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The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac fusion for the following conditions:

· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially threaded cannulated screws in various diameters and lengths to enhance sacroiliac joint fusion. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. The purpose of this submission is to add the Posterior Oblique approach technique.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Simpact Sacroiliac Joint Fixation System components with components from any other system or manufacturer. The Life Spine Simpact Sacroiliac Joint Fixation System components should never be reused under any circumstances.

Based on the provided text, the document is an FDA 510(k) clearance letter for a medical device called the "Life Spine SIMPACT Sacroiliac Joint Fixation System." This type of document does not contain the details of a study on device performance against specific acceptance criteria for AI/ML-based devices. The content focuses on the regulatory clearance process for a traditional implantable medical device, asserting substantial equivalence to existing predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device, as this document does not pertain to such a device or studies.

The document discusses:

• Device Name: Life Spine SIMPACT Sacroiliac Joint Fixation System
• Regulation Number/Name: 21 CFR 888.3040, Smooth Or Threaded Metallic Bone Fixation Fastener
• Regulatory Class: Class II
• Product Code: OUR, HWC
• Indications for Use: Sacroiliac fusion for specific conditions (dysfunction, augmentation in sacropelvic fixation, fractures).
• Device Description: Fully threaded and partially threaded cannulated screws made from titanium alloy 6AL-4V-ELI.
• Purpose of Submission: To add the Posterior Oblique approach technique.
• Predicates: Medtronic, Inc. Rialto Sacroiliac Fusion System (K161210) and others.
• Substantial Equivalence: Based on design, materials, indications for use, sizing, and mechanical performance (for the new technique).

There is no mention of AI or ML, nor any performance data related to algorithms, expert readers, or ground truth for diagnostic accuracy studies. The "Performance Data" section explicitly states: "There are no new devices in this submission, only Design of Experiment validating Posterior Oblique approach." This refers to non-clinical performance (e.g., mechanical testing, not clinical AI performance).

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The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac fusion for the following conditions: · Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months. · To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially threaded cannulated screws in various diameters and lengths to enhance sacroiliac joint fusion. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Simpact Sacroiliac Joint Fixation System components with components from any other system or manufacturer. The Life Spine Simpact Sacroiliac Joint Fixation System components should never be reused under any circumstances.

Here's a breakdown of the acceptance criteria and study information for the Life Spine SIMPACT Sacroiliac Joint Fixation System, based on the provided FDA 510(k) summary:

This device is not an AI/ML powered device, therefore no AI-specific information is available. The submission is for a traditional medical device (sacroiliac joint fixation system) and focuses on demonstrating substantial equivalence to existing predicate devices through material and mechanical performance testing, rather than clinical performance or AI algorithm validation.

However, I can extract the information relevant to a traditional medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (e.g., number of screws tested) for the ASTM F543 tests. These are typically benchtop mechanical tests performed on a sufficient number of samples to ensure statistical validity and representativeness. The data provenance is laboratory testing rather than patient data.

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

Not applicable. This device is not AI-powered, and ground truth in the context of clinical expert consensus is not relevant for this type of mechanical testing. The "ground truth" here is adherence to mechanical standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical consensus in diagnostic studies, not for mechanical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is not an AI-assisted diagnostic tool, so no MRMC study or AI-related comparative effectiveness was performed.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through adherence to recognized international standards for medical device materials and mechanical testing (ASTM F543). The performance is compared to that of legally marketed predicate devices, implying that the predicate devices' performance against these standards sets the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable. This device does not involve a training set.

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The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially threaded cannulated screws in various diameters and lengths to enhance sacroiliac joint fusion. The purpose of this submission is to add the Tri-Fin Screw to the SIMPACT Sacroiliac Joint Fixation System. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine SIMPACT Sacroiliac Joint Fixation System components with components from any other system or manufacturer. The Life Spine SIMPACT Sacroiliac Joint Fixation System components should never be reused under any circumstances.

The provided text is a 510(k) summary for a medical device called the Life Spine SIMPACT Sacroiliac Joint Fixation System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing raw performance data or detailed study results for a new AI/software-as-a-medical-device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/ML performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies.

The performance data mentioned in the document is limited to:

• Engineering analyses
• Static Screw Pull-Out & Screw Driving Torque testing to ASTM F543 (A2 & A3)

This testing was done to demonstrate substantial equivalency in mechanical performance to the predicate device (Life Spine Sacroiliac Joint Fixation System (K141246)), not to assess the performance of an AI/ML algorithm or a diagnostic device.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on showing mechanical/design equivalence to a predicate, not meeting specific performance metrics for an AI/ML or diagnostic device.
2. Sample sizes used for the test set and the data provenance: Not applicable/not present. The testing mentioned (screw pull-out, torque) would have specific sample sizes for mechanical tests, but these are not for a "test set" in the context of AI/ML or clinical imaging data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present. This is not an AI/ML or diagnostic device requiring expert-established ground truth from images or clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not present.
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 present. This device is a mechanical fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not present in the context of what you're asking. The "ground truth" for this device would be its mechanical properties matching the standard or predicate.
8. The sample size for the training set: Not applicable/not present. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable/not present.

In summary, the provided document is a 510(k) for a mechanical spinal implant, not a software or AI-based medical device. Therefore, the detailed questions about AI acceptance criteria, ground truth, and study methodologies for AI/ML performance do not apply to the contents of this document.

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