Search Results

The GS Medical AnyPlus II Spinal Fixation System is composed of a non-cervical spinal fixation devices. It is intended for use as posterior pedicle screw fixation system (T1-S2), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all following indications regardless of intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, reduction screw, canulated screws, long arm screws, cortical screws, and a set screw). The screws are available with diameters ranging from 4.5 to 10.5mm, and lengths ranging from 20-100mm in 5mm increments. They are available in noncannulated, cannulated, and longarm geometries with both mono and poly types for each geometry option. All AnyPlus II Spinal Fixation System implant components are manufactured from Ti6AI4V ELI according to ASTM F136.

These implants are supplied non-sterile and are not reusable. The instruments in this system are supplied non-sterile, are reusable, and patient contacting materials are fabricated from Precipitation Hardened Stainless Steels (STS630 and STS555) that complies with ASTM F899.

The provided text is a 510(k) summary for a medical device called the "AnyPlus II Spinal Fixation System." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical or AI-driven study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, training sets, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted from this document.

The document details:

• The device's name, regulation, and classification.
• Indications for use.
• Description of the device components and materials.
• A comparison to a predicate device (AnyPlus Spinal Fixation System, K172546), claiming substantial equivalence.
• Performance data consisting of biomechanical testing (static and dynamic axial compression bending, static torsion testing) according to ASTM F1717. This testing aims to show equivalent biomechanical performance to the predicate device (K091717, which seems to be an earlier predicate referenced for biomechanical comparison, rather than the primary equivalence predicate K172546).

In summary, this document does not contain the type of clinical or AI performance study details requested. It is a regulatory submission for a physical medical implant, not a software or AI device requiring such detailed performance evaluation against clinical ground truth.

Ask a specific question about this device

The GALAXY MIS Screw System is intended to provide immobilization of the posterior, non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The GALAXY MIS Screw System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The GALAXY MIS Screw System consists of GALAXY MIS SCREW (cannulated polyscrews), GALAXY MIS ROD (straight type rods and pre-bent type rods) and GALAXY Set Screw (set screw components) that can be inserted via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F 136). The implants will be provided non-sterile.

This FDA submission is for a medical device, the GALAXY MIS Screw System, which is a pedicle screw spinal system used for spinal fixation. As such, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested categories regarding clinical study details (like sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable in this context.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. For non-clinical (mechanical) testing, sample sizes typically refer to the number of devices or components tested, and provenance is not relevant.

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

This is not applicable. Ground truth, in the context of clinical studies and AI, refers to expert-validated diagnoses or outcomes. This submission involves non-clinical mechanical testing, where the "ground truth" is defined by the physical properties measured against engineering standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are used in clinical studies to resolve disagreements among experts or raters. Mechanical tests are typically performed according to standardized protocols without expert adjudication in this sense.

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

This is not applicable. The device is a surgical implant, not an AI-powered diagnostic tool, and therefore no MRMC study would be conducted.

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

This is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was defined by the acceptance criteria established in the ASTM F1717 standard for various mechanical properties (static compression, tension, torsion, dynamic compression bending). This is a technical standard rather than an expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

This is not applicable, as there is no training set for this device.

Ask a specific question about this device

The Dali Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use:

• degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
• spondylolisthesis;
• trauma (i.e. fracture or dislocation);
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• tumor;
• stenosis, and;
• failed previous fusion (pseudoarthrosis)

This system is comprised of screws, set screws, rods, crosslink and connectors. The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.

The provided text describes the "Dali Spinal Fixation System," a Class III medical device for spinal fixation. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

• Static compression bending
• Static torsion
• Dynamic compression bending (in accordance with ASTM F1717-10)
• Gripping-push down (in accordance with ASTM F1798) |
  | Material Equivalence | The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537), which are the same materials used in predicate devices. |
  | Design Equivalence (substantially similar) | The Dali Spinal Fixation System shares technological characteristics similar to the predicate devices, including similar design. |
  | Intended Use / Indications for Use | The device's intended use and indications for use as a non-cervical spinal fixation device (posterior pedicle fixation T1-S2/ilium, or anterolateral fixation T8-L5) for skeletally mature patients as an adjunct to fusion for conditions like degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion are deemed substantially equivalent to legally marketed predicate devices. |
  | Overall Safety and Effectiveness | The Dali Spinal Fixation System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use. |

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

The document explicitly states: "Clinical data and conclusions were not needed for this device." This means there was no clinical test set involving human subjects. The evaluation was based on non-clinical (bench) testing. Therefore, there is no sample size for an clinical test set or data provenance (country of origin, retrospective/prospective clinical data).

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

Not applicable. As no clinical data was required or used, there was no need for experts to establish ground truth for a clinical test set. The acceptance was based on engineering and material equivalence to predicate devices.

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

Not applicable. No clinical test set with human data requiring adjudication was performed.

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 spinal fixation system (physical implant), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not performed.

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

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

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

For the non-clinical performance evaluation, the "ground truth" was established by standardized mechanical testing protocols (e.g., ASTM F1717-10 for dynamic compression bending, and ASTM F1798 for gripping-push down) and material specifications (ASTM F136 for Titanium alloy, ASTM F1537 for CoCrMo alloy). The "truth" was that the device met or exceeded the performance of the predicate devices under these controlled, quantifiable conditions.

8. The sample size for the training set

Not applicable. This device is a physical implant evaluated through bench testing and comparison to predicate devices, not an AI or machine learning model that requires a training set.

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

Not applicable, as there was no training set.

Ask a specific question about this device

The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: 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 Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes 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); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient. The modifications contained herein consist of the addition of pedicle screw sizes to the SFS system.

The provided 510(k) summary for the Lanx Spinal Fixation System (K122145) describes a device modification, specifically the inclusion of additional pedicle screw sizes. As such, the submission primarily focuses on demonstrating substantial equivalence to the previously cleared predicate device rather than conducting a de novo study with acceptance criteria and a detailed comparative study for a novel device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not provide a table of explicit, quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device.

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

The document mentions "Engineering analysis" and "Engineering analyses" but does not specify:

• The sample size of any test set (e.g., number of pedicle screws or constructs tested).
• The data provenance (e.g., country of origin, retrospective or prospective nature).

These analyses would typically involve mechanical testing (e.g., fatigue, static strength) of various screw sizes and configurations.

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

This type of information is not applicable to this 510(k) submission. For a device modification like this, where the focus is on mechanical properties and substantial equivalence, "ground truth" established by experts in an clinical or imaging context is not relevant. The "ground truth" would be established by engineering standards and test methodologies.

4. Adjudication Method for the Test Set:

This is not applicable for the type of engineering analysis described. Adjudication methods (like 2+1, 3+1) are typically used for clinical or image-based studies where multiple readers assess outputs against a reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-interpretation devices, not for a spinal fixation system modification focused on mechanical properties. Thus, there is no mention of the effect size of human readers improving with or without AI assistance.

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

No, a standalone study was not done. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on engineering standards and established mechanical test methodologies to evaluate the mechanical performance of the pedicle screws and the overall system. The comparison is made against the predicate device's known performance and relevant ASTM or ISO standards for spinal implants.

8. The Sample Size for the Training Set:

This concept is not applicable to this submission. The device is not an AI/machine learning model that requires a "training set." The engineering analyses performed are deterministic mechanical tests.

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

This is not applicable as there is no "training set" for this device.

Ask a specific question about this device