Search Results

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis: disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonumon of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The femoral stem is for cementless use only.

The Zimmer M/L Taper Hip Prosthesis is a modular, titanium alloy femoral stem designed to replace the proximal femur in total hip arthroplasty. It is flat, collarless and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge shaped prosthesis is designed for cementless use and is circumferentially coated with titanium alloy plasma spray over the proximal body region. A subset of the subject devices are coated with Calcicoat hydroxyapatite tricalcium phosphate coating (HA/TCP) over the coating.

The provided text is a 510(k) summary for the Zimmer M/L Taper Hip Prosthesis, which describes its indications for use, technological characteristics, and a summary of performance data. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the detailed elements requested in your prompt.

Therefore, many of the requested elements (e.g., specific acceptance criteria, reported device performance metrics against those criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not present in this document.

This submission relies on non-clinical tests (performance testing, fatigue testing, range of motion testing) and states that clinical test data is not provided. The purpose is to show that the modified device is substantially equivalent to existing, legally marketed predicate devices, implying that if the predicates met their safety and effectiveness requirements, this device, being substantially equivalent, also meets them.

Here's a breakdown of what can be extracted or inferred, and what is explicitly not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not provide specific quantitative acceptance criteria (e.g., "fatigue strength must exceed X MPa") or detailed performance metrics (e.g., "fatigue strength was Y MPa"). It broadly states that tests were completed to "determine equivalence" and "show compatibility and safe and effective use."

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

• Test Set Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not specified, but likely from in-house laboratory testing given it's non-clinical. No mention of country of origin or retrospective/prospective nature as this is not a clinical study.

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

• Not Applicable. For non-clinical, mechanical tests, "ground truth" is typically established by engineering standards and measurement techniques, not human expert consensus.

4. Adjudication Method for the Test Set:

• Not Applicable. This is not a clinical or imaging study requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document explicitly states: "Clinical test data is not provided for the subject device." Therefore, no MRMC study was performed or reported here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not Applicable. This is a physical medical device (hip prosthesis), not an algorithm or AI system.

7. Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" would be engineering specifications, material properties, and mechanical performance standards, measured through established laboratory methods.

8. Sample Size for the Training Set:

• Not Applicable. This is a physical device, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It reports on non-clinical engineering tests to show the new device's performance aligns with legally marketed predicate devices. It does not contain the detailed clinical study information or AI algorithm validation data that your prompt is designed to elicit.

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Total hip replacement for patients with: severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for patients with: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
The femoral stem is for cementless use only.

The purpose of this submission is to update the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology Instructions for Use to include MR Conditional labeling within the precaution section. The device package label will also be updated to include the MR Conditional symbol. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization. The subject devices are intended for use in hip arthroplasty.

The provided text describes a 510(k) premarket notification for the "Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling." This submission is to update the Instructions for Use to include MR Conditional labeling, and therefore, does not involve studies proving clinical performance of the hip prosthesis itself. Instead, the studies focus on the MR safety of the device.

Here's an analysis of the provided information concerning the acceptance criteria and study proving MR safety:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text does not specify the sample size used for the non-clinical MR safety tests. The data provenance is not explicitly stated in terms of country of origin, but it is clear these were non-clinical (in-vitro/benchtop) tests, not studies on human subjects, so concepts like "retrospective or prospective" do not apply.

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

This information is not applicable. The "ground truth" for MR safety in this context is established by adherence to recognized ASTM standards (ASTM F2503-13, ASTM F2182-11a, ASTM F2119-07, ASTM F2052-14) for evaluating physical interactions of the device with an MR environment. This is a technical assessment rather than an expert clinical consensus.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for interpreting clinical data or images by multiple experts. For non-clinical bench testing, the results are objectively measured and evaluated against the established standard's criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission is for MR labeling, not for demonstrating the clinical effectiveness of the hip prosthesis itself or comparing human reader performance with and without AI assistance.

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

No, a standalone algorithm performance study was not done. This submission is about the MR safety of a physical implant, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these tests is defined by the acceptance criteria specified in the referenced ASTM standards for evaluating MR safety parameters (RF-induced heating, image artifact, magnetic displacement). These standards provide objective methodologies and pass/fail criteria.

8. The Sample Size for the Training Set

This information is not applicable. There is no AI algorithm being trained in this submission. The tests are physical evaluations of a medical device.

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

This information is not applicable, as there is no training set for an AI algorithm. The ground truth for the non-clinical tests is established by the methods and criteria outlined in the relevant ASTM standards for MR safety testing.

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Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disoular necrosis of thefemoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head: pathological fractures of the femoral neck: and osteoarthritis in which the femoral head is primarily affected.

The Zimmer M/L Taper Hip Prosthesis is a modular, titanium alloy femoral stem designed to replace the proximal femur in total hip arthroplasty. It is flat, collarless and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge-shaped prosthesis is designed for cementless use and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region. A subset of the subject devices are coated with Calcicoat hydroxyapatite tricalcium phosphate coating (HA/TCP) over the porous coating.

Please note that the provided text is a 510(k) summary for a medical device (Zimmer M/L Taper Hip Prosthesis), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria for a novel AI/software medical device.

Therefore, the requested information elements related to AI/software performance studies (such as acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document. The document describes a traditional medical device (hip prosthesis) and its non-clinical performance testing.

However, I can extract the information that is present in the document which aligns with your request for device performance and study details, interpreting "acceptance criteria" through the lens of device validation for mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for the proximal and distal fatigue testing or bacterial endotoxin testing.
The data provenance is non-clinical testing, performed by the manufacturer, Zimmer, Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This is not applicable as the document describes non-clinical mechanical and biological testing for a hardware device, not an AI/software medical device requiring expert-established ground truth. The "ground truth" here is the physical performance of the device against established standards.

4. Adjudication Method for the Test Set
This is not applicable for mechanical and biological non-clinical testing. Performance is assessed against quantitative standards outlined in the ISO and USP guidelines.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic AI/software devices, not for a hip prosthesis.

6. If a Standalone Performance Study was done
Yes, standalone (non-clinical) performance testing was done on the device itself. This included:

• Proximal fatigue testing to ISO 7206-6
• Distal fatigue testing to ISO 7206-4
• Bacterial endotoxin testing to USP39-NF34 Chapter 161

7. The Type of Ground Truth Used
For the non-clinical performance testing, the "ground truth" was defined by:

• Engineering performance standards (ISO 7206-6, ISO 7206-4) for mechanical properties.
• Biological safety limits (USP39-NF34 Chapter 161) for endotoxin levels.

8. The Sample Size for the Training Set
This is not applicable. The device is a physical hip prosthesis, not an AI/software algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for a physical device.

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Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The femoral stem is for cementless use only.

The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is a modular, wedge-shaped stem that is coated with Ti-6A1-4V titanium alloy plasma spray.

The provided text describes a 510(k) premarket notification for a hip prosthesis, not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable or mentioned in this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance as these are not relevant to this type of device submission based on the provided information.

However, I can extract the information that is relevant to the "acceptance criteria" and "study" for this particular device submission:

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

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: Not applicable. This submission relies on non-clinical testing of the device itself, not patient data in the context of an AI/ML test set.
• Data Provenance: Not applicable. The "data" refers to the results of non-clinical device testing, not patient data.

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. Ground truth as typically defined for AI/ML algorithms is not relevant here. Device performance is assessed through engineering and biocompatibility testing.

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 that assists human readers.

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

• Not applicable.

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

• Not applicable in the context of AI/ML. The "ground truth" for this device's performance is established by recognized engineering standards and biocompatibility requirements for hip prostheses.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

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Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

This femoral stem is for cementless use only.

The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is a modular, wedge-shaped stem that is coated with commercially pure titanium alloy plasma spray.

The modular neck options allow for soft tissue balancing and easier restoration of the hip joint center of rotation. The modularity feature will allow surgeons to independently equalize leg length and optimize offset while, at the same time, maximizing joint stability for a variety of patient anatomies.

The provided document describes a 510(k) premarket notification for the "Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System." This is a medical device submission for a hip prosthesis, and as such, the acceptance criteria and study data provided are related to the physical and mechanical performance of the device, not diagnostic or AI performance.

Therefore, many of the typical questions for AI/diagnostic devices regarding sample size, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of submission.

Here's the breakdown of the information that is applicable and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System met performance requirements and is as safe and effective as its predicate." The specific numerical or qualitative acceptance criteria for "performance requirements" are not detailed in this summary document. These would typically be established through recognized standards (e.g., ISO for implant materials and mechanical testing) and internal company specifications for the similar predicate device.

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

• Sample Size: Not specified. For non-clinical testing of a hip prosthesis, "samples" would refer to the physical devices or components subjected to laboratory tests (e.g., fatigue testing, wear testing).
• Data Provenance: Not specified, but inherently "non-clinical" (i.e., laboratory testing). The country of origin for the data is Zimmer, Inc. (Warsaw, IN, USA). The studies are prospective in the sense that they are conducted specifically for this submission, but they are not clinical studies on human subjects.

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

• Not applicable. For mechanical testing of medical devices like a hip prosthesis, "ground truth" is established by physical measurements, engineering principles, and adherence to recognized standards, rather than expert human interpretation.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review contexts, typically in diagnostic studies. This is a non-clinical device performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is for evaluating the impact of a diagnostic tool (often AI) on human reader performance, which is not relevant for a hip prosthesis itself. The comparison here is between the new device and its predicate device based on manufacturing, materials, and intended use, and non-clinical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This question pertains to AI algorithms. The Zimmer M/L Taper Hip Prosthesis with Kinectiv™ Technology System is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

• Engineering and Materials Standards / Predicate Device Performance: The "ground truth" for non-clinical testing of this device would be established by conforming to relevant industry standards (e.g., ISO standards for orthopedic implants), internal Zimmer specifications, and demonstrating equivalence to the performance of the legally marketed predicate device (Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology).

8. The Sample Size for the Training Set

• Not applicable. This question refers to machine learning models. This document describes a physical medical device.

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

• Not applicable. This question refers to machine learning models.

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Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

This femoral stem is for cementless use only.

The Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology is a modular, wedgeshaped stem that is coated with commercially pure titanium alloy plasma spray that is available with and without Calcicoat Ceramic Coating. This stem is designed for cementless use only.

The modular neck option allows for soft tissue balancing and easier restoration of the hip joint center of rotation. The modularity feature will allow surgeons to independently equalize leg length and optimize offset while, at the same time, maximizing joint stability for a variety of different patients' anatomies.

The provided text describes a 510(k) premarket notification for a medical device, the Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish independent safety and effectiveness.

Therefore, the requested information regarding acceptance criteria for a device's performance, a study proving it meets these criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not applicable in this context.

Here's why and what the document does provide:

1. Acceptance Criteria and Reported Device Performance:

   • Not applicable for this type of submission. A 510(k) does not typically involve setting specific performance acceptance criteria for a new device's performance that then needs to be met by a study. Instead, the device's design, materials, manufacturing, and intended use are compared to an existing predicate.
   • The document states: "Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis with Modular Neck Technology met performance requirements and is as safe and effective as the predicate devices." This is a general statement indicating comparative performance, not performance against independent numerical acceptance criteria.

2. Sample Size for Test Set and Data Provenance:

   • Not applicable. There is no "test set" in the sense of a clinical or retrospective dataset used to directly evaluate the device's performance against specific metrics. The non-clinical testing refers to bench testing (e.g., mechanical, fatigue, wear) to ensure the device performs similarly to the predicate under simulated conditions. The document does not specify sample sizes for these tests.

3. Number of Experts and Qualifications for Ground Truth:

   • Not applicable. There is no "ground truth" to establish in the context of expert review for diagnostic accuracy or similar performance metrics. The assessment is primarily engineering-based for mechanical properties and a comparison to the predicate's known safety and efficacy profile.

4. Adjudication Method:

   • Not applicable. No human adjudication of results is described, as there isn't a complex diagnostic or outcome assessment being performed by human readers for the device itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable. MRMC studies are used to assess the diagnostic accuracy or effectiveness of an imaging algorithm or diagnostic device, often comparing human reader performance with and without AI assistance. This device is a hip implant, not an imaging or diagnostic AI device.

6. Standalone Performance Study:

   • Not applicable. A "standalone" study typically refers to the algorithmic performance of an AI or diagnostic device without human interaction. This device is a physical implant.

7. Type of Ground Truth Used:

   • Not applicable. Ground truth for clinical outcomes or diagnostic accuracy is not relevant here. The "proof" is based on non-clinical engineering testing and the demonstrated conceptual equivalence to established predicate devices.

8. Sample Size for Training Set:

   • Not applicable. This device is a physical hip implant, not a machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established:

   • Not applicable. As above, no training set for an algorithm is involved.

In summary, the provided document is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of materials, design, and intended use, rather than detailed clinical studies with specific performance acceptance criteria, expert adjudication, or AI algorithm evaluation.

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Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The Zimmer M/L Taper Hip Prostheses are flat, collarless, modular femoral stems with a proximal to distal taper in the mediolateral plane. The prostheses are circumferentially coated with titanium alloy plasma spray over the proximal body region and are available in standard and extended offset options, with or without Calcicoat Ceramic Coating. An additional size option and an additional neck length option are being added to the previously cleared Zimmer M/L Taper Hip Prosthesis system.

Here's an analysis of the provided text regarding the Zimmer® M/L Taper Hip Prosthesis, focusing on acceptance criteria and study information:

Based on the provided document, the device described (Zimmer® M/L Taper Hip Prosthesis) is a medical implant in the orthopedic category, specifically for hip replacement. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously cleared devices, rather than prove safety and effectiveness through extensive clinical trials for novel devices.

Therefore, the "acceptance criteria" and "study" described in the document are primarily focused on demonstrating substantial equivalence to predicate devices, rather than performance against a set of quantitative metrics for a new, innovative device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary. There was no specific "test set" of patients or data evaluated for a de novo performance study. The assessment was based on comparing the device's design, materials, and intended use against existing predicate devices.
• Data Provenance: Not applicable for a clinical test set. The "data" used for demonstrating equivalence would be design specifications, material characterizations, and existing regulatory information from the predicate devices.

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

• Number of Experts: Not applicable. Given that "Clinical data and conclusions were not needed for this device," there was no "ground truth" to be established by panels of experts in the traditional sense of a clinical trial. The "experts" involved were likely internal Zimmer engineers and regulatory specialists, and subsequently, FDA reviewers who assessed the substantial equivalence claim.
• Qualifications of Experts: FDA reviewers are typically well-versed in engineering, medical device regulations, and relevant clinical fields, but their role here was not to establish clinical ground truth for a novel device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set to adjudicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical data and conclusions were not needed for this device." This type of study is typically performed to compare the diagnostic performance of a new medical imaging device or AI algorithm with human readers, and it is not relevant for a hip prosthesis 510(k) submission focused on substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This device is a passive hip prosthesis, not an active device, diagnostic tool, or an AI algorithm. Therefore, "standalone performance" in the context of an algorithm or diagnostic device is irrelevant.

7. The Type of Ground Truth Used

• Type of Ground Truth: In this 510(k) context, the "ground truth" is established by the legally marketed predicate devices. The new device's design, materials, and intended use are considered "true" in so far as they are substantially equivalent to these already-cleared devices, meaning they are considered safe and effective for their intended purpose. There is no external clinical ground truth (e.g., pathology, outcomes data) generated specifically for this submission.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of a hip prosthesis 510(k) submission. This concept applies primarily to machine learning algorithms or devices requiring iterative development based on data.

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

• Ground Truth for Training Set: Not applicable, as there was no training set.

Summary of the Study and Acceptance Criteria for K060040:

The "study" supporting the Zimmer® M/L Taper Hip Prosthesis (K060040) was a non-clinical analysis to demonstrate substantial equivalence to already legally marketed predicate devices. The acceptance criteria were met by demonstrating that the modified device (an additional size and neck length option for an existing line) shares the same technological characteristics, intended use, and performs comparably in non-clinical assessments (as implied by the "Analysis of the modified devices indicates that they are substantially equivalent to the predicates") such that it raises no new questions of safety or effectiveness. No new clinical data or human-in-the-loop studies were required or conducted for this particular submission.

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Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating is a modular, titanium alloy femoral stem designed to replace the proximal human femur in total hip arthroplasty. It is flat, collarless, and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge-shaped prosthesis is designed for cementless use and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region. Calcicoat® Ceramic Coating (hydroxyapatite tricalcium phosphate [HA/TCP]) has been added to the porous coating to aid bony ingrowth.

This document describes a 510(k) premarket notification for a medical device, the Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data with detailed acceptance criteria and performance metrics against human readers or pathology.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, expert adjudication, MRMC studies, standalone algorithm performance, and sample sizes for training/test sets as would be found in AI/ML device submissions are not applicable here.

The crucial information provided relates to the non-clinical performance and comparison to a predicate device.

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)

• Not applicable for this type of submission. This submission relies on non-clinical testing and comparison to a predicate device, not a human reader performance study or a clinical test set with a specific sample size of cases in the way an AI/ML device would. The "test set" here refers to the physical samples of the device undergoing non-clinical tests. The document does not specify the number of hip prostheses tested. The provenance would be the manufacturing site (Warsaw, IN, USA).

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. "Ground truth" in the context of this device does not pertain to expert review of images or data, but rather to the physical, chemical, and mechanical properties of the device as assessed through non-clinical testing.

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

• Not applicable. Adjudication methods are relevant for clinical trials or expert consensus in data labeling, which is not part of this 510(k) submission.

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

• No. This is a medical device (hip prosthesis), not an AI/ML diagnostic or assistive tool. Therefore, MRMC comparative effectiveness studies are not relevant.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• The "ground truth" for this device's performance is established through non-clinical testing (e.g., mechanical strength, wear resistance, biocompatibility, coating adhesion, etc.) according to recognized standards and engineering principles, demonstrating that it meets performance requirements and is equivalent to the predicate device.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged: nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The Zimmer® M/L Taper Hip Prosthesis is a modular, titanium alloy femoral stem designed to replace the proximal human femur in total hip arthroplasty. It is flat, collarless, and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge-shaped prosthesis is designed for cementless use and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region.

This document, K032726, is a 510(k) premarket notification for a medical device called the "Zimmer® M/L Taper Hip Prosthesis." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving safety and effectiveness through extensive clinical trials with acceptance criteria for device performance as would be seen for novel devices or those undergoing a PMA.

Therefore, the requested information about acceptance criteria, detailed study designs, sample sizes, expert involvement, and ground truth establishment, does not directly apply in the same way as it would for a study proving the efficacy and safety of a novel device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

There are no explicit quantifiable acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) reported for this device in this 510(k) summary, as it is a hip prosthesis, not a diagnostic AI device.

Instead, the "performance" demonstrated is substantial equivalence to predicate devices based on non-clinical testing.

• Acceptance Criteria (Implied for 510(k) substantial equivalence): The device must demonstrate similar material properties, mechanical performance (e.g., fatigue strength, fixation), and intended use as the predicate devices. It must not raise new questions of safety or effectiveness.
• Reported Device Performance:
  • "Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis met performance requirements and is as safe and effective as the predicate devices."

2. Sample Size for Test Set and Data Provenance:

• Test Set Description: The document refers to "Non-clinical testing." This typically involves laboratory testing of physical device samples (e.g., in vitro mechanical tests, material characterization). It's not a "test set" in the context of clinical data for AI algorithms.
• Sample Size: The document does not specify the number of hip prostheses samples tested.
• Data Provenance: Not applicable in the context of clinical data. It would be lab-generated data.
• Retrospective/Prospective: Not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This pertains to establishing ground truth for diagnostic or prognostic algorithms, not for the mechanical testing of a hip implant. The "ground truth" here would be established by validated engineering testing standards and protocols.

4. Adjudication Method:

• Not applicable. Adjudication relates to expert consensus on clinical data for algorithms.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, this was not done. MRMC studies are specific to evaluating diagnostic imaging systems or AI algorithms with human readers. This device is a hip prosthesis.

6. Standalone (Algorithm Only) Performance:

• No, this was not done. This device is a physical hip prosthesis, not an algorithm.

7. Type of Ground Truth Used:

• Engineering Standards and Benchmarking against Predicate Devices: The "ground truth" for this device's performance would be established through adherence to recognized international and national standards for orthopedic implants (e.g., ISO, ASTM standards for fatigue, material properties) and comparison to the known performance characteristics of the predicate devices. This is implied by "Non-clinical testing."

8. Sample Size for Training Set:

• Not applicable. "Training set" refers to data used to train machine learning models. This is a physical medical device.

9. How Ground Truth for Training Set Was Established:

• Not applicable. As above, there is no "training set" in this context.

In summary, for K032726, the "study" demonstrating the device meets "acceptance criteria" is a set of non-clinical (laboratory/mechanical) tests to show substantial equivalence to already cleared predicate devices. The 510(k) pathway does not typically require or present the kind of detailed clinical efficacy and safety data, expert reviews, and ground truth establishment that would be seen for novel diagnostic algorithms or drugs.

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