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The Altus Spine Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the Altus Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Altus Spine Pedicle Screw System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136 and cobalt chrome meeting the requirements of ASTM F1537. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

This document describes a 510(k) premarket notification for the "Altus Spine Pedicle Screw System." It is a submission to the FDA seeking to demonstrate substantial equivalence to legally marketed predicate devices, not primarily a study proving a device meets specific acceptance criteria related to AI/software performance.

Therefore, many of the requested details, such as "acceptance criteria and reported device performance" in the context of an AI study, "sample sizes used for the test set and data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," and "ground truth for training set," are not applicable to this document.

This document focuses on the mechanical and material equivalence of a physical medical device (pedicle screws) to predicate devices, supported by bench testing.

Here's a breakdown of what is in the provided text, and why the requested information isn't present:

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

   • Acceptance Criteria (Implicit): For this mechanical device, the acceptance criteria are not explicitly stated in a quantitative table. Instead, the "acceptance" is demonstrating substantial equivalence to predicate devices through various tests.
   • Reported Device Performance: The document states that "Dynamic compression bend tests was performed in accordance with ASTM F1717-15. Flexion-extension, torsional grip, and axial grip was preformed in accordance with ASTM F1798-13. Bench tests demonstrated that the Altus Spine Pedicle Screw System is substantially equivalent to the predicate device."
   • Why a table isn't here: The specific numerical results of these bench tests are not provided in this summary document. The FDA 510(k) summary typically summarizes the conclusion of the tests (substantial equivalence) rather than raw data.

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

   • N/A. This is a mechanical device, and the "tests" refer to bench tests (e.g., mechanical load and fatigue testing), not clinical or AI data. There's no "test set" in the context of patient data.

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):

   • N/A. Ground truth from experts is relevant for diagnostic AI. Here, "ground truth" for a mechanical device would be its physical properties and mechanical performance under specified loads.

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

   • N/A. Adjudication is for resolving discrepancies in expert labeling/diagnosis, which is not applicable to mechanical bench testing.

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:

   • N/A. This is a physical device, not an AI system that assists human readers.

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

   • N/A. Again, this is not an algorithm.

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

   • Implicit Ground Truth: For a physical device, mechanical properties, material composition (conforming to ASTM standards), and performance under specified load conditions (bench testing results) serve as the "ground truth" for demonstrating equivalence. This is not derived from expert consensus on medical images or pathology.

8. The sample size for the training set:

   • N/A. There is no "training set" for this type of device.

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

   • N/A. No training set exists.

In summary, the provided text pertains to a physical medical device (pedicle screws) and its regulatory clearance via a 510(k) submission, based on demonstrating substantial equivalence through bench testing. The questions asked are highly specific to the evaluation of AI/machine learning medical devices, which is not the subject of this document.

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The Reform Pedicle Screw 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3.

The provided text is a 510(k) summary for a medical device (Reform Pedicle Screw System) and does not describe acceptance criteria or a study proving that an AI/device meets acceptance criteria. Instead, it details the indications for use, technical characteristics, and a performance testing summary related to demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the context of an AI device. The document describes a physical medical device (pedicle screw system) and its regulatory clearance process based on substantial equivalence, not the performance of an AI algorithm against defined acceptance criteria.

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The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: 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, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm Systems. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems. When used with the 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems.

When used with the 3.5/6.0 mm and 4.0/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5/5.5 mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be lined to the Matrix System.

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors.

Synthes USS

• 6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
• 5.5 mm Rod System: Matrix
• 5.0 mm Rod System: USS Small Stature

CerviFix

• 3.5 mm Rod Systems: CerviFix, Axon, Synapse
• 4.0 mm Rod System: Synapse

The Synthes Matrix System is an addition to Synthes' existing posterior thoracolumbar spine systems. The Matrix System consists of a family of non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2), posterior hook fixation (T1-L5) or anterolateral fixation (T8-L5). The implants include pedicle bone screws, polyaxial pedicle screws, monoaxial pedicle screws, polyaxial heads, reduction screws, reduction heads, locking caps, transconnectors, transverse bars, rods and hooks. The implants are primarily manufactured from titanium (ASTM F67 - 06), titanium alloy (ASTM F1295 - 05), cobalt-chromium-molybdenum alloy (ASTM F1537 - 08) or nitinol (ASTM F2063 - 05), similar to the predicates.

The subject of this submission is the addition of transverse bars and tapered rods.

The document describes the Synthes Matrix System, a spinal fixation device. The study provided focuses on non-clinical performance testing rather than clinical trials with human subjects or AI performance.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Synthes conducted the following non-clinical testing..." but does not detail the number of units tested for each type of test.
• Data Provenance: The testing was non-clinical, conducted by Synthes. It does not involve human subjects, so concepts like country of origin or retrospective/prospective don't apply in the medical imaging sense.

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

• This question is not applicable to the provided document. The study is a non-clinical, mechanical performance test, not a study evaluating human judgment or diagnostic accuracy. The "ground truth" here is compliance with ASTM standards, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

• Not applicable. As noted above, this is a mechanical performance test, not a study involving human readers or adjudicators of medical data.

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

• No. This is a non-clinical performance study of a spinal fixation device, not a study involving AI or human readers of medical images.

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

• No. This is a non-clinical performance study of a spinal fixation device, not an algorithm.

7. The type of ground truth used

• The "ground truth" implicitly used for this non-clinical testing is the mechanical performance requirements specified in ASTM F1717–09 standards for static compression bend, static torsion, and dynamic compression bend testing. The device's performance was compared against these established industry standards and against predicate devices.

8. The sample size for the training set

• Not applicable. This is a non-clinical performance study of a physical device, not an AI algorithm that requires a training set.

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

• Not applicable for the same reason as point 8.

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The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a pedicle screw system (T1 - S2), a posterior hook and sacral/iliac screw fixation system or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. 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, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

Not Found

This document describes the Quantum Spinal System, a medical device, and its regulatory clearance through the 510(k) pathway. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way that an AI/ML device submission would.

The provided text describes a traditional medical device (spinal fixation system) and its substantial equivalence to predicate devices, rather than an AI/ML device with performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested fields are not applicable to the information contained in the provided document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in a quantifiable way typical for AI/ML device performance. The document states:

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

• Not applicable / Not provided. This document describes a spinal implant, not a data-driven device that requires a "test set" in the AI/ML sense. The performance data refers to mechanical and material testing, not clinical data sets.

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

• Not applicable / Not provided. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on a dataset. This information is not relevant to the clearance of a spinal implant.

4. Adjudication method for the test set:

• Not applicable / Not provided. Adjudication methods are used in AI/ML studies to resolve disagreements among experts in labeling data. This is not pertinent to the current device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable / Not provided. This device is a surgical implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not applicable / Not provided. There is no algorithm for this device.

7. The type of ground truth used:

• Not applicable / Not provided. The "ground truth" for a spinal implant's safety and effectiveness is established through engineering testing (e.g., biomechanical strength, material compatibility), pre-clinical studies, and clinical experience with similar predicate devices, rather than a "ground truth" for data labeling. The regulatory decision is based on substantial equivalence to predicate devices which have an established safety and effectiveness profile.

8. The sample size for the training set:

• Not applicable / Not provided. This device does not involve machine learning; therefore, there is no "training set."

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

• Not applicable / Not provided. As there is no training set for an AI/ML model, this question is not relevant.

In summary: The provided document is a 510(k) summary for a traditional medical device (spinal fixation system). The regulatory review for such devices focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through engineering performance data (e.g., mechanical testing conforming to ASTM standards), material safety, and similarity in design and intended use. The concepts of "acceptance criteria" and "study proving device meets acceptance criteria" for AI/ML devices, involving test sets, ground truth, experts, and reader studies, are not applicable to this type of traditional device clearance.

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