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1. The TITAN Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
   Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid
   arthritis.Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted,
   separated from its blood supply or where the surgeon's experience indicates that alternative methods
   of treatment are unsatisfactory.Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not
   acceptable (e.g., revision of a failed primary component).Shoulder Hemiarthroplasty is also indicated for:
   Ununited humeral head fractures.Avascular necrosis of the humeral head.Rotator cuff arthropathy.Deformity and/or limited motion.The humeral component is intended for cemented or uncemented use. The glenoid component is intended for
   cemented use only.
2. The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe
   arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint
   must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is
   necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures including
   proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to
   gross rotator cuff deficiency. The glenoid baseplate is intended for cementless application with the addition of
   screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body
   component is intended for cementless use.
3. The Ascension HRA System is intended for resurfacing of the humeral head due to:
   Patients disabled by either non-inflammatory or inflammatory arthritis (i.e., rheumatoid arthritis,
   osteoarthritis and avascular necrosis)Mild or moderate humeral head deformity and/or limited motionPost-traumatic arthritisMalunions of the humeral headAcute fractures of the humeral headPatients with an intact or reparable rotator cuffContraindications:
   Infection, sepsis, and osteomyelitisOsteoporosisMetabolic disorders which may impair bone formationOsteomalaciaRapid joint destruction, marked bone loss or bone resorption apparent on roentgenogramRevision procedures where other devices or treatments have failed4. The Ascension Modular Radial Head is intended for:
   Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain,
   crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

• joint destruction or subluxation visible on x-ray
• resistance to conservative treatmentPrimary replacement after fracture of the radial headSymptomatic sequelae after radial head resectionRevision following failed radial head arthroplasty5. The Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty.
  Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone
  stock inadequate.

The purpose of this submission is the addition of MR Conditional information to the labeling of the predicate devices.
There are no other changes proposed in this submission. The following aspects of the devices are not impacted by
the additional labeling and remain identical to the predicate devices as cleared in their respective 510(k)s.
• Intended Use/Indications for Use
• Contraindications
• Design and Dimensions
• Performance Specifications
• Materials
• Biocompatibility

The provided document is a 510(k) summary for the Smith & Nephew TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), and Katalyst Bipolar Radial Head System (Katalyst).

However, the document does not contain information about an AI/ML-based medical device or any study demonstrating its performance against acceptance criteria. Instead, it focuses on the addition of MR Conditional information to the labeling of existing predicate devices. The "Non-Clinical Performance Data" section describes the testing performed to ensure MR compatibility, which is a different type of performance testing than what would be expected for an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML-based medical device from this document. The document describes a traditional medical device submission for orthopedic implants.

To answer your request, if this were a document about an AI/ML device, I would look for sections describing:

• Clinical Performance Study: Details about how the AI/ML model's output was evaluated, often involving a comparison to a ground truth or human expert readings.
• Performance Metrics: Specific metrics like sensitivity, specificity, AUC, F1-score, accuracy.
• Acceptance Criteria: Predetermined thresholds for these metrics that the device must meet to be considered effective.
• Test Set Description: Information on the size, source, and characteristics of the data used for testing.
• Ground Truth Establishment: How the definitive diagnosis or finding for the test data was determined (e.g., expert consensus, pathology, long-term follow-up).
• Reader Study Information: If applicable, details about human reader performance with and without AI assistance.

Since the provided document does not contain this type of information, I must state that it is not possible to fulfill the request based on the given input.

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Use of the Modular Radial Head Implant may be considered for :

• . Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
  • a. joint destruction and/or subluxation visible on x-ray; and/or
  • b. 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 EVOLVE® Modular Radial Head Implant System is being extended to include additional size stems and heads. The design features of these additional sizes are identical to the previously submitted and cleared stems and heads under 510(k); K991915- EVOLVE® Modular Radial Head.

This document describes a 510(k) submission for the EVOLVE® Modular Radial Head, specifically for an extension to include additional size stems and heads. The submission asserts substantial equivalence to a previously cleared device (K991915).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit acceptance criteria or a study that directly reports the performance of the EVOLVE® Modular Radial Head against such criteria. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared device.

The "acceptance criteria" in this context are implicitly met if the new sizes are shown to be substantially equivalent to the predicate device in terms of design features, intended use, operating principles, and materials, with adequate support from materials data and testing results.

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

The document does not specify a "test set" in the traditional sense of a clinical trial or performance study involving patients. The evaluation is based on engineering principles and comparison to a predicate device. Therefore, no information is available regarding:

• Sample size used for a test set.
• Data provenance (country of origin, retrospective/prospective).

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

This information is not applicable to this type of regulatory submission. There was no "ground truth" to establish through expert consensus as it's not a diagnostic or AI-based device requiring such validation. The regulatory review is performed by FDA personnel based on submitted technical documentation.

4. Adjudication Method for the Test Set

This is not applicable as there was no test set requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation, often with AI assistance, to assess the impact of AI on reader performance. The EVOLVE® Modular Radial Head is an implantable orthopedic device.

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

No, a standalone performance study was not done. This is also relevant for AI/diagnostic algorithms. The device itself is a physical implant; it does not have an "algorithm-only" performance to evaluate in this context.

7. The Type of Ground Truth Used

As this is a mechanical medical device and the submission focuses on substantial equivalence based on engineering and materials data, the concept of "ground truth" (expert consensus, pathology, outcomes data) as it applies to diagnostic or prognostic devices is not directly relevant or used in the provided summary. The "ground truth" for demonstrating safety and effectiveness for a mechanical device is typically established through:

• Design specifications and analysis: Ensuring the design meets engineering requirements.
• Material properties: Verifying materials meet established standards.
• Mechanical testing: Bench testing for strength, fatigue, wear, etc. (Though specific results are not detailed in this summary, they are mentioned as being provided).
• Clinical history of the predicate device: The safety and effectiveness of the predicate device (K991915) serves as the primary "ground truth" indirectly, as the new device is demonstrated to be identical or substantially equivalent.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device.

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

This is not applicable as there is no training set.

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The ExploR™ Modular Radial Head Replacement Device is intended for:

1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
   a) Joint destruction and/or subluxation visible on x-ray
   b) Resistance to conservative treatment
2. Primary replacement after fracture of the radial head
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty
   The device is intended for single use with or without bone cement.

The ExploR™ Modular Radial Head Replacement Device is a two-piece cobalt alloy prosthesis consisting of a stem and a head. The tapered stem is cemented into the intramedullary canal of the radius. The enlarged head has a highly polished concave surface to articulate with the natural bone of the humerus. The proximal portion of the sterns are roughened by a titanium Bond Coat coating. The components connect via a dove-tail joint secured by a locking screw. The device is available in four head diameters, 18mm, 20mm, 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.

This looks like a 510(k) premarket notification document for a medical device. Based on the provided text, the device is the ExploR™ Modular Radial Head Replacement Device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

1. Degenerative/post-traumatic disabilities (pain, crepitation, decreased motion, joint destruction/subluxation on X-ray, resistance to conservative treatment)
2. Primary replacement after radial head fracture
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty |
   | Safety and Effectiveness | Demonstrated through substantial equivalence to predicate devices (K040611, K984290, K002644, K991915) based on technological characteristics (materials, design, sizing, indications) and non-clinical testing. |
   | Biocompatibility | Implied to be acceptable as it uses materials similar to legally marketed predicate devices. |
   | Mechanical Integrity | Engineering analysis and mechanical testing were provided. |

Study Proving Device Meets Acceptance Criteria:

The document explicitly states: "Clinical Testing: None provided as a basis of substantial equivalence."

This indicates that clinical studies were not performed to demonstrate the device meets acceptance criteria in the traditional sense of a clinical trial proving safety and efficacy. Instead, the basis for market clearance (substantial equivalence) relies on non-clinical data and comparison to predicate devices.

Given the lack of clinical testing, the following information points related to clinical studies (test sets, ground truth, expert involvement, MRMC, standalone performance, training sets) are not applicable in this case.

Therefore, for the specific questions you asked about a study proving the device meets acceptance criteria:

1. A table of acceptance criteria and the reported device performance: (Provided above) The acceptance criteria are largely implied by the description and intended use of the device, and its similarity to predicate devices. The reported performance refers to its physical characteristics and functionality as designed.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was performed for substantial equivalence.

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 device is a physical 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 is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. No machine learning training set was used.

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

In summary:

This 510(k) submission successfully achieved market clearance based on non-clinical testing (engineering analysis and mechanical testing) and the demonstration of substantial equivalence to existing, legally marketed predicate devices. "Substantial equivalence" here means that the new device has the same intended use and technological characteristics as the predicate devices, or if there are differences, those differences do not raise new questions of safety or effectiveness. No clinical studies were required or provided.

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The Modular Radial Head Replacement Device is intended for:

1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, creptation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
   a) Joint destruction and/or subluxation visible on x-ray
   b) Resistance to conservative treatment
2. Primary replacement after fracture of the radial head
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty
   The device is intended for single use with bone cement.

The Modular Radial Head Replacement Device is a two-piece prosthesis consisting of a stem (Ti-6Al-4V) and a head (Co-Cr-Mo). The tapered stem is cemented into the intramedullary canal of the radius. The head has a highly polished concave surface to articulate with the natural bone of the humerus and ulna. The proximal portion of the stems are roughened with a Bond Coat surface. The components connect via a dove-tail joint secured by a locking screw. The device is available in three diameters, 18mm, 20mm and 22mm with head heights that vary from 8 to 20mm. Stems are available in six diameters with varying lengths.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) premarket notification for a medical device (Modular Radial Head Replacement Device).

Here's what the document indicates:

• Non-Clinical Testing and Clinical Testing: The document explicitly states "none provided as a basis of substantial equivalence." This means no new testing was submitted to demonstrate the device's performance against specific acceptance criteria.
• Substantial Equivalence: The FDA's letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This regulatory pathway relies on demonstrating that the new device is as safe and effective as a legally marketed device that is already on the market, rather than requiring new performance studies against predefined acceptance criteria.

Therefore, since no study was conducted or reported in this document to demonstrate performance against acceptance criteria, most of the requested information cannot be extracted.

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The Ascension® Modular Radial Head is intended for:

• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral 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 Ascension® Modular Radial Head is an anatomically designed, single-use, modular prosthesis designed for replacement of the proximal end of the radius. It is made from ASTM F1537 cobalt chromium alloy. Head components available in six sizes and stem components available in four sizes are interchangeable and achieve assembly by means of a taper connection.

The provided text describes a 510(k) premarket notification for the Ascension® Modular Radial Head, a radial head prosthesis. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the following information is not applicable or extractable from the provided document:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Explanation:

The 510(k) pathway, as indicated by the document (K032686), is for demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparisons of:

• Intended Use: The Ascension® Modular Radial Head has an intended use as described in the document, which is compared to the predicate devices.
• Technological Characteristics: The device description details its materials (ASTM F1537 cobalt chromium alloy), design (anatomically designed, single-use, modular prosthesis, six head sizes, four stem sizes, taper connection), which are compared to the predicate devices (Avanta Orthopaedics, Inc., Radial Head Implant (K982288) and Wright Medical Technology, Inc., Modular Radial Head (K991915)).
• Performance Data: The document explicitly states "A comparison of materials and design features, as well as performance tests and analyses, demonstrate that the Ascension® Modular Radial Head is substantially equivalent to the predicate devices." However, it does not provide the details of these performance tests (e.g., acceptance criteria, test results, methodology, sample sizes, or ground truth establishment). The specific details of these "performance tests and analyses" are typically found in other sections of the 510(k) submission, such as the biocompatibility, mechanical testing, or sterility data, but are not present in this summary.

This kind of submission typically focuses on engineering and material performance tests (e.g., fatigue strength, wear, construct stability) relevant to an orthopedic implant, rather than clinical study-based performance metrics with expert ground truth or AI algorithms.

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Use of the Modular Radial Head Implants may be considered for :

• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
  • joint destruction and/or subluxation visible on x-ray; and/or
  • 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 Modular Radial Head is manufactured from Cobalt Chrome (ASTM F 1537) . The stem is designed to be a two-piece modular design that is assembled at the time of implantation. The proximal portion of the head is concave and has rounded contours. The head and stem are available in standard sizes and +2 and +4 configurations.

The information provided describes a medical device submission (K991915) for a "Modular Radial Head" prosthesis. However, the provided text does not contain specific acceptance criteria, details of a clinical study, or performance metrics beyond a statement about mechanical test data.

Therefore, I cannot fulfill most of your request based on the given input. The document focuses on the regulatory submission process, intended use, and the FDA's determination of substantial equivalence.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not provided. The document states, "Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents," but it does not specify what those requirements (acceptance criteria) were or what the specific test results were.
• Reported Device Performance: Not provided. Only a general statement about meeting requirements is present.

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 (Test Set): Not provided. The document refers to "mechanical test data" but gives no details about the size or nature of any test set (e.g., number of implant samples, number of patients).
• Data Provenance: Not provided. There is no mention of country of origin or whether any data was retrospective or prospective. Given it's "mechanical test data," it's likely bench testing, not patient data in the typical sense.

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

• Not applicable / Not provided. The "ground truth" concept usually applies to studies involving human interpretation or clinical outcomes. This document only mentions "mechanical test data," which typically relies on established engineering standards and measurements, not expert consensus on interpretations.

4. Adjudication method for the test set:

• Not applicable / Not provided. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert opinions, which is not relevant to mechanical testing.

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

• No. This is a medical device for orthopedic joint replacement, not an AI-assisted diagnostic tool. An MRMC study is not relevant here.

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

• No. This is not an AI algorithm.

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

• Not provided (but implied by "mechanical test data"): For mechanical testing of an implant, the "ground truth" would typically be defined by engineering specifications, material properties, and performance benchmarks (e.g., load-bearing capacity, fatigue life) measured objectively. The document does not specify these.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.

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

• Not applicable / Not provided. This is not an AI/machine learning device.

In summary, the provided text is a regulatory clearance letter and a summary of the device's intended use and design. It confirms that "Mechanical test data demonstrated that it meets the requirements cited in the FDA Guidance Documents" but does not detail the specific criteria, the study methodology, or the results of those mechanical tests.

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