Search Results
Found 30 results
510(k) Data Aggregation
(126 days)
Indiana 46804
Re: K233592
Trade/Device Name: BioPoly Radial Head Implant Regulation Number: 21 CFR 888.3170
Classification Name | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Regulation Number | 888.3170
The BioPoly Radial Head Implant is indicated 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:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o 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 BioPoly Radial Head Implant is a hemiarthroplasty device designed to restore the articular surface and spacing of the proximal head of the radius in patients following fracture resection and/or degenerative disability The implant is supplied with head diameters of 20mm, 23mm, and 26mm; and stem diameters of 6mm, 7mm, 8mm, +3mm, and +6mm height offsets for the radius in patients following fracture, resection, and/or degenerative disability.
This document is a 510(k) Premarket Notification from the FDA regarding the BioPoly Radial Head Implant. It certifies the device's substantial equivalence to previously marketed predicate devices. The document outlines the device's intended use and provides a summary of non-clinical tests conducted.
However, the provided text does not contain any information about a study proving the device meets acceptance criteria through human-in-the-loop performance, nor does it refer to an AI/ML powered device. The acceptance criteria discussed are for non-clinical, mechanical, and material properties of the implant itself, not related to an AI's performance or a clinical study that would involve the elements requested in the prompt (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance of an algorithm).
Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related clinical study design (sample size, expert adjudication, MRMC, etc.). The document focuses on the mechanical and material aspects of a physical implant and its substantial equivalence to predicate devices, which is a different regulatory pathway than for AI/ML-powered medical devices.
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(155 days)
, Florida 33156
Re: K231188
Trade/Device Name: ALIGN Radial Head System Regulation Number: 21 CFR 888.3170
Classification Name: Elbow joint radial (hemi-elbow) polymer prosthesis Classification Number: 21 CFR §888.3170
The Align Radial Head System and accessories are designed specifically 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:
- o Joint destruction and/or subluxation.
- o 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 system is intended for press fit use.
The subject Align Radial Head System and the predicate Align Radial Head System (K172688) are a radial head prosthesis and instrumentation platform that is designed to orient the radial head perpendicular to the axis of forearm rotation. It consists of cobalt chrome modular heads in different sizes with cobalt chrome locking screws, titanium alloy stems, necks, and specialized instrumentation.
The provided text is a 510(k) summary for the ALIGN Radial Head System, which is a medical device for radial head replacement. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.
Therefore, many of the requested sections related to AI/ML study components (such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) are not applicable to this type of regulatory submission and are not present in the provided text.
The "acceptance criteria" discussed in this document refer to the criteria for demonstrating substantial equivalence to a predicate device, primarily through mechanical testing to ensure safety and effectiveness.
Here’s the information based on the provided text, with "N/A" for sections not covered by this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Similarities to Predicate Device (K172688): | The Align Radial Head System demonstrates similarities in:Intended useIndications for UseMaterials (cobalt chrome modular heads, cobalt chrome locking screws, titanium alloy stems, necks)Design (fundamental scientific technology - designed to orient the radial head perpendicular to the axis of forearm rotation)Performance (implied through mechanical testing)Sterility |
| No New Issues of Safety or Effectiveness: | The device "does not present any new issues of safety or effectiveness" compared to the predicate. |
| Mechanical Testing Equivalence: | Mechanical testing which established equivalency included static and fatigue compression testing. "Based on the verification results, the subject device is as safe and effective as the legally marketed predicate Align Radial Head System (K172688)." The only technological difference noted is "new radial head and stem sizes." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A. This document describes mechanical testing of a physical medical device, not a study involving a "test set" of data or patient provenance in the context of an AI/ML device. The testing would involve physical samples of the device components. The document does not specify the number of samples used for static and fatigue compression testing.
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)
N/A. Not applicable to mechanical testing of a physical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable to mechanical testing of a physical implant.
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
N/A. Not applicable as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. Not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be established engineering standards and specifications for material strength, fatigue life, and structural integrity under simulated physiological loads, which are used to determine if the device performs equivalently to the predicate. This document does not elaborate on specific standards or the methodology of establishing "ground truth" beyond stating "mechanical testing" was performed.
8. The sample size for the training set
N/A. Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
N/A. Not applicable as this is not an AI/ML device.
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(129 days)
Trade/Device Name: DePuy Synthes Radial Head Replacement System Regulation Number: 21 CFR 888.3170
|
| Classification | Class II
Regulation Number: 21 CFR §888.3170
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.
This document is regarding the DePuy Synthes Radial Head Replacement System-MR Conditional. The Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 –24mm in length. The Radial Head is manufactured from wrought CoCrMo alloy. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone. The devices in scope of the subject submission are being reviewed for MR Conditional labeling in addition to the previously cleared indications for use.
Please find the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria below:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Magnetically Induced Displacement Force (ASTM F2052-15) | Not explicitly stated, but generally implies forces should be within safe limits for patient use. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
| Magnetically Induced Torque (ASTM F2213-17) | Not explicitly stated, but generally implies torque should be within safe limits for patient use. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
| Radio Frequency (RF) Heating (ASTM F2182-11a) | Not explicitly stated, but generally implies heating should be within safe limits for patient use. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
| Image Artifacts (ASTM F2119-07 (2013)) | Not explicitly stated, but generally implies artifacts should be acceptable and not obscure critical information for diagnosis. | The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no different questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set or the data provenance for the non-clinical performance data. It refers to "non-clinical testing" conducted to support the conditional safety of the implants in the MR environment. This type of testing typically involves testing physical samples of the device and not human patient 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)
This information is not applicable. The studies conducted were non-clinical performance tests on the device itself, not studies involving human subjects with clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The studies conducted were non-clinical performance tests on the device itself, not studies involving human subjects requiring adjudication.
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. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical implant (Radial Head Replacement System), not an algorithm or AI system. The testing performed was related to its performance in an MR environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance data, the "ground truth" would be the established safety standards and measurement methodologies outlined in the ASTM standards (F2052-15, F2213-17, F2182-11a, F2119-07 (2013)). These standards define the acceptable limits and procedures for testing device performance under specific conditions.
8. The sample size for the training set
This information is not applicable as the device is a physical medical implant, not an AI or algorithm-based system that requires training data.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical medical implant, not an AI or algorithm-based system that requires training data and ground truth establishment for a training set.
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(93 days)
KWI, Elbow joint radial (hemi-elbow) polymer prosthesis (21 CFR 888.3170)
5.
KWI, Elbow joint radial (hemi-elbow) polymer prosthesis (21 CFR 888.3170)
- 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. - 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. - 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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(99 days)
Tennessee 38119
Re: K212872
Trade/Device Name: Avenger Radial Head System Regulation Number: 21 CFR 888.3170
|
| Regulation Number: | 21 CFR 888.3170
The Avenger Radial Head System 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 radial-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 components are intended for uncemented use.
The Avenger Radial Head System is a two-piece modular system comprised of cobalt chrome (ASTM F 1537) head and stem components. The system consists of a range of lengths and diameters for the stem as well as heads in a range of diameters and heights to accommodate the patient anatomy. The subject of this 510(k) is to clear a new range of stem implants (+4mm offset stems) that can be used to extend the current range of the Avenger Radial Headle modular system. The implant allows for replacement of the radial head.
The provided document describes the clearance of the "Avenger Radial Head System" by the FDA. However, it does not include detailed information regarding acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to previously cleared predicate devices. It mentions "Performance Testing: Head disassembly (ASTM F2009) was performed for the Avenger Radial Head System, +4mm offset stems comparing to the previously cleared K192754 devices. Fatigue testing, sterilization and endotoxin testing were able to adopt into the previously cleared devices." This indicates that some performance testing was done, but the specific acceptance criteria and the quantitative results are not provided in this document.
Therefore, I cannot populate the table or answer most of your specific questions based on the input text.
Information NOT available in the provided document:
- A table of acceptance criteria and the reported device performance: While performance testing related to head disassembly, fatigue, sterilization, and endotoxin is mentioned, the specific acceptance criteria (e.g., maximum force for disassembly, number of cycles for fatigue) and the actual reported device performance values are not detailed.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical medical device (radial head prosthesis) and not an AI/diagnostic software.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For a physical device, "ground truth" typically refers to established engineering standards or physical measurements, which are implied by the mention of ASTM F2009 and other testing, but not explicitly detailed as "ground truth."
- The sample size for the training set: Not applicable for a physical device.
- How the ground truth for the training set was established: Not applicable for a physical device.
What is available (though limited in detail):
- Study that proves the device meets the acceptance criteria: Performance Testing, including "Head disassembly (ASTM F2009)," "Fatigue testing," "sterilization," and "endotoxin testing." The document states these tests were performed and were "able to adopt into the previously cleared devices," suggesting the results were consistent with or met the requirements established for the predicate devices.
- Type of device: Physical medical device (radial head prosthesis).
- Indications for Use: Replacement of the proximal end of the radius for various conditions, including degenerative/post-traumatic disabilities, primary replacement after fracture, symptomatic sequelae after radial head resection, and revision after failed arthroplasty. Intended for uncemented use.
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(99 days)
Tennessee 38119
Re: K192754
Trade/Device Name: Avenger Radial Head System Regulation Number: 21 CFR 888.3170
|
| Regulation Number: | 21 CFR 888.3170
The Avenger Radial Head System 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 radial-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 components are intended for uncemented use.
The Avenger Radial Head System is a two-piece modular system comprised of cobalt chrome (ASTM F 1537) head and stem components. The system consists of a range of lengths and diameters for the stem as well as heads in a range of diameters and heights to accommodate the patient anatomy. The stems are offered in short and long lengths. The heads are offered in heights of standard, +2 and +4 configurations. The implant allows for replacement of the radial head.
The provided text describes the Avenger Radial Head System, a medical device, and its FDA 510(k) clearance. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding AI/algorithm performance. The document focuses on regulatory clearance based on substantial equivalence to predicate devices and general performance testing (mechanical and biocompatibility).
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study evaluating AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth types related to an AI device.
The document primarily discusses:
- Device Name: Avenger Radial Head System
- Intended Use/Indications for Use: Replacement of the proximal end of the radius for various conditions (degenerative/post-traumatic disabilities, radial head fracture, sequelae after radial head resection, revision of failed arthroplasty). The components are intended for uncemented use.
- Regulatory Information: Class II device, Regulation Number 21 CFR 888.3170 (Elbow joint radial (hemi elbow) polymer prosthesis), Product Code KWI.
- Material: Cobalt chrome (ASTM F 1537) for the head and stem components.
- Substantial Equivalence: Demonstrated to be substantially equivalent to previously cleared devices (Wright Medical Evolve® Modular Radial Head - K060731, K991915; Stryker (SBI/Avanta) Radial Head - K982288) based on similar indications, materials, and geometry.
- Performance Testing (Mechanical/Biocompatibility):
- Head disassembly (ASTM F2009)
- Fatigue testing (ASTM F2887)
- Bacterial endotoxin testing (LAL)
No information regarding AI, algorithm performance, or the other specific points requested is available in the provided text.
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(142 days)
Warsaw, Indiana 46580
Re: K183618
Trade/Device Name: Revolution Radial Head Regulation Number: 21 CFR 888.3170
|
| Classification: | 21 CFR §888.3170
The Ignite Orthopedics Revolution Radial Head is indicated 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:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o 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 Revolution Radial Head is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 – 24mm in length.
The Revolution Radial Head is manufactured from wrought CoCrMo alloy conforming to ASTM F1537.
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
This is a 510(k) premarket notification for the Revolution Radial Head, a medical device for radial head replacement. The provided document is a clearance letter from the FDA, a 510(k) summary, and indications for use. It details the device's characteristics and its substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength | Bending stress analysis demonstrated that the strength of the worst-case Revolution Radial Head is greater than the strength of the worst-case predicate device and is adequate for its intended use. |
| Endotoxin Level | Endotoxin testing of worst-case samples using the Limulus amebocyte lysate (LAL) method demonstrated an endotoxin level of |
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(107 days)
, Florida 33176
Re: K172688
| Trade/Device Name: Align Radial Head System Regulation Number: 21 CFR 888.3170 |
|---|
| Common Name |
| Classification |
The Align Radial Head System and accessories are designed specifically 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:
- o Joint destruction and/or subluxation,
- o 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 system is intended for press fit use.
The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit. Combined with its unique instrumentation, the Align Radial Head System offer the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved.
The Align Radial Head System is comprised of:
- · Multiple sized CoCr Radial Heads with Locking Screw
- Multiple sized titanium alloy Stems, titanium plasma spray coated
- · System specific instrumentation.
This document is a 510(k) premarket notification for the "Align Radial Head System," a medical device. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device meets specific acceptance criteria with quantifiable metrics. Therefore, many of the requested categories for device performance studies cannot be directly extracted or are not applicable.
Here's an attempt to answer based on the provided text, highlighting where information is unavailable or not directly relevant to the request as phrased for AI/software-centric device studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility, and packaging. |
| Mechanical Performance | Passed static, shear, and abrasion testing. |
| Material Characterization | Performed as part of equivalence testing. |
| Biocompatibility | Implied through substantial equivalence to predicate device materials. |
| Sterility and Packaging | Found to be similar to the predicate device. |
Note: The document states "Preclinical analysis and testing demonstrated that the Align Radial Head System is substantially equivalent to the predicate device currently marketed. Mechanical and characterization testing which established equivalency included static, shear and abrasion testing." However, specific quantitative acceptance criteria (e.g., "shear strength must be > X MPa") and the exact numerical results are not provided.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing mentioned (mechanical and characterization) would involve physical samples of the device, not a "test set" of data in the context of an AI/software study. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of device testing described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. The ground truth for this device (an implantable prosthesis) would be established through engineering specifications, material science, and pre-clinical mechanical testing, not by expert consensus on a test set in the way AI/software studies use "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for human review of data or images to establish ground truth, which is not the type of testing described for this physical medical 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 information is not applicable. This document describes an orthopedic implant, not an AI or software device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established through engineering specifications, material properties, and physical mechanical testing results (static, shear, and abrasion tests) designed to confirm the device's functional integrity and safety. It's not expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI devices.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. As above, this device does not use a "training set" in the computational sense.
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(126 days)
|
| Classification Name: | Elbow joint radial (hemi-elbow) polymer prosthesis per 21 CFR
888.3170
Florida 32826
Re: K132735
Trade/Device Name: Axia Radial Head System Regulation Number: 21 CFR 888.3170
Radial head arthroplasty
The Axia Radial Head System is intended to reduce or relieve pain and restore function and motion to the elbow.
- Radial head replacement for degenerative or post-traumatic disabilities when presenting with . pain, crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
- 0 Joint destruction and/or subluxation
- Resistance to conservative treatment O .
- Primary radial head replacement after fracture
- Symptomatic sequelae after radial head resection ◆
- Revision following failed radial head arthroplasty .
CAUTION: This device is intended for uncemented use only.
The Axia Radial Head System is a 2-part system comprised of a radial head implant and a radial stem implant. There are 6 sizes of radial heads and 6 sizes of stem implant is available in 3 offset sizes. The large combination of implant sizes and the amount size interchangeability in the system allows for better reproduction of individual patient anatomy.
The Axia Radial Head System radial head implants are made from cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. The radial head stems are made from titanium alloy (Ti-6Al-4V).
The provided text describes the Axia Radial Head System, a medical device, and its regulatory submission (K132735). It details the device's technical specifications, intended use, indications for use, and a single performance test conducted. However, the document does not contain information typically associated with acceptance criteria and a study to prove a device meets those criteria in the context of diagnostic or AI-driven medical devices.
The information provided pertains to the substantial equivalence of a physical orthopedic implant (radial head prosthesis) to a legally marketed predicate device, as part of a 510(k) submission to the FDA. The "acceptance criteria" here are defined by the FDA's regulatory requirements for substantial equivalence, primarily focusing on materials, design, and performance characteristics compared to a predicate.
Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable as they relate to studies for diagnostic devices or AI algorithms that predict or classify outcomes. This document describes a mechanical device for joint replacement.
Below is an attempt to structure the available information as requested, with explicit notes about what information is not present or not applicable given the nature of the device.
Acceptance Criteria and Device Performance Study (K132735 - Axia Radial Head System)
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, "acceptance criteria" are interpreted as demonstrating substantial equivalence to a predicate device (Evolve® Radial Head System - K060731) through shared technological characteristics and indications for use, and confirming the mechanical integrity of a critical component.
| Acceptance Criteria (Demonstration of Substantial Equivalence and Mechanical Performance) | Reported Device Performance (Axia Radial Head System) |
|---|---|
| Pertaining to Substantial Equivalence: | |
| 1. Shared Indications for Use: The device must have indications for use that are substantially equivalent to the predicate device. | Meets Criteria: The Axia Radial Head System shares identical indications for use with the Evolve Radial Head System, including: Radial head replacement for degenerative or post-traumatic disabilities (pain, crepitation, decreased motion at radio-humeral/proximal radio-ulnar joint with joint destruction/subluxation or resistance to conservative treatment), primary radial head replacement after fracture, symptomatic sequelae after radial head resection, and revision following failed radial head arthroplasty. Both are intended for uncemented use only. |
| 2. Shared Technological Characteristics (Head Implants): Materials, sizes, diameters, connection to stem, and surface finish of the radial heads must be substantially equivalent. | Meets Criteria: Both Axia and Evolve radial heads are made from CoCrMo (ASTM F1537), come in 6 sizes (18mm-28mm diameter range), use a taper connection to the stem, and have a polished articular surface. The only difference noted is that Evolve offers +2mm and +4mm offset heights, while Axia has "1 height per size" for the head, implying offsets are managed differently or at the stem level. The document concludes that "The technological features... are substantially equivalent." |
| 3. Shared Technological Characteristics (Stem Implants): Materials, sizes, diameters, offset options, connection to head, surface finish, and fixation method of the stems must be substantially equivalent. | Meets Criteria: Both Axia and Evolve stems come in 6 sizes, have +0mm, +2mm, +4mm offset options, use a taper connection to the head, have a polished surface, and are designed for non-cemented fixation. The material differs (Axia: Ti6Al4V ASTM F136; Evolve: CoCrMo ASTM F1537) and diameter ranges are slightly different (Axia: 5mm-10mm; Evolve: 4.5mm-9.5mm). However, the document concludes that "The technological features... are substantially equivalent," implying these differences do not raise new questions of safety or effectiveness. The Axia system is also noted to have axially symmetric geometry, similar to the predicate implied by "shared technological characteristics." |
| Pertaining to Mechanical Performance: | |
| 4. Modular Connection Strength: The taper connection between the radial head and stem must demonstrate sufficient resistance to component disassembly, exceeding anticipated clinical requirements. | Meets Criteria: Modular Connection Testing per ASTM F2009 was performed. The worst-case taper connection strength was found to be equivalent to 9 times the peak in vivo force when assembled using the worst-case method. When using the recommended surgical technique, the connection strength was over 26 times the peak clinical load. These results indicate the taper design will provide sufficient connection strength. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify a "sample size" in the context of patient data or clinical cases. The performance testing was a mechanical bench test on device components.
- For the Modular Connection Testing (ASTM F 2009), the test used "worst case test components and worst case assembly conditions." The exact number of components tested for this mechanical evaluation is not provided.
- Data Provenance: Not applicable in the context of patient data. The "data" comes from laboratory bench testing of physical device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable as this is a mechanical device performance test, not a diagnostic study requiring expert ground truth for interpretation of clinical data.
4. Adjudication Method for the Test Set
- Not applicable. The "test set" was mechanical components undergoing physical stress testing, not clinical cases requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. This type of study is relevant for diagnostic performance, typically for medical imaging devices or AI algorithms that assist human readers. The Axia Radial Head System is a physical orthopedic implant.
6. If a Standalone Study (i.e., algorithm-only performance) was done
- No, a standalone study was not done. This is relevant for AI algorithms. The performance test conducted was for the mechanical integrity of the device components.
7. The Type of Ground Truth Used
- The "ground truth" for the Modular Connection Testing was implicitly defined by the ASTM F2009 standard for determining axial disassembly force and comparison to "loads reported in the clinical literature for high demand patient activities." This is a measured mechanical property compared against established biomechanical data, not a clinical pathology, expert consensus, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI algorithm, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. This device is not an AI algorithm, and therefore does not have a "training set."
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(101 days)
Prosthesis
Classification: 21 CFR 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis
Class
System Acumed Anatomic Radial Head Long Stems Acumed ARH Slide-Loc'" System Regulation Number: 21 CFR 888.3170
The Acumed Anatomic Radial Head System, the Acumed Anatomic Radial Head Long Stems, the Acumed ARH Slide-Loc™ System, and accessories are designed specifically for:
- 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 and/or subluxation, 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 device is intended to be press fit or cemented.
The Acumed Anatomic Radial Head Long Stems and the Acumed ARH Slide-Loc "" System include modular heads and stems with accessories to anatomically replace the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.
The provided document (K131845) is a 510(k) summary for the Acumed Anatomic Radial Head Long Stems and ARH Slide-Loc™ System, which are elbow hemi-prostheses. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way one might see for a diagnostic AI device.
Therefore, many of the requested elements regarding acceptance criteria, study design, ground truth, and expert involvement are not applicable or cannot be extracted from this type of regulatory submission. This document describes non-clinical (bench) testing to characterize the strength of the device.
Here's an attempt to answer the questions based on the provided text, indicating where information is not applicable (N/A) or not provided (NP):
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or specific numerical performance results from the non-clinical tests. It broadly states that the devices "underwent static and cyclic load testing to characterize their strength." The comparison table focuses on material, dimensions, and design features, not performance metrics related to acceptance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria. The implicit acceptance criterion for a 510(k) is that the device is "substantially equivalent" to a legally marketed predicate device, ensuring similar safety and effectiveness. This is assessed through design, material, and in this case, non-clinical (mechanical) testing. | The devices "underwent static and cyclic load testing to characterize their strength." The results were presumably sufficient to demonstrate substantial equivalence to the predicate device, but no specific performance data (e.g., load sustained, cycles to failure) is provided. |
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 for Test Set: Not specified. This refers to the number of devices or components tested in the static and cyclic load assessments.
- Data Provenance: Not applicable in the context of device mechanical testing. These tests are typically performed in a laboratory setting by the manufacturer or a contract testing facility. It's not clinical data from patients.
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)
- Number of Experts: Not applicable. For mechanical testing of an elbow prosthesis, "ground truth" is not established by medical experts interpreting images or patient outcomes. It's determined by engineering standards and measurements.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant interpretations in clinical studies or for establishing ground truth from multiple human readers. This is mechanical bench 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
- MRMC Study: No. This document describes a medical device (prosthesis), not an AI diagnostic tool.
- Effect size of AI improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: No. This device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For mechanical testing, the "ground truth" would be established by the physical properties of the materials and the mechanical performance of the device as measured against engineering standards (e.g., ASTM standards for implants). The document refers to "static and cyclic load testing to characterize their strength," implying that the measured mechanical properties are the "ground truth" for evaluating the physical integrity of the device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning study requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
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