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The device is intended to be used in the management of segmental diaphyseal bone loss of either humerus or tibia or femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.

OsteoBridge® IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a series of modular intramedulary rods segments that may be used as either proximal or distal segments. The segments are designed to be attached together to form a complete intramedullary rod using semiciteular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod and bridge the bonaliped with middle section of either humerus, tibia or femur. Reducing bushings allow the use of different diameter nails proximally and distally to provide optimal fit of the intract and with the medillary canal of the proximally and and distal segments of the bone to be fixed. All components of the OsteoBridge® Humeral IDSF -Intramedullary Segment Fixation Rod System are manufactured from Ti-6Al-4V Titanium Alloy conforming to ASTM F-136. The device is divided into three categories/product size ranges that are suitable for each boney application; humerus, tibia or femur (see tables below).

The provided text describes a medical device, the OsteoBridge® IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System, and does not contain information about an AI/ML powered device. Therefore, it is impossible to extract the requested information regarding acceptance criteria and studies that prove an AI device meets these criteria.

The document details the device description, intended use, mechanical testing methods, and standards followed for this intramedullary fixation rod system. It is a traditional medical device submission, not an AI/ML submission.

Therefore, I cannot provide the requested information for the following reasons:

• No AI/ML device: The document pertains to a physical medical device (intramedullary rods) and does not mention any artificial intelligence or machine learning components.
• No acceptance criteria for AI performance: Since there's no AI component, there are no acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• No study proving AI performance: The mechanical testing described is for the physical device's structural integrity, not for algorithm performance.

Please provide a document related to an AI/ML medical device if you wish for me to extract information on its acceptance criteria and a study proving it meets those criteria.

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The Orthogenesis LPS System is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include:

• metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
• patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur;
• patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
• revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia.
  The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.

The Orthogenesis LPS components are designed to be implanted for the replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia. Unlike primary hip and knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). A total of roovenon and renoration in those cases where no part of the femur can be salvaged.

The provided text describes a 510(k) summary for the Orthogenesis LPS System, a total femur/proximal tibial replacement prosthesis. This submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study demonstrating the device meets specific performance acceptance criteria.

The 510(k) process is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. It typically relies on comparing the new device to existing ones rather than extensive novel studies with acceptance criteria.

Therefore, the input does not contain the information required to answer the prompt in detail, as it pertains to a different type of regulatory submission. The requested information (acceptance criteria, specific study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is typically found in documentation for clinical trials or performance studies that aim to prove a device's performance against predefined metrics, which is not the primary purpose of a 510(k) summary.

However, based on the information available, I can report the following in relation to substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices, rather than meeting specific quantifiable performance thresholds from a novel study.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable for a 510(k) substantial equivalence submission in the context of a performance study. No separate "test set" in the sense of a clinical trial or algorithm validation dataset is described. The submission relies on comparison to existing, legally marketed devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This information is not part of a 510(k) summary where the primary assessment is regulatory review against predicate devices rather than expert-adjudicated ground truth data.

4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication by experts is described in this 510(k) summary.

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 device is a physical prosthesis, not an AI/software device. Therefore, no MRMC study involving human readers or AI assistance would be relevant or conducted for this type of product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical prosthesis, not an algorithm, so standalone performance in the context of AI is irrelevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
For a 510(k), the "ground truth" for demonstrating substantial equivalence is implicitly the established safety and effectiveness of the legally marketed predicate devices. The new device is deemed equivalent if it raises no new questions of safety and effectiveness and performs as well as or better than the predicate. Direct 'ground truth' from pathology or outcomes data specifically for the new device's own clinical study is typically not required for 510(k) clearance, though design verification and validation testing (e.g., mechanical testing) would occur.

8. The Sample Size for the Training Set
Not applicable. This pertains to AI/machine learning model development, which is not relevant for this physical medical device and its 510(k) submission.

9. How the ground truth for the training set was established
Not applicable. As above, this pertains to AI/machine learning model development.

Summary of the Study (510(k) Assessment for Substantial Equivalence):

The "study" presented here is a 510(k) premarket notification to the FDA. The objective was to demonstrate substantial equivalence of the Orthogenesis LPS System to several predicate devices already on the market.

• Predicate Devices:

  • S-ROM Noiles (references K896048, K905810, K924940)
  • Sulzer Orthopedics MOST™ System (K973087)
  • Wright Medical Segmented Orthopaedic System (SOS) (K933281)
  • Howemedica MRS (K972401 and K965164)

• Methodology: The determination of substantial equivalence was based on a detailed comparison of the new device's:

  • Indications for use
  • Design
  • Materials
  • Sterilization
  • Packaging
  • Performance testing (implied, not detailed, likely mechanical/biocompatibility testing to show similar performance characteristics to predicates)
  • Conformance with voluntary performance standards (not specified which ones).

• Conclusion of the 510(k): The FDA reviewed the submission and determined that the Orthogenesis LPS System is substantially equivalent to the referenced predicate devices, allowing it to be marketed. This determination was made on June 27, 2001.

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The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive bone lesion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture.

The Clinical Indication for Use is:

"The Segmental Defect Replacement System, when used with bone cement, is indicated for pathologic fractures or impending pathologic fractures of the diaphysis of the humerus secondary to metastatic bone disease and hematologic malignancies."

The Segmental Defect Replacement System is an array of proximal and distal intramedullary rods which, when locked together, replace the resected diseased segment and fixation in the remaining humeral bone The system includes a locking device to secure the rod components, and instrumentation to facilitate stock. insertion.

Modular bistemmed intramedullary rod system with rigid cam locking mechanism designed to provide intraoperative adjustment after cementing components into the proximal and distal segments of the resected humerus.

Materials: Ti-6Al-4V NiTi alloy (locking system)

The provided text describes a 510(k) summary for a "Segmental Defect Replacement System." This document is a premarket notification for a medical device aiming to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the specific information requested regarding acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies is not present in the provided text.

The document focuses on comparing the proposed device to existing predicate devices based on:

• Intended Use: Reconstruction of the humeral diaphysis with extensive bone lesions due to metastatic disease, myeloma, or lymphoma, placing the humerus at risk for pathologic fracture.
• Design: Modular bistemmed intramedullary rod system with a rigid cam locking mechanism for intraoperative adjustment after cementing components.
• Materials: Ti-6Al-4V, NiTi alloy (locking system).

The document states: "The Segmental Defect Replacement System has been evaluated by use of the static and fatigue tests. It has been shown to be substantially equivalent to the predicate devices." However, it does not provide details about the specific acceptance criteria for these tests, the performance metrics achieved, or the study design/results for demonstrating this substantial equivalence beyond this general statement.

In summary, the provided content is a regulatory submission for substantial equivalence, not a detailed report of a clinical or performance study with defined acceptance criteria and study results.

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