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The Ensemble CMC is intended to replace the first metacarpal and the trapezium in cases of theumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

The Ensemble CMC implant is a single use, uncemented, one-piece interpositional joint prosthesis designed to fit in the space between the trapezium and first metacarpal for patients with early stage arthritis of the carpometacarpal joint (CMC). The Ensemble CMC is not intended to interact with other devices. It has upper and lower surfaces that are saddle (toroidal) shaped to match the anatomy of the base of the first metacarpal and the trapezium. The design of the Ensemble CMC allows for flexion-extension, abduction-adduction, and circumduction motions. The implant is manufactured with an On-X® PyroCarbon (pyrocarbon) layer encasing a graphite core and comes in three sizes. Each device is provided sterile in packaging containing a single implant, Instructions for Use, and patient chart labels.

A series of non-powered, hand-held manual surgical instruments can be used to prepare the joint space before implantation of the Ensemble CMC.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary:

This device (Ensemble CMC) is a medical implant, not an AI/ML algorithm or a diagnostic tool. Therefore, the concept of a "test set," "ground truth," "expert consensus," "MRMC study," or "standalone algorithm performance" as described in the prompt's context for AI/ML devices is not directly applicable to this submission. The "study" here refers to non-clinical mechanical testing, not a clinical trial or performance evaluation against a diagnostic standard.

Here's an analysis of the provided text in the requested format, interpreting "acceptance criteria" as the performance aspects evaluated for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • The document mentions "cadaveric testing" for range of motion and impingement, but does not specify the sample size (i.e., number of cadavers or samples tested).
  • For the other mechanical tests (material, joint biomechanics, static, endurance), the document refers to "non-clinical mechanical testing" but does not specify sample sizes of implants tested.
• Data Provenance: The cadaveric testing implies biological samples, but the country of origin is not specified. Given it's an FDA submission, it's likely conducted in or for the US market, but this is an inference. The other mechanical testing is laboratory-based; provenance is not applicable in the same way as clinical data.
• Retrospective or Prospective: Not applicable as this is not a study on clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable in the context of AI/ML ground truth. For an implant, "ground truth" would relate to accepted engineering and biomechanical principles, as well as the physical properties of the materials. No "experts" are noted in the role of establishing diagnostic ground truth or labeling data. The engineers and scientists conducting the mechanical tests would be qualified in their respective fields.

4. Adjudication Method

• Not applicable. This relates to diagnostic interpretation consensus, which is not relevant for an orthopedic implant's mechanical testing.

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

• No. This is not an AI/ML device for diagnostic assistance, so an MRMC study comparing human readers with and without AI assistance was not conducted.

6. Standalone (Algorithm Only) Performance

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

7. Type of Ground Truth Used

• For the mechanical and cadaveric testing, the "ground truth" is defined by:
  • Engineering specifications and standards: For material, static, and endurance testing.
  • Biomechanical principles and anatomical observation: For joint biomechanics, range of motion, and impingement confirmed through cadaveric studies.
  • Comparison to predicate devices: The overall goal was to demonstrate "substantial equivalence" to established, legally marketed predicate devices, meaning performance characteristics were compared to these existing devices.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The device itself is manufactured, not "trained."

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an AI/ML algorithm.

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The Stablyx CMC Arthroplasty Implant System is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis or post fracture deformation or bone loss which present as either painful, unstable thumb or a thumb with limited range of motion. The implant is intended for uncemented, press fit use.

The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) ioint. The single piece prosthesis has a highly polished. saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal. The saddle surface of the Stablyx CMC prosthesis articulates aqainst the saddle surface of the trapezium, allowing for flexion-extension, abduction-adduction and opposition motions. The prosthesis is available in fixe sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile. The Stablyx CMC Arthroplasty System is comprised of: Multiple sized hemi joint prosthesis System specific instrumentation

The provided text is a Fragment of a 510(k) Pre-market Notification for a medical device called the "Stablyx CMC Arthroplasty Implant System". This document is primarily focused on demonstrating substantial equivalence to a predicate device, as required by the FDA.

Based on the information provided, it is not possible to answer the detailed questions regarding acceptance criteria and a study proving the device meets those criteria. The document states:

1. "Engineering analysis and testing demonstrated that the Stablyx CMC Arthroplasty System is substantially equivalent to the predicate device currently marketed."
2. "Characterization testing, including gravimetric testing and analysis established equivalency."
3. "Therefore, the subject device is as safe and effective as legally marketed predicate devices."

This indicates that comparisons were made to a predicate device (Stablyx CMC Arthroplasty Implant System (K111068)) to establish substantial equivalence. However, the document does not provide:

• A table of acceptance criteria with reported device performance.
• Details about a sample size used for a test set or data provenance in a clinical study.
• Information about experts establishing ground truth.
• An adjudication method.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• Details of a standalone performance study.
• The type of ground truth used.
• Sample size for a training set or how its ground truth was established, as these are typically associated with machine learning or AI device development, which is not indicated here.

The "Performance Testing" section vaguely refers to "Engineering analysis and testing" and "Characterization testing, including gravimetric testing and analysis" to establish equivalency. This likely refers to bench testing (e.g., mechanical properties, wear resistance, dimensional analysis) to ensure the new device performs similarly to the predicate device and meets relevant performance standards for orthopedic implants.

In summary, the provided FDA 510(k) document is a regulatory submission focused on substantial equivalence based on engineering and characterization testing, not on clinical study data with acceptance criteria as typically defined for performance studies of AI/ML-driven devices or devices requiring extensive human reader involvement.

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The Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion. This implant is intended for uncemented, press fit use.

The Stablyx CMC Arthroplasty System is a hemi monoblock prosthesis for replacement of the first metacarpal carpometacarpal (CMC) joint. The single piece prosthesis has a highly polished, saddle shaped (toroidal) articular surface which mirrors the normal anatomy of the base of the first metacarpal. The saddle surface of the Stablyx CMC prosthesis articulates against the saddle surface of the trapezium, allowing for flexionextension, abduction-adduction and opposition motions.

The prosthesis is available in five sizes, and is made of Cobalt Chrome (CoCr) with a Titanium Plasma Spray (TPS) coated stem which may assist in biological fixation. The stem is intended to press fit into the medullary canal. Each prosthesis is packaged and provided sterile.

The Stablyx CMC Arthroplasty System is comprised of:

• Multiple sized hemi ioint prosthesis .
• System specific instrumentation .

The provided document is a 510(k) summary for the Skeletal Dynamics Stablyx CMC Arthroplasty Implant Set. It describes a medical device, and 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with specific acceptance criteria, sample sizes, and ground truth methodologies that would be common for AI/Software as a Medical Device (SaMD) clearances.

Therefore, much of the requested information regarding acceptance criteria and study particulars for device performance in the context of an AI/SaMD product is not applicable to this traditional medical implant submission.

However, I can extract information related to the demonstration of "performance" as it pertains to showing substantial equivalence.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of a "test set" as understood for AI/SaMD. The document mentions "cadaveric testing," but the number of cadavers or specific samples tested is not provided.
• Data Provenance: "Cadaveric testing" implies human cadaveric tissue. The country of origin is not specified. The study is implicitly prospective as it involves testing of the new device.

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

• Not Applicable (N/A): This type of information (experts for ground truth) is not relevant for a 510(k) submission for a mechanical implant. The assessment of "performance" is based on engineering analyses and biomechanical testing, compared against established standards or predicate device performance. There isn't a "ground truth" establishment in the sense of expert labeling for an AI algorithm.

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

• Not Applicable (N/A): Adjudication methods are typically for consensus building among experts on image or data interpretations, which is not relevant for this device submission.

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

• No: An MRMC comparative effectiveness study is not relevant for this type of medical implant. These studies are typically conducted for AI-powered diagnostic or assistive tools to evaluate their impact on human reader performance.

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

• Not Applicable (N/A): This refers to AI algorithm performance. This device is a physical implant, not an algorithm.

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

• Not Applicable (N/A) / Different Context: The concept of "ground truth" in this context would likely refer to established biomechanical principles, engineering standards, and the known performance characteristics of predicate devices. The "performance testing" referenced "engineering analysis and cadaveric testing" which would generate data amenable to such comparisons, rather than a "ground truth" derived from expert consensus on clinical data.

8. The sample size for the training set

• Not Applicable (N/A): This refers to AI model training data. This device is a physical implant, not an AI model.

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

• Not Applicable (N/A): This refers to AI model training data. This device is a physical implant, not an AI model.

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The Ascension® NuGrip® CMC Implant is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present as either a painful, unstable thumb or a thumb with limited range of motion.

The Ascension NuGrip CMC Implant is a single-use, uncemented one-piece implant for the basal thumb joint. It is constructed of a graphite core encased in a layer of pyrolytic carbon. The device is offered in 9 different combinations of 3 head and 4 stem sizes. The NuGrip represents incremental design modifications to the Ascension PyroHemiSphere, including an extended proximal spherical head, a collar at the head base, modified stem geometry, and additional implant sizes.

The provided text is a K112278 510(k) premarket notification for the Ascension® NuGrip® CMC Implant. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices. However, it explicitly states that no clinical performance data were needed to support substantial equivalence of the design modifications.

Therefore, there is no information in the provided text to answer most of your questions, as they pertain to clinical studies and performance data.

Here's what can be extracted based on the document:

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

Since no clinical performance data was provided or deemed necessary, there are no specific clinical acceptance criteria or reported device performance metrics in the context of a clinical study. The device's substantial equivalence was based on non-clinical performance data and material/process equivalence to predicate devices.

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

Not applicable, as no clinical performance data was provided.

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

Not applicable, as no clinical performance data was provided.

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

Not applicable, as no clinical performance data was provided.

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 device is an implant, not an AI-assisted diagnostic tool.

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

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

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

Not applicable, as no clinical performance data was provided. The "ground truth" for this submission was based on the substantial equivalence of the device's materials, design modifications, and non-clinical performance to existing, cleared predicate devices.

8. The sample size for the training set:

Not applicable, as no clinical performance data was provided.

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

Not applicable, as no clinical performance data was provided.

Summary based on the provided text:

The information explicitly states: "No clinical performance data were needed to support substantial equivalence of the design modifications." This means the regulatory pathway for this device did not require a clinical study with human patients to demonstrate safety and effectiveness for this specific submission. Instead, substantial equivalence was established through:

• Identical materials and processes to the predicate Ascension® PyroHemiSphere® CMC implant.
• Non-clinical performance data and analysis, including:
  • CMC Joint Biomechanics Review
  • Static Compression-Bending Testing
  • Basal Thumb Implant Endurance Testing
  • System Verification Report/Strength Analysis
  • PyroCarbon Wear Characteristics Analysis
• The determination that design modifications do not raise new issues of safety or effectiveness.
• Unchanged indications for use and intended function from the predicate devices.

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The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with:

• Localized pain and palpable crepitation at the base of the thumb on the "grind test" (circumduction with axial compression of the thumb)
• Decreased motion, pinch, and grip strength
• X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination.
• Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity

The EXTREMITY MEDICAL Trapezium Prosthesis

The provided text is a 510(k) summary for the EXTREMITY MEDICAL Trapezium Prosthesis. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or not present in this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics. The core "acceptance criteria" for K092548 is demonstrating substantial equivalence to predicate devices in terms of indications for use, materials, design, and principles of operation.
• Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, functional outcomes) are reported for the EXTREMITY MEDICAL Trapezium Prosthesis itself. The study's "performance" is its argument for substantial equivalence.

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

• Sample Size: Not applicable. This document is a regulatory submission for substantial equivalence, not a clinical study reporting on patient outcomes with a specific test set.
• Data Provenance: Not applicable for a test set of the device itself. The data provenance for the predicate devices would be from their original studies or regulatory submissions, which are not detailed here.

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

• Not applicable. There is no "test set" in the context of clinical performance evaluation described here, nor is there a ground truth established by experts for performance data of this specific device.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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

• No. This is a medical implant, not an AI diagnostic tool. MRMC studies and "human readers improve with AI" are not relevant to this device.

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

• No. This is a medical implant, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this submission is the established safety and effectiveness of the predicate devices. The new device aims to demonstrate it is substantially equivalent to these already-approved devices, rather than establishing de novo safety and effectiveness through clinical trials with a primary ground truth (like pathology or outcomes data for a novel treatment).

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an algorithm being developed.

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

• Not applicable. See point 8.

Summary of what the document does provide regarding the "study" for acceptance:

• Study Type: This is a predator-based 510(k) submission, not a clinical or performance study of the subject device. The "study" here refers to the process of comparing the new device against legally marketed predicate devices.
• Acceptance Criteria (Implicit for 510k): The device is "accepted" (cleared for market) if it is found to be "substantially equivalent" to legally marketed predicate devices. This means it must have:
  • The same intended use as the predicate device.
  • The same technological characteristics as the predicate device; OR
  • Different technological characteristics from the predicate device that do not raise different questions of safety and effectiveness; AND
  • The information submitted to FDA, including appropriate scientific data, demonstrates that the device is as safe and effective as the legally marketed device.
• Device Performance (as presented): The document states: "The EXTREMITY MEDICAL Trapezium Prosthesis is substantially equivalent to its predicate devices. This conclusion is based upon the fact that this device is substantially equivalent in terms of indications for use, materials, design and principles of operation." No specific performance data (e.g., clinical outcomes, wear rates, complication rates) for the EXTREMITY MEDICAL Trapezium Prosthesis are presented. Performance is inferred from equivalence to the predicates.
• Predicate Devices Used for Comparison:
  • Wright Medical, Metallic CMC Spherical Implant K960534
  • Wright Medical, Orthosphere Ceramic Spherical Implant, K030319
  • Wright Medical, Swanson Titanium Carpal Scaphoid Implant, K864490
  • Wright Medical, Swanson Titanium Carpal Lunate Implant, K864491
  • Wright Medical, TIE-IN Trapezium, K033529
  • Wright Medical, Trapezium Implant, K781756
  • Ascension Orthopedics, PyroSphere, K042690
  • Ascension Orthopedics, PyroCarbon Lunate, K080997

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ARTELON STT Spacer is intended to be implanted into the scaphotrapeziotrapezioidal (STT) joint as an interpositional spacer between the scaphoid bone and the trapezialtrapezioid bones. The device is intended to be used in thumb disabilities caused by osteoarthritis.

ARTELON STT Spacer is a woven one-piece, L-shaped implant made of ARTELON, a polycaprolactone based polyurethaneurea.

This submission is for a medical device (Artelon STT Spacer), not an AI/ML powered device. Therefore most of the requested information regarding AI/ML powered devices, such as acceptance criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not applicable.

Here's a breakdown of the relevant information provided:

1. Table of acceptance criteria and reported device performance: Not explicitly stated in the provided text in the format of acceptance criteria and reported performance. The document states, "A collection of tests have been successfully completed. The results from the performance testing demonstrate that ARTELON STT Spacer provides appropriate assurance of safety and effectiveness." However, specific quantitative or qualitative acceptance criteria and their corresponding results are not detailed.

2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device approval summary, not a study report for an algorithm. The testing described is likely mechanical and biocompatibility testing of the physical implant, not a test set for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation does not apply here.

4. Adjudication method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done as this is a medical device (implant) and not a reader-dependent diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: Not applicable in the context of an AI/ML algorithm. For the device, safety and effectiveness would be established through mechanical testing, biocompatibility studies, and potentially clinical trials (though not detailed here for this 510(k) summary).

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Additional Information from the document:

• Device Name: Artelon® STT Spacer
• Intended Use: "ARTELON STT Spacer is intended to be implanted into the scaphotrapeziotrapezioidal (STT) joint as an interpositional spacer between the scaphoid bone and the trapezialtrapezioid bones. The device is intended to be used in thumb disabilities caused by osteoarthritis."
• Comparison to Predicate Devices: The submission states that the Artelon STT Spacer is substantially equivalent to:
  • K040070 Artelon® CMC Spacer (Artimplant AB)
  • Swanson Trapezium Implant (Dow Corning Wright - a pre-amendment device)
• Basis for Equivalence: The Artelon STT Spacer is made of the same material (ARTELON) and has the same basic design as the Artelon CMC Spacer. It also serves a similar function (space-filling for osteoarthritis) to the Swanson Trapezium Implant.
• Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, and therefore presents no new concerns of safety and effectiveness.

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Artelon® CMC Spacer Arthro intended to be implanted into first carpometacarpal joint (CMC-I) as an interpositional spacer between the trapezial bone and the first metacarpal bone. The device is intended to be used in thumb disabilities caused by osteoarthritis.

ARTELON CMC Spacer Arthro is a woven textile device made of ARTELON fibres. ARTELON is a biocompatible, degradable material made of polycaprolactone-based polyurethaneurea. ARTELON CMC Spacer Arthro is designed to act as an interposition part in the joint. The purpose of the vertical portion is to separate the surfaces of the arthritic joint from each other. The purpose of the horizontal portion of ARTELON CMC Spacer Arthro is to fixate the device. ARTELON CMC Spacer Arthro is a single-use device packaged in double sterile barriers. The ARTELON CMC Spacer Arthro wings are fixed in place using commercially available suture anchors (non-absorbable, diameter approximately 2 mm) in combination with two double-armed class I nonabsorbable USP size 1 sutures.

The provided text is a 510(k) summary for the ARTELON CMC Spacer Arthro. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

Instead, the submission relies on bench testing to demonstrate performance and substantial equivalence to a previously cleared device.

Therefore, many of the requested details about acceptance criteria and study design for measuring device performance cannot be extracted from this document because such a study was not performed or reported in this summary.

Here's a breakdown of the information that can be extracted or inferred based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. No clinical "test set" in the context of a performance study (e.g., measuring disease detection accuracy) was conducted for this 510(k) submission. Performance was assessed via bench testing and comparison to a predicate device.
• Data Provenance: Not applicable for a clinical performance study. The submission describes bench testing which would typically be conducted in a laboratory setting.

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

• Not applicable. No ground truth establishment by experts for a clinical performance study was reported.

4. Adjudication Method for the Test Set

• Not applicable. No clinical performance study requiring adjudication was reported.

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

• No, a MRMC comparative effectiveness study was not done. The document does not describe any human-in-the-loop performance evaluation or comparison with AI assistance.

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

• No, a standalone (algorithm only) performance study of this nature was not done. The device is a physical implant, not an algorithm. Performance was assessed through engineering bench tests and comparison to a predicate device.

7. Type of Ground Truth Used

• For demonstrating equivalence: The "ground truth" was the performance and characteristics of the predicate device (ARTELON CMC Spacer, K040070), along with compliance to recognized standards (ISO 10993, ISO 14971, etc.) through bench testing.
• For clinical outcomes: Not applicable, as detailed clinical outcomes data from a specific study for this device's 510(k) submission are not provided.

8. Sample Size for the Training Set

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

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

• Not applicable. This device is a physical implant, not an AI/ML algorithm.

Summary of the 510(k) Approach:

The 510(k) submission for the ARTELON CMC Spacer Arthro focused on demonstrating substantial equivalence to a previously cleared device (ARTELON CMC Spacer, K040070). This involved:

• Bench Testing: Ensuring the new device met the same "release specifications" as the predicate device and complied with relevant ISO and AAMI standards for biocompatibility, sterilization, packaging, and risk management.
• Comparison of Features: Highlighting the similarity in dimensions, materials, basic design, and intended use between the new device and the predicate.

This type of submission typically does not include de novo clinical studies with specific performance metrics like sensitivity or specificity, or studies involving human readers or AI algorithms for diagnostic purposes. The "acceptance criteria" here are primarily around meeting engineering specifications and demonstrating equivalency to a device already deemed safe and effective by the FDA.

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The Ascension® CMC is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.

The Ascension® CMC is intended for use as a hemi joint replacement for the base of the first metacarpal of the carpometacarpal (CMC) joint. The Ascension CMC is a one component prosthesis having a saddle configuration articular surface which bears against the mating saddle articular surface of the trapczium. The saddle design allows for flexion-extension joint motion and abduction-adduction motion. It is designed to be a press fit device. Each device is comprised of a pyrocarbon layer encasing a machined graphite substrate. The graphite substrate material is impregnated with a small amount (I atomic percent) of tungsten. This small amount of tungsten renders the graphite substrate radiopaque. The device is provided sterile in packaging containing a single device.

The provided text describes a 510(k) Premarket Notification for the Ascension® CMC device, a wrist joint carpal trapezium polymer prosthesis. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, most of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "Performance tests conducted on Ascension CMC devices," "in vitro material biocompatibility tests," and "pre-clinical animal tests."

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

• Not applicable/Not specified, as no human-expert-driven ground truth establishment for a diagnostic/AI device is described. The "ground truth" here refers to the results of the performance, biocompatibility, and animal tests.

4. Adjudication Method for the Test Set

• Not applicable/Not specified, as no human-expert-driven adjudication process for a diagnostic/AI device is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a prosthesis, not an AI or diagnostic imaging device that would typically involve human readers.

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

• Not applicable. This device is a medical implant (prosthesis), not a standalone algorithm.

7. The Type of Ground Truth Used

• The "ground truth" implicitly used for demonstrating substantial equivalence are the results of specific engineering performance tests, in vitro material tests, and pre-clinical animal studies. These tests are presumed to provide definitive data on the device's characteristics and safety.

8. The Sample Size for the Training Set

• Not applicable/Not specified. There is no mention of a "training set" for an algorithm, as this is a medical device (prosthesis).

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

• Not applicable/Not specified. There is no mention of a "training set" or its ground truth establishment for an algorithm.

Summary of the Study type based on the provided text:

The study described is a demonstration of substantial equivalence to a predicate device (Ascension® PHS, K041451) through:

• Performance tests on Ascension CMC devices.
• In vitro material biocompatibility tests.
• Pre-clinical animal tests.

The goal of these "tests" or "studies" was to show that the Ascension® CMC performs as intended and is as safe and effective as the previously cleared predicate device, rather than to meet specific, quantifiable acceptance criteria that are typically established for novel diagnostic or AI-powered devices. The success criterion here is the FDA's determination of "substantial equivalence."

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1. Rheumatoid arthritis

• 2. Traumatic arthritis
• 3. Osteoarthritis
• 4. Post Fracture deformation or bone loss

Not Found

I am sorry, but based on the provided document, I cannot fulfill your request for details about acceptance criteria, device performance, and study information. The document is a 510(k) clearance letter from the FDA for a device called "Modular Thumb Implant."

This letter confirms that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. However, this type of document does not typically contain detailed information about acceptance criteria, specific device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

The 510(k) clearance process focuses on demonstrating substantial equivalence, not necessarily on presenting exhaustive clinical trial data with specific performance metrics and acceptance criteria in the way you've outlined for AI/ML device studies.

The document only provides:

• Device Name: Modular Thumb Implant
• Regulation Number and Name: 21 CFR 888.3770, Wrist joint carpal trapezium polymer prosthesis
• Indications for Use: Rheumatoid arthritis, Traumatic arthritis, Osteoarthritis, Post Fracture deformation or bone loss.
• Product Code: KYI

To find the information you're looking for, you would generally need to refer to the actual 510(k) submission summary, sometimes publicly available on the FDA website, or directly to the manufacturer's technical documentation or publications if such studies were conducted and published.

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The device is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb with limited range of motion.

The Nexa Orthopedics CMI implant and surgical instruments are provided in 3 sizes. The device is intended to be implanted into the metacarpal of the thumb. The device is made of pyrocarbon. No new materials are used in the development of this implant.

The provided text is a 510(k) summary for the Nexa carpometacarpal (CMI) implant. This document is a premarket notification to the FDA for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and device performance results.

Therefore, the information requested in your prompt (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) is not available within the provided text.

The document states:

• "Documentation is provided which demonstrated the device to be substantial equivalent to other legally marketed devices."
• "The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device."

This indicates that the FDA's decision was based on a comparison to an already approved device, likely through engineering bench tests and a review of the device's design and materials, rather than a clinical trial with specific performance metrics against pre-defined acceptance criteria.

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