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The Tranquil-L™ Interbody System is intended for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone.

The Tranquil-L Interbody System is a lumbar interbody fusion system. Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The implants are offered in various angles, widths, heights, and lengths to meet patient anatomy for the lumbar spine. Implants are provided sterile via gamma irradiation. Instruments are provided clean and non-sterilization at the user's facility.

The purpose of this special 510(k) is to gain clearance for modifications to existing lumbar implants and add implant footprints for the DLIF surgical approach.

This FDA 510(k) Premarket Notification is for the Tranquil-L Interbody System, a lumbar interbody fusion system. The document states that engineering analysis and confirmatory testing were conducted to demonstrate substantial equivalence to previously cleared devices. However, the provided text does not contain specific acceptance criteria or reported device performance metrics in a table format. It also lacks details regarding the sample size, data provenance, expert involvement for ground truth, adjudication methods, or specific standalone or MRMC study results.

Therefore, based solely on the provided text, I cannot provide a detailed answer to your request regarding acceptance criteria and the study that proves the device meets them, as this information is not present.

The document primarily focuses on establishing "substantial equivalence" of the modified Tranquil-L Interbody System to its predicate devices by indicating that:

• Materials are identical to the primary predicate (Titanium Alloy (Ti-6Al-4V ELI) per ASTM F3001).
• Geometry differences are slight, and analysis and testing have shown equivalent performance.
• Engineering analysis and confirmatory testing were conducted, including dynamic compression and dynamic compression shear per ASTM F2077.

Without specific performance metrics from these tests and the acceptance thresholds, a table of acceptance criteria and reported performance cannot be generated. Similarly, information regarding ground truth establishment, expert qualifications, and study design details (sample size for test/training, provenance, MRMC, standalone) are not available in this document.

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The Kodiak C Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Kodiak C Cervical Cages are intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Kodiak C Cervical Cages are intended to be used with an FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of nonoperative treatment prior to treatment.

The Kodiak C Corpectomy Cages are indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed, or unstable vertebral body due to trauma/fracture or tumor, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Kodiak C Corpectomy Cages are intended to be used with autograft and/or allograft bone. The Kodiak C Corpectomy Cages are intended to be used with an FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

The Met One Technologies Kodiak C Cervical Cage is a cervical intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The cervical cages have a central cavity to permit the packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces to resist expulsion, and lattice windows for radiographic visualization. The implants are additively manufactured from Ti-6A1-4V ELI and are available in a variety of height, footprints, and lordotic configurations to suit individual patient anatomy.
The Met One Technologies Kodiak C Corpectomy Cage is a thoracolumbar vertebral body replacement device (VBR) that is implanted to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The corpectomy cages have a central cavity to permit the packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces to resist expulsion, and lattice windows for radiographic visualization. The implants are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.

This document is a 510(k) Summary for the Kodiak C Spinal Implant System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving performance against specific acceptance criteria in the context of AI/ML or diagnostic performance.

Therefore, the information requested regarding acceptance criteria, study details (sample size, data provenance, expert qualification, adjudication, MRMC, standalone performance, ground truth), training set sample size, and ground truth establishment cannot be fully provided from the given document. This document describes mechanical and material testing, not diagnostic or AI performance.

Here's an attempt to answer based on the provided text, highlighting what is present and what is missing:

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

The document lists performance tests conducted, but it does not explicitly state quantitative acceptance criteria or reported numerical performance values for these tests. It only states that the device "demonstrated substantial equivalence" to predicate devices, implying that the results met relevant industry standards (e.g., ASTM standards) but without providing the actual data or specific thresholds.

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

• Test set sample size: Not specified. The document refers to "the following test modes" and implies mechanical testing of devices, not clinical studies with patient data.
• Data provenance: Not applicable in the context of mechanical device testing. The tests are likely performed in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is a medical device approval involving mechanical properties and material composition, not diagnostic interpretation by experts. Ground truth in this context would refer to material specifications and engineering standards, not expert medical opinions.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations of data, not for objective mechanical test results.

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

• No. This document does not mention any MRMC study or AI assistance. The device is a physical spinal implant.

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

• No. This document does not pertain to an algorithm or AI.

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

• The "ground truth" for this type of device (spinal implant) would be established by engineering specifications, material standards (e.g., ASTM F3001 for Ti-6Al-4V ELI), and biomechanical testing standards (e.g., ASTM F2077, ASTM F2267). The device's performance is compared against these known, objective standards to demonstrate substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This document does not describe an AI/ML device that requires a training set.

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

• Not applicable. This document does not describe an AI/ML device.

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The Stable-C Interbody System is an anterior cervical interbody fusion system. The Stable-C Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is to be used with supplemental fixation cleared for use in the cervical spine. The system is intended to be used with autogenous or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.

The Stable-C Interbody System is an anterior cervical interbody device comprised of a cage (lordotic angles of 0 , 6°, and 12°) made from Ti-6Al-4V per ASTM F3001 and two fixation anchors made from Ti-6-Al-4V ELI per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text is a 510(k) premarket notification FDA letter for a medical device called the "Stable-C Interbody System." This document primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices.

It does NOT describe a study involving an AI/Medical Device that uses machine learning, nor does it provide details about acceptance criteria and performance data in the context of an algorithm's accuracy or effectiveness.

The "Performance Data" section in the document refers to mechanical testing of the physical implant device to prove its structural integrity and safety, not the performance of an AI algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, details of a study proving algorithm performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from the provided text because it is not relevant to an AI/ML medical device.

To answer your request, I would need a document describing the validation and performance of an AI/ML-based medical device.

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The Tranquil-L Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.

The Tranquil-L Interbody System is intended for use at either one level or two contiguous levels (L2-S1) in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The patients may have had a previous non-fusion spinal surgery at the involved level(s). The Tranquil-L device is intended to be used supplemental fixation systems.

The Tranquil-L Interbody System is made of Ti-6Al-4V ELI. The implant is offered in various angles, widths, heights, and lengths to meet patient anatomy for the lumbar spine. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The purpose of this traditional 510(k) is to gain clearance for additional implant footprints for the ALIF surgical approach.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Tranquil-L Interbody System." It outlines the device's indications for use, its classification, and a comparison to predicate devices, along with performance data.

However, the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device.

Instead, this document pertains to a physical orthopedic implant device (intervertebral body fusion device) designed for spinal surgery. The "performance data" mentioned refers to mechanical engineering principles and mechanical testing (e.g., compression, compression shear, subsidence, and expulsion testing) of the physical implant, not the performance of a software algorithm or AI.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size for test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study and effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document describes the regulatory clearance process for a traditional physical medical device based on substantial equivalence to existing predicate devices, focusing on its mechanical properties and intended surgical use. It is not about an AI/ML-driven diagnostic or therapeutic device.

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