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510(k) Data Aggregation
(217 days)
Total Joint Orthopedics, Inc.
The Klassic HD® Hip System is intended for prosthetic replacement without bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular . necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists. ●
- Revision of a previously failed hip arthroplasty. ●
- Patients who require a total hip replacement. ●
The Klassic HD Hip System employs prostheses designed to help surgeons restore hip joint biomechanics. The purpose of this 510(k) is to add the Platform Acetabular System consisting of the Platform Acetabular Shell with Ti-Coat and Platform Acetabular Inserts with E-Link (Neutral and Hooded) to the Klassic HD Hip System. The Platform Acetabular Shells are fabricated from Ti6Al4V per ASTM F136 and the Platform Acetabular Inserts with E-Link are made from Vitamin E. UHMWPE material. The subject acetabular components are available in various sizes ranging in outer diameters of 44mm to 64mm to match patient anatomy and are compatible with 28mm, 32mm, and 36mm heads. The subject components are provided sterile, for single use, by prescription only.
The provided document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Platform® Acetabular System. This document does not describe a study involving an AI/Machine Learning device, nor does it present acceptance criteria and performance data for such a device in the manner requested.
Instead, this document pertains to a hip joint prosthesis, specifically acetabular components (shells and inserts). The "performance data" discussed relates to mechanical and material testing of these implantable devices, not to an AI's diagnostic or predictive capabilities.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device (AI/ML) meets these criteria, as the provided text describes a medical implant. The information in the prompt about "AI vs without AI assistance," "standalone algorithm performance," "number of experts," and "ground truth" is not applicable to the content of this FDA clearance letter.
To answer your request, I would need a document describing the testing and validation of an AI/Machine Learning device.
However, I can extract the information relevant to the mechanical device described in this document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table with explicit "acceptance criteria" and "reported device performance" in the typical AI/ML context (e.g., sensitivity, specificity, AUC). Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to predicate devices. The implicit "acceptance criterion" for these tests is that the subject device's performance must be comparable to or better than the predicate devices and meet relevant ASTM/ISO standards to ensure safety and effectiveness.
| Test Performed | Implied Acceptance Criterion (from a regulatory perspective) | Reported Device Performance Summary (from document) |
|---|---|---|
| Push out testing (ASTM F1820-13) | Performance comparable to predicate devices and within standard limits for secure fixation. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Lever out testing (ASTM F1820-13) | Performance comparable to predicate devices and within standard limits. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Axial Torque Disassembly Testing (ASTM F1820-13) | Performance comparable to predicate devices and within standard limits for construct stability. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Impingement Testing (ASTM F2582-20) | Performance comparable to predicate devices and within standard limits for range of motion and impingement resistance. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Acetabular Shell Fatigue Testing (ASTM F3090-20) | Resistance to fatigue comparable to predicate devices and meeting standard requirements for expected service life. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Deformation Testing (ISO 7206-12) | Deformation properties comparable to predicate devices and within standard limits. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Material wear (engineering analysis) | Wear characteristics comparable to predicate devices, demonstrating acceptable long-term performance. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| Range of motion (engineering analysis) | Range of motion comparable to predicate devices, supporting intended function. | "Testing and engineering analyses demonstrated that the subject acetabular components perform as safe and effective compared to the predicate components and are substantially equivalent to the predicate." |
| LAL testing requirements | Compliance with LAL (Limulus Amebocyte Lysate) testing for endotoxin levels to ensure sterility/safety. | "Additionally, the Klassic HD® Hip System is in compliance with LAL testing requirements for orthopedic implants." |
2. Sample size used for the test set and data provenance:
This document describes physical and engineering tests on manufactured components (hip implants), not data analysis on a medical image dataset. Thus, "sample size for the test set" would refer to the number of physical components tested for each mechanical property, which is not specified in detail (e.g., "N=X components"). The "data provenance" is derived from these physical tests conducted by the manufacturer as part of their submission to the FDA. The tests are "non-clinical" (i.e., not involving human subjects).
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. "Ground truth" in this context refers to established engineering and material science standards (ASTM, ISO). Expert mechanical engineers and material scientists would design and interpret these tests, but it's not analogous to clinical expert consensus for image labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a clinical study involving human readers or interpretation.
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 document is not about an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is not about an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the material and mechanical properties of the device is established by ASTM and ISO international standards for orthopedic implants, and the comparative performance to legally marketed predicate devices.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
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(370 days)
Total Joint Orthopedics, Inc.
The Klassic Knee System is intended for prosthetic replacement in treatment of the following:
· Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- · Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Klassic Knee System is indicated for cemented use only, except for the Klassic Femur with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®, which are indicated for cementless use.
The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts and Ultra-PS® Tibial Inserts, which are fabricated with E^X Poly, to the Klassic® Knee System. E^X Poly is a crosslinked UHMWPE containing alpha-tocopherol. The subject Klassic® Knee CR/Congruent and Ultra-PS® Tibial Inserts are available in various sizes and thicknesses to match patient anatomy.
The provided text is a 510(k) summary for the Klassic Knee System, focusing on the addition of new tibial inserts. It outlines the device description, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML or diagnostic performance.
The document primarily describes the regulatory submission for a physical medical device (knee implants) and its substantial equivalence to previously cleared devices based on bench testing and engineering analyses for wear, stability, stress, range of motion, and modular disassembly. It does not mention any AI/ML components, digital image analysis, or diagnostic performance evaluation studies that would typically involve acceptance criteria for metrics like sensitivity, specificity, or AUC, or require a test set with ground truth established by experts.
Therefore, I cannot extract the requested information (1-9) from the provided text. The document is about a mechanical orthopedic implant, not a diagnostic AI/ML device.
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(60 days)
Total Joint Orthopedics, Inc.
The Klassic® Knee System is intended for prosthetic replacement of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NID): avascular necrosis and osteoarthritis
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- · Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
The Klassic® Femur with Aurum®, is being introduced as a line extension for use with the Klassic® Knee System for cemented implantation during total knee arthroplasty. The Klassic® Femur with Aurum® is manufactured from Titanium alloy (Ti6Al4V per ASTM F136) with a titanium nitride surface.
The provided text is a 510(k) Premarket Notification for a Knee Joint Prosthesis (Klassic® Knee System). It details the device's indications for use, its classification, and a comparison to predicate devices, particularly focusing on a new line extension, the Klassic® Femur with Aurum®.
This document does not contain any information regarding AI/ML device performance testing, clinical studies with human readers, or ground truth establishment relevant to AI/ML systems. The "acceptance criteria" discussed are likely related to the mechanical and biocompatibility performance of the knee implant, not an AI/ML algorithm's diagnostic accuracy.
Therefore, I cannot provide an answer based on the prompt's request for AI/ML device performance without the presence of such information in the provided text.
The closest relevant sections in the provided text are:
- Non-Clinical Bench Testing and Engineering analyses: These were performed to evaluate the physical properties of the Klassic® Femur with Aurum® (e.g., strength of coating, fatigue, wear, stability, contact stress, range of motion, patella-femoral resistance). This refers to the mechanical integrity and function of the physical implant, not an AI algorithm.
- LAL testing requirements for orthopedic implants: This refers to Limulus Amebocyte Lysate testing for bacterial endotoxins, a biocompatibility test, not an AI algorithm's performance.
To answer your request, the input text would need to describe a study evaluating an AI/ML algorithm's performance, including details such as:
- Acceptance criteria for algorithm metrics (e.g., sensitivity, specificity, AUC).
- Test set characteristics (sample size, data provenance, image types).
- Ground truth establishment (number and qualifications of experts, adjudication methods).
- Human reader studies (MRMC design, effect sizes of AI assistance).
- Standalone algorithm performance.
- Training set details (sample size, ground truth methodology).
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(21 days)
Total Joint Orthopedics, Inc.
The Klassic® Knee System is intended for prosthetic replacement of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur with Cobalt 3D®, and the Klassic® Tibial Baseplate with Ti-Coat® which are indicated for cementless use.
The purpose of this Special 510(k) is to add the Klassic® Tibial Inserts, PS-Max®, an additional posterior stabilizing design option, to the Klassic® Knee System (K112906). The Klassic® Tibial Inserts, PS-Max® are available in various sizes and thicknesses to match patient anatomy and provide surgical options.
This submission describes the Klassic® Knee System Tibial Inserts, PS-Max®, a medical device intended for prosthetic replacement in knee arthroplasty. The submission is a Special 510(k), meaning it aims to add a new design option to an already cleared Klassic® Knee System (K112906). The primary goal is to demonstrate substantial equivalence to a predicate device, the Klassic® Tibial Inserts, PS-Post™ (K183596).
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the subject device met pre-determined acceptance criteria for various verification activities. However, it does not explicitly list the quantitative acceptance criteria or the specific reported device performance values in a table format within the provided text. It generally states that the device "met the pre-determined acceptance criteria" and that "the results of analysis and testing indicate that the subject tibial inserts are substantially equivalent to the predicate components."
The types of tests performed indicate the areas for which performance criteria would have been established:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Femoral/Tibial Stability Characteristics | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Contact Stress Evaluation | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Range of Motion | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Knee Simulator Wear | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Tibial Insert Post Strength and Fatigue | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Tibial Insert Modular Disassembly | Indicated to be substantially equivalent to the predicate. (Specific values not provided) |
| Compliance with LAL requirements for orthopedic implants | "in compliance with LAL requirements for orthopedic implants." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance. It only mentions "Bench testing and engineering analysis were performed." This implies laboratory-based testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study appears to be engineering and bench testing, not involving human expert assessment of a test set for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. The study focused on bench testing, which doesn't typically involve adjudication in the clinical sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes bench testing and engineering analysis, not a clinical MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This question is not directly applicable as the device is a physical knee implant component, not a software algorithm. The "standalone" performance here refers to the physical properties of the insert as tested in a lab, separate from human implantation. The bench tests performed are essentially the "standalone" evaluation of the device's physical and mechanical characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this type of device (physical implant) is established by engineering specifications, industry standards (e.g., LAL requirements), and comparative performance with a legally marketed predicate device. The tests performed (stability, contact stress, range of motion, wear, strength, fatigue, modular disassembly) are designed to assess these physical and mechanical properties against pre-defined engineering targets and the performance of the predicate.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not a machine learning or AI device that requires a "training set."
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(98 days)
Total Joint Orthopedics, Inc.
The Klassic® Knee System is intended for prosthetic replacement of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- Patients with failed previous surgery where pain, deformity, or dysfunction persists
- Correctable varus-valgus deformity and moderate flexion contracture
- Revision of a previously failed knee arthroplasty
- Patients who require a total knee replacement.
The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
The Klassic® Knee System employs prostheses designed to help surgeons restore knee joint biomechanics intra-operatively. The purpose of this 510(k) is to add the posterior stabilizing Klassic® Knee Femur, PS-Post; Klassic Femoral Pegs; and the Klassic® Tibial Insert, PS-Post with Standard Poly; and the Klassic® Tibial Insert, PS-Post with E-Link® Poly; to the Klassic Knee System. The subject femoral and tibial components are available in various sizes and thicknesses to match patient anatomy.
The document provided is a 510(k) premarket notification letter from the FDA to Total Joint Orthopedics, Inc. regarding their Klassic Knee System. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations. While it mentions that "All results met the predetermined acceptance criteria," it does not provide the specific acceptance criteria or the detailed study results that prove the device meets these criteria.
Therefore, I cannot extract the requested information from this document.
Missing Information:
- Detailed Acceptance Criteria: The document states that "All results met the predetermined acceptance criteria," but it does not list what those criteria are.
- Specific Device Performance Data: While it mentions types of engineering analysis and testing (e.g., Modular Peg Strength Analysis, Knee Simulator Wear, Tibial Insert Post Fatigue), it does not provide the reported performance values that resulted from these tests.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set Information): None of this detailed study information is present in the provided FDA letter. This type of information would typically be found in the 510(k) submission summary or a more detailed technical report, not in the FDA's clearance letter itself.
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(35 days)
Total Joint Orthopedics, Inc.
The Klassic Knee System is intended for prosthetic replacement in treatment of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Klassic Knee System is indicated for cemented use only, except for the Klassic Femur with Cobalt 3D™, and the Klassic Tibial Baseplate with Ti-Coat®. which are indicated for cementless use.
The purpose of this 510(k) is to add size 5, 10mm Sombrero Patella components in Standard Poly and E-Link Poly to be used in conjunction with the Klassic® Knee System during total knee replacement. The components are manufactured from ultrahigh molecular weight polyethylene or Vitamin E blended ultrahigh molecular weight polyethylene with a 40mm diameter and 10mm thickness.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the product submitted in K190280:
The document (K190280) describes a 510(k) submission for new sizes of patella components (size 5, 10mm Sombrero Patella in Standard Poly and E-Link Poly) to be added to the existing Klassic® Knee System. The primary method of demonstrating substantial equivalence is through engineering analyses and comparison to predicate devices that are already cleared.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Conformance | Not explicitly detailed in the provided text as specific numerical criteria, but implied to be within acceptable limits for knee prosthetic components. | "The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of conformance. This implies they meet the same or similar conformance standards as the previously cleared predicate devices (K150105 & K180159). |
| Contact Area | Not explicitly detailed in the provided text as specific numerical criteria, but implied to be within acceptable limits for knee prosthetic components to ensure proper articulation and wear characteristics. | "The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of contact area. This implies they maintain appropriate contact area similar to the previously cleared predicate devices. |
| Contact Stress | Not explicitly detailed in the provided text as specific numerical criteria, but implied to be within acceptable limits to prevent material degradation and ensure longevity of the implant. | "The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of contact stress. This suggests the contact stresses are within acceptable physiological and material limits, comparable to the predicate devices. |
| Mechanical Strength | Not explicitly detailed in the provided text as specific numerical criteria, but implied to be sufficient to withstand the physiological loads and stresses experienced in a knee joint over the expected lifespan of the implant. | "The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of mechanical strength. This implies the new components possess adequate strength comparable to the predicate devices. |
| Peg Geometry | Not explicitly detailed in the provided text as specific numerical criteria, but implied to be consistent with the existing Klassic Knee System to ensure proper fixation and compatibility. | "The results of these analyses indicate that the subject Sombrero Patellae are substantially equivalent to the predicate Sombrero Patellae" in terms of peg geometry. This ensures the pegs are properly sized and shaped for intended use and fixation within the larger Klassic Knee System. |
| LAL Testing | Compliance with LAL (Limulus Amebocyte Lysate) testing requirements for orthopedic implants, typically to ensure absence of endotoxins. The specific acceptance criteria for LAL are standardized but not detailed here. | The subject components are in "compliance with LAL testing requirements for orthopedic implants." This indicates they passed the standard LAL test, demonstrating a safe level of endotoxins. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a clinical study with a "test set" in the traditional sense of patient data. Instead, it relies on engineering analyses and comparison to predicate devices. Therefore:
- Sample Size for Test Set: Not applicable as it's not a clinical study with patient data. The "test set" would be the specific physical components (size 5, 10mm Sombrero Patellae) that were subjected to the engineering analyses. The number tested is not specified but would typically be one or more samples per analysis to ensure consistency.
- Data Provenance: Not applicable as it's engineering analysis, not patient data from a specific country or collected retrospectively/prospectively. The analyses are performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. For engineering analyses, "ground truth" is established through engineering principles, material science, and regulatory standards, not by expert consensus on clinical images or outcomes.
- Qualifications of Experts: The analyses would be performed by qualified engineers or technicians with expertise in biomaterials, biomechanics, and medical device testing, but this is not a ground truth establishment by clinical experts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no ambiguous patient data requiring adjudication. The results of the engineering analyses are typically objective measurements and calculations compared against established criteria or predicate device performance.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This is a medical device for knee replacement components, not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, this is not an AI/algorithm-driven device. It's a physical orthopedic implant.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" in this context refers to the established performance characteristics and safety profile of the predicate devices (size 1-4 Sombrero Patellae, K150105 & K180159), as well as established engineering and material science principles and regulatory standards for orthopedic implants. The new device components are deemed substantially equivalent if they meet these established engineering performance benchmarks or demonstrate comparable performance to the predicates.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable.
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(30 days)
Total Joint Orthopedics, Inc.
The Klassic HD® Hip System is intended for prosthetic replacement without bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJ): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of a previously failed hip arthroplasty.
- Patients who require a total hip replacement.
The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The purpose of this Special 510(k) is to add smaller sizes of the Acetabular Cups, Acetabular Inserts, and Ceramic Femoral Heads and to add both smaller and predicate sizes of Hooded and Low Profile Acetabular Inserts with XLPE material.
This document is a 510(k) Summary for the Klassic HD® Hip System, a medical device for hip replacement. It generally outlines the device's indications for use, description, predicate devices, and a statement of substantial equivalence to previously cleared devices.
However, the document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the way requested in the prompt. It states that "all results met the pre-determined acceptance criteria identified in the Design Control Activities" and that the "information summarized in the Design Control Activities Summary demonstrates that the modified Klassic HD® Hip System met the pre-determined acceptance criteria for the verification activities." It also lists the types of testing performed (e.g., burst strength testing, fatigue testing, wear testing, etc.) and the relevant ISO and ASTM standards.
Crucially, the document explicitly says that the details of the acceptance criteria and the study results are "summarized in the Design Control Activities Summary," which is not provided in the input text.
Therefore, I cannot provide the specific details requested in your prompt based solely on the provided text. The document acts as a summary and refers to another internal document for the detailed evidence of compliance.
Key Missing Information:
- Specific Acceptance Criteria: The document mentions "pre-determined acceptance criteria" but does not list them.
- Reported Device Performance: While it states the device "met" the criteria, the actual performance values are not provided.
- Sample Sizes: No sample sizes are mentioned for any of the tests.
- Data Provenance: No information on the origin of data (country, retrospective/prospective).
- Experts/Ground Truth: This type of medical device (hip implant) does not typically involve "experts establishing ground truth" in the diagnostic AI sense. Its acceptance criteria relate to mechanical and material performance, not diagnostic accuracy. Therefore, questions about expert numbers, qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable in this context.
- Training Set Sample Size/Ground Truth: Not applicable for this type of device.
What the document does state regarding testing:
- Engineering analysis and testing included: burst strength testing, fatigue testing, post-fatigue burst strength testing, pull-off testing of ceramic femoral heads (per ISO 7206-10), push-out, lever-out, axial torque disassembly (per ASTM F1820), Range of Motion (per ISO 21535), impingement testing (per ASTM F2852), and wear testing (per ISO 14242).
- LAL testing requirements: The device is in compliance with LAL testing requirements for orthopedic implants per AAMI ST-72.
- Conclusion: "all results met the pre-determined acceptance criteria identified in the Design Control Activities."
In summary, while the document confirms that testing was done and acceptance criteria were met, it does not provide the details of those criteria or the results, stating they are in the "Design Control Activities Summary."
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(49 days)
Total Joint Orthopedics, Inc.
The Klassic® Knee System is intended for prosthetic replacement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJ): . avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis ●
- Patients with failed previous surgery where pain, deformity, or dysfunction . persists
- . Correctable varus-valgus deformity and moderate flexion contracture
- Revision of a previously failed knee arthroplasty .
- . Patients who require a total knee replacement
The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts with E-Link®, Ultra-PS® Tibial Inserts with E-Link®, Sombrero Patellae with E-Link® and Domed Patellae with E-Link® ("E-Link® Knee Components") to the Klassic® Knee System. These components are manufactured from E-link®, a Vitamin E blended UHMWPE crosslinked by gamma irradiation. The E-Link® Knee Components are available in various sizes and thicknesses to match patient anatomy.
The provided text is a 510(k) summary for the Klassic® Knee System. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML-enabled device. The document is for a traditional medical device (knee replacement system) and focuses on substantial equivalence based on engineering analyses and bench testing, rather than performance metrics related to diagnostic or predictive accuracy.
Therefore, I cannot provide the requested information. The document does not describe any AI/ML model.
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(28 days)
Total Joint Orthopedics, Inc.
The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- · Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- · Revision of a previously failed hip arthroplasty.
- Patients who require a total hip replacement.
The Total Joint Orthopedics Klassic HD® Hooded Acetabular Insert with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly are permanently implanted devices for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The subject inserts are fully compatible for use with the previously cleared Klassic HD® Hip System and are manufactured from UHMWPE crosslinked by gamma irradiation and infused with vitamin E. The subject inserts are sterilized by ethylene oxide gas and intended for single-use only.
This document is a 510(k) premarket notification for a medical device, a hip implant. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing details of a study on device performance that would typically include acceptance criteria and specific performance metrics like those for an AI/ML diagnostic tool. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this text.
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance
The document states that "The information summarized in the Design Control Activities Summary demonstrates that the Klassic HD® Hooded Acetabular Inserts with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly meet the pre-determined acceptance criteria for the verification activities." It also lists the types of tests performed.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Lever out strength | Pre-determined | Met acceptance criteria |
| Push Out Strength | Pre-determined | Met acceptance criteria |
| Torque Disassembly Strength | Pre-determined | Met acceptance criteria |
| Impingement | Pre-determined | Met acceptance criteria |
| Wear | Pre-determined | Met acceptance criteria |
| LAL testing | Requirements | In compliance |
Note: The specific numerical values for the acceptance criteria and the device's performance are not provided in this summary. The document only confirms that the "pre-determined acceptance criteria" were met.
The remaining questions (2-9) are largely not applicable or cannot be answered from the provided text, as this is a regulatory submission for a physical orthopedic implant, not a software or AI/ML-based diagnostic device. The document describes mechanical performance testing and equivalency to a predicate device, not a "study" in the sense of clinical trials or AI model validation.
Here's why and what limited information could be inferred:
- 2. Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical implants, not a "test set" of data. The document does not specify the number of implants tested in each category.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance tests is established by engineering standards and measurements, not expert radiologists or similar medical professionals.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is irrelevant for mechanical testing of an implant.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI/ML diagnostic tools, not an orthopedic implant.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML diagnostic tools, not an orthopedic implant.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical tests, the ground truth would be physical measurements and established engineering standards and methodologies. The document does not elaborate further.
- 8. The sample size for the training set: Not applicable. This is for AI/ML models. For a physical device, "training" would refer to design iterations and early testing.
- 9. How the ground truth for the training set was established: Not applicable for AI/ML sense. For device development, "ground truth" during design would involve engineering principles, materials science, and testing against industry standards.
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(59 days)
Total Joint Orthopedics, Inc.
The Klassic® Knee System is intended for prosthetic replacement with the use of bone cement of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- · Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Klassic® Knee System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to add All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS® to the Klassic Knee System. These components are manufactured with ultrahigh molecular weight polyethylene (UHMWPE). The CR/Congruent and Ultra-PS® A11-Poly Tibias are available in sizes to match various patient anatomies.
This document is an FDA 510(k) premarket notification for a medical device, the Klassic® Knee System. This type of document is a regulatory submission to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not typically a study report designed to "prove" a device meets specific acceptance criteria in the way a clinical trial or performance study would. It focuses on engineering analyses and comparisons to predicate devices for safety and effectiveness.
Therefore, the requested information elements related to clinical studies, ground truth establishment, expert review, sample sizes for test and training sets, and MRMC studies are largely not applicable or not present in this type of regulatory filing. The "acceptance criteria" here refer to the engineering performance criteria used to demonstrate substantial equivalence, not clinical performance metrics.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Engineering) | Reported Device Performance |
|---|---|
| Material: Ultrahigh molecular weight polyethylene (UHMWPE) | The new components (All-Poly Tibias, CR/Congruent and All-Poly Tibias, Ultra-PS®) are manufactured from UHMWPE, consistent with predicate devices and established material for orthopedic implants. |
| Biocompatibility: LAL (Limulus Amebocyte Lysate) testing | The All-Poly Tibias have undergone LAL testing and are in compliance with requirements for orthopedic implants, ensuring they do not cause clinically significant adverse reactions due to endotoxins. |
| Mechanical Performance: Contact Area and Surface Stress | Engineering analyses were performed. The results indicate these aspects are substantially equivalent to the predicate components, suggesting similar wear characteristics and load distribution. (Specific numerical criteria not provided in this summary). |
| Mechanical Performance: Overall Strength | Engineering analyses were performed. The results indicate overall strength is substantially equivalent to the predicate components, suggesting the device can withstand expected physiological loads. (Specific numerical criteria not provided in this summary). |
| Mechanical Performance: Cement Fixation Features | Engineering analyses were performed. The results indicate cement fixation features are substantially equivalent to the predicate components, implying comparable stability and longevity of the cemented implant. (Specific numerical criteria not provided in this summary). |
| Design/Function Equivalence to Predicate Devices | The information summarized in the Design Control Activities Summary demonstrates that the subject All-Poly Tibias met the "pre-determined acceptance criteria for the verification activities" by being substantially equivalent to predicate Klassic Knee System (K112906, K140942, K150105, K153075, K153310) and Natural Knee II All-Poly Tibia (K936159). |
| Intended Use Equivalence to Predicate Devices | The device is intended for prosthetic replacement with bone cement for conditions like NIDJD, IJD, failed previous surgery, correctable varus-valgus deformity, and revision, which are consistent with the predicate indications. |
| Modular Components with Varying Sizes | The new components are available in sizes to match various patient anatomies, consistent with the modular design of the Klassic Knee System. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable for a clinical test set. The submission refers to "Engineering analyses" for mechanical performance. These analyses would typically involve simulated testing (e.g., finite element analysis, structural testing) rather than a clinical "test set" of patients.
- Data Provenance: The analyses are based on engineering principles and relevant standards for orthopedic implants, likely conducted by the manufacturer or a contract lab. Specific countries of origin are not mentioned, but the submission is to the U.S. FDA. The data is pre-market verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. This document describes engineering verification testing, not a clinical study requiring expert ground truth establishment for a diagnostic output.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpretation of results by multiple readers. This document outlines engineering test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done including effect size of improvement with AI vs without AI assistance
- Not applicable. This device is a total knee replacement system, not an AI-powered diagnostic or assistive technology. 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 a physical medical device (knee implant), not an algorithm or software. "Standalone performance" in this context would refer to the mechanical performance of the implant itself, which is what the engineering analyses assess.
7. The Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance: The "ground truth" for this type of submission is typically established by recognized engineering standards (e.g., ISO, ASTM for orthopedic implants) and the established performance and safety profile of the legally marketed predicate devices. The new device's engineering performance is compared against these benchmarks to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This document does not describe the development of an algorithm or AI model that would require a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an algorithm, this question is not relevant.
In summary: This FDA 510(k) summary focuses on demonstrating that a modified knee implant system is substantially equivalent to existing predicate devices through engineering analyses and material compliance, rather than presenting a clinical study with detailed patient data, expert reviews, or AI performance metrics.
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