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TEMA Elbow system is intended for use in cemented applications for patients suffering from disability due to:

1. Elbow joint destruction which significantly compromises the activities of daily living
2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain
4. Revision where other devices or treatments have failed.
5. Correction of severe functional deformity.
6. Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
7. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion

The unlinked, semi-constrained version is for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.

TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies.

The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly.

The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.

TEMA Elbow system - Line extension introduces two new sizes of Ulnar stems to the ulnar stem range already cleared; moreover, a design change is introduced for the axle component, ulnar body component and for the humeral body compared to the original cleared version.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the TEMA Elbow system - Line extension.

It's important to note that the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on proving that a new medical device meets specific acceptance criteria in a clinical study. The document primarily discusses non-clinical (bench) testing. Therefore, several requested categories (like ground truth, expert qualifications, adjudication, MRMC studies, training set size) are not applicable or cannot be extracted from this type of FDA submission.

Acceptance Criteria and Device Performance

The core of this submission is to demonstrate that the "TEMA Elbow system - Line extension" is substantially equivalent to the previously cleared "TEMA Elbow system (K181362)". The acceptance criteria, in this context, are not explicit pass/fail thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) but rather the demonstration that the new device's performance, particularly mechanical, is comparable or superior to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document uses terms like "demonstrated" and "substantially equivalent" rather than specific numerical performance metrics typical for software or diagnostic devices.

Study Details (Based on available information)

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

• Sample Size (Test Set): Not applicable in the context of a clinical test set from this document. The "test set" here refers to the physical samples used in bench tests. The document does not specify the number of physical components or prototypes tested for "Range of Motion," "Stability," "Fatigue," "Fretting-Corrosion," or "Wear Evaluation."
• Data Provenance: Not applicable. The document describes non-clinical (bench) testing, not human or animal data. The manufacturing company is LimaCorporate S.p.A. based in Italy.

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

• Not applicable. This was a non-clinical (bench) study. Ground truth in this context would likely be engineering specifications or established test standards, not expert clinical consensus.

4. Adjudication method for the test set

• Not applicable. As a non-clinical (bench) study, there is no mention or need for a clinical adjudication method.

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 physical elbow prosthesis, not an AI-powered diagnostic or assistive tool.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant.

7. The type of ground truth used

• For the non-clinical (bench) tests, the "ground truth" would be established engineering standards, material properties, and performance benchmarks for orthopedic implants, typically defined in ASTM or ISO standards. The document doesn't specify these exact standards but refers to "mechanical evaluations (both bench tests and rationales)."

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

• Not applicable. No training set.

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The LATITUDE EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The LATITUDE EV™ Total Elbow Arthroplasty system is intended for cemented use only.

The LATITUDE EVI™ Total Elbow Arthroplasty system is a total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The LATITUDE EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the prosthesis is a semiconstrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.

The provided text is a summary of an FDA 510(k) premarket notification for a medical device called the LATITUDE EV™ Total Elbow Arthroplasty system. This document focuses on the regulatory approval and comparison to predicate devices, and therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning AI/algorithm performance.

The document explicitly states: "No clinical studies were performed." This indicates there was no study conducted to assess the performance of the device in a clinical setting in the context of this 510(k) submission. Furthermore, there is no mention of any AI or algorithmic component to the device.

Therefore, I cannot provide the requested information.

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TEMA Elbow System is intended for use in cemented applications for patients suffering from disability due to:

• 1. Elbow joint destruction which significantly compromises the activities of daily living
• 2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
• 3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain
• 4. Revision where other devices or treatments have failed.
• 5. Correction of severe functional deformity.
• 6. Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
• 7. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion

The unlinked, semi-constrained version is intended for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of dislocation or disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.

TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies.

The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly.

The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.

All of the system components are available in different sizes.

The modularity of the polyethylene ulnar component also allows replacement of the ulnar bearing, if needed, without removal of the humeral and ulnar assemblies. The modularity also provides an additional advantage that if replacement of the humeral and/or ulnar body is needed (e.g. due to damage from a traumatic event or due to excessive wear of the bushing of the humeral body) and the stem components are well fixed. the stems do not need to be removed and only disconnection of the humeral and ulnar bodies from the stems is required for their revision.

The provided text is a 510(k) Summary for the TEMA Elbow System. It describes the device, its indications for use, and compares it to predicate devices. However, this document does not contain information about the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

The TEMA Elbow System is a mechanical prosthetic device, and the evaluation for its substantial equivalence relies on non-clinical mechanical testing and a comparison of its design and materials to existing predicate devices.

Therefore, I cannot provide the requested information for an AI/ML device, as the document pertains to a traditional medical implant.

Specifically, the document does NOT contain information on:

• A table of acceptance criteria and reported device performance (for an AI/ML device).
• Sample sizes for a test set or data provenance (relevant to AI/ML studies).
• Number of experts or their qualifications for ground truth establishment (relevant to AI/ML studies).
• Adjudication methods (relevant to AI/ML studies).
• MRMC comparative effectiveness studies including effect sizes for human readers (relevant to AI/ML studies).
• Standalone algorithm performance (relevant to AI/ML studies).
• Type of ground truth used (relevant to AI/ML studies).
• Sample size for the training set (relevant to AI/ML studies).
• How ground truth for the training set was established (relevant to AI/ML studies).

The "Non-Clinical Testing" section mentions mechanical testing for the device's ability to perform in a substantially equivalent manner, but these are engineering tests for a physical implant, not a study of an AI/ML algorithm's diagnostic or prognostic performance. The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of TEMA Elbow System to the predicate devices."

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The Latitude EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Latitude EV™ Total Elbow Arthroplasty system is intended for cemented use only.

The Latitude EV™ Total Elbow Arthroplasty system is a total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The Latitude EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the prosthesis is a semi-constrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.

This document is a 510(k) premarket notification for a medical device (LATITUDE EV Total Elbow Arthroplasty). It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance testing. Crucially, it explicitly states: "No clinical studies were performed."

Therefore, based on the provided text, there is no information to answer the questions regarding acceptance criteria and a study proving the device meets those criteria, as no clinical studies were conducted.

The device clearance relies on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical bench testing and process validations, not on meeting specific performance acceptance criteria derived from a clinical trial.

To reiterate the reason for not being able to provide the requested information:

• No clinical studies were performed. This means there was no study designed to prove the device meets acceptance criteria in a clinical setting.
• The acceptance criteria for this 510(k) submission were likely focused on demonstrating mechanical performance, material properties, and biological safety through bench testing, which is different from clinical performance metrics.

Therefore, I cannot populate the table or answer the specific questions about clinical study design, sample sizes, expert involvement, ground truth, or MRMC studies because such studies were not conducted for this FDA clearance.

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The Lattude EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Latitude EVIM Total Elbow Arthroplasty system is intended for cemented use only.

The Latitude EV™ Total Elbow Arthroplasty system is a 2- or 3-part total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The Latitude EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the elbow. The prosthesis is a semi-constrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.

The Latitude EV™ humeral and ulnar stems are available in multiple sizes for primary and revision surgery and include a plasma spray coating. The optional radial implant is uncoated and is available in several sizes corresponding to the humeral and ulnar construct size selected.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Latitude EV™ Total Elbow Arthroplasty device:

Based on the provided 510(k) summary, this device is a medical implant, not an AI/software device, which explains why many of the requested AI-specific points (like MRMC studies, standalone performance, training data, etc.) are not applicable.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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Indications for use when used with a hemi-elbow implant:

The SBi rHead Radial Head is indicated for use in 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 .

Indications for use when used with a uni-elbow implant:

The SBi Radial-Capitellar Implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis
• . Inflammatory degenerative joint disease including rheumatoid arthritis
• Correction of functional deformity .
• Revision procedures where other treatments and devices have failed and .
• . Treatment of fractures that are unmanageable using other technologies

The SBirHead, tHead Lateral, and rHead Recon prostheses are implants that are intended to replace the proximal end of the radius. The implants consist of two (2) parts, the head and a stem, which fit together. The rHead™ Standard is designed with a Morse taper coupling mechanism to firmly attach the head onto the stem. The rHead™ RECON is designed with a "ball/socket" (bipolar) coupling mechanism between the head and stem which adds an element of alignment flexibility. The rHead™ Lateral is designed using a dovetail coupling mechanism.

The stem is made from a Cobalt Chrome alloy (CoCrMo) with or without a powder titanium (Ti) coating. The radial stem geometry is designed to anatomically fit within the intramedullary canal. The intramedullary surfaces of the stem are roughened to assist in optimal fixation. A version of the stem may be plasma sprayed with a powder titanium coating to further assist in optimal fixation. The extended stem provides additional fixations where excess bone loss due to trauma has occurred. Stems are for cemented or uncemented use when used with the rHead heads.

Each component is supplied in various sizes to support the differences in human anatomies. Each implant can be used in either the right or left arm and the heads and stems are modular.

rHead Radial Head Extended Stems are made from a Cobalt Chrome alloy (CoCrMo) with or without a powder titanium (Ti) coating. rHead Radial Head Extended Stems are configured to fit the rHead, rHead Recon, and rHead Lateral heads as well as rHead, rHead Recon, and rHead Lateral heads that fit the Radial Capitellum radial head implants.

The rHead, rHead Lateral, and rHead Recon prostheses are used with trials and surgical instruments including a sterilization tray.

The implants are intended for single use only.

The provided text is a 510(k) Premarket Notification Summary for the SBi rHead™ Radial Head Extended Stems. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description, intended use, and materials.

However, this document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table and study details. The document states that "Documentation is provided which demonstrated the SBi rHead™ Radial Head Extended Stems to be substantially equivalent to other legally marketed SBi devices," but it does not elaborate on what that documentation entails in terms of performance studies.

Based on the provided text, the answer to your request is that the document does not contain the information needed to describe acceptance criteria and associated performance study details.

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The Tornier Inc. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthitis and rheumatoid arthritis; correction of functional, deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Tornier Inc. Latitude Elbow Prosthesis is intended for cemented use only.

Total Elbow replacement is used to treat a number of clinical conditions such as severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. They are also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of surgery is to restore the elbow joint to its best working condition and to reduce or eliminate pain. The Tornier Inc. Latitude Elbow Prosthesis is intended to accomplish these goals. The Tornier Inc. Latitude Elbow Prosthesis is intended for use as a cemented total elbow.

The Tornier Inc. Latitude Elbow Prosthesis is a 3-part system consisting of a humeral, an ulnar and a radial component.The humeral implant is modular and consists in the assembly of various sizes of humeral stem and humeral spool in order to better reproduce the functionality of the natural humerus. The prosthesis is a non constrained prosthesis and when it is used with the ulnar cap the prosthesis becomes a constrained prosthesis.

The present device submission corresponds to several changes made to the device cleared in the latest 510k K070787.

This document is a 510(k) premarket notification for the Tornier Inc. Latitude Elbow Prosthesis. It describes modifications to an existing device and demonstrates substantial equivalence to predicate devices through various evaluations.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study details:

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

The provided text does not contain a table of acceptance criteria nor reported device performance in the manner typically associated with clinical performance studies or specific quantitative metrics for AI/ML devices.

Instead, the submission focuses on demonstrating substantial equivalence through various engineering and design-related evaluations rather than clinical performance metrics:

Crucially, this document is for a medical implant (prosthesis), not an AI/ML diagnostic or predictive device. Therefore, the concepts of sensitivity, specificity, accuracy, and reader performance you've asked about (typical for AI/ML) are not applicable here. The "acceptance criteria" here are related to engineering validation, material properties, and comparison to a predicate device, focusing on safety and efficacy in a mechanical context.

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

• Test Set Sample Size: Not explicitly stated for specific tests.
  • "Cadaver evaluations" were performed, but the number of cadavers is not mentioned.
  • "Mechanical bench testing" was performed, but the number of test samples is not specified.
• Data Provenance: Not specified, as this is primarily internal testing and evaluation data, not clinical patient data in the sense of AI/ML studies.

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

This section is not applicable to this type of device submission. Ground truth, in the context of this device, refers to engineering specifications, material properties, and functional performance benchmarks rather than expert consensus on medical images or diagnoses.

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

This section is not applicable as there is no "adjudication" in the sense of reviewing disagreements among experts on a test set for this mechanical 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

This section is not applicable as this is a medical implant, not an AI-assisted diagnostic tool.

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

This section is not applicable as this is a physical medical device, not an algorithm.

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

The "ground truth" for this device's evaluation would be based on:
* Engineering specifications and design requirements: For CAD evaluations.
* Biomechanical principles and established testing standards: For mechanical bench testing and cadaver evaluations. This would include metrics like range of motion, stability, load-bearing capacity, wear resistance, etc., compared against natural joint mechanics or predicate device performance.
* Industry standards for sterilization and packaging.

8. The sample size for the training set

This section is not applicable as this is a physical medical implant, not an AI/ML device requiring a training set.

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

This section is not applicable as this is a physical medical implant, not an AI/ML device.

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The Tornier Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthtitis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Tornier Elbow Prosthesis is intended for cemented use only.

Total Elbow replacement is used to treat a number of clinical conditions such as severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. It is also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of such surgery is to restore the cloow joint to its best working condition and to reduce or eliminate pain. The Latitude Tornier Elbow Prosthesis is intended to accomplish these goals. The Tornier Elbow prosthesis is intended for use as a cemented total elbow.

The Latitude Tornier Elbow Prosthesis is a 3-part system consisting of a humeral, an ulnar and a radial component. The humeral implant is modular and consists in the assembly of various sizes of humeral stem and humeral spool in order to better reproduce the functionality of the natural humerus.

The prosthesis is a non-constrained prosthesis and when it is used with the ulnar cap the prosthesis becomes a semi-constrained prosthesis.

The present device submission corresponds to a modification in the assembly of the humeral stem with the humeral spool. Included in the modification the material of the ring stop has changed from UHMWPE to PEEK-OPTIMA. The radial components and the ulnar components are not modified. The technological characteristics (design, materials, manufacturing, sterilization, sizing and indications) of the modified humeral spool and humeral screw components are similar or identical to the predicate devices.

The provided text is a summary of safety and effectiveness information for a medical device (Latitude Tornier Elbow Prosthesis) and correspondence from the FDA regarding its 510(k) submission. It does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications for a clinical validation study.

The document primarily focuses on:

• Device classification and regulatory information.
• Device description, materials, and intended use.
• The FDA's determination of substantial equivalence to predicate devices, allowing the device to be marketed.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document is a regulatory approval notice, not a clinical study report.

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The SBI Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The SBI Lateral Assembly Radio-Capitellar implant is intended for cemented use only.

The SBI Lateral Radio Capitellar Implant provides an alternative to hemi-arthroplasty of the proximal radial head. The implant is used for the treatment of degenerative joint disorders of the radio-capitellar joint allowing activities of daily living to be performed with no or significantly reduced pain. The radio-capitellar implant is designed to be used with the radial stem components of the rHead and rHead Recon stem implants cleared for market under 510(k) K011819 and K023604 respectively.

This document is a 510(k) summary for the SBI Lateral Radio Capitellum, an elbow joint prosthesis. It outlines the device's description, intended use, materials, and its substantial equivalence to previously marketed devices. However, it does not contain the information required to answer the questions about acceptance criteria and study details.

The provided text does not include any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC or standalone). This document is a regulatory submission for premarket notification (510(k)), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested table and study details based solely on the input given.

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The RHS is intended for:

1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepation 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 long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.

The RHS has been designed in order to provide surgeons and patients with a joint prosthesis to restore function and relieve pain of the radial part of the elbow joint. The RHS has an anatomical design, which reproduces the kinematics of the radial joint. The RHS consists of two components: a metal radial stern and a metal-polyethylene radial head.

This is a radial head prosthesis submission, not an AI/ML device, therefore, the requested information about acceptance criteria, study details, and AI/ML specific metrics (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable.

The provided document is a 510(k) Premarket Notification for the "RHS" radial head prosthesis. The purpose of this type of submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not to prove performance against specific acceptance criteria in the manner of an AI/ML diagnostic device study.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

However, based on the general information provided for medical devices, I can extract information relevant to "claims" and "indications for use" as they relate to what a device is designed to do, which can be seen as a form of "acceptance criteria" in a broader sense for a non-AI/ML device.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from Indications for Use and Device Description)

Since this is a prosthesis and not a diagnostic device, "performance" is largely demonstrated through substantial equivalence to predicate devices and the physical properties of the materials, rather than metrics like sensitivity or specificity. "Acceptance criteria" in this context refer to the conditions under which the device is intended to be used and the clinical problems it aims to address.

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

• Not Applicable. This is a 510(k) for a physical implant, not an AI/ML diagnostic device requiring a "test set" in the computational sense. Substantial equivalence is typically demonstrated through comparison of design, materials, manufacturing processes, intended use, and sometimes non-clinical testing (e.g., mechanical testing, biocompatibility) to predicate devices, rather than a clinical study with a "test set" of patient data for performance evaluation against specific metrics.

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. See point 2.

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

• Not Applicable. See point 2.

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 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 directly for performance evaluation in the AI/ML sense. For a prosthesis, "ground truth" might pertain to established biomechanical principles, material standards (e.g., ASTM, ISO), and historical clinical outcomes of predicate devices that establish the safety and effectiveness of the type of device. Formal "ground truth" to evaluate diagnostic accuracy is not relevant here.

8. The sample size for the training set:

• Not Applicable. See point 2.

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

• Not Applicable. See point 2.

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