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510(k) Data Aggregation
(189 days)
The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications
Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.
SIRION X must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine.
The Sirion Lateral Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.
The provided document, a 510(k) summary for the SIRION Lateral Lumbar Interbody System, does not contain information regarding a study that proves a device meets acceptance criteria related to an AI/ML medical device.
The document describes a medical device, an intervertebral body fusion system, and its substantial equivalence to previously cleared predicate devices. The "Non-clinical Test Summary" explicitly states that tests like Static and Dynamic compression/shear, Subsidence, and Expulsion were conducted, and a "Clinical Test Summary" explicitly states: "No clinical studies were performed."
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets the acceptance criteria, as the document pertains to a traditional medical device (spinal implant) and not an AI/ML-driven diagnostic or treatment device that would typically involve the kind of performance evaluation you're asking about (e.g., sensitivity, specificity, human reader improvement).
The information you asked for, such as sample sizes for test sets, data provenance, expert consensus, adjudication methods, MRMC studies, standalone performance, and training set details, is relevant to AI/ML device evaluations, but is not present in this 510(k) submission for a physical implant.
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(59 days)
When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used 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 or retrolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement.
The Biomet Spine Fusion System implants are intervertebral body fusion/vertebral body replacement devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of the devices have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of PEEK (OPTIMA LT1®) per ASTM F2026, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, commercially pure titanium per ASTM F1580, and may include tantalum markers per ASTM F560. The expandable Biomet Spine Fusion System implants incorporate PEEK (OPTIMA LT1® per ASTM F2026) spacer components and titanium alloy (Ti-6Al-4V ELI per ASTM F136) endplate components that orient into predetermined lordotic angles of 0, 8 and 12 degrees. The expandable implants are available in 7 to 14mm heights, an 11mm width, and 25, 30 and 35mm lengths. The subject Biomet Spine Fusion System implant is provided sterile only.
The provided document describes a 510(k) premarket notification for the Biomet Spine Fusion System, indicating it is a medical device submission to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not present in this type of regulatory submission. The performance assessment here is primarily based on mechanical testing, not human reader performance or clinical outcomes.
Here's the information that can be extracted and a clear statement about what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with corresponding performance metrics in a clinical context. Instead, it states that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet or exceed predicate device performance in mechanical tests | "In all instances, the modified device met or exceeded predicate device performance, functioned as intended..." |
| Function as intended | "...functioned as intended and therefore demonstrated substantial equivalence to the predicate device(s)." |
| Comparable properties to previously cleared devices | "Performance data presented also demonstrated comparable properties to the previously cleared devices." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of this mechanical testing study. The performance data refers to results from physical tests of the device components.
- Data Provenance: Not applicable. The data is generated from mechanical testing of the device components, not from patient data, and thus does not have a country of origin or a retrospective/prospective classification in the typical sense of a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in this context, would relate to clinical outcomes or expert diagnoses, which are not part of this mechanical testing. The "ground truth" for mechanical testing would be the established engineering specifications and performance limits of the predicate device.
4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for clinical trials or studies involving expert assessment, which is not described here.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical intervertebral body fusion device and does not involve AI or human image readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone (algorithm-only) performance evaluation was not done. This device is a physical implant, not a software algorithm.
7. The type of ground truth used
For the mechanical testing, the "ground truth" is established by engineering safety and performance standards (e.g., ASTM F2077, ASTM F2267) and the performance specifications of the legally marketed predicate devices. The goal is to demonstrate that the new device's mechanical properties are equivalent to or better than those of the predicate.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a training set. The "training" in product development for such a device refers to engineering design and testing iterative processes, not data training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of machine learning. The design and testing of the device are based on established engineering principles, material science, and regulatory guidance for spinal implants.
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(175 days)
The Intersomatic Cervical Device - DICOM PEEK is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-C3 disc to the C7-T1 disc). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with additional supplemental fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.
The Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK is indicated for intervertebral body spinal 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 I spondylolisthesis at the involved level(s). DIMEI and TLIF Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The DIMEI and TLIF Spinal Implant is to be used with additional supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK were developed as implants for the stabilization of the cervical and lumbar spinal column. The implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery.
Here's an analysis of the provided text regarding acceptance criteria and study information for the Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, and Intersomatic Transforaminal - TLIF PEEK devices.
Based on the provided FDA 510(k) summary, these devices are intervertebral body fusion devices, and the submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific, quantifiable acceptance criteria from a clinical study for a novel AI/software function.
Therefore, most of the requested fields related to AI/software performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this particular device submission. The "acceptance criteria" here refer to the regulatory standards and testing required for this type of medical implant to demonstrate safety and effectiveness equivalent to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Testing: | |
| Invibio® PEEK Optima LT1 | Conforms to ASTM F2026 |
| Titanium alloy | Conforms to ASTM F136 |
| Non-clinical Mechanical Testing (per ASTM F2077): | |
| Static compression | Results indicate equivalence to predicate devices. |
| Dynamic compression | Results indicate equivalence to predicate devices. |
| Static torsion | Results indicate equivalence to predicate devices. |
| Dynamic torsion | Results indicate equivalence to predicate devices. |
| Non-clinical Subsidence Testing (per ASTM F2267): | |
| Subsidence performance | Results indicate equivalence to predicate devices. |
| Overall Substantial Equivalence: | The devices are substantially equivalent to predicate devices in terms of intended use, design, materials used, mechanical safety, and performances. |
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 applicable. The testing described is non-clinical mechanical testing of the physical implant, not a study involving patient data or a "test set" in the context of AI/software performance.
- Data Provenance: Not applicable. The data comes from benchtop mechanical testing, not human subjects.
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. Ground truth as typically defined for AI/software (e.g., diagnostic labels) is not relevant for this type of mechanical device testing. The "ground truth" for mechanical testing is established by adherence to ASTM standards and engineering principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical or expert-based adjudication in the context of this submission. The "adjudication" for mechanical testing is based on whether the device passed the specified ASTM standards.
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. No MRMC study was performed as these are physical medical implants, not AI/software for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. No algorithm-only performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this submission are the established ASTM standards for mechanical testing of intervertebral body fusion devices.
8. The sample size for the training set
- Not applicable. There was no "training set" in the context of an AI/software algorithm.
9. How the ground truth for the training set was established
- Not applicable. There was no "training set" or corresponding ground truth to establish.
Summary of the Study:
The provided document describes a 510(k) premarket notification for three intervertebral body fusion devices: Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, and Intersomatic Transforaminal - TLIF PEEK.
The study relied on non-clinical mechanical testing to demonstrate "substantial equivalence" to previously marketed predicate devices, as is common for Class II medical devices in the 510(k) pathway.
Specifically, the following analyses were conducted:
- Static and dynamic compression per ASTM F2077
- Static and dynamic torsion per ASTM F2077
- Subsidence per ASTM F2267
The manufacturer, Osteomed Implantes, LTDA, concluded that the DICOM PEEK, DIMEI PEEK, and TLIF PEEK devices are equivalent to the predicate devices based on similarities in principles of operation, technology, materials, and indications for use, supported by the results of these non-clinical evaluations.
No clinical studies were performed. The submission explicitly states this.
Ground Truth for Non-clinical Testing: The ground truth for this type of testing is adherence to the specified ASTM international standards (ASTM F2077 for compression/torsion and ASTM F2267 for subsidence), which are recognized benchmarks for evaluating the mechanical properties of intervertebral body fusion devices. The devices are expected to meet or exceed the performance of the predicate devices under these test conditions.
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(177 days)
The INTESS Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). INTESS Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The INTESS Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The INTESS Lumbar Cage was developed as implants for the stabilization of the lumbar spinal column. The INTESS implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery.
The provided text is a 510(k) summary for a medical device called the INTESS Lumbar Cage. It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices.
However, the provided document explicitly states under "6. CLINICAL TEST SUMMARY": "No clinical studies were performed".
This means that the document does not contain any information about:
- Acceptance criteria for device performance based on clinical data.
- A study that proves the device meets specific performance criteria through clinical data.
- Sample sizes for test sets (as no test set from a clinical study was used).
- Number of experts, their qualifications, or adjudication methods for ground truth (as no clinical ground truth was established through expert review).
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (clinical).
- Training set size or how its ground truth was established (as no AI/algorithm training was performed or reported).
The 510(k) summary focuses entirely on non-clinical testing (static and dynamic compression, subsidence, and expulsion) to demonstrate substantial equivalence based on mechanical safety and performance and material properties to legally marketed predicate devices, rather than clinical performance (e.g., efficacy or safety in patient outcomes).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in a clinical context, as the document explicitly states no clinical studies were performed. The acceptance criteria and "proof" presented are entirely based on the equivalence of mechanical properties to existing devices.
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