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510(k) Data Aggregation
(85 days)
The Amplify Surgical DualXSLIM® T/PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. The Amplify Surgical DualXSLIM® T/PLIF is indicated for unilateral or bilateral implantation. The DualXSLIM® T/PLIF implants are intended for single use.
The purpose of this 510(k) is to offer the DualXSLIM® T/PLIF as additional sizes and lordosis options to the previously cleared DualX (K181397). The DualX implants are a family of expandable interbody fusion devices that expand sequentially in lateral and then vertical directions. The implants are designed to be used in minimally invasive spine surgery. The DualXSLIM® T/PLIF implants are offered in a variety of sizes to accommodate patient anatomical needs. All implant components are manufactured from Ti-6A1-4V ELI per ASTM F136.
This document is a 510(k) summary for the Amplify Surgical DualXSLIM® T/PLIF intervertebral body fusion device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study of the device's diagnostic performance against specific acceptance criteria relevant to an AI/ML powered medical device.
Therefore, the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies for an AI/ML device is not applicable or available in this document.
This document describes a traditional medical device (implant) and its mechanical performance testing, not a diagnostic AI/ML device.
Here's a breakdown of why each requested point is not applicable:
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A table of acceptance criteria and the reported device performance: Not applicable. This document is for a physical implant, not an AI/ML diagnosis. It focuses on mechanical testing relative to standards (ASTM F2077, F2267) rather than diagnostic performance metrics (e.g., sensitivity, specificity).
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Sample size used for the test set and the data provenance: Not applicable. This refers to physical "tests" (e.g., static/dynamic compression) on the device, not a test set for an algorithm. The "test sets" would be the manufactured devices themselves.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no concept of "ground truth" established by experts in the context of mechanical testing for an implantable medical device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to expert consensus for diagnostic ground truth, which is not relevant here.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic devices.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For mechanical tests, the "truth" is determined by the physical properties measured against engineering standards.
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The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
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How the ground truth for the training set was established: Not applicable, for the same reason as above.
In summary, this 510(k) document is for an intervertebral body fusion device and details mechanical performance testing, not the diagnostic performance of an AI/ML algorithm. Therefore, the specific questions related to AI/ML device performance and validation cannot be answered from this provided text.
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(171 days)
The Toro-L Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Toro-L Interbody Fusion System is intended for use in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracy disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Toro-L Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis.
Integrity Implants' Toro-L Interbody Fusion System incorporates a bi-directional expandable interbody fusion device and a monolithic interbody fusion device intended for use in the thoracolumbar spine.
Once implanted, the Toro-L interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The Toro-L interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The Toro-L Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.
The Toro-L Interbody Fusion System implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and Ti-6Al-4V per ASTM F2924) and are offered in a range of sizes and lordotic options to accommodate variations in patient anatomy.
The Toro-L Interbody Fusion System expandable implant has integrated ramps and a threaded actuator that allow the implant to be inserted in a non-expanded form, and then subsequently expanded to full width and desired height through continuous expansion. When the desired height is achieved, the locking system is engaged to secure the construct in its final expanded configuration. The implant is then post-packed with bone graft.
The monolithic implant is a non-expanding conventional spacer with the interior space of the device divided into two compartments for bone graft containment.
Both the expandable and monolithic configurations have protrusions on the superior and inferior surfaces of the endplates of the implant to grip the adjacent vertebral endplates to resist expulsion.
The subject implant and instruments are offered non-sterile and are intended to be steam sterilized by the user prior to use.
This is a medical device 510(k) summary for the Toro-L Interbody Fusion System, which is a spinal implant. The document does not contain information related to AI/ML device performance, acceptance criteria for such, or studies involving human readers or ground truth as it pertains to AI/ML.
Therefore, I cannot fulfill your request for the specific information regarding AI/ML device performance, acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The provided text focuses on the mechanical and biological testing of the physical implant to demonstrate substantial equivalence to previously cleared devices.
Here's what the document does provide:
- Device Name: Toro-L Interbody Fusion System
- Regulatory Class: Class II (Product Codes MAX, PHM)
- Intended Use: Intervertebral body fusion of the spine in skeletally mature patients, with
autogenous and/or allogeneic bone graft and supplemental internal spinal fixation systems. Intended for use in the thoracic spine (T1-T12) and thoracolumbar junction (T12-L1), and lumbar spine (L1-S1) for symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation. Can also be used as an adjunct to fusion in patients with multilevel degenerative scoliosis. - Predicate Devices:
- Non-Clinical Tests Conducted (Bench Performance Testing):
- Static Axial Compression in accordance with ASTM F2077
- Dynamic Axial Compression in accordance with ASTM F2077
- Static Compression Shear in accordance with ASTM F2077
- Dynamic Compression Shear in accordance with ASTM F2077
- Wear Debris and Particle Characterization in accordance with ASTM F1877
- Subsidence in accordance with ASTM F2267
- Biocompatibility Assessment: In accordance with ISO 10993-1, including cytotoxicity testing in accordance with ISO 10993-5.
The conclusions state that based on these bench tests and biocompatibility assessment, the device demonstrates substantial equivalence and that any differences do not impact safety and effectiveness. This entire document describes a physical medical device, not an AI/ML-driven one.
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(40 days)
The DualX™ PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DualX™ PLIF is indicated for unilateral implantation.
The DualX™ LLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to L5, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The DualX™ TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The DualX™ Lumbar Intervertebral Body Fusion Device implants are an expanding family of interbody fusion devices that expand sequentially in lateral and then vertical directions. The implants are designed to be used in minimally invasive spine surgery and, in the collapsed configuration, are between 12.3 mm wide (TLIF and PLIF) and 13.3mm wide (LLIF).
After entering the joint space, the implants expand laterally to maximize the contact area around the cortical rim of the vertebral bodies. The implants then expand vertically to maintain distraction of the vertebral bodies and maximize clearance for exiting nerve roots. The implants are binary, and each implant can only be locked out in the fully expanded state. Specific sizes are included in the system with various expanded heights to optimize the fit for the patient.
The DualX™ Lumbar Intervertebral Body Fusion Device is made from titanium that conforms to ASTM F136.
This looks like a 510(k) premarket notification for a medical device called the DualX™ Lumbar Intervertebral Body Fusion Device. The provided document does not contain information typically found in a study proving a device meets acceptance criteria, especially not for an AI/algorithm-based device.
The document describes a modification to the sterilization trays of the device, allowing for non-sterile implants to be sterilized by the end user. It explicitly states: "mechanical testing was not required to demonstrate substantial equivalent mechanical strength since there are no modifications to the implants and instruments. The substantial equivalence of mechanical strength for the DualX™ Lumbar Intervertebral Body Fusion Device was established in the clearance of K181397."
This means the submission is not about proving the initial performance of the device itself (the implant), but rather about a change in how it is processed (sterilization trays), and relies on the previously established substantial equivalence of the device's mechanical strength under K181397.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI-based device, as this is a physical medical implant called an "intervertebral body fusion device" and the submission is for a minor modification to its packaging/sterilization.
If you have a document related to K181397 or a different type of medical device (like an AI/algorithm-based one) that includes performance study data, I would be happy to analyze that.
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