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The Simple Locking IntraMedullary (SLIM) System is intended as a temporary implant for alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes:

• Femur and tibia in the pediation (child and adolescent), and small-stature adults such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases.
  . Humerus, ulna, fibula in all patient populations

The Simple Locking Intra-Medullary (SLM) system consists of intramedullary fixation devices for use in long bones. The solid shaft, bevelled point, and pre-determined or blank length options is designed for easy insertion in the medullar canal. Anchorage of the device is achieved through a conical thread to obtain a stable fixation in the epiphyses or cortical bone, which aims to reduce the risk of migration. Internal features, such as a hexagonal drive and an internal mechanical thread in the device, are designed for capture and guidance during insertion and retrieval. Additional proximal and distal locking holes allow pinning to ensure fixation with locking pegs when required, and the Bullet screws allow fixation of smaller diameter shafts that cannot be cross-pinned due to their size. The SLIM implants are manufactured in medical grade Stainless Steel (SS316L, ASTM F138). The rods are available in seven diameters: 2.0.2.6.3.2. 4.0. 4.8. 5.6 and 6.4 mm, from 80mm up to 400 mm in length allows end user to customize the length of the rod.

The provided text describes a medical device's 510(k) submission to the FDA, focusing on substantial equivalence to predicate devices, rather than detailed acceptance criteria and a study proving device performance against such criteria. As such, much of the requested information is not available in the text.

Here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not specified, but based on the nature of the tests (bench testing, animal model) and the "non-clinical" designation, it would be laboratory-generated data.

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

• Not Applicable. This submission details non-clinical bench testing and an animal model, not studies requiring expert review for ground truth establishment.

4. Adjudication method for the test set:

• Not Applicable. No human-based adjudication methods were mentioned as this was non-clinical testing.

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 is a mechanical device, not an AI-powered diagnostic tool.

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

• Not Applicable. This device is an implant, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" would be established by validated test methodologies and measurements against engineering specifications or comparative performance to predicate devices (e.g., comparing load-bearing capacity, fatigue life, pull-out strength).
• For the animal model validation, the "ground truth" would be related to successful surgical technique demonstration and expected biological/mechanical outcomes in the animal.

8. The sample size for the training set:

• Not Applicable. This device doesn't involve 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 above)

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

The text describes a series of non-clinical, bench-top mechanical tests and validation in an animal model to demonstrate the substantial equivalence of “The Simple Locking IntraMedullary (SLIM) System” to its predicate devices. The primary goal was to ensure that new components (Bullet screws, new pins/pegs, SLIM blanks) and the system as a whole performed equivalently or better than previously-cleared components and predicate devices.

Key tests performed include:

• Static four-point bending bench testing
• Fatigue four-point bending bench testing
• Pull-out & Push-out strength
• Surgical technique validation on an animal model
• Evaluation of Shaft to Bullet assembly migration resistance (static and cyclic loading)
• Static and fatigue four-point bending of the Bullet screws
• Comparative loading in a physiologically relevant setting of the SLIM and Bullet against the predicate device
• Functional testing of a cutting operation for an associated instrument (Intro-OP Implant Cutter (ICON) Prototype).

The conclusion of these tests was that the Bullet screws were "found equivalent for their intended uses," and the locking pegs were "considered that they perform equivalently" to simple locking pins in terms of torsion, drive torque, and axial pull-out. The SLIM blanks were deemed to have the same mechanical resistance due to identical materials and dimensions, and new pins/pegs were expected to have the same or higher mechanical resistance due to similar or larger diameters and materials.

No clinical testing was provided as a basis for substantial equivalence. The justification for this device's acceptance relied entirely on these non-clinical performance data and the conclusion that the "anticipated benefits of such a system clearly outweigh the possible residual risks."

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The Y3 Proximal Femoral Plate System is intended for the temporary internal fixation of fractures and osteotomies of the greater trochanter or of the proximal femur.

It is indicated for the following:

• Re-attachment of the greater trochanter following osteotomy in THA
• Trochanteric and intertrochanteric fractures
• Extended trochanteric osteotomy
• Periprosthetic femoral fractures
• Comminuted fractures
• Mal-unions and non-unions
• Fractures in osteopenic bone

The Y3 Proximal Femoral Plate System is an innovative fixation device intended for the treatment of proximal femoral fractures and osteotomies. The unique Y-shape design divides the proximal portion of the plate into anterior and posterolateral branches, thus intended for stability at the Greater Trochanter level both in rotation and translation while reducing the prominence of the implant. Fixation options include locking and non-locking screws in addition to cerclage cables. The Y3 Proximal Femoral Plate System is manufactured in medical grade Titanium Alloy Ti-6AI-4V ELI as per ASTM F136. The Y3 Proximal Femoral Plate System is available in four lengths: 135, 185, 235 and 285 mm. Left and right versions are offered to accommodate the anatomical shape of the proximal femur.

The provided text describes a 510(k) premarket notification for the Y3 Proximal Femoral Plate System, a medical device for internal fixation of fractures and osteotomies. The FDA determined that the device is substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain information about:

• Acceptance criteria for device performance in a clinical study. The provided document focuses on mechanical equivalence and non-clinical performance data.
• A study proving the device meets specific acceptance criteria.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set.
• How ground truth for the training set was established.

The document explicitly states: "No clinical testing is provided as a basis for substantial equivalence." This means that the FDA's determination of substantial equivalence for this device was based on non-clinical performance data (bench testing, calculations) and a review of scientific literature, rather than data from a clinical trial with specific performance metrics against acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document, nor can I provide information regarding clinical study design elements such as sample sizes, expert involvement, adjudication, or ground truth establishment, as these were not part of the submission described.

The document focuses on demonstrating that the Y3 Proximal Femoral Plate System is substantially equivalent to existing devices based on:

• Intended Use: Similar indications.
• Design: Similar fixation methods (screws, cerclage cables) and materials (Titanium Alloy).
• Mechanical Properties: Bench testing and calculations showing equivalent or superior performance (stiffness, yield strength, bending strength) to the predicate device.
• Literature Review: Analysis of published literature on trochanteric fixation to address identified clinical hazards.

Non-clinical Performance Data Summary (as provided):

Study Proving Equivalence (Non-Clinical):

• Verification Calculations: Evaluated resistance and mechanical properties of the Y3 system components in comparison to predicate systems.
• Static and Fatigue Bench Testing: Confirmed the validity of calculations and demonstrated equivalent performance to the predicate NCB system.
• Scientific Literature Search/Clinical Evidence Review: Identified and analyzed published peer-reviewed literature regarding trochanteric fixation, specifically for the two predicate systems, to establish substantial equivalence by addressing clinical hazards from the device Risk Analysis.
• Cadaveric Study (cited from literature): A biomechanical hip extension study on cadaveric models showed the antero-lateral locking plate (referring to a plate with similar design principles to Y3) significantly reduced greater trochanter anterior migration compared to a lateral locking plate.

Regarding the other requested information, the document states:

• Sample size used for the test set and the data provenance: Not applicable as no clinical test set for performance was used. Non-clinical bench testing was performed.
• 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 expert ground truth was performed.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical implant, not an AI diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical implant.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the non-clinical testing, "ground truth" would be the measured physical properties and performance metrics established through validated testing procedures. For the literature review, the "ground truth" would be the findings reported in peer-reviewed scientific publications.
• The sample size for the training set: Not applicable as there is no AI component or training set described.
• How the ground truth for the training set was established: Not applicable.

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