Search Results

Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:

• the use of EXPEDIUM 4.5, EXPEDIUM 6.35, VIPER 2, VIPER SAI, EXPEDIUM VERSE, VIPER PRIME (without stylet control), SYMPHONY OCT and the TriALTIS Spine System is indicated,

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the acquired image (CT. MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.

The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™ 4.5, EXPEDIUM™ 5.5, EXPEDIUM™ 6.35, VIPER™ 2, VIPER™ SAI, VIPER PRIME™, EXPEDIUM VERSE™, SYMPHONY™ OCT and TriALTIS™ screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the Medtronic StealthStation navigation system and associated tracking arrays.

This document is a 510(k) premarket notification for the "TriALTIS Navigation Enabled Instruments". It's a regulatory submission to the FDA, not a study report detailing AI/algorithm performance. Therefore, most of the information requested in your prompt (acceptance criteria for AI, study details like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) is not present in this document.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices. It describes the physical device, its intended use, and confirms that its technological characteristics (design, materials, performance) are consistent with the predicates.

Here's a breakdown of what can and cannot be answered from the provided text:

Information NOT available in this document regarding AI/algorithm performance:

• 1. A table of acceptance criteria and the reported device performance (for an AI/algorithm): This document does not describe performance metrics or acceptance criteria for an AI or algorithm. It's for a physical medical instrument.
• 2. Sample size used for the test set and the data provenance: Not applicable, as there's no AI algorithm being tested in the traditional sense.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 navigation instrument, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does provide, related to its "performance" (as a physical device):

The document mentions "Performance Data" in Section I, but this refers to engineering analyses and compatibility testing for the physical instrument, not an AI algorithm.

• Acceptance Criteria Mentioned (for the physical instrument's performance):

  • Rigidity of Connections and Instrument During Use
  • Instrument Verification
  • Accuracy Verification

• Study described that proves the device meets these criteria:

  • Type of Study: "A dimensional comparison and engineering analysis demonstrates that the TriALTIS Navigation Enabled Instrument meet performance requirements..."
  • Compatibility Testing: "Compatibility testing was performed with Medtronic StealthStation System S8 using StealthStation Spine Software Version 1.2.0 (1.2.0-20) using automatic intraoperative 3D Scan on an OARM Imaging System according to set up and installation instructions outlined in Medtronic's StealthStation S8 Spine with O-arm and 3D Fluoro Imaging Pocket Guide."

• Sample Size: Not specified for the engineering analysis or compatibility testing in terms of "cases" or "patients." It's likely component-level testing or a few test runs with the integrated system.

• Data Provenance: Not explicitly stated (e.g., country of origin), but it would be laboratory/engineering test data.

• Ground Truth: For a physical instrument, ground truth would be established through engineering specifications, calibrated measurement tools, and functional success/failure in controlled test environments. This isn't the same as clinical diagnostic ground truth.

In essence, the prompt's questions are designed for a submission involving an AI/Machine Learning device, whereas this document pertains to a physical surgical navigation instrument.

Ask a specific question about this device

The CONDUIT™ LLIF Cages with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. CONDUIT™ LLIF Cage is to be used with supplemental fixation. The CONDUIT™ LLIF Cages (>20 degrees) must be used with CONDUIT™ Lateral Switch Plate and supplemental fixation. When used with or without the CONDUIT™ Lateral Switch Plate, the system is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The purpose of this Traditional 510(k) is to seek marketing clearance for 22-degree and 30degree lordosis angled CONDUIT™ Lateral Lumbar Intervertebral Fusion (LLIF) Cages in the CONDUIT™ line of lumbar interbody cages with additional cage height of 14 to 18 mm. The CONDUIT™ line of lumbar interbody cages includes lordosis angles of 0, 8, and 16 degrees.

The CONDUIT™ LLIF Cage is used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using an LLIF (Lateral Lumbar Intervertebral Fusion) approach with cancellous bone graft and/or corticocancellous bone graft materials, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The CONDUIT™ LLIF Cage is intended to be used from L2-S1 in patients with DDD and up to Grade I spondylolisthesis or retrolisthesis at one or two contiguous levels. The device is intended to be used alongside supplemental spinal fixation, either applied anteriorly or posteriorly (e.g., using posterior pedicle screws). The CONDUIT™ Lateral Switch Plate is an optional device that connects to the CONDUIT™ LLIF Cage and adjacent vertebral body(s) to provide additional migration resistance and stability via DePuy Synthes AEGIS Screws. When used with or without the CONDUIT™ Lateral Switch Plate, the system is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

The CONDUIT™ LLIF Cage is made from Ti-6A1-4V alloy (ISO 5832-3) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The provided text describes a 510(k) premarket notification for a medical device, specifically the CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage and CONDUIT™ Instruments. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through clinical trials in the same way a PMA (Premarket Approval) submission would.

Therefore, the information typically requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria (such as detailed performance metrics from a clinical study, sample sizes for test/training sets, ground truth establishment methods, expert qualifications, and MRMC studies for AI devices) is not present in this document.

The document details non-clinical tests performed to demonstrate substantial equivalence, primarily mechanical and material testing, to show that the new variations (additional angles and cage heights) of the CONDUIT™ LLIF Cage are as safe and effective as existing legally marketed predicate devices.

Here's a breakdown of what is available and why the requested information is largely absent:

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

   • Acceptance Criteria: For a 510(k), the primary "acceptance criterion" is demonstrating substantial equivalence to predicate devices. This is achieved by showing similar indications for use, technological characteristics, and performance (often through non-clinical testing).
   • Reported Device Performance: The document lists the types of non-clinical tests performed, but it does not provide a table of quantitative acceptance criteria or the specific numerical results of these tests (e.g., maximum load for dynamic axial compression). It simply states that these tests were "evaluated to demonstrate substantial equivalence."

   Therefore, a table cannot be constructed with the detailed performance metrics you requested from this document.

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

   • This document describes non-clinical, mechanical testing of physical devices, not a study involving patient data or AI algorithms. Therefore, there are no "sample sizes" in the context of patient test sets or data provenance (country of origin, retrospective/prospective). The "samples" would be the number of physical cages and instruments subjected to mechanical tests. This specific number is not provided in the summary, only the types of tests.

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

   • Not applicable. This is not an AI/diagnostic device where expert interpretation of images or data would establish ground truth. Substantial equivalence for this intervertebral fusion cage is based on engineering design, material properties, and mechanical performance compared to predicates.

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

   • Not applicable for a mechanical device submission.

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 not an AI-assisted diagnostic device.

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

   • Not applicable. This is not an AI algorithm.

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

   • The "ground truth" for this type of device lies in its mechanical integrity, biocompatibility, and ability to facilitate fusion as demonstrated by the predicate devices. The non-clinical tests (e.g., ASTM standards) are designed to assess these characteristics, comparing the new device's performance to established engineering standards or the performance of predicate devices. There's no "expert consensus" on imaging or diagnosis in this context.

8. The sample size for the training set:

   • Not applicable. There is no AI model or training set involved.

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

   • Not applicable. There is no AI model or training set involved.

Summary of Device Performance (from the document):

The submission states:
"The following tests and analyses were performed on the subject device system to demonstrate that the additional angles of the CONDUIT™ LLIF Cage are substantially equivalent to other predicate devices:

• Dynamic Axial Compression (ASTM F2077-18)
• Dynamic Compression Shear (ASTM F2077-18)
• Static Axial Compression analysis (ASTM F2077-18)
• Static Compression Shear (ASTM F2077-18)

Expulsion analysis (ASTMF1839-08) and Subsidence analysis (ASTM F2267-04) were evaluated to demonstrate substantial equivalence.

The additional angled CONDUIT™ LLIF Cages with CONDUIT™ Lateral Switch Plate Construct testing was evaluated and due to the high level of confidence in previous dynamic testing as well as the addition of a Switch Plate resulting in a non-worst-case condition in all Static type tests (ASTM F2077, ASTM F2267 and F1839) was evaluated to demonstrate substantial equivalence.

MRI Safety Testing per ASTM F2052-15, ASTM F2182-17, ASTM F2119-07 and ASTM F2182-19e2 was evaluated to demonstrate substantial equivalence.

The subject device is substantially equivalent to legally marketed predicate devices with respect to indications for use, design, function, material composition, and performance testing standards."

Ask a specific question about this device

The EXPEDIUM® Spine 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 of the thoracic, lumbar and sacral spine.

The EXPEDIUM® Spine System is intended for noncervical pedicle fixation for the following indications: 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pediatic patients, the EXPEDIUM® System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scolosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM® System is intended to treat pediatric patients diagnosed with: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM® System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM VERSE® 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 deformites of the thoracic, lumbar and sacral spine.

The EXPEDIUM VERSE® System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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); 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 EXPEDIUM VERSE® System is intended for noncervical pedicle fixation 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM VERSE® System metallic implants are indicated as an adjunct to fusion to treat progressive spinal deformities (1.e, scoliosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis. Additionally, the EXPEDIUM VERSE® system is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM VERSE® system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM® Spine System and the EXPEDIUM VERSE® Spine Systems consists of metallic implants intended to provide immobilization and stabilization of spinal segments. The EXPEDIUM® Spine System and the EXPEDIUM VERSE® Spine Systems also consists of longitudinal rods, monoaxial screws, polyaxial screws, uniplanar screws, reduction screws, cable/wire screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers.

This document is a 510(k) summary for the EXPEDIUM® Spine System and EXPEDIUM VERSE® Spine System, primarily focused on obtaining clearance for modified Indications for Use to broaden indications in the pediatric population. It does not contain information about acceptance criteria or a study proving device performance against acceptance criteria.

The document discusses the device description, indications for use, similarities and differences with predicate devices, and materials. Under "J. Performance Data," it explicitly states:

"Additional performance data is not provided since this submission seeks a broadening of pediatric indications only."

Therefore, I cannot extract the requested information from the provided text. The document indicates that no new performance data or studies were conducted or provided for this submission regarding performance against acceptance criteria.

Ask a specific question about this device

When the CONFIDENCE 114 High Viscosity Spinal Cement is used in conjunction with the VIPER® and EXPEDIUM® Fenestrated Screw Systems, the cement is integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER® and EXPEDIUM® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. The CONFIDENCE™ High Viscosity Spinal Cement is a self-curing, high viscosity, radiopaque acrylic bone cement (PMMA), previously cleared by FDA in premarket notifications K060300 and K112907. The formulation of the spinal cement has not changed from the original clearance.
2. The VIPER® and EXPEDIUM® Fenestrated Screw Systems are designed with a cortical fix screw shank that is fully cannulated with lateral fenestrations at the distal end which allow for the controlled delivery of CONFIDENCE™ High Viscosity Spinal Cement. The design of the distally fenestrated screws provides a controlled means to deliver PMMA cement into the vertebral body. The screws are available in diameters of 4.35, 5.0, 6.0, 7.0, 8.0, 9.0 and 10.0mm and lengths of 30-80mm (in 5mm increments). Screws with lengths of 30mm have three fenestrations and screw lengths of 35mm and longer have six fenestrations. The VIPER® fenestrated screws are compatible with the VIPER System, VIPER2 and EXPEDIUM 5.5 Spine Systems (K111136) and the EXPEDIUM fenestrated screws are compatible with the EXPEDIUM VERSE® System (K142185).

This FDA 510(k) summary describes the submission for the CONFIDENCE™ High Viscosity Spinal Cement and the VIPER® and EXPEDIUM® Fenestrated Screw Systems. It mostly focuses on establishing substantial equivalence to predicate devices and describes the materials and intended use. However, it does not provide detailed acceptance criteria or the specific studies that prove the device meets these criteria in the format requested.

The document states that "Non-clinical testing and clinical data were submitted to characterize the subject components in this notification. The data provided supports the substantial equivalence of the subject devices," and "The performance testing, clinical literature, and substantial equivalence justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device." However, the specifics of these tests, including acceptance criteria, outcome measures, sample sizes, ground truth establishment, or expert qualifications, are not disclosed in this summary.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be gathered and what cannot:

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

• Cannot be filled. The document does not provide a table of acceptance criteria or specific performance metrics from studies. It broadly states that "performance testing" was done to demonstrate substantial equivalence.

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

• Cannot be filled. The document mentions "clinical literature" and "clinical data" but does not specify sample sizes, provenance, or study design (retrospective/prospective) for any test sets.

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)

• Cannot be filled. The document does not discuss the establishment of ground truth or the involvement/qualifications of experts in any testing.

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

• Cannot be filled. No information on adjudication methods is present.

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

• Cannot be filled. This device is a bone cement and screw system, not an AI device for image interpretation. Therefore, an MRMC study comparing human readers with/without AI assistance would not be applicable.

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

• Cannot be filled. Not applicable as this is a physical medical device (bone cement and screws), not an algorithm or AI system.

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

• Cannot be filled. The document does not describe how ground truth was established for any studies mentioned.

8. The sample size for the training set

• Cannot be filled. Not applicable as this is a physical medical device, not an algorithm that requires a training set. If "training set" refers to mechanical testing or animal studies, those specifics are not provided.

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

• Cannot be filled. Not applicable for the reasons stated in point 8.

Conclusion:

This 510(k) summary serves to demonstrate substantial equivalence for a bone cement and fenestrated screw system. It highlights the physical characteristics, intended use, and similarities to predicate devices. However, it does not contain the detailed performance study information, acceptance criteria, or methodological specifics typically found in a clinical study report or a 510(k) summary for a diagnostic or AI-based device, which would address the points raised in the prompt. The document explicitly states "Non-clinical testing and clinical data were submitted," but the summary itself does not contain the specifics of these submissions.

Ask a specific question about this device