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When used with the ProMIS Fixation System, the ProMIS Extension Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion, for the following acute and chronic instabilities or deformities of the lumbar, and sacral spine: degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The ProMIS Extension Rod System is compatible with Premia Spine's Slender Tulip Polyaxial Pedicle Screws for extending the ProMIS Fixation System to a single adjacent level.

The ProMIS Extension Rod System (also referred to as PER System) is composed of a fusion rod (Turret™ Rod) with a spherical head at one end and a rod on the other end. The Turret™ Rod's end is connected to a pedicle screw at the adjacent vertebrae to be fused, while the spherical head attaches to the Tulip's head of Premia Spine's pedicle screw of the existing fusion system using a designated Set Screw and a Ring Nut.

The spherical head of the ProMIS Extension Rod System is designed to be positioned on Premia Spines' Slender Tulip Polyaxial Pedicle Screws. The Rod is available in two lengths 60 and 75 mm in a diameter of 6 mm.

All components of the ProMIS Extension Rod System are made of Titanium alloy (Ti-6Al-4V ELI per ASTM F136).

The FDA 510(k) summary for the ProMIS Extension Rod System describes the device's mechanical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not specified in the provided document. The document states that "All devices functioned," implying that the tested devices represent the system.
• Data Provenance: The testing was performed on the ProMIS Extension Rod System, which is manufactured by Premia Spine Ltd. in Netanya, Israel. The study is a prospective bench test study, as it describes the performance of the device itself.

3. Number of Experts and their Qualifications for Ground Truth:

Not applicable. This device is a mechanical implant, and its performance is evaluated through objective physical testing (bench testing) rather than expert interpretation of data like images or patient outcomes. Therefore, "ground truth" established by human experts is not relevant in this context.

4. Adjudication Method for Test Set:

Not applicable, as the evaluation is based on objective mechanical testing, not human interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a medical device, specifically an orthopedic implant, where performance is assessed through mechanical bench testing. MRMC studies are typically used for diagnostic or screening devices that involve human interpretation of results (e.g., radiology AI).

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical medical device, not a software algorithm. Its performance is inherent to its mechanical properties.

7. Type of Ground Truth Used:

Mechanical properties and performance standards as defined by ASTM F1717. The "ground truth" is the objective physical behavior of the device under specific loads and conditions, measured against established engineering standards or in comparison to predicate devices.

8. Sample Size for Training Set:

Not applicable. This is a physical medical device, not an AI or machine learning system that requires a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable. There is no training set for this type of medical device.

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The ProMIS™ Fixation System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimal invasive (MIS) instrumentation.

The ProMIS™ Fixation System consists of 3 main single use implanted parts:

1. ProMIS™ Fusion Rods: a straight or bent rod of various lengths.
2. Polyaxial Pedicle Screws: cannulated and non- cannulated screw bodies with self-tapping flutes and rounded or self-drilling tips, available in three diameters (5.5mm, 6.5mm, with length ranging from 25 to 60, in increments of 5mm.
3. Setscrew.

All components are manufactured from Ti6Al4V per ASTM F136

Rods up to 100mm in length and the Pedicle Screws are provided sterile (gamma irradiated).

Rods exceeding 100mm are supplied non-sterile (steam/autoclave sterilization by the end user).

The provided text is a 510(k) summary for the Premia Spine Ltd.'s ProMIS™ Fixation System. It details a "Special 510(k) notice" for a modification to a previously cleared device (K150380).

Based on the information provided, this submission does not describe:

• Acceptance criteria for an AI/ML-driven device. The device is a "Thoracolumosacral Pedicle Screw System," which is a physical implant used in spinal surgery, not an AI/ML software device.
• A study proving device meets acceptance criteria related to AI/ML performance. The "Performance Data" section explicitly states, "The ProMIS™ Fixation System was subjected to static torsion and dynamic compression testing per ASTM F1717." This refers to mechanical testing of the physical implant, not a clinical study involving AI or human interpretation of images.
• Sample sizes for test sets, data provenance, expert numbers, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI/ML models. These concepts are entirely absent from the document as they are not relevant to the type of device being described.

Therefore, it is not possible to extract the requested information regarding AI/ML device acceptance criteria and study details from the provided text. The document focuses on demonstrating substantial equivalence for design modifications to a physical medical implant, primarily through mechanical performance testing.

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The VersaLink™ Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; tracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The VersaLink™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.

The VersaLink™ System consists of 6 Ti-6AI-4V main parts:

1. The VersaLink rod (the Rod); a spinal fixation rod with a dedicated ring end designed to enable robust attachment to the pedicle screw head above the crossbar.
2. Ring nut: dedicated nut designed to be tightened on the Ring Set Screw and firmly fix the VersaLinkTM Rod on the pedicle screw head.
3. VersaLink Ring Set Screw Torx: dedicated setscrews with double thread designed to allow attachment of the VersaLink™ Rod device to the head of the pedicle screw above the crossbar.
4. Crossbar rod: a bent rod designed to fit the average angle of the lumbar vertebra pedicles. It is horizontally attached to two pedicle screws on the same vertebra in order to reduce peak loads by better distributing the loads between the pedicle screws.
5. Polyaxial Pedicle screws
6. Torx Setscrew.

The provided text is a 510(k) summary for the VersaLink™ Fixation System, a medical device for spinal fixation, and it discusses performance data related to mechanical testing, not a study involving human subjects or AI. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria and performance of a device proven through a study.

Specifically, the text details:

• Device Name: VersaLink™ Fixation System
• Intended Use/Indications for Use: To provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of various spinal instabilities and deformities.
• Device Description: Components include a VersaLink rod, ring nut, VersaLink Ring Set Screw Torx, Crossbar rod, Polyaxial Pedicle screws, and Torx Setscrew, all made of Ti-6AI-4V.
• Performance Data: "The VersaLink™ Fixation System was subjected to static compression, static torsion, and dynamic compression testing per ASTM F1717. All devices functioned and met their acceptance criteria."
• Substantial Equivalence: The device is deemed substantially equivalent to a predicate device (ProMIS™ Fixation System) based on similar intended use, indications, materials, components, technological characteristics, and principles of operation.

The prompt, however, asks for details typically found in a clinical study or AI model validation, such as:

1. A table of acceptance criteria and the reported device performance: While the text states "All devices functioned and met their acceptance criteria" for mechanical tests, it does not provide the specific numerical acceptance criteria or reported performance values for these tests in a table format.
2. Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing of a physical device; there's no "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the ground truth is derived from the physical properties and behavior of the materials and design under specified loads, measured against established ASTM standards.
8. The sample size for the training set: Not applicable (no "training set" for a physical device).
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided text describes the mechanical performance testing of a physical medical device (spinal fixation system) against engineering standards, not the validation of an AI-powered device or a clinical study that would involve expert readers, patient data, and human-in-the-loop performance. Therefore, I cannot extract the requested information from this document.

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The ProMIS™ Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.

The ProMIS™ Fixation System consists of 3 main single use implanted parts:

1. ProMIS™ Fusion Rods: a straight or bent rod with various lengths.
2. Polyaxial Pedicle screws.
3. Setscrew.

All components are manufactured from Ti6Al4V per ASTM F136.

This document describes a 510(k) premarket notification for the Premia Spine Ltd.'s ProMIS™ Fixation System, which is a thoracolumbosacral pedicle screw system. The purpose of this 510(k) is to modify the sterilization method of certain rods, add new rod lengths, and introduce a modified set screw and new instrumentation. The document asserts substantial equivalence to a previously cleared device (K150380).

1. Table of Acceptance Criteria and Reported Device Performance

• Engineering analysis and functional demonstration: For the mechanical performance of the modified set-screw and the overall system, demonstrating adherence to design specifications and non-deterioration of current worst-case scenarios.

8. Sample Size for the Training Set

Not applicable. There is no training set for an AI algorithm in this device submission.

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

Not applicable. There is no training set for an AI algorithm in this device submission.

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The ProMIS™ Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with MIS instrumentation.

The ProMIS™ Fixation System consists of 3 main parts:

• 1. ProMIS™ Fusion Rods: a straight or bent rod with various lengths.
• 2. Polyaxial Pedicle screws.
• 3. Setscrew.

All components are manufactured from Ti6Al4V per ASTM F136.

The provided text describes a medical device called the ProMIS™ Fixation System and its 510(k) summary for FDA clearance. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a study to meet specific acceptance criteria with performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested details about acceptance criteria and study design are not present in this document.

However, based on the Performance Data section, the acceptance criteria are implicit in the ASTM F1717 standard for spinal implant constructs. The device's performance is demonstrated by its compliance with this standard.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the system was subjected to these tests, implying it met the criteria, but does not provide specific numerical performance results.

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

Not applicable. This document describes mechanical testing of a physical device, not an AI or diagnostic algorithm that would require a test set of data/images. The "data provenance" mentioned in your template (country of origin, retrospective/prospective) is relevant for clinical or AI studies, which this is not.

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

Not applicable. Ground truth for mechanical testing is established by the physical properties of the materials and the mechanical outcomes measured, not by expert consensus on data interpretation.

4. Adjudication method for the test set

Not applicable. Mechanical testing outcomes are typically objectively measured and do not require expert adjudication in the same way clinical data interpretation would.

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 is a medical device for spinal fixation, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance data in this context is the results of the mechanical tests performed according to ASTM F1717. These tests directly measure the physical performance and durability of the device under stress conditions, establishing whether it meets the engineering standards for spinal implants.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is physical device testing, not an AI/machine learning application.

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

Not applicable. There is no training set for this type of test.

Summary of the Study:

The "study" described in the document is a pre-clinical mechanical performance assessment. The ProMIS™ Fixation System was subjected to standard mechanical tests: static compression, static torsion, and dynamic compression, as specified by the ASTM F1717 standard. The purpose of these tests was to demonstrate the substantial equivalence of the ProMIS™ System to the predicate devices (THUNDERBOLT™ and LANCER™ Pedicle Screw Systems) in terms of mechanical properties and safety/effectiveness for its intended use. The document concludes that the performance data demonstrates substantial equivalence, indicating that the device met the mechanical acceptance criteria implied by the ASTM F1717 standard.

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