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The Patient Specific Distal Femur is intended for the replacement of diseased or deficient bone in the distal femur. It is indicated for:
Limb salvage procedures where radical resection and replacement of the bone is required Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Ligament deficiencies Tumor resection Revision of previously failed total joint arthroplasty Trauma

The Patient Specific Distal Femur and its components are for single use only.

The Patient Specific Distal Femur and is components are for cemented use only.

The Patient Specific Distal Femur is a patient-specific system that is intended for the replacement of diseased or deficient bone in the distal femur. The Patient Specific Distal Femur and its components are intended for cemented use only. The system is comprised of a range of stems, collars coated with hydroxyappetite (HA) or without coating (stippled or smooth), a range of shafts, femoral components (including axle, bushes and circlip), bumpers and a femoral epiphysis component, (i.e. SMILES TKR).

The materials used in the manufacture of the Patient Specific Distal Femur include titanium alloy (Ti-6Al-4V), cobalt-chromium-molybdenum (Co-Cr-Mo) and ultra-high molecular weight polyethylene (UHMWPE).

The device is for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "Patient Specific Distal Femur." It is a regulatory approval document and, as such, does not contain the detailed study information typically found in a scientific paper or clinical trial report.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Explanation: The document states, "The Patient Specific Distal Femur has been evaluated through non-clinical performance testing for disassembly of the distal femur and fatigue and wearing testing of the knee. The Patient Specific Distal Femur met all of the acceptance criteria." However, it does not specify what those acceptance criteria were (e.g., specific load endurance limits, wear rates, etc.). It only confirms that the device passed them.

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

• Sample Size for Test Set: Not specified. This document only mentions "non-clinical performance testing," which implies mechanical or lab testing, not human subjects.
• Data Provenance: Not applicable for non-clinical testing in terms of geographic origin or retrospective/prospective human data. The testing was conducted on the device itself.

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

• This is not applicable as the document refers to "non-clinical performance testing" (mechanical/lab testing), not an assessment requiring expert clinical judgment for ground truth.

4. Adjudication method for the test set:

• Not applicable for non-clinical performance testing. Adjudication methods like 2+1 or 3+1 typically apply to human reader studies where there's a need to resolve discrepancies in 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:

• No, an MRMC study was not done. This device is a physical medical implant (a knee prosthesis), not an AI diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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:

• For the non-clinical performance tests mentioned (disassembly, fatigue, wearing), the "ground truth" would be established by engineering standards and specifications for mechanical integrity, durability, and biocompatibility. The document does not explicitly state these standards but implies their use by mentioning "acceptance criteria."

8. The sample size for the training set:

• Not applicable. This device is a physical implant, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, there is no training set for this type of device.

Summary of what the document focuses on:

The entire document pertains to a 510(k) submission, which aims to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. This is primarily established through comparisons of:

• Intended Use
• Technological Characteristics
• Materials
• Non-clinical performance data (as briefly summarized here)

The "Performance Data" section in this 510(k) is very concise and only states that the device "met all of the acceptance criteria" for the mentioned non-clinical tests. It doesn't provide the detailed methodology, specific acceptance values, or raw results of these tests, which would typically be found in a more comprehensive study report. This level of detail is usually reviewed by the FDA but not always included in the publicly available summary letter.

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The JTS® Extendible Distal Femoral Implant is intended to be used for cemented limb salvage procedures in paediatric (between the ages of 2 and 21) cases where radical resection and replacement of the distal femur is required with the following conditions:

• patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
• surgical intervention for severe trauma, revision knee arthroplasties, failed previous prosthesis and/or oncology indications; and
• malignant diseases (e.g., osteogenic sarcoma).
  The JTS® Extendible Distal Femoral Implant and its components are for single use only.

The JTS® Extendible Distal Femoral Implant is a patient specific system that is used to replace bone which is lacking or damaged or must be removed (e g., due to tumor). The device consists of components (defined below) which are available in a range of sizes depending on the size and needs of the patient. Every configuration includes a telescoping shaft with a gearbox, magnet, and extension screw assembly for extending the implant when required by the patient.
Components available in patient specific sizes:

• Femoral Telescoping Shaft
• Femoral Block
• Extension Screw
• Femoral Shaft
• Tibial configurations for knee joint including passive rotating hinge, rotating hinge (polyethylene), and metal cased tibia components
• Passive Bearing
• Tibial Passive Stem
• HA Coated Extra-cortical Plate that is integral to the Femoral Shaft
• Hydroxyapatite Collar that is integral to the Femoral Shaft
• Bumper Pad
• Bushes
• Axles
  The specific design of the implant is based on the surgeon's description of the case and patient radiological information. The key dimensions for each JTS® Extendible Distal femoral Implant are derived from the generic device specifications and by taking measurements from the patient's X-rays and/or CT scans. The implant is designed and manufactured for each patient.
  The JTS® External Drive Unit is used periodically to lengthen the prosthesis when the patient's limb length discrepancy needs to be addressed. The JTS® External Drive Unit creates a magnetic field which interacts with the magnet in the telescoping shaft to lengthen the implant.

The provided text is a 510(k) summary for the JTS® Extendible Distal Femoral Implant. This document focuses on establishing substantial equivalence to predicate devices for a medical implant.

Based on the content, this document does not describe a study involving performance metrics like sensitivity, specificity, accuracy, or reader improvement in an AI context. Instead, it discusses the technical characteristics, intended use, and substantial equivalence of a physical medical device.

Therefore, many of the requested categories related to AI/algorithm performance studies cannot be filled from the given text.

Here's a breakdown of what can be extracted and explanations for what cannot:

Acceptance Criteria and Device Performance (as described for a physical implant)

The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance acceptance criteria for a new, standalone study of the device's functional performance in a clinical setting. The "performance" here refers to its design and intended use matching existing cleared devices.

Information Not Applicable / Not Available from the Provided Text:

The following requested items are specific to the evaluation of AI/algorithm performance and are not found in this 510(k) summary for a physical medical implant.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document does not describe a clinical study for performance testing of an algorithm.
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. "Ground truth" in the AI sense is not established for this device.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided text is a regulatory filing for a physical medical device (an extendable distal femoral implant), not for an artificial intelligence or algorithm-based device. Therefore, the detailed questions about AI performance studies, ground truth establishment, and expert involvement are not applicable to this document.

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Intended for the replacement of diseased or deficient bone in the proximal femur. It is indicated for: Limb salvage procedures where radical resection and replacement of the bone is required Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Ligament deficiencies Tumor resections Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques Revision of previously failed total joint arthroplasty Trauma The METS® Modular Proximal Femur and its components are for single use only The METS® Modular Proximal Femur and its components are for cemented use only

The single use METS® Modular Proximal Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the proximal femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft with or without an integral extension piece, stem and collar that is available hydroxyapatite (HA) coated or uncoated, stippled or smooth. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Proximal Femur is offered with an optional set of trochanters which are only to be used forhard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo)

I am sorry, but the provided text describes a medical device, the METS® MODULAR PROXIMAL FEMUR, which is a hip joint metal/polymer semi-constrained cemented prosthesis. The information focuses on its classification, intended use, indications for use, and a declaration of substantial equivalence to predicate devices based on non-clinical performance testing and clinical evaluation through published papers and post-market surveillance.

This document does not contain information about:

1. Acceptance criteria and reported device performance in a table format for AI/algorithm-based performance. The document refers to "non-clinical performance testing" for the device's physical attributes (disassembly force testing) and "clinical evaluation... based upon published papers and post market surveillance" to support its substantial equivalence. These are not performance metrics for an AI system.
2. Sample size used for the test set or data provenance related to AI validation.
3. Number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study with human readers and AI assistance.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcome data, etc.) for AI models.
8. Sample size for the training set (for an AI model).
9. How the ground truth for the training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving an AI device's performance, as the provided text pertains to a traditional medical implant and its regulatory submission, not an AI or algorithm-based device.

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The METS® Modular Total Femur is intended for the replacement of the total femoral bone.
Limb salvage procedures where radical resection and replacement of the bone is required
Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies
Tumor resections
Revision of previously failed total joint arthroplasty
Trauma
Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
All of the METS® Modular Total Femur tibial and acetabular components are for cemented use only
All of the METS® Modular Total Femur and their components are for single use only

The single use METS® Modular Total Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's, 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Total Femur is offered with an optional set of trochanters which are only to be used for hard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. A range of shafts, femoral component (including axle, bushes and circlip), bumper and the SMILES knee (available in 3 types of arrangements and in a rotating or fixed configuration). The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra high molecular weight polyethylene (UHMWPE).

The provided text describes a medical device, the METS® MODULAR TOTAL FEMUR, and its regulatory clearance process (510(k) summary). However, it does not contain information related to software performance, AI algorithms, or detailed acceptance criteria for a study proving such performance.

The "Performance Data" section specifically states:

• Non Clinical Testing: "The results of the non-clinical performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate devices. The Performance testing included: knee fatigue and wear test, disassembly force testing for the taper connections, ASTM F1800-07." This refers to mechanical and material performance of the physical implant, not a software or AI component.
• Clinical Performance Conclusions: "Clinical evaluation was carried out based upon published papers and post market surveillance." This indicates a review of existing literature and real-world data, not a specific clinical study with defined acceptance criteria for a device's performance that would involve expert review or ground truth establishment in the way your request describes.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and reported device performance: This document does not define numerical acceptance criteria for "device performance" in the context of an algorithm or AI.
2. Sample size used for the test set and data provenance: No such test set is described for performance evaluation in the context of an algorithm.
3. Number of experts used to establish ground truth and their qualifications: Not applicable to the type of performance data presented.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or reported for this device's performance as described.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical implant.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
9. How ground truth for the training set was established: Not applicable.

The document focuses on the mechanical safety and effectiveness of a femoral implant and its substantial equivalence to previously cleared predicate devices, based on physical testing and literature review. It is not an AI/software device and thus does not include the type of performance study details you are asking for.

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The JTS® Extendible Implant is intended to be used for cemented limb sparing procedures in paediatric (between the ages of 2 and 21) cases where radical resection and replacement of the distal femur is required with the following conditions:

• . patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment,
• surgical intervention for severe trauma, revision knee arthroplasties, failed . previous prostheses and/or oncology indications; and malignant diseases (e.g., osteogenic sarcoma).
  The JTS® Extendible Implant and its components are for single use only.

The JTS® Extendible Implant is a patient specific system that is used to replace bone which is lacking or damaged or must be removed (e.g., due to tumor). The JTS® Extendible Implant is a distal femoral (passive hinge tibia) implant. The device consists of components (defined below) which are available in a range of sizes depending on the size and needs of the patient. Every configuration includes a telescoping shaft with a gearbox, magnet, and extension screw assembly for extending the implant when required by the patient.
Components available in patient specific sizes:

• Femoral Telescoping Shaft .
• Femoral Block .
• Extension Screw .
• Femoral Shaft .
• Passive Hinge .
• Passive Bearing .
• Tibial Passive Stem .
• HA Coated Extra-cortical Plate that is integral to the Femoral Shaft .
• Hydroxvapatite Collar that is integral to the Femoral Shaft .
• Bumper Pad ◆
• Bushes .
• Axles .
  The specific design of the implant is based on the surgeon's description of the case and patient radiological information. The key dimensions for each JTS® Extendible Implant are derived from the generic device specifications and by taking measurements from the patient's X-rays and/or CT scans. The implant is designed and manufactured for each patient.
  The JTS® External Drive Unit is used periodically to lengthen the prosthesis when the patient's limb length discrepancy needs to be addressed. The JTS® External Drive Unit creates a magnetic field which interacts with the magnet in the telescoping shaft to lengthen the implant.

The provided text describes a 510(k) summary for the JTS® Extendible Implant, a medical device. It focuses on the general description of the device, its intended use, and a list of performance tests conducted to establish substantial equivalence to predicate devices, rather than detailed acceptance criteria and the specifics of a study proving those criteria are met in the way one might expect for a diagnostic or AI-driven device.

Therefore, many of the requested items related to acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, and comparative effectiveness studies are not present in the provided document. The performance tests listed are primarily engineering and mechanical evaluations of the implant itself, not clinical effectiveness studies in the typical sense for a diagnostic device.

Here's a breakdown based on the provided text, with "N/A" for information not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a table format for the device's clinical performance or diagnostic accuracy. Instead, it lists various engineering and mechanical performance tests. The "reported device performance" is implicitly that the device passed these tests and was deemed "as safe and effective" as the predicate devices.

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

• Sample Size (Test Set): Not specified. The document only mentions "summary of clinical data of compassionate use patients and foreign patients." This suggests a compilation of existing patient data rather than a newly designed test set for a specific study.
• Data Provenance: "Compassionate use patients and foreign patients" (implicitly retrospective, no specific countries mentioned).

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

• Number of Experts: N/A. The document does not describe the establishment of a "ground truth" by experts for this clinical data. The clinical data mentioned appears to be real-world outcomes.
• Qualifications of Experts: N/A.

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

• Adjudication Method: N/A. Not applicable as no explicit 'test set' requiring expert adjudication for ground truth is described.

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

• MRMC Comparative Effectiveness Study: No. This type of study is typically for diagnostic imaging devices involving human interpretation, not for an orthopedic implant.
• Effect Size: N/A.

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

• Standalone Performance: N/A. This device is an implant, not an algorithm.

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

• Ground Truth Type: For the mentioned "summary of clinical data," it would primarily refer to outcomes data (implicitly, actual patient outcomes from use of the implant in real-world scenarios). There is no mention of expert consensus or pathology serving as ground truth for a study.

8. The sample size for the training set

• Sample Size (Training Set): N/A. This is an orthopedic implant, not a machine learning model, so there is no concept of a "training set" in this context.

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

• Ground Truth Establishment (Training Set): N/A. Not applicable.

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