Search Results

The Altus Spine Navigation System reusable instruments are indicated to be used during the preparation and placement of Altus Spine Valencia Pedicle Screw System and Altus Spine Monaco Pedicle Screw System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Altus Spine Navigation System reusable instruments are specifically designed for use with the Medtronic StealthStation® System S8, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

• For a comprehensive summary of indications, the IFU for the specific system of use must be directly referenced: Altus Spine Valencia Pedicle Screw System / Altus Spine Monaco Pedicle Screw System.

The Altus Spine Navigation System is intended to pair with either the Altus Spine Valencia Pedicle Screw System or Altus Spine Monaco Pedicle Screw system to provide immobilization and stabilization 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 Navigation system may be used for noncervical pedicle fixation via posterior percutaneous approach with MIS instrumentation.

The Altus Spine Navigation System reusable instruments are surgical instruments for use with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. The Altus Spine Navigation System includes the following instruments dedicated to screw placement: Screwdrivers and Taps. The Altus Spine Navigation System is to be used with the following Altus Spine Systems:

▪ Altus Spine Valencia Pedicle Screw System
▪ Altus Spine Monaco Pedicle Screw System

All instruments are made of stainless steel per ASTM F899. All instruments are reusable instruments provided non sterile. The Altus Spine Navigation System instruments are not compatible with implants from other manufacturers. The Altus Spine Navigation System are designed for use only with Medtronic StealthStation® System S8 (V2.1.0) and the Medtronic NavLock® Tracker System.

Based on the provided FDA 510(k) clearance letter for the Altus Spine Navigation System, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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 used for the test set (number of instruments tested or number of trials). It only mentions that the Altus Spine Navigation System was "tested side-by-side with the primary predicate device."

Regarding data provenance:

• Country of Origin: Not specified, but implied to be related to Altus Partners, LLC (Pennsylvania, USA) and Medtronic (USA).
• Retrospective or Prospective: The testing described ("tested side-by-side") suggests a prospective performance evaluation conducted specifically for this 510(k) submission.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. The nature of the testing (recognition, location accuracy, dimensional accuracy, and critical length using ASTM F2554) suggests an objective, measurement-based ground truth rather than a subjective expert assessment of images or clinical outcomes.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given the objective, measurement-based nature of the performance tests (ASTM F2554, dimensional comparisons), an adjudication process like 2+1 or 3+1 (typically used for subjective assessments by multiple readers) would not be applicable or necessary.

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.

No, an MRMC comparative effectiveness study was not done.

This device (Altus Spine Navigation System) is a set of reusable surgical instruments designed to interface with an existing navigation system (Medtronic StealthStation® System S8). It is not an AI-powered diagnostic software or a device that directly assists "human readers" in interpreting medical images. Therefore, a study comparing human reader performance with and without AI assistance is not relevant to this device's function or clearance.

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

Yes, the performance tests described are essentially "standalone" device performance tests.

The tests evaluated the instruments themselves in their ability to be recognized and tracked accurately by the Medtronic StealthStation® System S8, and their dimensional accuracy. This is a characteristic of the device itself, independent of a specific surgeon's performance or interpretation during a procedure. It's about the technical performance of the physical instruments.

7. The Type of Ground Truth Used

The ground truth used for these performance tests was objective, measurement-based data derived from:

• Standardized Test Methods: Adherence to ASTM F2554 for recognition and location accuracy.
• Physical Measurements: Dimensional accuracy and critical length comparisons.

This is not a ground truth derived from expert consensus, pathology, or outcomes data, as those are typically used for diagnostic or therapeutic devices where subjective interpretation or clinical effect is being assessed.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. The Altus Spine Navigation System is a set of physical surgical instruments, not an AI/machine learning algorithm that requires a training set.

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

As the concept of a training set is not applicable, this question is not relevant to the Altus Spine Navigation System.

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, 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.

Ask a specific question about this device

The Altus Spine Interbody Standalone Fusion System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

When used with both the cover plate and four (4) provided screws, the Altus Spine Interbody Standalone Fusion System requires no additional supplemental fixation. In any other instance, additional supplemental fixation systems cleared by the FDA for use in the lumbar spine must be used.

Implants with hyperlordotic angles > 20 degrees, regardless of screw usage, must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems).

The interior of the interbody spacer component is intended to be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.

The Altus Spine Interbody Standalone Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The device is used singly or in pairs to better approximate the anatomical variations observed in different vertebral levels and/or patient anatomy.

The Altus Spine Interbody Standalone Fusion System implants are made of Polyetheretherketone (PEEK) with Tantalum that conforms to ASTM 2026 and ASTM 560 and Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The Altus Spine Interbody Standalone Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion, but is the sufficient strength to provide column support even in the absence of fusion for prolonged periods. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. The anterior superior and inferior surface of the interbody has holes to accept screw to penetrate the intervertebral body endplates for added stability.

This document is a 510(k) Premarket Notification for a medical device called the "Altus Spine Interbody Standalone Fusion System." It outlines the device's indications for use, its description, and a comparison to predicate devices to demonstrate substantial equivalence.

However, the provided text does not contain any information regarding acceptance criteria for an AI-powered device, nor does it describe a study proving an AI device meets such criteria.

The document is for a traditional medical device (an intervertebral body fusion device) made of PEEK, Tantalum, and Titanium Alloy. The "Summary of Non-Clinical Tests Submitted" section mentions tests in accordance with ASTM standards (F2077-14, F2267-04, and ASTM Draft Std. F04.25.20.02) to demonstrate substantial equivalence to previously cleared integrated ALIFs. These are engineering and mechanical tests for a physical implant, not performance metrics for an AI algorithm.

Therefore, I cannot fulfill your request as the provided input does not contain the necessary information about an AI device's acceptance criteria or performance study.

Ask a specific question about this device

The Altus Spine Sochi OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: Traumatic spine fractures and/or traumatic dislocations; Instability or deformity; Failed previous fusions (e.g. pseudarthrosis); Tumors involving the cervical spine; Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Altus Spine Sochi OCT System is also intended to restore the integrity of the spinal column even in the absent of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Altus Spine Sochi OCT System may be used with the Theken Coral Spinal System with the use of transition rods and rod connectors.

The Altus Spine Sochi OCT Spinal 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 Sochi OCT Spinal System attaches to the vertebral body by means of screws to the 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 provided text describes a 510(k) premarket notification for a medical device called the "Altus Spine Sochi OCT Spinal System." This document is an FDA clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study data for the device itself.

Based on the provided text, the device is deemed substantially equivalent, and the clearance is based on the absence of testing required because the device is identical in design, dimensions, and instrumentation to the predicate device. Therefore, no studies were conducted to prove the device meets acceptance criteria, as the acceptance criteria are met by virtue of being identical to a previously cleared device.

Specifically, the document states:

• "No testing is required. The Altus Spine Sochi OCT Spinal System are manufactured the same as the primary predicate Theken Atoll OCT Spinal System (K083863)."
• "The Altus Spine Sochi OCT Spinal System is the same as the primary predicate in regards to implant materials and surgical technique. The only difference between the primary predicate and the Altus Spine Sochi OCT Spinal System is the name. There were no design changes to the primary predicate when compared to the Altus Spine Sochi OCT Spinal System."

Therefore, I cannot extract the information requested regarding acceptance criteria and performance study details because the submission is based on substantial equivalence to an existing device, not on new performance testing. The "proof" is that it is the same as an already cleared device.

Ask a specific question about this device

The Altus Spine HA 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 HA 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 HA 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/lumbar system the Altus Spine HA Pedicle Screw System may also be used for the same indications listed above as an adjunct to fusion.

The Altus Spine HA 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 HA Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spine 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, cobalt chrome meeting the requirements of ASTM F1537 and Hydroxyapatite meeting the requirements of ASTM F1185. Other components included in this submission are (e.g., cross connectors, lateral connectors, inline connectors, dominos, etc.). Only the HA coated screws are supplied sterile packaged. All other components are supplied non-sterile.

This document is a 510(k) Premarket Notification from the FDA regarding the Altus Spine HA Pedicle Screw System. It declares the device substantially equivalent to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/software performance.

Instead, the document explicitly states:

"No testing is required. (e.g., engineering rational demonstrated that no new worst-case was introduced with the addition of the HA screws and all other components were previously cleared in (K200322). Altus Spine HA Pedicle Screw System are manufactured the same as the primary predicate Altus Spine Pedicle Screw System (K200322). Hydroxyapatite coating and sterile packing are processed the same as the primary predicate Whistler Modular Pedicle Screw System (K182478)."

This indicates that the submission relies on engineering rationale and substantial equivalence to previously cleared predicate devices, rather than new performance studies with specific statistical acceptance criteria for a new AI/software component. The device is a physical medical implant (pedicle screw system), not an AI/software device.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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 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.

Ask a specific question about this device

The Fuji Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Fuji Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

The purpose of this submission is to add the addition of a 4.5mm screw offering for the current FDA cleared Fuji Cervical plate System. It is intended for anterior fixation of the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with both self-tapping and self-drilling bone screws. The plates are available in a variety of lengths addressing multiple levels of fixation (one to four). The Fuji Cervical Plate System includes graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with the options of either self-tapping or self-drilling threads.

This document describes a 510(k) premarket notification for a medical device called the "Fuji Cervical Plate System." This is a spinal implant used for spinal fusion, not an AI/Software as a Medical Device (SaMD). Therefore, the information typically contained in an acceptance criteria and study section for SaMD products (such as a table of performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this submission.

Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Altus Spine Cervical Plate System K163061), primarily through non-clinical bench testing and engineering analysis, rather than clinical performance (e.g., diagnostic accuracy or treatment efficacy measured in human subjects).

Here's a breakdown of the relevant information provided in the document:

Device: Fuji Cervical Plate System
Type of Device: Spinal Intervertebral Body Fixation Orthosis (Implantable Hardware)
Regulatory Pathway: 510(k) Premarket Notification (demonstrates substantial equivalence to a predicate device)

Given that this is a hardware device for spinal fixation, not an image analysis or diagnostic AI, the requested information on acceptance criteria and study proving performance in the context of AI/SaMD is not present and not relevant to this specific FDA clearance.

The document implicitly states that the acceptance criteria for this type of device are typically related to:

• Mechanical performance: Ensuring the device can withstand the forces it will experience in the human body (e.g., fatigue, static strength). This is assessed through non-clinical bench testing.
• Biocompatibility: Ensuring the materials are safe for implantation. (Stated as Titanium Alloy that conforms to ASTM F136).
• Design equivalence: Demonstrating that the new features (e.g., 4.5mm screw offering) do not introduce new safety or effectiveness concerns compared to the predicate device.

What is described in the document as evidence:

• Summary of Non-Clinical Tests Submitted: "Engineering analysis was presented to demonstrate that the Fuji Cervical Plate System line extension does not present a new worst case in performance and is substantially equivalent to the predicates."
  • This implies that tests such as static compression, pull-out strength, fatigue testing, or other biomechanical assessments were performed, and their results met pre-defined engineering and mechanical standards. However, the specific acceptance values or detailed results are not provided in this summary document.
• Substantial Equivalence Conclusion: "The Fuji Cervical Plate System is substantially equivalent to the predicate devices in terms of intended use, material used, and performance. The device has a similar design, dimensions and instrumentation to the predicate devices."

To reiterate, the questions about AI/SaMD performance metrics and study design (e.g., MRMC, expert ground truth, training/test sets) are not applicable to the Fuji Cervical Plate System as presented in this FDA 510(k) summary.

Ask a specific question about this device

The Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s).

The Altus Spine Interbody Fusion is to be combined with cleared supplemental fixation systems.

The Altus Spine Titanium Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Altus Spine Titanium Interbody Fusion System implants are made of PEEK with Tatalum conforming to ASTM F2026 and ASTM F560 and Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The Altus Spine Titanium Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.

The provided document is a 510(k) premarket notification letter from the FDA for the "Altus Spine Interbody Fusion System." This letter and the accompanying 510(k) summary pertain to a medical device (an intervertebral body fusion device) and not an AI or software as a medical device (SaMD). Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

1. Indications for Use: The system is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at specific spinal levels (L2-S1), requiring six months of non-operative treatment, and may include patients with previous non-fusion surgery or Grade 1 spondylolisthesis. It must be combined with cleared supplemental fixation systems.
2. Technological Characteristics: The purpose of this submission is to include PEEK and Titanium alloy intervertebral body fusion devices into the existing Altus Spine Interbody Fusion System family. The core design and fundamental technology remain the same as the predicate devices, with only minor dimensional changes.
3. Non-Clinical Tests: Engineering analysis was presented to demonstrate that the revised system does not present a new worst-case performance and is substantially equivalent to the predicates. This typically involves mechanical testing (e.g., static and dynamic compression, torsion) to show the device meets established performance standards for interbody fusion devices, but specific details of these tests or their acceptance criteria are not provided in this summary.

In summary, as this is a medical device clearance based on substantial equivalence, the type of information requested (AI/SaMD-specific details) is not present in this document.

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 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