Search Results

CAPSTONE™ SPINAL SYSTEM
The CAPSTONE™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

CLYDESDALE PTC™ SPINAL SYSTEM
The CLYDESDALE PTC™ Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE PTC™ Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

CRESCENT™ SPINAL SYSTEM
The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature of nonoperative treatment. These implants are to be used autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

CRESCENT™ SPINAL SYSTEM TITANIUM
The CRESCENT Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with Medronic supplemental fixation which has been cleared by the FDA for use in the lumbar spine.

DIVERGENCE-L™ ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplementation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the DIVERGENCE-L™ Anterior Oblique Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non- operative treatment. The DIVERGENCEL™ Anterior/ Oblique Lumbar Fusion System interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cage is also required to be used with autogenous bone graft. These implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.

The Intervertebral Body Fusion Device Systems are intended for vertebral body fixation of the thoracic or lumbar spine during the development of a thoracic or lumbar spinal fusion. Lumbar interbody fusion devices are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.

This document [K191788](https://510k.innolitics.com/search/K191788) is a 510(k) premarket notification for Medtronic Intervertebral Body Fusion Device Systems (specifically, the CAPSTONE™ Spinal System, CLYDESDALE PTC™ Spinal System, CRESCENT™ Spinal System, CRESCENT™ Spinal System Titanium, and DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System).

The submission is primarily focused on an MRI Update for these existing devices, meaning the purpose is to provide data demonstrating their safety and compatibility within the Magnetic Resonance (MR) environment. This is a common type of submission for established medical devices when new safety information or a change in labeling regarding MR compatibility needs to be supported.

Based on the provided text, there is no AI/ML component to this specific submission. The "device" in question refers to intervertebral body fusion implants, which are passive mechanical implants, not software algorithms or AI-driven systems. Therefore, most of the requested information regarding acceptance criteria and studies for an AI/ML device is not applicable to this document.

Here's a breakdown based on the information provided, highlighting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

• ASTM F2052 (measurement of magnetically induced displacement force)
• ASTM F2213 (measurement of magnetically induced torque)
• ASTM F2119 (evaluation of MR image artifacts)
• ASTM F2182 (measurement of radio frequency induced heating)

The Medtronic Intervertebral Body Fusion Device Systems have been labeled in accordance with ASTM F2503 "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment." |
| No significant adverse interactions, displacement, torque, heating, or artifacts beyond specified limits during MRI. | (Implicitly met as the conclusion states the devices are "as safe and effective" as predicates and are labeled for MR safety.) Specific quantitative performance data from these tests (e.g., exact displacement forces, temperature increases, artifact sizes) are not provided in this summary document, but would have been included in the full submission. |

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 (N/A) for an AI/ML test set.
• The performance data provided is for MR safety testing of physical implants, not an AI/ML algorithm. The "test set" would consist of the physical devices themselves and the materials they are made from, subjected to various MR field conditions in a lab environment.
• Data provenance is typically from controlled laboratory testing environments, not patient data in the context of AI/ML.

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

• Not Applicable (N/A). This is a question relevant to AI/ML model evaluation involving human expert interpretation. For physical device MR safety testing, ground truth is established by physical measurements and compliance with ASTM standards, not expert consensus on interpretations.

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

• Not Applicable (N/A). Adjudication methods are for human interpretation of data, often in AI/ML performance studies. MR safety testing involves physical measurements and engineering evaluations.

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 (N/A). There is no AI/ML component or human-in-the-loop scenario described in this submission. This is a K-number for physical intervertebral body fusion devices and their MR compatibility, not an AI/ML software.

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

• Not Applicable (N/A). This document concerns physical intervertebral body fusion implants, not a standalone AI/ML algorithm.

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

• Not Applicable (N/A) in the context of AI/ML.
• For the MR safety testing, the "ground truth" (or reference standard) is defined by the ASTM test methods and their specified thresholds/parameters. For example, a certain level of magnetically induced displacement is acceptable, and exceeding that is considered unsafe.

8. The sample size for the training set

• Not Applicable (N/A). There is no AI/ML algorithm in this submission, and therefore no training set.

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

• Not Applicable (N/A). There is no AI/ML algorithm or training set discussed in this document.

Summary of Document K191788:

This 510(k) premarket notification is for intervertebral body fusion device systems (implants used in spinal surgery). The core of this particular submission is an MRI Update, which means the manufacturer is providing data to demonstrate the safety and compatibility of these existing physical implants when subjected to Magnetic Resonance (MR) imaging environments. The document details the various predicate devices and the indications for use of the Medtronic systems. The "performance data" section explicitly lists MR safety testing conducted according to recognized ASTM standards. The conclusion states that based on this data, the devices are "as safe and effective as the following predicates" and have been appropriately labeled for MR safety. The document does not involve any artificial intelligence, machine learning, or software algorithm performance evaluation.

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The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody device is intended for interbody fusion in skeletally mature patients and is to be used with supplementation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the DIVERGENCE-L™ Interbody device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non-operative treatment. The DIVERGENCE-L™ Interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches include anterior and oblique.

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vasular structures or anterior oblique above the bifurcation (1-L5) of the vascular structures. The indications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) Degenerative Disc Disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.

The DIVERGENCE-LIM Anterior/Oblique Lumbar Fusion System consists of plates, bone screws, and interbody cages.

The DIVERGENCE-L™ Anterior/Oblique Lumbar interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The cages are manufactured from medical grade Polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.

The DIVERGENCE-L™ Anterior/Oblique Lumbar plates and bone screws are available in a broad range of size offerings intended for anterior screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior or oblique approach. The DIVERGENCE-L™ Anterior/Oblique Lumbar plate and bone screws are made from titanium alloy and are provided sterile.

The subject devices are manufactured from ASTM F2026 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136 -Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The subject interbody cages, plates, and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation. The subject instruments are reusable and provided non-sterile. The subject instruments must be cleaned and sterilized by the hospital.

The provided text describes the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System, an intervertebral body fusion device. However, this is a 510(k) summary for a medical device and not a study proving the device meets acceptance criteria regarding algorithm performance.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Explanation:

The document is a regulatory submission to the FDA for a medical device (an implantable spinal fusion system), not for a device that uses an algorithm or AI. The "acceptance criteria" discussed in the document refer to the criteria for regulatory clearance (substantial equivalence to predicate devices), material specifications (e.g., PEEK, titanium alloy), and general device safety and performance tests (e.g., non-pyrogenicity endotoxin testing).

The mentions of "clinical data" refer to published retrospective clinical data for similar lumbar interbody fusion devices, used to support the claim that adding allogenic bone graft and expanding the indication to include deformity conditions poses no new risks. This is a review of existing literature to support the safety and effectiveness of the device's indications and material options, not a performance study of an AI or algorithm-based device.

Thus, all the specific points about acceptance criteria and studies related to algorithm performance (test sets, training sets, ground truth, experts, MRMC studies) are not applicable to this document.

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The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody is indicated for interbody fusion in patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion Interbody cage is also required to be used with autogenous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine. Interbody cages with a lordosis of 18° or greater must be used with at least supplemental, anterior fixation.

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior oblique above the bifurcation (1-L5) of the vascular structures. The indications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) Degenerative Disc Disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.

When used together, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System components can be used only to treat patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels.

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System consists of plates, bone screws, and interbody cages.

The DIVERGENCE-L™ Anterior/Oblique Lumbar interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and must be used with supplemental fixation. The cages are manufactured from medical grade Polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.

The DIVERGENCE-L™ Anterior/Oblique Lumbar plates and bone screws are available in a broad range of size offerings intended for anterior screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior or oblique approach. The DIVERGENCE-LTM Anterior/Oblique Lumbar plate and bone screws are made from titanium alloy and are provided sterile.

The subject devices are manufactured from ASTM F2026 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The subject interbody cages, plates, and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.

The subject instruments are reusable and provided non-sterile. The subject instruments must be cleaned and sterilized by the hospital.

The provided text describes a 510(k) premarket notification for a medical device, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to prove efficacy or safety from scratch.

Therefore, the information you're asking for, which is typically associated with studies proving device performance against specific acceptance criteria (like human reader studies, ground truth establishment, sample sizes for training/test sets in AI/ML, effect sizes for AI assistance, etc.), is not applicable or present in this document.

This document details:

• Device Description: What the device is (plates, bone screws, interbody cages), its materials, and sterilization.
• Indications for Use: The medical conditions and anatomical locations for which the device is intended.
• Technological Characteristics Comparison: How the new device is similar to its predicate devices.
• Performance Data: This section does not report clinical outcomes or diagnostic accuracy via human or AI evaluation. Instead, it reports engineering and material testing designed to demonstrate the device's physical properties meet established standards for similar devices.

Here's a breakdown of the specific points you requested, in the context of this document:

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

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

This document does not describe patient or image data test sets. The "test set" here refers to physical samples of the device components (interbody cages, plates, bone screws) used for mechanical and biocompatibility testing. The exact number of samples tested for each mechanical test is not specified in the summary, nor is the country of origin or whether if it was retrospective or prospective.

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):

This information is not applicable. "Ground truth" in the context of clinical or diagnostic performance studies is not relevant to this 510(k) submission, which focuses on engineering performance and material safety. Expert review typically refers to clinical or diagnostic interpretation, which is not the subject of these tests.

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

This information is not applicable, as there is no diagnostic or clinical interpretation test set with human readers to adjudicate.

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

This information is not applicable. This is a submission for a spinal implant, not an AI or diagnostic imaging device.

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

This information is not applicable. This is a submission for a spinal implant, not an AI or diagnostic imaging device.

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

This information is not applicable. The "ground truth" for this device's performance is defined by adherence to established mechanical testing standards (ASTM F1717, F2077, F2267, F-04.25.02.02) and biocompatibility principles. There is no clinical "ground truth" established in this document.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable. There is no "training set" or corresponding ground truth process as this is not an AI/ML device.

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