaluations) and a comparison of indications for use, materials, and design.

Ask a specific question about this device

The INTEGRA® Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The INTEGRA® Freedom Wrist Arthroplasty System is intended for cemented use.

The INTEGRA® Freedom Wrist Arthroplasty (IFW) System three part semi-constrained implant system designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint. IFW is intended for patients with intractable pain and loss function due to traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis. The system consists of three major components:

• Radial implant made from Cobalt Chromium Molybdenum Alloy (CrCoMo) .
• . Carpal plate - (includes two variable angle screws with locking caps) - made from Titanium Alloy
• . Carpal Poly bearing - made from Ultra-High-Molecular-Weight Polyethylene (UHMWPe)
  Portions of the radial implant and carpal plate have a titanium plasma sprayed coating. The implant system is provided with instrumentation necessary to complete the procedures for which the system is indicated. The components are intended to be implanted together as a system, not individually as hemi-arthroplasty components and are intended for cemented fixation.

The Integra® Freedom Wrist Arthroplasty System is a medical device, and the provided document is a 510(k) summary for its clearance. This summary details non-clinical tests performed to demonstrate substantial equivalence to previously cleared devices. It does not describe a study involving human subjects, AI systems, or the specific criteria typically associated with clinical performance evaluation of an AI/ML device.

Therefore, the requested information components related to AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this document. This document focuses on the mechanical and material performance of the implant itself.

Here's a breakdown of the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The results of these performance tests met their respective acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test, only that the device met them.

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

Not applicable. The tests mentioned are non-clinical (mechanical/material performance) rather than studies on a "test set" of patient data.

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

Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or outcomes. These are non-clinical engineering tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used in clinical trials or expert review processes for diagnostic accuracy, not physical device testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This is a non-clinical device clearance for a physical implant, not an AI/ML diagnostic or assistive tool.

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

No, a standalone algorithm performance study was not done. This refers to the performance of an AI/ML algorithm without human intervention, which is not relevant to this physical implant.

7. The Type of Ground Truth Used

Not applicable in the AI/ML context. For these non-clinical tests, "ground truth" would be the objectively measured physical properties/performance of the device under specific test conditions (e.g., maximum load bearing before failure, precise wear rates). The standards referenced (ASTM F543, F1160, F1044, F1147, F1978) define the methods for establishing these objective measurements.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML "training set" for this physical device.

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

Not applicable. There is no AI/ML "training set" for this physical device.

Ask a specific question about this device

The Maestro™ Total Wrist System is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Scapholunate Advanced Collapse (SLAC) and other functional deformities.
5. Trauma, including fractures of the distal radius and/or carpal bones.

The radial and carpal components are intended to be implanted with bone cement.

The Maestro™ Wrist Fracture Replacement System consists of a two piece radial component and a molded carpal bearing component for total wrist replacement. The radial component is composed of a distal body with a modular stem. The distal bodies have a highly polished bearing surface located anatomically. The Maestro™ Tapered Carpal Component is composed of three subcomponents - a carpal head, a carpal plate and a capitate stem. The carpal head is composed of polyethylene molded on to a metallic base. The carpal plate has a male taper which mates with a female taper in the carpal head. The plate features threaded screw holes that mate with the heads of spherical locking screws. Screws are available with both fixed and variable heads. The variable screws allow the surgeon to angle the screws upon insertion while still locking the screws to the plate. The capitate stem then screws into internal threads on the reverse side of the taper on the carpal plate to complete the implant.

The provided text is a 510(k) Summary for a medical device called the Maestro™ Wrist Fracture Implant. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

Because no clinical testing was performed or provided, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria. The information requested in your prompt (e.g., sample size, ground truth, expert qualifications, MRMC study, standalone performance, training set details) is typically found in clinical study reports, which are absent in this submission.

The document only mentions "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." However, it does not provide details on the specific acceptance criteria for this non-clinical testing or the results themselves in a structured format.

Ask a specific question about this device

The Maestro™ Total Wrist System is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Scapholunate Advanced Collapse (SLAC) and other functional deformities
5. Trauma, including fractures of the distal radius and/or carpal bones
   The device is intended to be implanted with bone cement.

The Maestro™ Total Wrist System consists of a two piece radial component with a molded bearing and a three-piece carpal component. The radial component is composed of a distal body with a modular stem. The distal bodies come in three sizes and have a molded polyethylene bearing surface. The stem is modular, assembled in the operating room by a screw assembly. The carpal component consists of a carpal head, a carpal plate and a capitate stem. The carpal head comes in 3 heights, standard, +2 and +4. This allows the surgeon to adjust for soft tissue laxity. Two lengths of carpal plates give the surgeon options of screw placement. Like the radial stems, the capitate stems screw to the plate and head.

The provided text is a 510(k) summary for the Maestro™ Total Wrist System, which is a medical device. This type of document is for premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not typically a report of a study proving a device meets acceptance criteria in the way a clinical trial or performance study for an AI/software device would.

Therefore, many of the requested details, particularly those related to AI/software performance studies, ground truth establishment, sample sizes for test and training sets, expert adjudication, and MRMC studies, are not applicable to this 510(k) submission for a non-AI/software medical device.

However, I can extract the relevant information regarding the non-clinical testing and general acceptance criteria as much as possible from the provided text.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. No "test set" in the context of a clinical performance study for an AI/software device is mentioned. The submission relies on substantial equivalence to existing devices and mechanical testing.
• Data Provenance: Not applicable.

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

• Not applicable. No "ground truth" establishment in this context is described.

4. Adjudication method for the test set

• Not applicable.

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/software device, and no MRMC study is mentioned.

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

• Not applicable. This is not an AI/software device.

7. The type of ground truth used

• Not applicable in the context of AI/software performance. For this non-AI device, the "ground truth" for acceptance is essentially the safety and effectiveness profile demonstrated by the predicate devices and confirmed by non-clinical (mechanical) testing, not by expert consensus on clinical data for the new device.

8. The sample size for the training set

• Not applicable. This is not an AI/software device.

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

• Not applicable. This is not an AI/software device.

Study Proving Device Meets Acceptance Criteria

The study that "proves" the device meets the acceptance criteria (in the context of a 510(k) for this type of device) is Non-Clinical Mechanical Testing.

• Description of the Study: "Mechanical testing has demonstrated the device's ability to [perform] under expected clinical conditions." The document does not provide details of the mechanical testing protocols, specific acceptance values (e.g., fatigue cycles, load limits), or results beyond this summary statement.
• Conclusion: The results of this mechanical testing, along with the demonstration of substantial equivalence in design, materials, and processing to the predicate devices, were sufficient for the FDA to determine substantial equivalence and clear the device for marketing.

Note: This 510(k) summary explicitly states: "Clinical Testing: None provided." This further confirms that no human clinical trials or performance studies were conducted to support this specific submission.

Ask a specific question about this device

The DePuy Biax A.F. Wrist System is intended to give patients limited wrist mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the wrist joint.

The DePuy Biax A.F. Wrist System is indicated for use as a replacement of wrist joints disabled by rheumatoid arthritis with pain, deformity and/or limited motion, degenerative or post-traumatic arthrosis, ankylosis of the wrist in malposition and advanced instability with carpal destruction

The DePuy Biax A.F. Wrist System is also indicated for revision of a failed previous wrist surgery.

CAUTION: The DePuy Biax A.F. Wrist System is for cemented use only.

The Biax A.F. Wrist System is a cemented, multiple component system to be used for the treatment, and revision, of wrist joints:
• The radial implant stem is made of ASTM F-75 Orthochrome with an articulating surface of UHWMPe. It is available in small, medium and large sizes.
• The 5-piece metacarpal implant is manufactured from F-75 Orthochrome and Titanium (Ti-6Al-4V ELI). It consists of a fixation plate, cemented and held in place with a central stem and two peripheral screws, and attached to an articulating head. All parts are available in a variety of sizes.

The provided text is a 510(k) summary for a medical device called the "Biax A.F. Wrist System", a wrist prosthesis. This type of document focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the way a diagnostic AI would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, as it relates to a diagnostic AI device.

Specifically, it lacks details on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods.
3. Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
4. Type of ground truth used (e.g., pathology, outcomes data).
5. Sample size for the training set or how ground truth for the training set was established.

Instead, the document primarily discusses the device's indications for use, its components, and its substantial equivalence to previously cleared predicate devices based on identical intended use, materials, sterilization, packaging, and design features.

Ask a specific question about this device

Indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint. To replace functionality of the joint due to deformity or elements stated above. The Universal Total Wrist is intended for cemented use.

The KMI Universal Total Wrist (UTW) System (both predicate and extra small) consists of the following components: the radial implant, the carpal plate implant, the carpal polymer component, and two bone screws. The system will now be offered in 4 (four) sizes: 'extra small', 'small', 'medium' and 'large'), each with 3 (three) matching polymer component sizes, which are available in yarvina thicknesses (height); standard, +1 and + 2, It is constructed of materials that have a long clinical history of proven acceptance and performance. This system is intended for use with cement and will be promoted as such in the UTW Surgical Protocol.

Here's an analysis of the provided text regarding the Universal Total Wrist System, focusing on acceptance criteria and supporting studies:

Based on the provided documents, this 510(k) submission (K030037) is a Special 510(k) Notification for a modification to an already cleared device, the Universal Total Wrist System. Specifically, it's for introducing an "extra small" size. Special 510(k)s often rely heavily on demonstrating substantial equivalence to a predicate device and may not involve extensive new clinical or performance studies in the same way a novel device might.

Therefore, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the traditional sense (e.g., performance metrics with defined thresholds for a new device) is not directly applicable or explicitly detailed in these documents for the modified device. Instead, the "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to the predicate device. The "study" is more accurately described as a comparison and analysis against the predicate.

Here's the breakdown of the information as requested, tailored to the context of a Special 510(k) for a size modification:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Study Details (Comparison for Substantial Equivalence)

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

   • Test Set: No clinical test set in the traditional sense is described. The "test set" for this submission consists of the engineering drawings and specifications of the "extra small" implant.
   • Data Provenance: The comparison is based on the design specifications and material properties of the new "extra small" component and the previously cleared "small" (predicate) component. The provenance is internal manufacturing and design data from Kinetikos Medical, Inc. This is a retrospective comparison against an already cleared predicate device.

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

   • No external experts were explicitly mentioned as being used to establish "ground truth" for this engineering comparison. The "ground truth" for the comparison is the design and material specifications of the predicate device, which were previously reviewed and cleared by the FDA. The manufacturer's internal engineering and quality assurance personnel would have performed the comparison.

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

   • No adjudication method in the context of expert review is described. The comparison relies on documented specifications. The FDA's review process itself acts as an adjudication that the presented information supports substantial equivalence.

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

   • No. This device is a mechanical implant (wrist prosthesis), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers/AI is irrelevant and was not conducted.

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

   • No. This is a physical medical device, not an algorithm.

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

   • The "ground truth" for this submission is the already established and FDA-cleared design, material, manufacturing, and performance characteristics of the predicate Universal Total Wrist System. The "extra small" size is demonstrating conformity to these established truths by being "identical" in all key aspects except size.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not a learning algorithm. The "training" for the predicate device would have involved a long clinical history of similar materials and designs, as explicitly stated: "It is constructed of materials that have a long clinical history of proven acceptance and performance." This refers to general knowledge about medical-grade materials, not a specific training dataset for this device.

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

   • Not applicable. As above, there's no "training set." The "ground truth" for the overall device's safety and effectiveness (as represented by the predicate) was established through previous FDA clearances based on established standards, material properties, mechanical testing, and clinical history of similar devices.

Ask a specific question about this device