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The Avanta carpal fusion plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, lunate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.

The Avanta carpal fusion plate is a low profile single piece construct designed to fit over the dorsal aspect of the carpal bones in the hand. The plate has spherical holes or slots that accommodate screws for fixation. The plate and screws are fabricated from implantable grade stainless steel.

The provided document describes a 510(k) premarket notification for a medical device: the Avanta Carpal Fusion Plating System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance through clinical studies with acceptance criteria in the same way a Premarket Approval (PMA) application would.

Therefore, the requested information regarding acceptance criteria, study sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for training and testing is not available in this document.

Here's why and what can be extracted:

• 510(k) Mechanism: A 510(k) submission establishes substantial equivalence to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and technological characteristics. Clinical performance data (like sensitivity, specificity, accuracy) based on specific acceptance criteria is generally not required unless special controls apply or substantial equivalence cannot be established through non-clinical means.
• Device Type: The Avanta Carpal Fusion Plating System is a metallic bone fixation appliance. Its safety and effectiveness are primarily demonstrated through material testing, mechanical testing, and comparison of design features to existing, cleared devices. It's not an AI/software device that would have performance metrics like those typically requested (e.g., sensitivity, specificity, AUROC).

Information Available from the Document:

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

   • Not applicable. The document does not define specific performance acceptance criteria (e.g., for accuracy, sensitivity, etc.) because it is a 510(k) for a physical implant, not a diagnostic or AI device. The "performance" is implicitly deemed acceptable if it's substantially equivalent to the predicate devices.

   Item	Avanta	KMI	Acumed
   Product

Name | Carpal Fusion Plate | KMI Wrist
Fusion System | Acumed Wrist
Fusion Plate |
| Use | Single use | Single use | Single use |
| Fixation | Bone screw | Bone screw | Bone screw |
| Material | Stainless steel | Stainless steel | Titanium |
| Indications
for use | Intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. | Same indications | Same indications |
* Reported Device Performance (Implicit): "The Avanta device and the predicate devices studied have similar design characteristics and intended use. The safety and effectiveness of the Avanta Carpal Fusion Plate is substantially equivalent to the predicate devices mentioned above."

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

   • Not applicable. This document pertains to a physical implant and its substantial equivalence. There is no "test set" of data or patient cases in the context of diagnostic accuracy. Clinical studies involving patient data with specific sample sizes for performance evaluation are not described.

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

   • Not applicable. No such information is present as this is not a diagnostic device requiring expert interpretation for ground truth.

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

   • Not applicable. Not a diagnostic device.

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-assisted diagnostic or imaging device.

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

   • Not applicable. This is not an algorithm-based device.

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

   • Not applicable. No ground truth in the context of diagnostic accuracy is relevant here. The "truth" for this device relates to its mechanical integrity, biocompatibility, and functional equivalence to similar implants already on the market.

8. The sample size for the training set:

   • Not applicable. No "training set" in the context of machine learning or diagnostic algorithm development is used for this type of device.

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

   • Not applicable. No training set ground truth to establish.

In summary, the provided K030881 document is a 510(k) premarket notification for a physical medical implant (carpal fusion plate). Its clearance is based on substantial equivalence to predicate devices, not on clinical performance studies that would generate the kind of data on acceptance criteria, reader studies, or algorithmic performance as typically seen for diagnostic devices or AI/ML-based products.

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Avanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.

The wrist implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the wrist.

Here's an analysis of the provided text regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria or quantifiable performance metrics for the Avanta Orthopaedics Wrist implant. Instead, the "study" demonstrating the device meets "acceptance criteria" is a comparison to a predicate device and a general statement about fatigue and wear testing.

Therefore, the table would look like this:

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

The document does not specify a sample size for a "test set" or provide details about data provenance (e.g., country of origin, retrospective/prospective). The "study" mentioned is not a clinical trial with human subjects or a defined test set in the traditional sense of evaluating a diagnostic algorithm. It refers to non-clinical fatigue and wear testing.

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

This information is not applicable as the document describes a medical device (wrist implant) for surgical replacement, not a diagnostic device or algorithm that requires a "ground truth" established by experts in a test set. The validation is based on engineering principles (fatigue, wear) and comparison to an existing predicate device.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. There is no mention of a test set requiring expert adjudication.

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

An MRMC study was not performed, or at least not mentioned. This type of study is typically used for diagnostic imaging devices or algorithms where human readers' performance is evaluated with and without AI assistance. The Avanta Orthopaedics Wrist implant is a physical implant.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not performed, or not applicable. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's functionality is established by engineering tests (fatigue and wear) and comparison to the established performance and safety of the predicate device. There is no mention of pathology, outcomes data, or expert consensus in relation to a "ground truth" for a diagnostic evaluation.

8. Sample Size for the Training Set

There is no mention of a training set. This concept applies to machine learning algorithms. The development of the wrist implant would involve engineering design and material science, not machine learning model training.

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

This information is not applicable as there is no mention of a training set.

Summary of the Study:

The "study" referenced in the document is a regulatory submission process to demonstrate substantial equivalence to an already legally marketed predicate device (Universal Total Wrist System, KMI, K961051). The core of this demonstration relies on:

• Design Characteristics Comparison: Highlighting similarities in product name, use (single use), fixation method (stem in intramedullary canal, screw fixation distally), constraint (semi-constrained), material (Co-Cr/UHMWPE/CPTi), and sizes.
• Indications for Use Comparison: Showing that the Avanta implant has the same indications as the predicate: replacement of the painful wrist joint due to rheumatoid arthritis, osteoarthritis, or post-traumatic arthritis.
• Non-Clinical Testing: A general statement about "Fatigue and wear testing have been performed on this devices to demonstrate substantial equivalence."

Essentially, the "acceptance criteria" appear to be met by demonstrating that the new device is functionally, materially, and geometrically similar to a device already deemed safe and effective, and that it has undergone basic engineering tests (fatigue and wear) to support its durability. The document does not describe a typical clinical trial or a study evaluating diagnostic performance.

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Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:

• Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
  • joint destruction or subluxation visible on x-ray .
  • resistance to conservative treatment .
• Primary replacement after fracture of the radial head .
  • Symptomatic sequelae after radial head resection .

The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

The provided text is a 510(k) Summary for a Radial Head Implant (K023604). This document focuses on demonstrating substantial equivalence to a predicate device through comparison of design characteristics, intended use, and materials, rather than establishing acceptance criteria or reporting performance metrics from a clinical study as would be typical for artificial intelligence/machine learning (AI/ML) devices.

Therefore, the requested information, which is highly relevant to AI/ML device performance and testing, cannot be extracted from this document. This document describes a traditional medical device (implant) and its clearance process, which relies on a comparison to an already-marketed device and mechanical testing, not a study evaluating algorithm performance.

Specifically:

• No acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) are present because this is a physical implant, not an AI/ML diagnostic tool. The "performance" discussed is in terms of material properties and mechanical strength, which are assessed through bench testing.
• No sample size for test set or data provenance is mentioned, as there is no "test set" of clinical cases for an algorithm.
• No number or qualifications of experts for ground truth, adjudication method, MRMC study, or standalone performance study is mentioned. These are all concepts related to evaluating diagnostic algorithms.
• No type of ground truth, training set size, or method for establishing training set ground truth is mentioned. Again, these are AI/ML specific details not applicable to this device submission.

The document indicates "Mechanical testing has been performed to demonstrate substantial equivalence." (p.2/2), implying the device's physical properties are comparable to the predicate. However, it does not detail the nature of this testing, specific metrics, or any defined acceptance criteria for these mechanical tests.

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Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.

The finger joint prosthesis like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the MCP joint of the hand.

The provided text describes a 510(k) premarket notification for the Avanta Orthopaedics Finger Joint Prosthesis, which aims to demonstrate substantial equivalence to a predicate device, the Sutter Finger Joint Prosthesis. The information is primarily focused on comparing the new device to the predicate device in terms of design characteristics, materials, and indications for use.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed through a comparison of key characteristics and a specific test.

Study Details

The provided text describes the basis for a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive de novo clinical study with detailed performance metrics against quantitative acceptance criteria.

1. 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 "Flexion testing was performed on the Avanta Product" but provides no details on the number of samples tested or the methodology.
   • Data Provenance: Not specified. It cannot be determined if the data is retrospective or prospective, or the country of origin.

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

   • Not applicable/Not specified. The study described is a bench test ("Flexion testing") for demonstrating mechanical equivalence, not a clinical trial requiring expert ground truth for diagnostic accuracy.

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

   • Not applicable. This is not a study involving human interpretation or clinical outcomes requiring adjudication.

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 is not a study involving AI assistance or human readers.

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

   • No. This is not an algorithm or AI device. The "Flexion testing" could be considered a form of standalone mechanical performance assessment, but not in the context of an algorithm.

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

   • Not explicitly stated in terms of "ground truth" for a diagnostic or clinical outcome. The "ground truth" for the flexion testing would likely be the objective measurements of the device's mechanical properties and its comparison to the predicate device's known mechanical properties or performance standards.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that would have a training set.

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

   • Not applicable. See above.

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Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:

• Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
  • joint destruction or subluxation visible on x-ray
  • resistance to conservative treatment
• Primary replacement after fracture of the radial head
  • Symptomatic sequelae after radial head resection
• Revision following failed radial head arthroplasty

The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

This submission describes a medical device, the Avanta Orthopaedics Radial Head Implant, and seeks to establish its substantial equivalence to a legally marketed predicate device, the Wright Medical Swanson Titanium Radial Head Implant. It is not a study proving device meets acceptance criteria in the traditional sense of a clinical trial or performance study against pre-defined statistical endpoints for a novel device. Instead, the submission argues for substantial equivalence based on similarities in design, materials, and intended use to a device already on the market.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable or explicitly stated in this type of 510(k) submission. However, I will extract and infer information where possible based on the provided text.

Here’s the information based on the provided 510(k) summary:

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

   Since this is a substantial equivalence submission, the "acceptance criteria" are not performance metrics in the typical sense (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance criteria are satisfied by demonstrating the new device is sufficiently similar to the predicate device in terms of design, materials, and intended use, such that it raises no new questions of safety or effectiveness. The reported "performance" is the comparison against the predicate.

   Item	Acceptance Criteria (Similarity to Predicate)	Reported Device Performance (Avanta Product)
   Product Name	Similar type of implant functionality	Radial Head Implant
   Use	Single use	Single use
   Fixation	Stem in intramedullary canal	Stem in intramedullary canal
   Constraint	Non-constrained	Non-constrained
   Material	Industry standard materials	Co-Cr/CpTi (predicate is Titanium)
   Sizes	Comparably sized	3 sizes (1, 2, 3) (predicate has 5 sizes)
   Indications for Use	Same indications for use	Same as predicate

   Conclusion of Performance: The submission states, "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 the device met the acceptance criteria for substantial equivalence.

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

   Not applicable. This is a submission for substantial equivalence based on design and material comparison to a predicate device, not a performance study involving a test set of patient data. There is no mention of a test set, patient data, or data provenance.

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

   Not applicable. No test set or ground truth in this context. The "ground truth" for the substantial equivalence claim relies on the established safety and effectiveness of the existing predicate device and comparison by regulatory bodies.

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

   Not applicable. No test set. The "adjudication" for substantial equivalence is carried out by the FDA during its review process.

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/imaging device, nor is it a comparative effectiveness study involving human readers.

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

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

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

   Not applicable to a conventional performance study. For substantial equivalence, the "ground truth" is effectively the regulatory approval and established safety and efficacy profile of the predicate device (Swanson Titanium Radial Head Implant), which has been marketed since 1994. The Avanta device is deemed safe and effective because it is substantially equivalent to the predicate.

8. The sample size for the training set

   Not applicable. There is no training set mentioned, as this is not a machine learning or diagnostic device performance study.

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

   Not applicable. No training set.

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The intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include:

• Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone,
• Failed fracture fixation with or without bone graft, ●
• Osteotomy and repair of distal radius malunion with or without bone graft. .

The distal radius plate like the predicate device includes various size plates, right, left, small, large, accessories and instruments. The bone screws enable the plate to be coupled to bone by securing the screws for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.

The provided text is a 510(k) summary for a medical device (Distal Radius Fracture Fixation Plate System) and does not describe primary studies with acceptance criteria or performance metrics for a novel diagnostic or AI-driven device. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design and intended use.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types and establishment methods) cannot be extracted from this document as it pertains to a different type of regulatory submission and device evaluation.

However, I can provide the following based on the available information:

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

This document does not present acceptance criteria or reported device performance in the manner requested for a diagnostic or AI device. The "performance" being assessed here is the substantial equivalence of the new device's design, materials, and intended use to existing predicate devices.

Study Proving Device Meets Acceptance Criteria:
The study is a comparison of the new device to predicate devices based on design characteristics and intended use to demonstrate "substantial equivalence" as required for a 510(k) application. The document explicitly states: "The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device."

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

Not applicable. This is a comparison of device specifications, not a clinical trial or performance study involving a test set of data.

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

Not applicable. Ground truth as typically understood for diagnostic/AI devices is not relevant to this type of device comparison. The "truth" being established is the similarity in design and function to legally marketed predicate devices, which is assessed by the FDA based on the provided technical documentation.

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

Not applicable. There is no test set or adjudication process in the context of a performance study described here.

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-assisted diagnostic device, and therefore no MRMC study addressing human reader improvement with AI would have been conducted or reported here.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable in the sense of clinical ground truth for diagnostic accuracy. The "ground truth" for this 510(k) submission is the established design, material, and intended use of the predicate devices, against which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set for an AI algorithm described.

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

Not applicable. There is no training set for an AI algorithm described.

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