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The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.

The Precision Spine Interspinous Plate System consists of an ISP female plate and an ISP male plate for posterior fixation of the spine in order to achieve fusion. The ISP female plate and an ISP male plate are available in multiple sizes to accommodate various patient anatomies. The ISP female plate and an ISP male plate feature teeth to interface with the bone of the spinous processes. The ISP male plate is passed through the insert such that, in their final position, the ISP female plate and an ISP male plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.

The screws are available in multiple variations of fixed or variable angle. All lengths are provided in Ø4.0mm for primary use, or Ø4.5 mm rescue use. They have self-drilling and selftapping threads. The screws are type II anodized in varying colors depending on the length and diameter. The plate has a tear drop shaped anti-back out mechanism to prevent the screws from backing out. The variable screw has a 4.5 degree cone angulation (9.0 degree total sweep) within the plate. The use of the screws is optional and the intent is to add further fixation to stop implant dislocation/ migration.

This document describes the Precision Spine Interspinous Plate System, a medical device. As such, acceptance criteria and performance data are related to the mechanical and biomechanical properties of the device, not to an AI/ML algorithm. Therefore, many of the requested categories in your prompt are not applicable.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for biomechanical tests. Instead, it states that the device's strength was found to be "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the acceptance criteria are implicitly met by demonstrating substantial equivalence to the performance of predicate devices.

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

• Sample Size: Not specified for the biomechanical tests.
• Data Provenance: The tests were conducted internally by Precision Spine or a contracted lab, as it falls under "Performance Data" from the manufacturer. It is a prospective study design as the tests are conducted to demonstrate performance of the new device. The country of origin of the data is not specified, but the manufacturer is based in Pearl, MS, USA.

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

• Not Applicable. This device is a physical implant, and its performance is evaluated through engineering tests (static and dynamic biomechanical testing), not through expert clinical interpretation or ground truth derived from expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

• Not Applicable. As above, this is a physical device subject to engineering and biomechanical testing, not clinical adjudication of interpretations.

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 implant, not an AI/ML algorithm.

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

• Not Applicable. This device is a physical implant, not an AI/ML algorithm.

7. The type of ground truth used:

• Engineering/Biomechanical Testing Standards: The "ground truth" for the device's performance is established by the results of standardized biomechanical static and dynamic testing. The implicit "ground truth" for substantial equivalence is the performance observed in predicate devices, which likely also underwent similar testing against established standards.

8. The sample size for the training set:

• Not Applicable. This document describes a physical medical device, not an AI/ML model that requires a training set.

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

• Not Applicable. This document describes a physical medical device, not an AI/ML model that requires a training set.

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The Reli SP Spinous Plating System of Precision Spine, Inc. is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.

The Precision Spine Reli SP Spinous Plating System consists of an ISP female plate and an ISP male plate for posterior fixation of the spine in order to achieve fusion. The ISP female plate and an ISP male plate are available in multiple sizes to accommodate various patient anatomies. The ISP female plate and an ISP male plate feature teeth to interface with the bone of the spinous processes. The ISP male plate is passed through the insert such that, in their final position, the ISP female plate and an ISP male plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes. The purpose of this submission is to offer an expanded size range for the Reli SP Spinous Plating System.

The provided text does not contain information regarding traditional acceptance criteria and device performance studies typically associated with AI/ML-driven medical devices. This document is a 510(k) premarket notification for a medical device called the "Reli SP Spinous Plating System," which is a spinal interlaminal fixation orthosis.

The document states that "Precision Spine has not conducted mechanical testing as part of this Special 510(k) Device Modification Premarket Notification." Instead, "An analysis was performed to determine the subject implants were substantially equivalent to the predicate devices, therefore no mechanical testing was conducted as part of this submission."

Therefore, I cannot provide the requested information in the format given, as the device is a physical implant and the regulatory submission relies on substantial equivalence to predicate devices rather than direct performance testing against specific acceptance criteria.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: Not applicable, as direct performance testing was not conducted. The submission is based on substantial equivalence.
2. Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set was performed.
4. Adjudication method for the test set: Not applicable.
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 implant, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical implant, not a standalone algorithm.
7. The type of ground truth used: Not applicable. The submission focuses on substantial equivalence based on manufacturing materials, indications for use, and design similarity to predicate devices.
8. The sample size for the training set: Not applicable. No training set for an algorithm was used.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a regulatory submission for a physical medical device based on substantial equivalence, not on performance testing against specific acceptance criteria derived from a study involving data sets or expert analysis.

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The Reliance Interspinous Plate System is a supplemental fixation device intended as an adjunct to fusion of the thoracolumbar (T1- S1) spine by fixation to the spinous processes in skeletally mature patients, and is indicated for the following:

• degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• spondylolisthesis
• trauma (i.e., fracture or dislocation)
• tumors

This device is not intended for stand-alone use.

The Reliance Interspinous Plate System consists of an interspinous process spacer-plate and process lock plate assembly for posterior fixation of the spine in order to achieve fusion. The interspinous process spacer-plate and process lock plate are available in multiple sizes to accommodate various patient anatomies. The insert features a lateral plate with teeth to interface with the bone of the spinous processes. The process lock plate also features teeth which contact the bone of the spinous processes. The process lock plate is passed through the insert such that, in their final position, interspinous process spacer-plate and process lock plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.

The provided submission is for the Reliance Interspinous Plate System, a medical device, not an AI/ML device. Therefore, the questions related to AI/ML device evaluation criteria such as sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, and standalone performance are not applicable.

However, based on the provided text, I can infer the acceptance criteria and how the device claims to meet those criteria for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML-specific questions (2-9), these are not applicable to this submission as it is for a physical medical device.

• 2. Sample size used for the test set and the data provenance: Not applicable (not an AI/ML device).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML device).
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (not an AI/ML device).
• 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 (not an AI/ML device).
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI/ML device).
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (not an AI/ML device). Ground truth for a physical device is typically based on engineering standards and mechanical testing results.
• 8. The sample size for the training set: Not applicable (not an AI/ML device).
• 9. How the ground truth for the training set was established: Not applicable (not an AI/ML device).

Summary of Acceptance Criteria and Study:

The acceptance criteria for the Reliance Interspinous Plate System are primarily based on mechanical performance testing against industry standards (ASTM F1717-13) and comparison of technological characteristics and indications for use to legally marketed predicate devices.

The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests:

• Static axial compression
• Static torsion
• Static axial pull-out
• Dynamic axial compression
• Static plate dissociation

The results of these tests demonstrated that the device's strength is sufficient for its intended use and is substantially equivalent to the predicate devices. The materials and design are also compared to predicate devices to establish substantial equivalence.

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The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.

The Precision Spine Interspinous Plate System consists of an ISP female plate and an ISP male plate for posterior fixation of the spine in order to achieve fusion. The ISP female plate and an ISP male plate are available in multiple sizes to accommodate various patient anatomies. The ISP female plate and an ISP male plate feature teeth to interface with the bone of the spinous processes. The ISP male plate is passed through the insert such that, in their final position, the ISP female plate and an ISP male plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.

This document describes a 510(k) premarket notification for the "Interspinous Plate System," a medical device. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a study with a test set, ground truth, or expert review typical for AI/software devices. Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided text based on your prompt:

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

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

• Sample Size: Not explicitly stated. The tests are for mechanical properties of the device, implying a small number of physical samples rather than patient data.
• Data Provenance: Not applicable in the context of patient data. The testing appears to be laboratory-based mechanical testing.

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)

• Not applicable. This device is a mechanical implant, and its performance is evaluated through physical tests, not by human expert interpretation of data.

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

• Not applicable. This device is a mechanical implant; human adjudication is not part of its performance evaluation.

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 not an AI or software device that involves human reader interpretation.

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 (expert consensus, pathology, outcomes data, etc)

• Ground Truth: The "ground truth" for the performance of this mechanical device is based on the established mechanical testing standards (e.g., ASTM F1717-13) and the comparative performance against legally marketed predicate devices. The "truth" is whether the device meets the mechanical strength and stability requirements for its intended use, as demonstrated through these physical tests.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

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

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

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