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This device is indicated for:

• Moderate to severe knee instability
• Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or proximal tibia
• Valgus, varus or flexion deformities
• The salvage of previously failed surgical attempts
• A total femoral replacement consisting of Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
• Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.
• Fluted stem extensions require the use of either a smooth or Trabecular, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.
• The Trabecular Metal collar may be used cemented or uncemented against the bone.
• All other constructs are for cemented use only.

The subject devices are intended for use in limb salvage arthroplasty.

This FDA 510(k) summary for the Zimmer® Segmental System does not describe a study involving a test set, expert ground truth, or an acceptance criteria table for device performance in the sense of an AI/ML or diagnostic imaging device determining a clinical outcome.

Instead, the document details a premarket notification for a knee and hip prosthesis system. The "performance data" section focuses on non-clinical tests to ensure the device's safety, compatibility (especially in an MRI environment), and mechanical integrity. It explicitly states that no clinical data was provided for the subject devices.

Therefore, most of the requested information regarding ground truth, expert consensus, MRMC studies, standalone performance, and training sets is not applicable to this submission.

However, I can extract the information that is present related to the "acceptance criteria" and "study" proving the device's adherence to safety and performance standards for a medical implant like this.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance for Zimmer® Segmental System (K192798)

This submission focuses on demonstrating the safety and effectiveness of the Zimmer® Segmental System as a knee and hip prosthesis, primarily through non-clinical testing and comparison to predicate devices, rather than through a clinical performance study with human subjects or an AI algorithm.

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

The document doesn't provide a quantitative "acceptance criteria" table in the format of precision, recall, or accuracy for a diagnostic device. Instead, the acceptance is based on meeting established standard test methods and internal criteria for the physical and material properties of the implant, especially regarding safety in an MRI environment and mechanical integrity.

Conclusion on Substantial Equivalence: "Non-clinical tests provided in this Traditional 510(k) establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment, as well as any differences do not raise new questions of safety and effectiveness. The subject devices are substantially equivalent to the legally marketed predicated devices."

2. Sample sizes used for the test set and the data provenance

• Sample Size: The document does not specify quantitative sample sizes for each non-clinical test (e.g., number of implant samples tested for fatigue). These are typically determined by the requirements of the specific ASTM or ISO standard applied.
• Data Provenance: The tests were non-clinical (laboratory/engineering tests) performed by Zimmer, Inc. The document does not specify a country of origin for the internal testing data, but the company is based in Warsaw, Indiana, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission.

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

Not applicable in the context of this device. "Ground truth" for an implant device is established through meeting material specifications, standardized mechanical performance, and biocompatibility requirements. This involves engineering and scientific expertise (materials scientists, mechanical engineers, etc.) in designing and testing the device, and regulatory experts validating compliance with standards, rather than clinical experts establishing a "ground truth" on patient outcomes for a test set.

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

Not applicable. Adjudication methods are relevant for clinical studies or studies using human readers/interpreters where disagreements need to be resolved. This submission relies on objective, repeatable non-clinical laboratory test results.

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 or diagnostic imaging device. No MRMC study was conducted.

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

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

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

For this type of device, the "ground truth" is defined by:

• Compliance with recognized industry standards (e.g., ASTM, ISO standards for MRI safety, biocompatibility, packaging).
• Demonstration of mechanical properties (e.g., fatigue strength, stress analysis) meeting design specifications necessary for intended use.
• Material properties meeting specified requirements (e.g., specific metal alloys, polymers).
• Demonstration that the manufacturing process consistently produces devices meeting these specifications (e.g., endotoxin limits).

These are validated through established laboratory test methods and engineering principles.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

Not applicable. (See #8)

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This device is indicated for:

• Moderate to severe knee instability
• Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or distal femur and/or proximal tibia
• Valgus, varus or flexion deformities
• The salvage of previously failed surgical attempts
  · A total femoral replacement construct consisting of MOST Options or Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
  · Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.
  · Fluted stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.
  • The Trabecular Metal collar may be used cemented or uncemented against the bone.
  • All other constructs are for cemented use only.

The Zimmer Segmental System Proximal Femoral Component is an implantable device, designed to replace the proximal portion of the natural femur. It is manufactured from Tivanium Ti-6Al-4V alloy. The subject device contains suture holes located on the medial and lateral sides for soft tissue attachment, a proximal male taper permitting use with various femoral head components, and a distal female taper that allows for attachment with compatible Zimmer Segmental System components.
The subject modifications are changes to the manufacturing process for the Zimmer Segmental System Proximal Femoral Component.

The provided text is a 510(k) summary for the Zimmer Segmental System Proximal Femoral Component. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) summary states:

• "Clinical data was not deemed necessary for the o subject device."
• "Non-Clinical Tests: Cleaning validation, including analysis of o bacterial endotoxin, organic contaminants, inorganic contaminants and cytoxicity."

This indicates that the submission primarily focused on demonstrating substantial equivalence through non-clinical tests related to cleaning validation and manufacturing process changes, rather than a performance study measuring specific clinical outcomes or device functionality against defined acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details from this document. The device's approval appears to be based on its similarity to existing, legally marketed predicate devices, with the changes primarily being to the manufacturing process.

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This device is indicated for:

• Moderate to severe knee instability
• Sigmificant bone loss and/or ligament deficiencies caused by neoplasms, traumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or proximal tibia.
• Valgus, varus or flexion deformities
• The salvage of previously failed surgical attempts
• A total femoral replacement consisting of the MOST Options® or Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
• Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.
• · Fluted stem extensions require the use of either a smooth or Trabecular, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.
• · The Trabecular Metal collar may be used cemented or uncemented against the bone.
• All other constructs are for cemented use only.

The Zimmer Segmental System is intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration. The Segmental System provides for cross compatibility between selected components from the MOST Options® System and NexGen® Rotating Hinge Knee System. A total mid-calf to hip replacement can be achieved using the Segmental System. The cleared distal femoral and the proposed distal femoral components are designed to be compatible with standard NexGen patella components.

I am sorry, but the provided text is a 510(k) summary for a medical device (Zimmer Segmental System XT Components), which focuses on establishing substantial equivalence to a predicate device. It does not describe a study that proves the device meets acceptance criteria in the context of an AI/ML device.

Therefore, I cannot extract the information requested regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document explicitly states under "Clinical Performance and Conclusions:" that "Clinical data and conclusions were not needed for this device." and mentions "results of non-clinical (lab) component fatigue performance testing" but does not provide details on specific acceptance criteria or performance metrics in a way that aligns with an AI/ML device evaluation.

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General Indications for the Segmental System:

• This device is indicated for: .
  • Moderate to severe knee instability
  • Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle
  • Valgus, varus or flexion deformities
  • The salvage of previously failed surgical attempts

Indications specific to the Variable Stiffness Stem extensions:

• Variable Stiffness stem extensions require the t use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone, but the remainder of the stem must be used uncemented.

The Variable Stiffness Stem extensions are intended to be used in the proximal and mid-shaft portion of the femur. They are available in either straight or bowed geometry and are made from Zimaloy™ Cobalt-Chromium-Molybdenum Alloy.

The Intercalary Segments are intended for the replacement of the mid-shaft portion of the femur or for use as a segment connected to other Zimmer® Segmental System components. They are made from Tivanium™ Ti-6Al-4V Alloy.

The provided text describes the Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments, a total hip prosthesis. The information focuses on its regulatory clearance (K081860) and comparison to predicate devices. However, it explicitly states:

"Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective."
"Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

This indicates that the acceptance criteria were based on non-clinical (lab) performance testing, and no clinical study was conducted or required for this 510(k) clearance. Therefore, a direct answer to some of the requested points, particularly those related to a clinical study, cannot be provided from the given document.

Here's the breakdown of the available information:

Acceptance Criteria and Device Performance

Since clinical data was not required, the acceptance criteria and performance are based on non-clinical (lab) testing comparing the device to its predicate devices. The document implies that the device met these non-clinical criteria by stating: "Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective."

Detailed Information Regarding the Study (where applicable from provided text)

1. Sample size used for the test set and the data provenance: Not applicable, as clinical studies with patient test sets were not performed or required. The testing referred to as "non-clinical (lab) performance testing" would involve mechanical or material samples, not human subjects.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring human expert ground truth was used.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication was used.

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: Not applicable. This device is a physical medical implant, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical implant.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical (lab) performance testing, the ground truth would likely be based on established engineering benchmarks, material science standards, and performance characteristics of the predicate devices, rather than clinical outcomes or expert consensus on patient data.

7. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set in that context.

8. How the ground truth for the training set was established: Not applicable, as per point 7.

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• This device is indicated for:
  • Moderate to severe knee instability
  • Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle
  • Valgus, varus or flexion deformities
  • The salvage of previously failed surgical attempts
• A total femoral replacement construct consisting of MOST Options proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
• Fluted stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar and the remainder of the stem must also be cemented against the bone.
• The Trabecular Metal collar may be used cemented or uncemented against the bone as long as the remainder of the stem extension is cemented.
• All other constructs are for cemented use only.

The Zimmer® Segmental System is a fully constrained cemented knee prosthesis intended to replace the distal femur and/or total knee in cases that require extensive resection and restoration. The Segmental Knee System provides for cross compatibility between selected components from the MOST System and the NexGen Rotating Hinge Knee Systems. When used with MOST System proximal femur and NexGen Rotating Hinge Knee tibial baseplates, a total mid-calf to hip replacement can be achieved. The distal femoral components are designed to be compatible with all current NexGen patella components. The Segmental System is a modular system comprised of fluted stem extensions, segments, articular surfaces and distal femoral components. The prosthesis is designed to be used with NexGen patellar and tibial components as well as the MOST System proximal femoral component.

Here's an analysis of the provided text regarding the Zimmer® Segmental System, focusing on acceptance criteria and the study proving it:

It's important to note that the provided documentation is a 510(k) premarket notification summary for a medical device. This type of submission relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials with predefined acceptance criteria for novel device performance.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for a 510(k) typically refers to demonstrating that the new device is as safe and effective as its predicate. For the Zimmer® Segmental System, the core acceptance criterion is substantial equivalence to the predicate devices. The performance data presented focuses on justifying this equivalence.

Study Details

The document states: "Clinical data were not needed for this device." This is a critical piece of information. Therefore, many of the typical questions for a clinical study involving AI or novel technology are not applicable here. The "study" proving the device meets acceptance criteria is primarily non-clinical (lab) performance testing.

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

   • Test Set Sample Size: Not specified. The document only mentions "non-clinical (lab) performance testing." Details on the number of components, configurations, or test repetitions are not provided in this summary.
   • Data Provenance: Not specified, but implied to be from Zimmer, Inc.'s internal or contracted lab testing.

2. 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. Since no clinical data or human interpretation was used to establish ground truth for a test set, there were no experts involved in this capacity. The "ground truth" for non-clinical testing would be measured physical properties (e.g., strength, fatigue life) against established engineering standards or predicate device performance.

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

   • Not Applicable. No human adjudication of a test set (e.g., images for diagnosis) was performed as clinical data was not used.

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:

   • Not Applicable. This is not an AI device, and no MRMC study or AI assistance was involved.

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

   • Not Applicable. This is a physical knee prosthesis, not an algorithm.

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

   • For the non-clinical testing, the "ground truth" would be engineering specifications, material properties, and mechanical performance standards relevant to orthopedic implants. Comparisons would likely have been made to the performance characteristics of the predicate devices under similar testing conditions.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device, so there is no training set in that context. If "training set" refers to design and development iterations, that information is not provided.

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

   • Not Applicable. As there is no training set in the AI/ML sense, this question does not apply.

Summary of the "Study" Proving Acceptance Criteria:

The Zimmer® Segmental System received 510(k) clearance based on non-clinical (lab) performance testing which demonstrated the device is "safe and effective." This testing would have focused on mechanical properties, material integrity, and other engineering characteristics to show that the new device performs comparably to its predicate devices, thereby establishing substantial equivalence. No clinical studies or human-in-the-loop performance evaluations were deemed necessary for this particular submission.

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