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Found 36 results
510(k) Data Aggregation
(196 days)
Ascension Orthopedics, Inc.
The Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The Freedom Wrist Arthroplasty System is intended for cemented use.
The Freedom Wrist Arthroplasty System consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint. The components are intented together as a system, not individually as hemi-arthroplasty components. The radial component is made of Cobalt Chrome Molybenum Alloy (CrCoMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal. The carpal implant is an assembly consisting of a titanium carpal plate, which is fixed into the carpal bones with a cemented central peg and locking caps. A convex Ultra-High-Molecular-Weight Polyethylene (UHMWPE) bearing is locked onto the carpal plate to articulate with the radial component.
Unfortunately, the provided text does not contain information about an AI/ML-based medical device study. The document is an FDA 510(k) clearance letter for the "Freedom Wrist Arthroplasty System," which is a physical medical device (a wrist implant).
The text primarily focuses on:
- Device Description: The components and materials of the wrist implant.
- Intended Use/Indications for Use: What the implant is designed to treat.
- Predicate Device Comparison: How it compares to previously cleared devices.
- Non-Clinical Testing: Specifically, tests related to MRI safety and compatibility (Magnetically Induced Displacement Force, Torque, RF-Induced Heating, Image Artifacts).
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or specific performance metrics for an AI/ML device, as this information is not present in the provided document.
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(29 days)
Ascension Orthopedics, Inc.
The ASCENSION Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
The ASCENSION Silicone MCP implant is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
The ASCENSION Silicone MCP and PIP implants are anatomically designed, single-use, one-piece, flexible hinge prostheses designed to be implanted without bone cement across the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joint. They are made from medical grade silicone elastomer. The proximal and distal stems of the prostheses are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. The MCP and PIP implants provide 90 degrees of flexion from full extension.
The provided text is an FDA 510(k) clearance letter for the Ascension Silicone MCP and Ascension Silicone PIP devices. This document focuses on the regulatory clearance of a physical medical device (finger joint prostheses) based on a special 510(k) for adding "MR Safe" labeling.
The information you've requested (acceptance criteria and study details for an AI/software device) is not present in this document. The document explicitly states:
- "Non-clinical performance data is not required to support the addition of MR Safe labeling to the subject devices."
- The determination of "MR Safe" was established through a "scientific rationale that addressed information about the electrical conductivity and magnetic properties of the device material per the FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'"
Therefore, I cannot provide the requested details because the device in question is not an AI/software medical device that underwent the type of performance study you're asking about.
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(64 days)
Ascension Orthopedics
Salto Talaris Total Ankle Prosthesis : The Salto Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Components are intended for cemented use only.
Integra XT Revision Ankle Replacement System: The Integra XT Revision Ankle Replacement System is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. Components are intended for cemented use only.
The Integra Salto Total Ankle System (Salto Talaris Total Ankle Prosthesis and the Integra XT Revision Ankle Replacement System) is a semi-constrained anatomical design. Both subsystems consist of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar resurfacing component.
This document is a 510(k) premarket notification from the FDA for a medical device called the "Integra Salto Total Ankle System." It's a clearance letter, not a study report. Therefore, it does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance in the context of an AI-powered diagnostic device, as the prompt requests.
The document discusses the substantial equivalence of the Integra Salto Total Ankle System to a predicate device, based on material, intended use, fundamental scientific technology, and functional/technological characteristics.
Specifically, it states:
- "Nonclinical Performance Data": The Salto Talaris Total Ankle Prosthesis and Integra XT Revision Ankle Replacement System were subjected to verification per standard ASTM F2665 to establish equivalent performance in comparison to the predicate device, covering tests like Tibial Tray Fatigue, Tibial Tray/Insert Locking, Tibial Tray Bone Fixation, Talar Dome Bone Fixation, and Talar Dome Fatigue.
- "Clinical Performance Data": "Clinical performance data is not required to demonstrate substantial equivalence to the predicate device."
Since this is a mechanical orthopedic device clearance and not an AI/diagnostic device, the concepts of acceptance criteria for AI performance (like sensitivity, specificity, AUC), sample sizes for test sets (in the context of images), expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable or present in this document.
Therefore, I cannot provide the requested information based on the provided text.
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(346 days)
ASCENSION ORTHOPEDICS
The proposed indications for use for the Integra® CAPTURE™ Screw System are as follows:
"The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
The proposed indications for use for the Integra® Ti6® Internal Fixation System are as follows: "The Ti6@ Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
The Integra® CAPTURETM Screw System and Integra® Ti6® Internal Fixation System consists of bone screws of various designs and sizes intended to fixate bones in cases of fractures, osteotomies, or fusions. The screws are self- drilling and self-tapping, and are manufactured from Ti-6Al-4V titanium alloy. This submission presents new cannulated (Digital Fusion) and non-cannulated (QuickSnap) screw designs that are line extensions to the current Integra® CAPTURE™ Screw System and Integra® Ti6® Internal Fixation System.
This document is a 510(k) premarket notification for the Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices. Crucially, as a 510(k) submission, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving novel effectiveness through clinical trials.
The document states:
"Clinical Performance Data: Clinical performance data was not necessary to demonstrate substantial equivalence."
Therefore, the specific information requested about acceptance criteria for device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details will not be available in this document as it explicitly states clinical performance data was not required or provided.
However, I can provide the non-clinical performance data and its findings, which were used to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Torsional Strength | Substantially equivalent or better than predicate device | Performed substantially equivalent or better than predicate device |
| Driving Torque | Substantially equivalent or better than predicate device | Performed substantially equivalent or better than predicate device |
| Axial Pullout Strength | Substantially equivalent or better than predicate device | Performed substantially equivalent or better than predicate device |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the document for the non-clinical tests.
- Data Provenance: The tests were conducted "per ASTM F543," which is a standard for metallic bone screws. This indicates laboratory testing, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for mechanical testing is based on established engineering standards (ASTM F543) and physical measurements, not expert human interpretation.
4. Adjudication method for the test set:
- Not applicable as the testing involves direct physical measurements against engineering standards rather than subjective interpretations 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 MRMC comparative effectiveness study was not done. This device is a bone fixation screw system, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is a physical medical device (screws), not an algorithm or software. Standalone performance as an algorithm is not applicable.
7. The type of ground truth used:
- Non-clinical performance data: Ground truth was established by adherence to ASTM F543 standards for mechanical properties (Torsional Strength, Driving Torque, Axial Pullout Strength) and comparison to predicate devices.
8. The sample size for the training set:
- Not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set. The "training" for the device's design and manufacturing would come from engineering principles and standards.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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(103 days)
Ascension Orthopedics
The Integra® External Fixation System is an external fixation device in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include:
- · Correction of deformity
- · Revision procedures where other treatments or devices have been unsuccessful
- · Bone reconstruction procedures
- · Fusions and replantations of the foot
- · Charcot reconstruction and Lisfranc dislocations
- · Ankle distraction (arthrodiastasis)
The Integra® External Fixation System is a single-use modular external fixator consisting of the following components: rings, foot plates, compression/distraction struts, half-pin bone screws, straight/olive wires, rods, nuts, bolts, clamps, and other modular fixator components. The modifications to the device include material and minor design updates to the Universal Wire Fixation Bolt and Slotted Posts which do not affect the safety and effectiveness of the device. An update was also made to the position of the olive on the 530mm olive wire. Lastly, the sharpness of the olive wire and k-wire were modified.
The provided text describes a 510(k) submission for the Integra® External Fixation System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study that establishes acceptance criteria for a novel device's performance.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this specific document. This document details modifications to an existing device and confirms that these modifications do not negatively impact its safety and effectiveness compared to the predicate.
However, I can extract information related to the performance comparison and the "acceptance criteria" as defined by substantial equivalence to the predicate device.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" for the modified device (Integra® External Fixation System K160830) is that its performance should be statistically equivalent to the predicate device (Integra® External Fixation System K140463) for the specific elements that were modified.
| Acceptance Criteria (for modified components) | Reported Device Performance (K160830) |
|---|---|
| Stiffness statistically equivalent to predicate | Stiffness was statistically equivalent to predicate. |
| Acceptable Torsional Strength | A torsional strength test was performed. (Result implicitly positive, otherwise substantial equivalence would be denied). |
| Acceptable Static Wire Retention | A static wire retention test was performed. (Result implicitly positive). |
| Acceptable Dynamic Wire Retention | A dynamic wire retention test was performed. (Result implicitly positive). |
| Olive wire position validation | Validation performed, no further verification needed. |
| Wire sharpness validation | Validation performed, no further verification needed (no effect on part strength). |
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: The document does not specify the exact sample sizes used for the dynamic, static, and torsional tests. It mentions "constructs were tested" implying multiple samples of the modified components.
- Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer as part of their design control and validation processes. It is prospective testing aimed at proving specific performance characteristics of the modified components.
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 is not applicable. The "ground truth" here is the physical and mechanical performance of the device components, measured through engineering tests, not an interpretation by medical experts. The evaluation is based on objective measurements and comparison to predefined engineering standards or the performance of the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessment. For mechanical testing, the results are quantitative and typically assessed against pre-defined engineering thresholds or comparative data from the predicate device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an external fixation system (a physical medical device), not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance assessment of the modified components is their measured mechanical properties and physical characteristics (e.g., stiffness, tensile strength, wire retention forces, olive position, sharpness). These are objective engineering measurements compared against the predicate device's corresponding properties.
8. The sample size for the training set
Not applicable. 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. This is not an AI/machine learning device.
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(153 days)
ASCENSION ORTHOPEDICS
The INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is intended for use in Total Shoulder Arthroplasty which is indicated 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 indicated 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)
The humeral component is intended for cemented or uncemented use.
The glenoid component is intended for cemented use only.
The Integra TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is a fully cemented all highly cross-linked polyethylene glenoid used in total shoulder arthroplasty for resurfacing the glenoid fossa. The glenoid component has one central peg with barbs and three peripheral pegs. The articulating surface of the glenoid device will be the same dimensions and sizes as existing Titan Modular Total Shoulder System three peg inline glenoids for consistent mismatching. The Fin-Lock™ Glenoid is intended to be a part of the TITAN™ Modular Shoulder System, 2.5 (K142413) and be used with the humeral component.
Based on the provided text, the acceptance criteria and the study results for the INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid are described in the "807.92(b)(1-2) – Nonclinical Tests Submitted" section.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The results of these performance tests met their respective acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. It only mentions that the device met them.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | Met the respective acceptance criteria for each test. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test sets in the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature). The tests are described as "nonclinical," implying they were conducted in a laboratory setting rather than using patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The tests described are "nonclinical" performance tests (e.g., mechanical testing, material characterization), which typically do not involve human experts establishing ground truth in the way clinical studies or diagnostic AI algorithms do.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As mentioned above, these are nonclinical performance tests, not clinical studies requiring adjudication of outcomes by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document describes nonclinical performance tests, not studies involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical implant (shoulder prosthesis), not an algorithm or AI. The tests performed are for the physical properties and performance of the implant itself.
7. The Type of Ground Truth Used
The ground truth for these nonclinical tests would be based on engineering specifications, material science standards, and mechanical testing protocols. For example, for a "Glenoid Pull-out Fixation Test," the ground truth would be a defined force threshold or displacement limit that the device must withstand according to established engineering principles for such implants. The document implies these standards were used by stating "met their respective acceptance criteria."
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device. There is no "training set" in the context of an AI/algorithm. The development and testing of a physical implant involve design iterations, material selection, and extensive pre-clinical testing, but not an AI-style training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for a physical medical device. The "ground truth" for the device's design and manufacturing would be based on biomaterial science, biomechanical engineering principles, clinical needs, existing standards for orthopedic implants, and the performance characteristics of predicate devices.
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(56 days)
Ascension Orthopedics
The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include:
- · Hammer toe deformity
- · Claw toe deformity
- Mallet toe deformity
- Other deformities of the feet and hands
The DigiFuse® implants are intended for single use only.
The Integra® DigiFuse® Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options.
This document is a 510(k) premarket notification for the Integra® DigiFuse® Cannulated Intramedullary Fusion System. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a separate, extensive study to define new acceptance criteria and prove performance against them.
Therefore, the requested information regarding acceptance criteria, device performance from a specific study, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not typically present or required in this type of submission.
Instead, the submission relies on demonstrating substantial equivalence to existing devices, meaning it performs as safely and effectively as a legally marketed device that does not require premarket approval (PMA).
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance:
This document does not present a table of specific acceptance criteria (e.g., specific clinical outcomes, sensitivity/specificity thresholds) and reported device performance against those criteria. The acceptance is based on demonstrating substantial equivalence to predicate devices, not on meeting new quantitative performance metrics from a distinct study.
2. Sample size used for the test set and the data provenance:
- No specific "test set" and corresponding sample size for clinical or AI performance evaluation are mentioned.
- The document states "Non-clinical evaluation and dimensional analysis was done to confirm substantial equivalence." This refers to engineering and material testing, not a clinical trial or performance study on a "test set" of patient data in the context of AI or diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a "test set" requiring ground truth established by experts in the context of clinical or diagnostic performance.
4. Adjudication method for the test set:
- Not applicable. No such test set or adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study or AI assistance is mentioned. This device is a physical implant (Cannulated Intramedullary Fusion System), not a software or AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm, so standalone AI performance is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a traditional 510(k) submission like this, the "ground truth" for the device's equivalence isn't clinical outcomes from a new study, but rather the established safety and effectiveness of the identified predicate devices. The "proof" is in demonstrating that the new device shares fundamental technological characteristics and has similar intended use, materials, and design principles to the predicates without raising new questions of safety or effectiveness. "Non-clinical evaluation and dimensional analysis" would be used to ensure the physical properties meet engineering standards applicable to the predicate devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of AI or machine learning for this physical implant device.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set mentioned, this question is not relevant.
Summary of what the document does provide regarding equivalence:
- Predicate Devices:
- Basis for Equivalence:
- The Integra® DigiFuse® Implant is made of the same material (Titanium Alloy (Ti 6A1-4V ELI)) as the Metasurg predicate device (K111536).
- The only difference with the Metasurg predicate is the addition of two new lengths for the Integra® DigiFuse® implant.
- These two new lengths are already within the length range of the Osteomed predicate device (K062863).
- The submission explicitly states: "There are no design, material, or indication differences between the proposed device and predicate devices." (This is crucial for 510(k) acceptance).
- Substantial equivalence was confirmed through "Non-clinical evaluation and dimensional analysis." This refers to engineering tests to ensure physical and mechanical properties are comparable to the predicates, not a clinical trial on patient-specific data.
In essence, the "acceptance criteria" for this specific 510(k) clearance are derived from the characteristics and performance of the legally marketed predicate devices. The study proving this "acceptance" is the non-clinical evaluation and dimensional analysis demonstrating that the Integra® DigiFuse® device is fundamentally the same as or comparable to its predicate devices, especially regarding materials, design, and intended use, and that any minor differences (like additional lengths) do not introduce new safety or effectiveness concerns.
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(91 days)
Ascension Orthopedics
The Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:
- systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
- primary arthritis (e.g. degenerative disease)
- secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved)
The Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union/mal-union of ankle arthrodesis, provided sufficient bone stock is present.
Note: In the United States, this device is intended for cemented use only.
The Integra® Total Ankle Replacement System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The prosthesis is composed of a tibial component, a talar component and an insert. Both the tibial component and talar component are secured to patient anatomy via bone cement; the intermediate insert is rigidly fixed to the tibial component intra-operatively. When all three components are implanted, the intermediate insert acts as a bearing along the talar component, enabling flexion and extension movement at the replaced joint.
Components are available in a variety of sizes and design configurations intended for both primary and revision applications.
For marketing purposes the Integra Total Ankle Replacement System will be released to market as the Cadence Total Ankle System.
The provided text describes a 510(k) premarket notification for the Integra Total Ankle Replacement System (also referred to as Cadence Total Ankle System), which is an ankle joint metal/polymer semi-constrained cemented prosthesis.
Based on the information provided, here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Objective | Reported Device Performance | Conclusion |
|---|---|---|
| Mechanical Stiffness | The stiffness of the Integra Total Ankle Replacement System was statistically equivalent to the predicate device. | Device met acceptance criteria. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size (number of devices/constructs) used for the test set in the mechanical testing. It only mentions that "the predicate construct and Integra Total Ankle Replacement System construct were tested both dynamically and statically." The data provenance is not specified beyond being part of a 510(k) submission, implying it's from the manufacturer's internal testing. It is a prospective test, as it was conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for the test set here refers to mechanical performance, not expert-derived clinical outcomes or interpretations. The acceptance criteria are based on engineering standards and comparison to a predicate device's mechanical properties.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for establishing ground truth in clinical studies involving multiple expert readers, not for mechanical performance 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 (prosthesis) submission, not an AI/software as a medical device (SaMD) submission. An MRMC study or AI-related effectiveness analysis is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an AI/SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" is established by the measured mechanical properties (specifically stiffness) of the devices under controlled dynamic and static conditions, compared to the predicate device. It's an engineering "ground truth."
8. The sample size for the training set
This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for physical device performance.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device submission.
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(78 days)
Ascension Orthopedics
The INTEGRA® TITAN™ Modular Total Shoulder System is a Total Shoulder Arthroplasty which is indicated for: Severely painful and/or disabled joint resulting from osteoarthritis 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 indicated 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 Hemiathroplasty is also indicated for: Ununited humeral head factures, 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™ Modular Total Shoulder System consists of a line of metaphyseal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The metaphyseal bodies and humeral stems are shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally-filling shape are designed to accommodate the natural humeral geometry and provide stable fixation. proximal bone loading and proper head placement. The humeral heads are offered with both concentric and eccentric articulating surfaces. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the all polyethylene cemented glenoid. The glenoid has multiple options: keeled or standard pegged (3 pegs). All glenoid options are designed to function with both the concentric and eccentric heads. The humeral components are intended for cemented or uncemented use, while the glenoid component is for use with cement only.
The provided document is a 510(k) Premarket Notification summary for the INTEGRA® TITAN™ Modular Total Shoulder System. This document outlines the device description, intended use, and a comparison to a predicate device, focusing on demonstrating substantial equivalence rather than a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML device or a clinical trial.
The "acceptance criteria" and "device performance" described are related to non-clinical mechanical testing of the orthopedic implant, not to diagnostic accuracy or clinical outcomes in the way one would assess an AI/ML device. Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of the available information:
1. Table of acceptance criteria and reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Taper Axial Disassembly Test | Not explicitly stated in the document, but can be inferred as meeting a predefined standard or benchmark for safe and effective performance of the taper connection. | "The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use..." |
| Fatigue Test | Not explicitly stated, but inferred as meeting a predefined standard or benchmark for the cyclic loading capability of the implant components, ensuring durability over time. | "The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use..." |
| Maximum Static Load Test | Not explicitly stated, but inferred as meeting a predefined standard or benchmark for the maximum force the device can withstand without failure. | "The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use..." |
| Impact Assembly Test | Not explicitly stated, but inferred as meeting a predefined standard or benchmark for the robust assembly of the modular components, likely involving resistance to impact forces during implantation or use. | "The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use..." |
| Suture Verification Report | Not explicitly stated, but inferred as ensuring that sutures, if any are part of the device or its intended use, function as designed and maintain structural integrity. This might be more related to surgical technique or a component of the implant. | "The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use..." |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria consists of the non-clinical tests listed above. The document states: "Testing to verify the performance of the INTEGRA® TITAN™ Modular Total Shoulder System included the following: Taper Axial Disassembly Test, Fatigue Test, Maximum Static Load Test, Impact Assembly Test, Suture Verification Report. The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use, and is substantially equivalent to the predicate device identified."
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified for these non-clinical mechanical tests. Typically, mechanical testing involves a certain number of test articles (e.g., usually 3, 5, or more per test condition as per ISO or ASTM standards) rather than "patients" or "data sets." Specific quantities are not disclosed in this summary document.
- Data Provenance: N/A. These are laboratory-based mechanical tests performed on device components, not based on human data from a geographic origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and established test standards (e.g., ASTM, ISO standards for orthopedic implants). It does not involve human expert interpretation in the way clinical diagnostic data would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This concept is for clinical data adjudication, not mechanical engineering tests.
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. This is a non-clinical 510(k) submission for a physical orthopedic implant, not an AI/ML diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. Not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For these mechanical tests, the "ground truth" is based on engineering specifications, material science principles, and established international or national standards for orthopedic implant mechanical performance (e.g., ASTM F2028-14 for humeral prostheses, or similar standards for fatigue, static loading, and taper connections). The "acceptance criteria" are derived from these standards and the predicate device's performance.
8. The sample size for the training set:
- N/A. There is no concept of a "training set" for physical mechanical device testing as there would be for an AI/ML algorithm. The design of the device is based on engineering principles and comparison to the predicate.
9. How the ground truth for the training set was established:
- N/A. Not applicable to this type of device and testing.
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ASCENSION ORTHOPEDIC
The Integra External Fixation System is an external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include:
- Correction of deformity
- Revision procedures where other treatments or devices have been unsuccessful
- Bone reconstruction procedures
- Fusions and replantations of the foot
- Charcot reconstruction and Lisfranc dislocations
- Ankle distraction (arthrodiastasis)
The Integra® External Fixation System is a single-use modular external fixator consisting of the following components: rings, foot plates, compression/distraction struts, half-pin bone screws, straight/olive wires, rods, nuts, bolts, clamps, and other modular fixator components. Special instruments (e.g. wrenches) are required for proper assembly of the apparatus. Adjustment of the fixator is possible during the course of treatment. When properly used by an experienced clinician, the Integra External Fixation System may preserve limb function by minimizing operative trauma to anatomical structures and preserving blood supply.
The Integra External Fixation System is a medical device and the provided text describes its regulatory clearance, not a study of its clinical performance with acceptance criteria typical for AI/software devices. The information available pertains to the mechanical performance of the device compared to a predicate, not clinical outcomes. Therefore, many of the requested categories for AI/software studies are not applicable.
Here's an attempt to answer the questions based on the provided text, highlighting where information is not available or not applicable:
Acceptance Criteria and Study for Integra External Fixation System (K140463)
The provided document describes the FDA 510(k) clearance for the Integra External Fixation System. This is a mechanical device, and the study described focuses on demonstrating its substantial equivalence to a predicate device through mechanical testing. It is not an AI/software device, and therefore, many of the requested metrics related to clinical studies, expert-based ground truth, and human-in-the-loop performance are not applicable or not provided in this regulatory submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria described relate to the mechanical stiffness of the Integra External Fixation System compared to a predicate device.
| Acceptance Criteria Objective | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Stiffness | "The stiffness of the 2 systems was compared and was statistically equivalent." | "The performance of the Integra External Fixation System was verified to be statistically equivalent to that of the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of number of devices tested, but it refers to "the construct" of both the predicate and the Integra system. This typically implies a statistically sufficient number of physical devices or components to perform mechanical testing.
- Data Provenance: The study was a prospective mechanical testing conducted by the manufacturer
(Ascension Orthopedics/Integra LifeSciences). The country of origin for the data is not specified but would likely be the location where the manufacturer's testing facilities are located (e.g., USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For mechanical device testing, "ground truth" is established by standard engineering principles and validated testing methodologies, not by clinical experts. The testing would be performed by engineers or technicians skilled in biomechanical testing.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving human interpretation or consensus, typically for diagnostic or prognostic devices. This was a mechanical engineering study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was a mechanical engineering comparison of two external fixation systems, not a clinical study involving human readers or AI assistance in interpretation.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- Not Applicable. This is a mechanical device, not an algorithm. There is no "standalone" algorithmic performance to report.
7. Type of Ground Truth Used
- The "ground truth" for this engineering study was the mechanical stiffness measured under dynamic and static loading conditions, as per established biomechanical testing standards. This would be quantified by physical measurements obtained from calibrated testing equipment.
8. Sample Size for the Training Set
- Not Applicable. This is a mechanical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this type of device, this question is not relevant.
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