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The Spider System Kolibri Cement Needle is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

The needle has the following characteristics:

• . entirely cannulated needle;
• threaded proximal end to screw the needle into the pedicle to temporarily link the . needle to the pedicle during the cement injection; .
• . luer-lock to allow the easy connection with standard syringes and with other system of injection of the cement;
• . windows in the distal end that allow the outflow of cement and its optimal distribution around the needle.
  The device is supplied in an appropriately labeled sterile packaging.

The provided text is a 510(k) summary for the Sintea Plustek's Spider System KOLIBRI Cement Needle. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria for device performance in the way a clinical trial for a complex diagnostic or therapeutic device might.

Therefore, many of the requested elements regarding acceptance criteria, performance studies, expert involvement, and ground truth are not applicable or not provided in this type of submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a 510(k) Pre-Market Notification, which aims to demonstrate that a new device is as safe and effective as an already legally marketed device (predicate device). It is not a clinical study or a performance study in the sense of establishing new performance metrics or efficacy. Instead, it relies on demonstrating equivalence through comparison of design, materials, and intended use.

Therefore, the following information is not applicable or not provided in this 510(k) summary:

1. Sample size used for the test set and the data provenance: Not applicable. No "test set" of patient data or samples was used for a performance study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established from expert review for a performance test set.
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. This device is a cement needle, not an AI-powered 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 instrument, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There was no "ground truth" used in the context of a performance study. The "truth" here is the prior FDA clearance of predicate devices and the demonstration that the new device is sufficiently similar.
7. The sample size for the training set: Not applicable. This device is a physical medical instrument, not a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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The Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions:

• Degenerative Disc Disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• . Spondylolisthesis
• . Trauma (fracture or dislocation)
• . Spinal stenosis
• Deformities or curvatures (scoliosis, kyphosis, lordosis) ●
• . Tumor
• . Pseudarthrosis
• . Failed previous fusion

The Sintea Plustek Anterior Cervical Plate system is made of medical grade titanium alloy Ti-6Al-4V according to ASTM-F136 and consists of plate and screws of various lengths to accommodate single or multilevel fusion and various patients' anatomy. All of the plates have 2.5mm thickness. One level plates are available from 18-38mm, two level plates from 34-56mm, three level plates from 68-112mm and 4 level plates from The screws are available in three configurations: 4mm diameter self 103-128mm. tapping screws in lengths of 10, 12, 14, 16 and 18mm. 4.5 diameter self tapping screws in lengths of 10, 12, 14, 16, and 18mm, 4mm diameter self drilling screws in lengths of 10, 12, 14, 16 and 18mm. The plates have an anti-backout feature based on an elastic ring The elastic ring is inserted into a (made titanium alloy Ti-6AI-4V as well). circumferential slot in the holes present on the plates. The ring can be deformed by the screw during the insertion in order to allow the screw to fit the hole of the plate. Once the screw it is completely inserted the ring return elastically to its original shape in order to prevent screw backout.

The provided text describes a medical device, the Sintea Plustek Anterior Cervical Plate System, and its 510(k) summary for FDA clearance. It focuses on the device's physical properties, indications for use, and a comparison to predicate devices, but does not describe an AI/ML-driven device or study parameters related to AI/ML performance.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's questions pertain to acceptance criteria and studies for an AI/ML device, which are not present in the provided document.

The document only states:

1. Acceptance Criteria and Device Performance (Mechanical Testing):
The study for this device was a mechanical performance test to demonstrate substantial equivalence, not an AI/ML performance study.

2. Sample size and data provenance (for AI/ML test set): Not applicable, as this is a mechanical medical device, not an AI/ML device.

3. Number of experts and qualifications (for AI/ML ground truth): Not applicable.

4. Adjudication method (for AI/ML test set): Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study (for AI/ML): Not applicable.

6. Standalone performance (for AI/ML algorithm): Not applicable.

7. Type of ground truth used (for AI/ML): Not applicable. The "ground truth" in this context refers to established mechanical testing standards (ASTM F1717-09) and performance of legally marketed predicate devices.

8. Sample size for the training set (for AI/ML): Not applicable.

9. How ground truth for the training set was established (for AI/ML): Not applicable.

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