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510(k) Data Aggregation
(59 days)
The ATTUNE Revision Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions:
- Severe instability, gross deformity and/or bone loss
- Failure of a previous knee reconstruction procedure.
- Trauma or tumor resection
- Absent or markedly insufficient collateral ligaments
The ATTUNE™ Revision Hinge Knee, comprised of a femoral, housing assembly, and tibial insert component, is compatible with devices of the ATTUNE Knee System and the ATTUNE Revision Knee System and is designed to replace the natural articulating surface of the knee joint in total knee arthroplasty. The femoral component is a metal/ultra-high molecular weight polyethylene (UHMWPE) implant intended for cemented use. The housing assembly component is composed of both metal and antioxidant (AOX) UHMWPE subcomponents. The tibial insert component is composed of AOX UHMWPE.
This document is a 510(k) Premarket Notification from the FDA for the "ATTUNE™ Revision Hinge Knee" device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of an AI/software device.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable to this particular document as it is for a mechanical implant and not an AI/software product. The information provided relates to the non-clinical testing of the physical implant's mechanical and material properties.
However, I can extract the relevant information regarding the tests performed for the determination of substantial equivalence (analogous to proving the device meets certain performance standards for a mechanical device).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria with reported performance values in a direct side-by-side comparison. Instead, it states that "The following tests were performed in support of the to demonstrate substantial equivalence of safety and efficacy with the predicate devices." This implies that the device performed equivalently to the predicate devices in these tests, satisfying the FDA's requirement for substantial equivalence.
| Test Type | Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Shear Testing | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| Fatigue Testing | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| Wear Performance | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| Stability Testing | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| Contact Pressure Testing | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| Biocompatibility | Substantially equivalent to predicate devices. | Performed in support of substantial equivalence and safety/efficacy. |
| MRI Safety Evaluation Testing | Substantially equivalent to predicate devices (if applicable). | Performed in support of substantial equivalence and safety/efficacy. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on specific sample sizes for these tests (e.g., how many specimens were shear-tested or fatigue-tested). It also does not mention data provenance as these are mechanical/materials tests, not human data studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a submission for a mechanical medical device, not an AI/Software device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for these tests would be the established engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a mechanical device submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical tests listed (Shear, Fatigue, Wear, Stability, Contact Pressure, Biocompatibility, MRI Safety Evaluation), the "ground truth" would be established engineering standards, material science specifications, and regulatory requirements relevant to orthopedic implants.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable.
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(413 days)
The ATTUNE Revision Cones are intended for use with the DePuy Revision Knee Systems in a revision total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
The ATTUNE Revision cone is to be fixated into ether the proximal tibia or distal femur with or without bone cement. After implantation of the cone, the mating compatible tibial or femoral component is affixed into the using bone cement.
THE POROUS TITANIUM ATTUNE REVISION CONES ARE INTENDED FOR CEMENTED OR CEMENTLESS USE.
The ATTUNE® Revision Cones provide supplemental metaphyseal fixation when necessary to make up for either the proximal tibia or distal femur bone loss. The ATTUNE Revision Cones are available in a variety of sizes of Femoral, Concentric, Tibial Bi-Lobe, and Tibial Tri-Lobe configurations. They are compatible with select, commercially available DePuy Orthopaedics tibial base plates and stemmed femoral components.
This document describes a 510(k) premarket notification for the ATTUNE® Revision Cones. It does not involve a device that relies on algorithms, AI, or machine learning, but rather a medical implant. Therefore, the requested information regarding acceptance criteria, study details for AI/algorithm performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance simply isn't applicable to this submission.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical performance testing for a medical implant, not an AI-driven diagnostic or therapeutic device.
However, I can extract information related to the device's performance and the non-clinical tests conducted to support its substantial equivalence, even if it doesn't align with the typical AI/ML criteria you've provided.
Here's a summary of the non-clinical tests performed, which serve as the "study" proving the device meets its mechanical and material acceptance criteria:
Non-Clinical Performance Data:
| Acceptance Criteria / Test | Reported Device Performance | Comments |
|---|---|---|
| Cone tibial fatigue testing per ASTM F1800 | Performed | Demonstrates durability and resistance to cyclical loading. |
| Cone tibial and femoral cement pulloff test | Performed | Evaluates the strength of the fixation method with bone cement. |
| Biocompatibility testing | Performed | Confirms the material's safety for use within the human body. |
| Particulate Analysis | Performed | Likely assesses wear particles generated from the device, important for long-term implant success. |
| Magnetic Resonance Imaging (MRI) safety evaluation testing | Performed, concluded no safety issues under specific conditions identified in labeling. | Assesses MRI compatibility, including magnetically induced force, torque, image artifact, and RF heating. |
| Bacterial Endotoxin Testing per ANSI/AAMI ST 72:2019 | Meets the requirement | Ensures the device is free from harmful levels of bacterial endotoxins. |
Regarding the specific questions about AI/ML studies:
- A table of acceptance criteria and the reported device performance: See table above, adapted for non-AI device.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. These were non-clinical, mechanical/material tests. "Sample size" would refer to the number of devices tested, which is not specified in this summary. Data provenance is not relevant.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical tests is typically established by engineering specifications and objective measurements, not expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Material and mechanical tests have clear pass/fail criteria, not subjective adjudication.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical implant, not a diagnostic AI.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device does not involve an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable to an AI context. For the non-clinical tests, the "ground truth" is adherence to industry standards (e.g., ASTM F1800, ANSI/AAMI ST 72:2019) and engineering specifications.
- The sample size for the training set: Not applicable. There is no training set for a mechanical implant.
- How the ground truth for the training set was established: Not applicable. There is no training set.
In conclusion, this document pertains to the regulatory clearance of a physical medical device (knee revision cones) and not an AI/ML-driven product. Therefore, the specific criteria for AI/ML studies are not met, as they are not relevant to this type of device submission. The "studies" conducted were non-clinical tests demonstrating the physical and material safety and performance of the implant.
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(56 days)
The b-ONE™ MOBIO™ Total Knee System is intended for total knee arthroplasty due to the following conditions: · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis. · Post-traumatic loss of knee joint configuration and function. · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Revision of previous unsuccessful knee replacement or other procedure · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture- management techniques. Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components: - · Ligamentous instability requiring implant bearing surface geometries with increased constraint. - · Absent or nonfunctioning posterior cruciate ligament. - · Severe anteroposterior instability of the knee joint The b-ONE™ MOBIO™ Total Knee System is intended for implantation with bone cement only. b-ONE™ MOBIO™ Total Knee System components are not intended for use with other knee systems.
The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial tray, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. This submission is to add a Stemmed Baseplate with modular Stem Extension options. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies. The b-ONE MOBIO Total Knee System Stemmed Tibial Baseplates are manufactured from forged titanium alloy. The baseplates are offered in 9 sizes with medial lateral dimensional range from 58-85mm and anterior posterior dimensional range from 58-85mm and anterior posterior dimensional range from 38-59mm. The baseplate is intended for cemented fixation. The Stemmed Baseplates mate with stem extensions through a threaded junction. The Tibial Stems are manufactured from forged titanium alloy. The Tibial Stems are offered in 3 diameters (12, 14, and 16mm) with various lengths ranging from 20-120mm. The stems are intended for cemented fixation. All system components are supplied sterile and are single use devices.
The provided text describes a 510(k) premarket notification for a medical device, the MOBIO Total Knee System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or reporting results from a study proving the device meets those criteria in the way one might expect for an AI algorithm or a diagnostic tool.
The "acceptance criteria" in this context refer to the requirements for demonstrating substantial equivalence for a new or modified medical device. The "study" proving the device meets these criteria is the collection of non-clinical tests and comparisons presented in the 510(k) submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't present a table with explicit "acceptance criteria" and "reported device performance" in the quantitative sense typical for a diagnostic or AI device. Instead, the acceptance criteria are implicitly met by demonstrating that the new device's performance, materials, and design are substantially equivalent to those of legally marketed predicate devices.
The "reported device performance" is essentially that the MOBIO Total Knee System is as safe and effective as the predicate devices based on the non-clinical tests performed.
| Category | Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Materials | Materials of construction are substantially equivalent to predicate devices. | Subject device uses forged titanium alloy for baseplates and stems, the same material class as commonly used in predicate knee systems. |
| Manufacturing | Manufacturing processes are substantially equivalent to predicate devices. | Standard manufacturing processes for medical implants are used, similar to predicate devices. |
| Sizes Offered | Sizes offered are comparable to predicate devices. | Tibial Baseplates offered in 9 sizes (medial-lateral: 58-85mm, anterior-posterior: 38-59mm). Tibial Stems offered in 3 diameters (12, 14, 16mm) with lengths from 20-120mm. These ranges are typical for total knee systems. |
| Product Design | Product design (shape, macrostructures) is substantially equivalent to predicate devices. | Design features are comparable to predicate devices, with minor differences not raising new safety/effectiveness questions. This submission focused on adding a Stemmed Baseplate with modular Stem Extension options to an existing cleared system. |
| Sterilization | Sterilization methods are substantially equivalent to predicate devices. | All system components are supplied sterile and are single-use devices, consistent with standard practice for surgically implanted devices. |
| Mechanical Performance | The device performs mechanically comparably to predicate devices for its intended use, as demonstrated by non-clinical tests. | Non-clinical studies included: Tibial Baseplate Fatigue, Torque Testing, Locking Mechanism Strength, Constraint, Contact Area and Contact Stress, Tibiofemoral Range of Motion. The results are implied to be acceptable as they support substantial equivalence. |
| Biocompatibility | The device materials are biocompatible, similar to predicate devices. | Biocompatibility testing was performed. The results are implied to be acceptable as they support substantial equivalence. |
| Shelf Life | The device maintains its safety and effectiveness over its stated shelf life. | Shelf Life Studies were performed. The results are implied to be acceptable as they support substantial equivalence. |
| Bacterial Endotoxin | The device is free from bacterial endotoxin within acceptable limits. | Bacterial Endotoxin Testing was performed. The results are implied to be acceptable as they support substantial equivalence. |
| Safety & Effectiveness | The device is as safe and effective as the legally marketed predicate devices. Differences in design/technology do not raise new safety/effectiveness questions. | "The information provided above supports that the MOBIO Total Knee System Stemmed Baseplate and Stem Extension components are as safe and effective as the predicate devices with the same intended use. Some minor differences in design and technology exist between the subject and predicate devices, however applicable reference devices have been cited to support the conclusion that these differences do not raise any new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and the Data Provenance
For a medical implant like a total knee system, studies are typically non-clinical (bench testing, mechanical testing) rather than involving patient test data sets in the way an AI algorithm would.
- Sample Size: Not explicitly stated in terms of "test set" size. The "samples" would be the individual components or assemblies tested for fatigue, torque, etc. The document does not specify the number of units tested for each non-clinical study.
- Data Provenance: The studies are non-clinical (bench testing), so there's no patient data involved in this 510(k) summary. These tests would have been conducted in a laboratory setting by the manufacturer or a contract research organization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable in the context of this 510(k) submission.
- Ground Truth for Non-Clinical Tests: For mechanical and material tests, the "ground truth" is established by adherence to recognized standards (e.g., ISO, ASTM) and engineering principles, not by expert consensus on clinical images or diagnoses. The "experts" would be the engineers and scientists performing and interpreting these tests.
- The document implies that the internal experts of b-ONE ORTHO, Corp. and potentially external labs were involved in conducting and evaluating these non-clinical tests, following established regulatory and scientific guidelines.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies, not for non-clinical mechanical testing of medical devices.
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 question is not applicable. This 510(k) is for a total knee replacement system, which is a physical implant, not an AI-assisted diagnostic tool or an imaging modality. There are no "human readers" or "AI assistance" involved in its direct function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The MOBIO Total Knee System is a physical medical device (an implant), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As this is a non-clinical 510(k) submission for a physical implant, the "ground truth" for the performance studies refers to:
- Adherence to validated test methods and standards: For example, fatigue testing would be evaluated against established standards for implant longevity.
- Material specifications: Conformance to established material properties for the titanium alloy.
- Design specifications: Proof that the device meets its design intent, often through dimensional verification and mechanical simulation/testing.
- Biocompatibility standards: Compliance with ISO 10993 series for biological evaluation of medical devices.
8. The sample size for the training set
This question is not applicable. As this device is a physical implant and not an AI algorithm, there is no "training set" in the machine learning sense. The "training" for such a device comes from engineering design, material science, and prior knowledge from predicate devices.
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set" for this type of medical device submission.
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(112 days)
The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.
Candidates for total knee replacement include patients with and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.
The provided text is a 510(k) summary for a medical device (ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology) and does not describe acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means showing that the new device is as safe and effective as a legally marketed device that does not require premarket approval. The "acceptance criteria" in this context are related to meeting established performance standards for orthopaedic implants and demonstrating similar characteristics to the predicate devices.
Here's a breakdown of what is provided, framed as closely as possible to your request for acceptance criteria and study information, considering that the primary goal here is substantial equivalence, not a standalone performance study with accuracy metrics.
1. A table of acceptance criteria and the reported device performance
The document does not present a table of acceptance criteria in the format typically used for AI/diagnostic device performance (e.g., sensitivity >X%, specificity >Y%). Instead, the "acceptance criteria" are implied by the performance standards for orthopaedic implants to demonstrate substantial equivalence, and "reported device performance" refers to the successful completion of these tests.
| Type of Test/Characteristic | Implied Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device "Performance" (Satisfied) |
|---|---|---|
| Tibial Base | ||
| Tray fatigue testing (ASTM F1800) | Meet standard fatigue requirements for knee implants. | Testing performed; results support substantial equivalence. |
| Peg fatigue testing | Meet standard fatigue requirements for peg fixation. | Testing performed; results support substantial equivalence. |
| Fixation testing | Demonstrate adequate fixation strength. | Testing performed; results support substantial equivalence. |
| Biocompatibility testing | Be biocompatible (non-toxic, non-irritating, etc.). | Testing performed; results support substantial equivalence. |
| Patella | ||
| Peg fatigue testing | Meet standard fatigue requirements for peg fixation. | Testing performed; results support substantial equivalence. |
| Biocompatibility testing | Be biocompatible (non-toxic, non-irritating, etc.). | Testing performed; results support substantial equivalence. |
| Coating Characterization | ||
| Static interfacial shear (ASTM F1044) | Meet standard static shear resistance. | Testing performed; results support substantial equivalence. |
| Static interfacial tensile (ASTM F1147) | Meet standard static tensile resistance. | Testing performed; results support substantial equivalence. |
| Interfacial shear fatigue (ASTM F1160) | Meet standard fatigue resistance for interfacial shear. | Testing performed; results support substantial equivalence. |
| Abrasion testing | Demonstrate acceptable abrasion resistance. | Testing performed; results support substantial equivalence. |
| Corrosion analysis (ASTM G5-14) | Demonstrate acceptable corrosion resistance. | Testing performed; results support substantial equivalence. |
| Chemical composition analysis (ASTM E2371, E1409, E1941-10, E1447-09) | Material composition matches specifications. | Testing performed; results support substantial equivalence. |
| Morphological evaluation | Surface morphology meets design specifications for porous coating. | Testing performed; results support substantial equivalence. |
| Biocompatibility testing | Be biocompatible. | Testing performed; results support substantial equivalence. |
| Bacterial Endotoxin Testing (ANSI/AAMI ST 72:2019) | Meet specified bacterial endotoxin limits. | Testing performed; results support substantial equivalence. |
| Technological Characteristics | Similar to predicate devices in principle of operation, intended use, classification, design, materials and fixation. | Detailed comparison provided, concluding similarity. |
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 lists various non-clinical tests. For these tests (fatigue, fixation, biocompatibility, coating characterization, etc.), the sample sizes are not explicitly stated in this summary. It is typical for these types of engineering tests to involve controlled laboratory specimens rather than patient data. Data provenance like country of origin or retrospective/prospective is not applicable here as these are laboratory tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI performance studies rather than the engineering and material performance tests described for this knee implant. The "ground truth" for these tests is established by the specifications and acceptance criteria of the ASTM and ANSI/AAMI standards themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to a method used to resolve discrepancies in expert interpretation, which is not relevant for the non-clinical, objective engineering tests 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
Not applicable. This is a knee implant, not an AI diagnostic device. No human-in-the-loop performance or MRMC studies were conducted for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is related to AI/diagnostic algorithms, not a knee implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the established industry standards (e.g., ASTM F1800, ASTM F1044, ANSI/AAMI ST 72:2019). The tests measure physical properties against defined limits or performance benchmarks within these standards.
8. The sample size for the training set
Not applicable. This is a physical device, and the evaluation is based on non-clinical engineering and material tests, not on machine learning or AI models which would require training sets.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
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