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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 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 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); turnor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Altus Spine Pedicle Screw System may be used for noncervical pedicle fixation via in posterior percutaneous approach with MIS instrumentation for the indications listed above. When used as an anterolateral thoracic/umbar system the Altus Spine Pedicle Screw System may also be used for the same indications listed above as an adjunct to fusion.

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 spine. Which 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 Rod-to-Rod Connectors, Lateral Connectors, Dominos and Cross Connectors. All 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.

I am sorry, but based on the provided text, I cannot provide the requested information. The document is an FDA 510(k) clearance letter for a medical device called the "Altus Spine Pedicle Screw System." This type of document establishes substantial equivalence to a predicate device based on material properties, design, and intended use, often supported by mechanical testing.

The document does not contain any information about an AI-powered device, a clinical study involving human readers, ground truth establishment for a test set, expert adjudication, or metrics like sensitivity, specificity, or AUC which are typically associated with AI/ML medical device performance studies.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (in the context of AI metrics).
• Sample sizes and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone AI performance.
• Type of ground truth used.
• Training set sample size and ground truth establishment.

The document specifically mentions "SUMMARY OF NON-CLINICAL TESTS SUBMITTED:" and lists "Static Compression Bending, Static Torsion, and Dynamic Compression Bending per ASTM F1717-15." These are mechanical engineering tests for the structural integrity of the pedicle screw system, not clinical performance data for an AI algorithm.

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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 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.

The Altus Spine Pedicle Screw System may be used for noncervical pedicle fixation via in posterior percutaneous approach with MIS instrumentations fisted above. When used as an anterolateral thoracic/umbar system the Altus Spine Pedicle Screw System may also be used for the same indications listed above as an adjunct to fusion.

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. 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.

The provided text describes the Altus Spine Pedicle Screw System and its clearance by the FDA, but it does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of an AI/medical imaging device.

The document K181339 is a 510(k) premarket notification for a mechanical medical device (pedicle screw system), not an AI or imaging device. The "studies" mentioned are non-clinical mechanical tests to ensure the device's physical strength and stability, not studies of diagnostic accuracy, reader performance, or AI algorithm performance.

Therefore, I cannot provide a response filling in the requested table and information points as they are pertinent to AI/imaging device studies, which are not present in the provided text.

Here is why most of your requested points cannot be answered from the provided text:

• Acceptance criteria and reported device performance (Table 1): The text mentions mechanical tests (static and dynamic compression bending, static torsion per ASTM F1717, and static screw-tulip dissociation per ASTM F1798). It states that "Test results demonstrate substantially equivalent mechanical performance of the subject device as compared to the predicates." However, it does not provide specific numerical acceptance criteria (e.g., "must withstand X N of force") nor the reported numerical performance of the Altus Spine Pedicle Screw System against these criteria.
• Sample size for the test set and data provenance: Not applicable, as this is a mechanical device, not an AI/imaging device evaluating data. The "test sets" would be physical prototypes for mechanical testing.
• Number of experts and qualifications for ground truth: Not applicable. Ground truth for mechanical performance involves engineers and test standards, not medical experts interpreting images.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance with and without AI assistance for tasks like image interpretation.
• Standalone (algorithm only) performance: Not applicable. There is no algorithm mentioned.
• Type of ground truth used: For mechanical tests, the "ground truth" is compliance with ASTM standards and comparable performance to predicates based on physical measurements of force, displacement, etc.
• Sample size for the training set: Not applicable. There is no AI model or training set.
• How ground truth for the training set was established: Not applicable.

In summary, the provided document describes a 510(k) submission for a physical implantable device (pedicle screw system) and discusses its mechanical testing, not an AI-powered diagnostic or imaging device.

Ask a specific question about this device

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 dise 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 MIS 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 MIS 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. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

This document is a 510(k) Premarket Notification from the FDA regarding the Altus Spine Pedicle Screw System. It is a regulatory approval document for a medical device and therefore does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/software devices.

The document concerns a physical medical device (pedicle screw system), not an AI/software device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biomechanical testing standards for physical implants, which are not detailed in this regulatory summary beyond a statement that "no new mechanical testing is warranted" because there are no new worst-case components.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment. This type of information is typically found in submissions for AI/ML-based medical devices or diagnostic software.

Ask a specific question about this device

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, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Altus Spine Pedicle Screw System is a multiple component, posterior fusion spinal fixation system which consists of pedicle screws, cannulated pedicle screw, reduction screws, extended tab implants, cross-connectors, locking caps, hooks, and rods 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. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

This document is a 510(k) premarket notification for the Altus Spine Pedicle Screw System, outlining its substantial equivalence to previously marketed devices. However, it does not describe an AI/ML device or a study that evaluates its performance against specific acceptance criteria.

The document discusses a medical device (pedicle screw system), not an AI/ML system. Therefore, most of the requested information (AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable to this submission.

Here's an analysis based on the provided document, reinterpreting the request for a non-AI/ML medical device submission:

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

   • Acceptance Criteria (Implicit): Substantial equivalence to predicate devices, meaning the device's technological characteristics, materials, and intended use do not raise new questions of safety or effectiveness compared to legally marketed devices.
   • Reported Device Performance:
     • Materials: Titanium Alloy conforming to ASTM F136.
     • Design & Function: Multiple component, posterior fusion spinal fixation system consisting of pedicle screws, cannulated pedicle screws, reduction screws, extended tab implants, cross-connectors, locking caps, hooks, and rods. Attaches to the vertebral body using screws to stabilize the spinal operative site during fusion.
     • Indications for Use: Immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. Specifically for noncervical pedicle and nonpedicle fixation for conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion. Also, for a posterior percutaneous approach with MIS instrumentation for similar indications.

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

   • Not applicable. This is a 510(k) submission for a non-AI/ML implantable device, which typically relies on mechanical testing and comparison to predicate devices, not clinical data sets in the way an AI/ML algorithm would. The submission explicitly states: "There are no new worst case components to this system; therefore no new mechanical testing is warranted." The substantial equivalence is based on engineering design, materials, and similarity to previously cleared devices.

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. Ground truth for an AI/ML test set is not relevant here. The "ground truth" equivalent for this device is its adherence to material standards (ASTM F136) and its functional design principles, assessed by the manufacturer's engineers and reviewed by FDA engineers/scientists.

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

   • Not applicable. This concept pertains to AI/ML clinical study design, not the mechanical and design review of a pedicle screw system.

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 for AI/ML devices that assist human readers (e.g., radiologists). The Altus Spine Pedicle Screw System is a physical implant, not a diagnostic aid.

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

   • Not applicable. This refers to AI/ML algorithm performance.

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

   • For this device, the "ground truth" for demonstrating safety and effectiveness is implicitly established through:
     • Material Standards: Conformance to ASTM F136 (Titanium Alloy).
     • Mechanical Performance (Implicit): Assumed to be equivalent to predicate devices which have undergone mechanical testing. The document states "no new mechanical testing is warranted" because there are no new worst-case components.
     • Clinical Efficacy/Safety (Implicit): Demonstrated by the long-standing safe and effective use of the predicate devices for similar indications.

8. The sample size for the training set

   • Not applicable. This is for AI/ML algorithms.

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

   • Not applicable. This is for AI/ML algorithms.

In summary, this document is a regulatory submission demonstrating substantial equivalence for a conventional medical device (pedicle screw system), not an AI/ML device. Therefore, the requested information geared towards AI/ML performance evaluation is largely irrelevant to the content of this specific FDA 510(k) summary.

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The Altus Spine Pedicle Screw System is a noncervical spinal fixation device intended to provide stabilization of the spinal segments. It is indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft only having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Altus Spine Pedicle Screw System may be used 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:

1. Degenerative Spondylolisthesis with objective evidence of neurologic impairment;
2. Fracture;
3. Dislocation;
4. Scoliosis;
5. Kyphosis;
6. Spinal Tumor;
7. Failed previous fusion (pseudoarthrosis).

When used as a non-posterior, non-pedicle anterolateral fixation system the specific indications are:

1. Degenerative disc disease as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
2. Spondylolisthesis;
3. Fracture;
4. Dislocation;
5. Scoliosis;
6. Kyphosis;
7. Lordosis;
8. Spinal stenosis;
9. Spinal tumor;
10. Failed previous fusion (pseudoarthrosis)

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. The device is supplied non-sterile and is intended for sterilization by hospital personal.

The provided text describes a 510(k) summary for the "Altus Spine Pedicle Screw System," a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical (mechanical) testing. It does not involve a clinical study with human patients, AI performance, or ground truth establishment in the way typically associated with AI/software medical devices.

Therefore, many of the requested categories in your prompt are not applicable to this document. I will fill in the relevant information and explicitly state when a category is not applicable based on the provided text.

Acceptance Criteria and Device Performance Study for Altus Spine Pedicle Screw System

This document describes the 510(k) submission for a spinal implant system, not a software or AI-driven device. The evaluation is based on demonstrating substantial equivalence through non-clinical mechanical testing, rather than clinical performance or AI algorithm metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as "sample size" in this context but refers to the number of device components or constructs tested for mechanical properties. The specific number of test articles for dynamic compression bending, static compression bending, and static torsion tests per ASTM F1717 is not detailed in the summary.
• Data Provenance: Not applicable in the context of clinical data. The data originates from mechanical laboratory testing of the device components.

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

Not applicable. "Ground truth" in this context refers to established mechanical standards and performance requirements for spinal implants, not expert human interpretation for AI/diagnostic purposes. The acceptance criteria are based on defined engineering standards (ASTM F1717).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretation of clinical data, which is not relevant to mechanical testing. The met the predetermined acceptance criteria implies a clear pass/fail based on quantitative measurements against the ASTM F1717 standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is a clinical study design used to evaluate the diagnostic performance of a system (often AI-assisted) by comparing multiple readers' interpretations of multiple cases. This device is a physical spinal implant, and its evaluation did not involve such a study.

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

Not applicable. This device is a physical implant, not an algorithm, so "standalone performance" in the AI sense is not relevant. The mechanical tests evaluate the device's inherent physical performance.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the Altus Spine Pedicle Screw System's mechanical performance is defined by adherence to established engineering standards and specifications, specifically ASTM F1717. This standard outlines methodologies and acceptance criteria for spinal implant constructs. The device's performance is compared against these quantitative mechanical benchmarks, not against pathology, outcomes data, or expert consensus in a clinical diagnostic sense.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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