Search Results

The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NDJD): 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® Acetabular Insert with XLPE ("Insert with XLPE") is a permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The Insert with XLPE is fully compatible for use with the previously cleared Klassic HD® Hip System and is manufactured from UHMWPE crosslinked by gamma irradiation. The Insert with XLPE is sterilized by ethylene oxide gas and intended for single-use only.

The provided text describes a 510(k) premarket notification for a medical device, the Klassic HD® Hip System, specifically focusing on the Klassic HD® Acetabular Insert with XLPE. This filing addresses substantial equivalence to predicate devices rather than proving a device meets specific performance criteria in a clinical setting in the way an AI/ML medical device might.

Therefore, the information required to answer your specific questions about acceptance criteria and a study that proves the device meets the acceptance criteria regarding AI/ML device performance (e.g., sensitivity, specificity, expert ground truth, MRMC studies) is not present in the provided document.

The document discusses non-clinical bench testing to support substantial equivalence. While it mentions "pre-determined acceptance criteria" for this bench testing, it does not specify what those criteria are or provide detailed results from a clinical study.

Here's an breakdown of why your questions cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document states that "bench testing results demonstrated that the Klassic HD® Acetabular Insert with XLPE is substantially equivalent and does not raise new questions of safety or effectiveness for total hip joint replacement when compared to the predicate devices." It also says the device "met the pre-determined acceptance criteria." However, it does not list these specific criteria (e.g., thresholds for wear, strength, etc.) nor does it present the quantitative results against those criteria.
2. Sample sizes used for the test set and the data provenance: This refers to clinical data for performance evaluation. The document only mentions "non-clinical bench testing" and "extensive material characterization." There is no mention of a human test set, data provenance (country, retrospective/prospective), or data collection methods for a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts for the test set: Not applicable as no clinical test set using expert judgment is described.
4. Adjudication method for the test set: Not applicable as no clinical test set using expert judgment is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. The study described is non-clinical bench testing, not a study involving human readers or cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hip implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical bench testing, "ground truth" would relate to engineering standards, material properties, and mechanical performance metrics (e.g., ultimate tensile strength, wear rates). The specific metrics are not detailed, but the document mentions "material characterization," "sterility validation," "Push Out, Lever Out, Axial Torque Disassembly and Impingement testing."
8. The sample size for the training set: Not applicable. This document describes a physical medical device (hip implant), not an AI/ML model that requires training data.
9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML model or training set discussed.

In summary, the provided document details a 510(k) submission for a physical medical device (hip implant), focusing on non-clinical bench testing for substantial equivalence. It does not provide the kind of information typically found in an AI/ML device submission regarding clinical performance, expert readers, or ground truth establishment relevant to AI algorithm validation.

Ask a specific question about this device

The Klassic HD™ Hip System is intended for prosthetic replacement in treatment of the following:

· Patient conditions of non-inflammatory degenerative joint disease (NID)D): 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 a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum. leg length. offset and version. The purpose of this 510(k) is to add Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems to the Klassic HD® Hip System. The modified stems can be mated with the previously cleared metal (CoCrMo) or ceramic femoral heads and UHMWPE acetabular components of the Klassic HD® Hip System.

The provided document is a 510(k) premarket notification for a medical device called the "Klassic HD™ Hip System." It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, the document does not contain information regarding detailed acceptance criteria, specific study designs, sample sizes for test or training sets, expert qualifications, or adjudication methods that would typically be found in a clinical study report or a more comprehensive technical document.

Therefore, I cannot provide the requested information for acceptance criteria and the study proving device performance in the format you specified.

The closest information available is related to engineering analyses and testing to establish substantial equivalence to predicate devices. This is not a study proving clinical acceptance criteria in the way you've described for AI models with ground truth and human reader comparisons.

Here's what can be extracted from the document regarding the engineering testing used to show substantial equivalence:

Acceptance Criteria and Device Performance (Based on Engineering Testing for Substantial Equivalence):
The document states that "The test results and analyses demonstrated that the modified stems are substantially equivalent to the predicate components." While specific numerical acceptance criteria are not explicitly detailed, the implied acceptance criterion for these engineering tests is successful completion without failure, indicating performance comparable to or better than the predicate devices.

Missing Information (Not available in the provided document):

• Sample size used for the test set and data provenance: Not applicable in the context of the mentioned engineering tests. These are likely cadaveric or mechanical testing, not a dataset of patient cases.
• Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. The "ground truth" for engineering tests is typically based on material science, biomechanical principles, and established testing standards.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, this is not an AI device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the engineering tests, the "ground truth" would be the successful completion of the tests according to established biomechanical and material standards for hip implants, demonstrating equivalence to already approved predicate devices. It's not a clinical "ground truth" as you'd find for a diagnostic AI.
• The sample size for the training set: Not applicable (this is not an AI device).
• How the ground truth for the training set was established: Not applicable (this is not an AI device).

Summary of available information:

The document describes an engineering evaluation for a hip implant system to demonstrate substantial equivalence to previously cleared predicate devices. The evaluation included Range of Motion testing, worst-case fatigue testing, and engineering analyses of disassembly properties and porous coating properties. The results of these tests and analyses were deemed sufficient to show substantial equivalence. This is a common approach for 510(k) clearances of mechanical devices, where the focus is often on material properties, design specifications, and biomechanical performance rather than clinical trials with patient outcomes or AI performance metrics.

Ask a specific question about this device

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 a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum, leg length, offset and version. The Klassic HD™ Hip System can be mated with metal (CoCrMo) or ceramic femoral heads and UHMWPE acetabular components.

This document is a 510(k) summary for a medical device called the "Klassic HD™ Hip System." It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a previously cleared device. However, it does NOT include the specific details needed to answer most of your detailed questions about acceptance criteria and study particulars for a standalone AI algorithm.

This document pertains to a physical orthopedic implant (hip system), not software, AI, or an imaging device. Therefore, many of your questions about AI study design, such as sample size for test/training sets, expert adjudication, MRMC studies, and ground truth types like pathology or outcomes data, are not applicable in this context.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not specified. The document only mentions "the company performed burst strength testing, fatigue testing, post-fatigue burst strength testing and pull-off testing." It does not state how many units were tested for each.
• Data Provenance: Not applicable in the context of device performance testing. These are material/mechanical tests, not patient data trials.

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 question is not applicable. The "ground truth" here refers to the physical properties and mechanical performance of the femoral heads. These are established through standardized engineering tests, not expert consensus or clinical evaluation in the way an AI algorithm's ground truth would be.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This question is not applicable. Adjudication methods are relevant for subjective assessments or when multiple human readers interpret data. For mechanical testing, the "ground truth" is typically the measured value against a pre-defined engineering specification.

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 document describes the testing of a physical hip implant component, not an AI or imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This question is not applicable. The device is a physical hip system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" here is based on engineering specifications and measurements from mechanical testing (burst strength, fatigue, post-fatigue burst strength, and pull-off testing). This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• This question is not applicable. There is no training set for a physical device being evaluated through mechanical testing.

9. How the ground truth for the training set was established:

• This question is not applicable. There is no training set mentioned in this document.

In summary: This 510(k) pertains to a physical medical device (hip implant) and its mechanical properties. The provided text outlines that mechanical tests were performed to demonstrate substantial equivalence, and those tests met pre-determined acceptance criteria. However, it lacks the specific numerical results of those tests and the detailed methodologies that would be required to answer questions typically asked about AI/software device studies.

Ask a specific question about this device

The Klassic HDTM 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 Offset Femoral Stem is a femoral component to be used within the Klassic HD Hip System as a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by helping to achieve proper leg length and offset. The Klassic HD Offset Femoral Stem is offered in both porous and non-porous options. Each configuration of the Klassic HD Offset Femoral Stem is offered in 9 sizes, is sterilized by gamma irradiation and is intended for single-use only.

Here's an analysis of the provided text regarding the Klassic HD™ Offset Femoral Stem, focusing on the acceptance criteria and the study performed, structured according to your requested points:

The provided 510(k) summary for the Total Joint Orthopedics Klassic HD™ Offset Femoral Stem describes a medical device component, not a software or AI-driven diagnostic device. Therefore, the information typically requested for AI/ML device studies regarding ground truth, expert adjudication, MRMC studies, and training/test sets is not directly applicable in this context.

Instead, the "acceptance criteria" and "study" refer to bench testing to demonstrate the physical and mechanical performance of the femoral stem and its substantial equivalence to predicate devices. The primary goal is to show that the new design (with a different neck shaft angle and offset) performs as safely and effectively as existing, legally marketed devices.

Here's the breakdown based on the provided text, reinterpreting the questions for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The exact numerical acceptance criteria (e.g., specific load cycles for fatigue testing, exact force for disassembly) are not explicitly stated in this summary but are implicit by referring to industry guidance and ASTM standards. The reported performance is a general statement that the device meets these criteria and is equivalent to predicates.

2. Sample Size Used for the Test Set and Data Provenance

This concept is not applicable as this is a physical medical device. The "test set" would refer to the number of physical samples of the femoral stem tested. The text does not specify the exact number of stems tested for each physical test (e.g., 5 stems for fatigue, 3 for disassembly).

• Data Provenance: Not applicable in the sense of patient data. The "provenance" of the testing is non-clinical bench testing, conducted in a laboratory environment, guided by FDA guidance (e.g., "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses") and ASTM standards (e.g., "ASTM F1814-97a - Standard Guide for Evaluating Modular Hip and Knee Joint Components").

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. "Ground truth" for a physical device like this is established through validated engineering tests following recognized standards, not by expert consensus on clinical data. The "experts" involved would be engineering and testing personnel, but their number and specific qualifications are not detailed beyond the general statement of following guidance and standards.

4. Adjudication Method for the Test Set

Not applicable. Test results for physical device characteristics are typically quantitative and objective (e.g., did it break or not, what was the force to disassemble). There is no "adjudication" in the sense of reconciling different expert opinions.

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

For this physical device, the "ground truth" is based on:

• Physical and Mechanical Performance Standards: Demonstrated by adherence to recognized national/international standards (e.g., ASTM F1814-97a) and FDA guidance for similar devices.
• Comparison to Predicate Devices: The key "ground truth" here is the performance characteristics of the legally marketed predicate devices. The new device must demonstrate "substantial equivalence" in these characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in that context.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of device.

Summary of the Study and Conclusion for the Klassic HD™ Offset Femoral Stem:

The study involved non-clinical bench testing on physical samples of the Klassic HD™ Offset Femoral Stem. These tests included:

• Neck fatigue testing
• Stem fatigue testing
• Axial disassembly evaluation
• Torsional disassembly evaluation
• Range of motion determination

The testing was conducted based on established guidance from the FDA ("Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses, Document 1647 dated September 17, 2007") and ASTM standards ("ASTM F1814-97a - Standard Guide for Evaluating Modular Hip and Knee Joint Components").

The objective of the study was to demonstrate that the Klassic HD™ Offset Femoral Stem is substantially equivalent to its predicate devices (Klassic HD Hip System, K100445, and Alloclassic Zweymuller SL Offset Femoral Stem, K033664) in terms of safety and efficacy. The conclusion drawn from these bench tests was that "All bench testing and evaluation demonstrates the Klassic HD Offset Femoral Stem is equivalent in regards to safety and efficacy, is suitable for Total Hip Arthroplasty and is substantially equivalent to predicate devices." This substantial equivalence determination was upheld by the FDA in their 510(k) clearance letter (K133832).

Ask a specific question about this device

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 is simple, easy to use, and based on clinically proven design philosophies. The Klassic HD Hip System employs a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum, leg length, offset and version.

The Klassic HD Hip System is comprised of modular components with varying sizes available for each component for a cementless hip joint replacement application. Components of the Klassic HD Hip System include the femoral stem, femoral head, femoral head adapter sleeve, acetabular cup, acetabular insert and cancellous bone screws. The implantable components are intended for single-use for a single patient only.

The titanium alloy femoral stems feature a neck shaft angle of 131°. Femoral stems are available in sizes 1-9 with neck lengths of 26-38mm in 4mm increments and stem lengths of 110-150mm in 5mm increments. The stem's proximal surface is either grit-blasted or porous-coated. Cobalt chromium femoral heads available in 32mm or 36mm diameters attach either directly to the stem trunnion or through the use of an adapter sleeve thereby offering -3.5mm, neutral, +3.5mm and +7mm offsets. The titanium alloy, hemispherical acetabular cups are available in 9 sizes ranging from 48-64mm in 2mm increments and incorporate a porous coated outer surface. The UHMWPE acetabular inserts attach through a snap-fit mechanism to the acetabular cup. Conventional, noncross-linked (32mm inner diameter) and cross-linked (32mm and 36mm inner diameter) UHMWPE insert versions are available in the Klassic HD Hip System. Both types of UHMWPE material have been utilized in previously cleared devices. Optional 6.5mm cancellous, titanium alloy bone screws allow for additional fixation of the acetabular cup to the bone.

The provided text is a 510(k) Premarket Notification for a medical device called the "Klassic HD™ Hip System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through bench testing for mechanical performance, rather than clinical studies on human subjects. Therefore, many of the requested categories related to clinical study design, such as sample size for test/training sets, data provenance, expert qualifications, adjudication methods, and MRMC studies, are not applicable in this context.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating mechanical performance that is "substantially equivalent" to predicate devices, and in accordance with recognized standards for orthopedic implants. The reported performance is that the device "exhibit[s] the appropriate mechanical characteristics for total hip joint replacement."

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in terms of number of physical test units, but the testing was "extensive bench testing" conducted on "the worst case femoral constructs" and "the worst case acetabular constructs" and "the worst case cancellous bone screw." This implies a selection of representatives for the most challenging use conditions.
   • Data Provenance: The study was a bench test (laboratory testing) of the physical device components. There is no human or patient data involved. Therefore, country of origin is not applicable in the typical sense; the testing was performed to U.S. FDA standards as part of a 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. The "ground truth" for bench testing of mechanical properties is established by engineering standards and measurement techniques, not by expert medical opinion or consensus. The "truth" is the physical measurement of the device's performance against predefined engineering specifications.

3. Adjudication method for the test set:

   • Not Applicable. As this was a bench test evaluating mechanical properties, there was no need for adjudication as typically understood in clinical studies (e.g., resolving discrepancies in expert interpretations). The results are objective physical measurements.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This was a premarket notification for a physical orthopedic implant, not a diagnostic or AI-driven decision support system. Therefore, MRMC studies and AI-related effectiveness are Not Applicable.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. See point 4. This is not an algorithm or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this study was engineering specifications and recognized standards for orthopedic implant mechanical performance. The device's performance was compared to these established benchmarks and to the performance of predicate devices.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. The device itself is the product being tested, not an algorithm being trained.

8. How the ground truth for the training set was established:

   • Not Applicable. See point 7.

Ask a specific question about this device