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510(k) Data Aggregation
(59 days)
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(273 days)
The Maxx Libertas Bipolar Head is intended for use in combination with a Maxx Libertas Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- Femoral neck and trochanteric fractures of the proximal femur;
- Osteonecrosis of the femoral head;
- Revision procedures where other devices or treatments for these indications have failed.
The Maxx Libertas Bipolar Head consists of three factory-assembled parts: a cobalt chromium outer shell, a UHMWPE liner, and a UHMWPE retention ring. The outer shell has a highly polished spherical outer surface for articulating with the acetabular joint socket. The liner has an hemispherical inner surface for articulating with the spherical head component of the Libertas femoral stem (28 mm). The retention ring provides a locking function to resist dislocation of the femoral head from the bipolar head.
The provided FDA 510(k) clearance letter and summary for the Maxx Libertas Bipolar Hip Head (K243634) describe the device and its intended use, but it does not contain information regarding statistically significant acceptance criteria derived from a clinical or standalone study comparing the device's performance against specific metrics.
Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (BioPro Bipolar Head, K100761) primarily through non-clinical mechanical testing and engineering analysis. This type of submission relies on showing that the new device is as safe and effective as a legally marketed device, often by demonstrating similar design, materials, and performance in simulated conditions.
Therefore, many of the specific details requested in your prompt (e.g., sample size for test set, expert qualifications, MRMC study, ground truth type) are typically not included in a 510(k) summary that relies solely on bench testing and
engineering analysis for substantial equivalence.
Here's an analysis of the information that is available and what is not based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Explicit acceptance criteria from a clinical study are not provided in the document. The summary focuses on equivalence to a predicate. | Mechanical Testing: - Range of Motion tests were performed. - Static push-out tests were performed. - Static Lever-out tests were performed. Engineering Analysis: - Impingement scenarios analysis was performed. Overall Conclusion: The device performed "identical to the predicate device," supporting substantial equivalence. |
2. Sample sized 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 applicable/Not provided. The "test set" in this context refers to physical test articles used for mechanical testing, not a patient cohort or imaging dataset. The number of physical samples tested is not specified in the summary.
- Data Provenance: Not applicable/Not provided in the summary. Mechanical testing data does not have country of origin in the same way clinical data would.
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. For mechanical and engineering testing, "ground truth" is established by standard engineering principles, test methods (e.g., ASTM or ISO standards, though not explicitly cited here), and simulation results, not by human experts interpreting clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to human interpretation of clinical data in studies, not to device mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/software devices where human-in-the-loop performance is evaluated. The Maxx Libertas Bipolar Hip Head is a physical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone performance evaluation in the context of an "algorithm only" or AI device was not done. The "standalone" performance here refers to the mechanical and engineering performance of the physical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating substantial equivalence for this device was established based on mechanical test results and engineering analysis comparing the subject device's performance to that of the predicate device under simulated conditions. There is no expert consensus, pathology, or outcomes data mentioned in this submission summary.
8. The sample size for the training set
- Not applicable. This term refers to data used to train AI models. This device is a physical orthopedic implant, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
Summary of what the study did demonstrate:
The provided document indicates that the Maxx Libertas Bipolar Hip Head gained 510(k) clearance primarily by demonstrating substantial equivalence to a predicate device (BioPro Bipolar Head, K100761). This was achieved through:
- Mechanical Testing: Including Range of Motion, Static push-out, and Static Lever-out tests.
- Engineering Analysis: Specifically for impingement scenarios.
- Technological Comparison: The subject device was deemed "identical to the Predicate Device in design, material, chemical composition, principle of operation."
The conclusion was that the device "performed identical to the predicate device" based on these non-clinical tests, thus supporting its substantial equivalence for the stated Indications for Use.
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(30 days)
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Correction of functional deformities.
- Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods.
- Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components and Primary PCK Components only).
The Freedom Total Knee System, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation
The Freedom Total Knee System All-Poly Tibial Plate implants have been developed with the desire to expand upon the already clinically successful Freedom® Total Knee System, melding together the best design features of various sub-systems into one. The implants will retain the key benefits of the All-Poly Tibial implant system while leveraging some of the modular, metal-backed systems (K090411, K182574, K243277). Using the All-Poly design, the articular surface, tibial baseplate, and stem are manufactured from a single component. This eliming from modularity, reduces the overall weight and subsidence risk, adds full radiolucency to the tibial implants, and comes at a reduced cost. Like the original All-Poly Implants, these new versions will be manufactured from GUR 1020 (Type 1) UHMWPE per ASTM F648.
To enhance the existing All-Poly Implant designs, the stem of these implants is being upgraded to the larger, finned stem/keel design from the modular Freedom® Total Knee System (K090411). This will provide the new All-Poly Tibial implanted stability post-operatively and allow surgeons to use the same instruments/surgical technique as the modular, metal-backed system. This will improve the harmony between the various Freedom® systems and ensure all produce the same strong clinical results.
This document is a 510(k) Premarket Notification from the FDA regarding a Knee Joint Prosthesis, specifically the Freedom Total Knee System (All-poly Tibial Plate). It does not contain information related to an AI/ML (Artificial Intelligence/Machine Learning) powered medical device. Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study data for an AI/ML device.
The document discusses substantial equivalence for a physical medical device (a knee implant) based on mechanical properties, design comparisons, and adherence to existing predicate devices. It does not mention any software, algorithms, or AI components that would require a study with acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC).
To provide the information you're asking for, I would need a document related to an AI/ML medical device.
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(255 days)
The Freedom® Total Knee System is indicated for the following:
• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components and Primary PCK Components only).
The Freedom® Porous Tibial Base Plate and Cementless Femoral Components are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.
The Freedom® Porous Tibial Base Plate is a line extension of the Freedom® Total Knee System comprising of tibial base plate components for cemented or uncemented use in total knee arthroplasty. Freedom® Porous Tibial Base Plates are intended for use with existing, compatible Freedom® femoral and tibial liner components. Freedom® Porous Tibial Base Plates are additively manufactured from Ti-6Al-4V ELI Grade 23 and include a porous lattice structure on the distal face. Freedom® Porous Tibial Base Plates are available in eight asymmetric design offerings (Sizes 1 – 8, Left / Right configurations), based on anterior / posterior (A/P) and medial / lateral (M/L) dimensions.
The provided document is a 510(k) premarket notification for a medical device, specifically the Freedom® Total Knee System - Porous Tibial Base Plate. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with strict acceptance criteria and performance analysis. Therefore, the information requested about acceptance criteria and a study proving the device meets them, typically found in a clinical trial report or a performance study for novel devices or software, is not directly applicable in the same way.
However, I can extract the information related to the non-clinical performance testing conducted to support the substantial equivalence claim. This testing serves as the "study" demonstrating that the device performs as intended and is similar to the predicate.
Here's an interpretation based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" for each test in the way a clinical trial might. Instead, the "acceptance" is implicitly defined by demonstrating that the subject device's performance is substantially equivalent to established performance standards or the predicate/reference devices. The "reported device performance" is summarized as the satisfactory completion of these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Tibial Tray Fatigue: Device must withstand fatigue loading per ASTM F1800. | All necessary testing performed. (Implies satisfactory performance meeting the standard). |
| Residual Particle Characterization: Device must meet acceptable levels of residual particles per ASTM F1877, comparable to literature. | Results were shown to be substantially equivalent to values presented in the literature for the reference device (K030623). |
| Porous Surface Characterization: Porous structure must meet specifications for various characteristics per ASTM F1854, F1160, F1044, F1978, F1147. | All necessary testing performed. (Implies satisfactory performance meeting the standards). |
| Sterilization: Device must achieve a sterility assurance level (SAL) of 10^-6 per ISO 11137-2. | Sterilization per ISO 11137-2. (Implies successful sterilization to the required SAL). |
| Endotoxin: Device must meet acceptable endotoxin levels per AAMI ST72. | Endotoxin per AAMI ST72. (Implies acceptable endotoxin levels). |
| Biocompatibility: Device materials must be biocompatible per ISO 10993-1, ISO 10993-5. | Biocompatibility per ISO 10993-1, ISO 10993-5. (Implies successful demonstration of biocompatibility). |
| Modular Disassembly: If applicable, modular components must meet disassembly force requirements (leveraged from reference device). | Modular disassembly testing was leveraged from the reference device (K090411) as the subject device uses an identical tibial insert locking mechanism. (Implies that the design similarity ensures equivalent performance without new testing). |
2. Sample sized used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of implants or test coupons used for each non-clinical test (e.g., how many tibial trays were fatigue tested). It mentions that "All testing was performed on worst case implants or test coupons as dictated by the relevant performance standards."
- Data Provenance: The tests are non-clinical (laboratory/mechanical testing), not human clinical data. Thus, terms like "country of origin" or "retrospective/prospective" are not applicable. The data originates from laboratory testing conducted by or for the manufacturer (Maxx Orthopedics, Inc.).
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 "test set" here refers to physical specimens (implants/coupons) for non-clinical testing, not patient data requiring expert interpretation or ground truth establishment. The "ground truth" for these tests is defined by the technical specifications and requirements of the referenced ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the tests are non-clinical, mechanical, and material evaluations performed against established standards, not clinical data requiring adjudication by experts.
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 is not applicable. The device is a physical knee implant, not an AI software or diagnostic tool used by human readers.
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 knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced ASTM and ISO standards. For example, the acceptable number of cycles for fatigue testing is defined by ASTM F1800. For residual particles, the "ground truth" is the acceptable range established in the literature for the reference device, as evaluated against ASTM F1877.
8. The sample size for the training set
This is not applicable. The device is a physical knee implant. There is no "training set" in the context of machine learning or AI. The manufacturing process is validated, and the device's design is based on engineering principles and existing predicate designs, not a data-driven training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
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(34 days)
The Freedom® Medial Congruent Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System. The Freedom® Total Knee System is indicated for the following:
- · Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, and polyarthritis.
- · Correction of functional deformities.
- · Post-traumatic loss of knee ioin contour, particularly when there is patellofemoral erosion.
- dysfunction, and/or prior patellectomy.
- · Moderate valqus, varus, or flexion trauma.
- · Knee fractures untreatable by other methods.
The Freedom® Medial Congruent Tibial Liner is intended for cemented use only. This device is for single use only.
Freedom® Medial Congruent Liners have been developed with the desire to achieve a higher level of constraint than typically achieved in a traditional CR knee design while also providing the femoral component with a medial-pivoting motion throughout a range of motion. They possess an anterior and buildup and a higher sagittal conformity of the medial compartment that interact with the femoral component, to provide additional constraint.
Designed to be used with the Freedom CR Femoral Component.
Eliminates the need to remove bone for a PS box.
Designed to allow high flexion.
Includes a deep anterior patellar cut-out to allow for tendon clearance.
Facilitates intraoperative flexibility, given compatibility with existing femoral and tibial baseplate options
The provided text is a 510(k) summary for a medical device called the "Freedom® Medial Congruent Liner." This document describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.
Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (Freedom Ultracongruent CR Tibial Liner, K182574) through non-clinical testing. Instead of specific numerical thresholds for performance, the acceptance is based on demonstrating equivalency or satisfactory performance relative to the predicate.
| Acceptance Criterion (Demonstrating Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Tibiofemoral Range of Motion (ASTM F2083 6.2.3): Equivalent maximum flexion angle. | Simulated Computer-Aided-Design software determined the range of motion (maximum flexion angle) of the Subject Device was equivalent to the Predicate Device. |
| Tibiofemoral Constraint Characterization (ASTM F1223 and F2083): Satisfy preestablished benchmark performance in comparison to the Predicate Device for anterior (A/P), medial/lateral (M/L), and internal/external constraint of the articular surface through various degrees of flexion. | The results satisfied the preestablished benchmark performance in comparison to the Predicate Device. |
| Tibiofemoral Contact Area and Contact Pressure (ASTM 2083 6.2.2): Equivalent throughout a range of motion compared to the Predicate Device. | The contact area and contact pressure was found to be equivalent throughout a range of motion compared to the Predicate Device. |
| Material: Identical to current Freedom UC tibial insert. | The material... of the MC tibial insert are identical to the current Freedom UC tibial insert. |
| Locking Tab Geometry: Identical to current Freedom UC tibial insert. | The... locking tab geometry of the MC tibial insert are identical to the current Freedom UC tibial insert. |
| Tibial Insert-Tray Disassembly Forces: Considered the same as for the MC tibial insert due to identical material and locking tab geometry. (No specific test reported, but inferred equivalence) | Given the identical material and locking tab geometry, disassembly testing is needed [to confirm, but implies expectation of equivalence]. |
| Sizing and Compatibility with Freedom CR Femoral Components: Same as for existing UC tibial inserts and femoral components. | The sizing and compatibility of the MC tibial inserts and the Freedom CR femoral components is therefore the same as for the existing UC tibial inserts and femoral components. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document indicates that the tests were performed on "the Subject Device." It does not specify a numerical sample size for the devices tested. Given that these are non-clinical (mechanical/simulation) tests, the "sample size" might refer to the number of simulations or physical prototypes tested, which is not stated.
- Data Provenance: The tests are non-clinical studies (simulations and characterization tests) rather than human subject data. Therefore, concepts like "country of origin" or "retrospective/prospective" do not apply. The data is generated from laboratory testing and computational modeling.
3. Number of Experts and Qualifications for Ground Truth
- This device's substantial equivalence is demonstrated through non-clinical engineering testing and simulation, not clinical data requiring expert review for "ground truth." Therefore, the concept of "experts" establishing ground truth in the radiological sense is not applicable here. The "experts" involved would be the engineers and scientists conducting and reviewing the test methods and results.
4. Adjudication Method for Test Set
- As this is non-clinical testing, there is no "adjudication method" in the sense of clinician review or consensus. The results are based on objective measurements and computational outcomes compared against predefined standards (ASTM standards) and the predicate device's performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not conducted or reported. This filing is for a medical implant (knee liner), not a software or AI product that assists human readers in diagnosis. The evaluation focuses on the mechanical and design properties of the implant itself.
6. Standalone (Algorithm Only) Performance
- No, this concept is not applicable. The device is a physical knee implant component, not a software algorithm.
7. Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" is derived from:
- Engineering Principles and Benchmarks: Adherence to established ASTM (American Society for Testing and Materials) standards (F2083, F1223).
- Computational Simulations: Computer-AAided-Design (CAD) software for range of motion.
- Direct Mechanical Comparison to Predicate Device: Physical and performance characteristics of the subject device are directly compared to those of the legally marketed predicate device.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The design and testing are based on engineering principles and comparison to a predicate, not data-driven model training.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set.
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(226 days)
The Freedom® - TiNbN Coated Knee is indicated for the following:
· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis.
· Correction of functional deformities.
· Post-traumatic loss of knee joint contour, when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
· Moderate valgus, varus, or flexion trauma.
- · Knee fractures untreatable by other methods.
· Revision surgery where sufficient bone stock and soft tissue integrity are present.
The Freedom® - TiNbN Coated Knee is intended for cemented use only. This device is for single use only.
The Freedom® - TiNbN Coated Knee comprises of Femoral Component and Tibial Component as described below,
- Femoral Knee Component CR and PS (Left and Right)
- Tibial Component (Tibial Base Plate)
Each of these components is described below.
The provided text does not describe a study involving an AI/ML powered medical device or a diagnostic device that would require the establishment of ground truth by experts or a comparative effectiveness study with human readers.
Instead, the document is a 510(k) premarket notification for the Freedom® - TiNbN Coated Knee, which is a knee joint prosthesis. The acceptance criteria and the "study" (referred to as "Non clinical Performance data") described in the document relate to the physical and material properties of this medical implant, not to a diagnostic or AI-driven system.
Therefore, I cannot answer your request based on the provided text, as the information you've asked for (such as ground truth establishment by experts, adjudication methods, multi-reader multi-case studies, and AI effect size) is irrelevant to the type of device described in the document.
The document discusses:
- Device Type: Knee joint prosthesis (mechanical implant).
- Purpose of Submission: Demonstrating substantial equivalence to legally marketed predicate devices for the purpose of market clearance.
- "Acceptance Criteria" / Performance Testing: Physical and material tests to ensure the implant meets safety and performance standards (e.g., wear resistance, coating adhesion, fatigue testing). This is not about diagnostic accuracy or AI performance.
- "Study" Data: Non-clinical (laboratory) performance data on the mechanical properties and coating characteristics of the knee implant.
If you have a document describing an AI/ML medical device, I would be happy to analyze it according to your criteria.
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(370 days)
The Libertas™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.
Total hip replacement is indicated for the following conditions:
- · Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Congenital hip dysplasia.
- · Acute traumatic fracture of the femoral head or neck.
- · Certain cases of Ankylosis.
- · Dislocation of the hip.
- · Correction of functional deformity.
- · Revision of failed joint reconstruction or treatment.
- · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.
Note
· The Modular Shell, Uncemented Stem and Taper Uncemented Femoral Stem are intended for press-fit, uncemented use only.
· The Cemented stem is intended for cemented use only.
This 510k is intended to add a Modular Liner made from Vitamin E containing HXLPE (E-XLPE) to the Libertas™ - Hip Replacement System and Libertas™ Acetabular Hooded Liner cleared under K180973 and K183365, respectively. These Modular Liners are designed to be used with the Libertas components already cleared under K180973. These are available in different sizes i.e. MA, MB, MD, MF, MH, MJ, MK and different variants for each size Viz, neutral offset, "+4 mm offset", "Elevated wall", "10° Oblique", "15° Oblique" and "+4 mm offset 10° Oblique".
This looks like a 510(k) summary for a medical device called the Libertas™ E-XLPE Modular Liner, which is a component for hip replacement systems. The document states that the device is substantially equivalent to previously cleared predicate devices.
However, the provided text does not contain information about a study proving the device meets acceptance criteria in the way typically seen for AI/ML-powered medical devices. The "Non-clinical Performance data" section describes a series of mechanical and material tests for the physical hip implant component, not a clinical study or AI/ML performance evaluation.
Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance studies (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training set details, or ground truth establishment).
Here's an analysis of what is present in relation to "acceptance criteria" and "proof":
Analysis of Provided Information Regarding Acceptance Criteria and Proof
The document focuses on demonstrating substantial equivalence to predicate devices through mechanical and material testing, which is the standard pathway for many Class II medical devices like this hip implant component. The "acceptance criteria" are implicitly tied to meeting the performance standards of these established predicate devices and the relevant ASTM/ISO standards.
The "study that proves the device meets the acceptance criteria" refers to the set of non-clinical bench tests listed.
1. A table of acceptance criteria and the reported device performance
Since this is a mechanical device, the "acceptance criteria" are the passing criteria for the referenced ASTM and ISO standards for properties like axial disassembly, offset pull-out, torque-out disassembly, impingement, range of motion, and material characteristics. The document states that these tests were "conducted to evaluate device function/mechanical performance and to demonstrate substantial equivalence," implying that the device met the acceptance criteria defined by these standards. However, the specific quantitative results of these tests and the exact thresholds for acceptance are not provided in this summary.
Implied Acceptance Criteria and Reported Performance (Based on available info):
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Axial Disassembly (ASTM F1820:13) | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| Offset Pull-out (ASTM F1820:13) | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| Torque-out Disassembly (ASTM F1820:13) | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| Impingement Test (ASTM F2582:14) | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| Range of Motion (ISO 21535-2007/Amd 1:2016) | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| Material Characterization (E-XLPE): | |
| ASTM F2565:13 | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| ASTM F2695:12 | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| ASTM F2759:11 | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| ASTM F648:14 | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| ASTM F2003:15 | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| ISO 5834-3:19 | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| ISO 5834-1:19 | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| ISO 5834-2:19 | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| Extraction Testing | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
| Biocompatibility testing | Implied to have met standard requirements for substantial equivalence. (Specific quantitative results not provided) |
2. Sample size used for the test set and the data provenance: Not applicable. These were non-clinical bench tests on physical devices, not a test set of data like in AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context refers to the results of the bench tests against established standards, not expert adjudication of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests would be the measured physical and material properties meeting the specifications outlined in the referenced ASTM and ISO standards.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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(28 days)
The Freedom® Primary PCK is designed to be used with the Freedom® Stemmed Tibial Components and as a part of the Freedom® Total Knee System, and is indicated for the following:
· Severe knee joint pain, loss of mobility due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
· Correction of functional deformities.
· Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
- · Moderate valgus, varus, or flexion trauma.
- · Knee fractures untreatable by other methods
· Revision surgery where sufficient bone stock and soft tissue integrity are present
The Freedom® Primary PCK is intended for cemented use only. This device is for single use only.
Not Found
I apologize, but the provided text from the FDA 510(k) clearance letter for the "Freedom Primary PCK" knee prosthesis does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device.
The document is a clearance letter for a physical medical device (a knee implant) and focuses on regulatory aspects like substantial equivalence to predicate devices, general controls, and indications for use. It does not mention any AI/ML components, performance metrics, or clinical study data related to an AI/ML algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Training set sample size.
- Ground truth establishment for the training set.
These details are typically found in the clinical study report or performance evaluation section of a submission for an AI/ML-driven device, which is not present in this regulatory clearance letter for a knee implant.
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(80 days)
The Libertas™ Acetabular Hooded Liner is intended for use in total hip arthroplasty, in conjunction with the Libertas™ Hip Replacement System. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.
Total hip replacement is indicated for the following conditions:
- · Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Congenital hip dysplasia.
- · Acute traumatic fracture of the femoral head or neck.
- · Certain cases of Ankylosis.
- · Dislocation of the hip.
- · Correction of functional deformity.
- · Revision of failed joint reconstruction or treatment.
- · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.
Not Found
This FDA letter for K183365, "Libertas™ Acetabular Hooded Liner," does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The provided text is a 510(k) clearance letter confirming that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, product codes, indications for use, and general controls, but does not delve into the technical performance of the device or how its safety and effectiveness were demonstrated through specific tests or studies.
Therefore, I cannot fulfill your request to describe acceptance criteria and associated studies based on the provided input. This type of information would typically be found in the more detailed 510(k) submission document itself, which is not included here.
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(126 days)
The Freedom® Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System. The Freedom® Total Knee System is indicated for the following:
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, and polyarthritis.
- Correction of functional deformities.
- Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods.
The Freedom® Ultra-Congruent Tibial Liner is intended for cemented use only. This device is for single use only.
The Freedom® Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System.
I apologize, but the provided text from the FDA 510(k) clearance letter for the Freedom Ultra-Congruent CR Tibial Liner does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The document is a standard FDA clearance letter confirming that Maxx Orthopedics, Inc. can market the device because it has been determined to be substantially equivalent to a legally marketed predicate device. It details:
- The regulatory classification and product code.
- The general controls provisions of the Act that apply.
- The Indications For Use for the device.
It does not include any technical performance specifications, clinical study results, or statistical analyses that would allow me to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study design, as that data is not present in the provided text.
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