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Mini and Micro Fragments Reconstruction System – NEOFIX is intended for small bone fracture fixation, arthrodesis, reconstruction, and osteotomy fixation. Examples include small bones of the hand, wrist, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Mini and Micro Fragments Reconstruction System – NEOFIX consists of plates and screws in a variety of designs and sizes. Straight plates are provided in various lengths and may be contoured to adapt to patient specific anatomy. Straight plates are available with screw holes to accommodate non-locking and locking screw designs. Plates also are provided in various geometric configurations that are commonly used in trauma and reconstructive surgery. The plates range in thickness from 0.7 mm to 2.7 mm, and are manufactured from commercially pure titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications or Ti-6Al-4V ELI alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

Self-tapping cortical screws are provided in locking and non-locking designs. The locking screws are provided with a thread diameter of 2.4 mm with a hexalobular instrument interface (Star Head) and a tapered thread tip to facilitate insertion. Locking smooth pins also are provided with a diameter of 2.4 mm in various lengths. The smooth pins are used with the Distal Radius Volar Plates. Non-locking cortical self-tapping screws are provided with thread diameters of 1.5, 2.0, 2.3, 2.4 and 2.7 mm, and in various lengths from 5 mm to 32 mm. The non-locking screws with thread diameters of 1.5, 2.0 and 2.3 mm have a cruciform instrument interface; the nonlocking screws with diameters of 2.4 and 2.7 mm have a hexalobular instrument interface. All screws are manufactured from Ti-6AI-4V ELI alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The document is a 510(k) premarket notification from the FDA for a medical device called "Mini and Micro Fragments Reconstruction System-Neofix." It primarily establishes substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with performance metrics.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, expert involvement, and ground truth cannot be fully extracted directly from this document. The document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices.

Here's an attempt to answer the questions based on the provided text, highlighting what is ascertainable and what is not:

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

The document does not explicitly present acceptance criteria in a table format with corresponding numerical device performance results. Instead, it asserts substantial equivalence based on similarity to predicate devices in terms of intended use, technological characteristics, materials, design principles, and packaging/sterilization methods.

It mentions:

• "Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis of the subject and predicate device designs, engineering analysis, and mechanical testing of the subject designs."

Without the actual dimensional analysis or mechanical testing results, specific performance metrics cannot be reported in a table. The "acceptance criteria" here would implicitly be that the new device's performance in these analyses is comparable or non-inferior to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "detailed dimensional analysis" and "mechanical testing," which would involve samples, but the specific sample sizes are not disclosed. Data provenance (country of origin, retrospective/prospective) is also not specified for these tests.

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)

This information is not provided in the document. The types of tests (dimensional analysis, engineering analysis, mechanical testing) typically rely on engineering standards and measurements, not necessarily expert clinical review to establish "ground truth" in the same way an AI diagnostic device would.

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

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which are not directly detailed here for the mechanical performance tests.

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 comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers, which this device (a metallic bone fixation system) is not.

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 device is a physical medical implant, not an algorithm, so this type of study is not applicable.

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

For the "detailed dimensional analysis," "engineering analysis," and "mechanical testing," the "ground truth" would be established by:

• Engineering standards and specifications: For dimensions, materials, and mechanical properties.
• Physical measurements and test results: Obtained from the mechanical testing, compared against established benchmarks or predicate device performance.

This is not "expert consensus" or "pathology" in the clinical sense, but rather adherence to engineering and material science principles.

8. The sample size for the training set

This information is not applicable as the device is a physical implant and not an AI algorithm requiring a training set.

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

This information is not applicable as the device is a physical implant and not an AI algorithm requiring a training set.

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The NeoOrtho NEOPLATE Spine Anterior Fixation System is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma, (including fractures), 3) tumors, 4) deformity (defined by kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Note: this device system is intended for anterior cervical intervertebral body fusions only.

The NeoOrtho NEOPLATE Spine Anterior Fixation System consists of a variety of shapes and sizes of bone plates, screws and instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NEOPLATE Spine Anterior Fixation System, structured to address your specific points:

The provided document describes a 510(k) premarket notification for the NEOPLATE Spine Anterior Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or setting performance criteria for diagnostic accuracy. Therefore, many of your requested points pertain to diagnostic AI/medical imaging systems and are not applicable to this type of device (a surgical implant).

This document outlines the mechanical performance testing conducted to demonstrate substantial equivalence, not to establish specific clinical acceptance criteria or evaluate the performance of an AI algorithm.

Description of Acceptance Criteria and Study: NEOPLATE Spine Anterior Fixation System

The NEOPLATE Spine Anterior Fixation System is a surgical implant. The "acceptance criteria" in this context refer to demonstrating substantial equivalence to a predicate device, primarily through material characterization and mechanical performance testing, rather than clinical efficacy or diagnostic accuracy.

The study conducted was a mechanical testing study performed according to ASTM F1717, a recognized standard for testing spinal implant constructs. The purpose was to show that the device's mechanical properties are equivalent to or better than those of a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a "sample size" in the context of patients or clinical data. The "test set" here refers to the number of physical device units or components that underwent mechanical testing. This information (e.g., number of plates/screws tested for each mechanical test) is not provided in the summary.
• Data Provenance: The mechanical testing was likely conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility. The country of origin of this testing data is not explicitly stated, but the manufacturer is based in Brazil. This is not a retrospective or prospective clinical study on human patients.

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

• Not Applicable. This device is a mechanical implant, not an AI or diagnostic imaging system. There was no "ground truth" established by experts in the context of diagnostic interpretation (e.g., radiologists interpreting images). The "ground truth" for mechanical testing is derived from engineering principles and the passed/failed status against pre-defined load/cycle specifications in the ASTM standard.

4. Adjudication Method for the Test Set

• Not Applicable. There was no adjudication method used for a "test set" in the sense of expert consensus on clinical or diagnostic outcomes. The mechanical tests have objective pass/fail criteria based on the ASTM F1717 standard.

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

• No. An MRMC study is designed for evaluating the diagnostic performance of systems, often comparing human readers with and without AI assistance to interpret medical images. This is not relevant for a spinal fixation implant, which is evaluated based on its mechanical integrity and substantial equivalence.

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

• Not Applicable. This device is a physical surgical implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for the mechanical testing was the engineering specifications and pass/fail criteria defined by the ASTM F1717 standard and compared against the performance of the predicate device. This is a mechanical/performance ground truth, not a clinical or pathological ground truth.

8. The Sample Size for the Training Set

• Not Applicable. This device did not involve the use of machine learning or AI, and therefore no "training set" was used.

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

• Not Applicable. As there was no training set (no AI/ML involved), there was no ground truth for a training set.

In summary, the provided document details a 510(k) submission for a surgical implant, not a diagnostic AI device. The "study" described is mechanical performance testing, and the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device in terms of material, design, dimensions, and mechanical integrity, as opposed to clinical efficacy or diagnostic accuracy.

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