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510(k) Data Aggregation
(261 days)
The COSINE™ Spacer is an interbody fusion device intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 at least six (6) months of non-operative treatment.
The COSINE™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.
This device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
COSINE™ Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.
COSINE™ Spacers are manufactured from titanium alloy per ASTM F136 or ASTM F1295. The endplates are additively manufactured from titanium powder, as specified in ASTM F3001, and an internal component is manufactured from radiolucent PEEK polymer.
This document pertains to the 510(k) premarket notification for the COSINE™ Spacer, an intervertebral body fusion device. Regulatory information for the device is provided in the document. However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.
The document states that:
- Mechanical testing (static and dynamic compression and compression-shear, and subsidence) was conducted in accordance with "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices.
- The subject implants have the same technological characteristics as the predicate devices, including design, intended use, material composition, and range of sizes.
- The subject interbody devices have been found substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use.
To answer your request, the following information is missing from the provided text:
- A table of acceptance criteria and the reported device performance: The document mentions mechanical testing was performed in accordance with standards, but it does not list specific acceptance criteria (e.g., minimum compression strength, subsidence limits) or the actual performance values achieved by the COSINE™ Spacer.
- Sample size used for the test set and the data provenance: This information is not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as the "ground truth" for mechanical testing is typically defined by engineering standards, not expert interpretation.
- Adjudication method for the test set: Not applicable for mechanical testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This is not applicable as the device is a physical implant, not an AI or imaging system requiring human reader interaction.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For mechanical testing, the "ground truth" would be the engineering specifications and performance limits defined by the referenced ASTM standards and FDA guidance. Specific quantitative values are not given.
- The sample size for the training set: Not applicable as this is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA communication confirms the clearance of the COSINE™ Spacer based on its substantial equivalence to predicate devices through mechanical testing. However, it does not detail the specific acceptance criteria, test results, or methodology (beyond mentioning adherence to standards) that would allow for a complete answer to your request.
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(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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(171 days)
When used as an interbody fusion device, the ProLift® Micro Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
The ProLift® Micro Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.
All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the ProLift® Micro Expandable System components with components from any other system or manufacturer. The ProLift® Micro Expandable System components should never be reused under any circumstances.
The provided text describes a medical device, the ProLift® Micro Expandable Spacer System, and its clearance through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data to establish specific acceptance criteria for device performance in a clinical setting.
Therefore, the document does not contain information typically found in a study that proves a device meets acceptance criteria related to AI/algorithm performance, human reader improvement, or detailed clinical efficacy. It focuses on the mechanical and material equivalence of the new device to existing ones.
Based on the provided text, I can extract information relevant to the device's technical specifications and the basis for its substantial equivalence, but not the specific clinical performance criteria, study design, or AI-related metrics requested in the prompt.
Here's an analysis of the information not present in the provided text, related to your specific questions:
- Acceptance Criteria and Reported Device Performance (Table): The document does not describe clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) or report specific clinical performance metrics. It focuses on mechanical testing for substantial equivalence.
- Sample Size for Test Set and Data Provenance: No clinical test set or patient data is mentioned as part of a performance study.
- Number of Experts and Qualifications: No experts were used to establish ground truth for a clinical test set because no such study is described.
- Adjudication Method: Not applicable as no clinical test set with ground truth is discussed.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned. The document is about a physical medical implant, not an AI or diagnostic tool that would directly assist human readers.
- Standalone Performance (Algorithm Only): Not applicable, as this is a physical implant, not an algorithm.
- Type of Ground Truth Used: Not applicable for a performance study in the context of your questions. The "ground truth" for this device relates to its mechanical integrity and biocompatibility, which are verified through material specifications and mechanical testing rather than clinical outcomes established by experts or pathology.
- Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable as this is not an AI/machine learning device.
Information that is extractable from the document, though not directly answering your specific questions about AI/clinical performance studies:
The document describes the mechanical performance data used to demonstrate substantial equivalence, which is a different kind of "acceptance criterion" based on engineering standards:
- Acceptance Criteria/Performance (Mechanical):
- Type of Testing: Static Axial Compression, Dynamic Axial Compression, Static Shear, and Dynamic Shear testing.
- Standard: According to ASTM F2077.
- Purpose: To demonstrate substantial equivalency to the predicate device (Life Spine ProLift Micro Expandable System K212520).
- Reported Performance: The document states that this testing "was presented to demonstrate the substantial equivalency," implying the device met the requirements of the standard consistent with the predicate. Specific numerical results are not provided in this summary.
In summary, the provided FDA 510(k) document is for a physical medical device (an expandable spinal spacer) and therefore does not contain the type of information requested about AI/algorithm performance studies, human-in-the-loop studies, or clinical ground truth establishment.
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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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(143 days)
PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, TransContinental® and TransContinental® M Spacers) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, and TransContinental® and TransContinental® M Spacers) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. The Constitution® PLIF Spacer is inserted using a posterior approach. The Signature® TLIF Spacer is inserted using a transforaminal approach. The Continental® ALIF Spacer is inserted using an anterior approach. The Transcontinental® and Transcontinental® M Spacers are inserted using an anterior or lateral approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
PATRIOT® Spacers are made from PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). The Signature® R Spacer also includes an internal titanium alloy or commercially pure titanium (ASTM F67) component, and the TransContinental® M Spacer also includes an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium. The titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295).
The provided text describes a 510(k) submission for PATRIOT® Spacers, which are intervertebral body fusion devices. The submission aims to gain clearance for additional spacers and sterile lumbar PATRIOT® spacers. The study presented is a confirmatory static compression testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| In accordance with ASTM F2077-03 | Subject device met all acceptable criteria |
The document states, "Confirmatory static compression testing was conducted in accordance with ASTM F2077-03 with the subject device meeting all acceptable criteria." This indicates that the acceptance criteria were defined by the ASTM F2077-03 standard, and the device successfully met those criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text only mentions "confirmatory static compression testing" without specifying the number of samples or whether the data was retrospective or prospective, or its country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of study. The study involves mechanical testing (static compression testing), not clinical or diagnostic evaluation requiring expert review of medical data. The "ground truth" here is the performance metrics defined by the ASTM standard.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human interpretation or adjudication involved in static compression testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This study is a mechanical test for substantial equivalence, not a clinical study involving human readers and AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not an algorithm-based device. PATRIOT® Spacers are physical medical devices (intervertebral body fusion devices), and the testing described is mechanical performance testing, not software or AI algorithm testing.
7. The Type of Ground Truth Used
The ground truth used for this study is the performance specifications and criteria outlined in the ASTM F2077-03 standard for static compression testing of intervertebral body fusion devices.
8. The Sample Size for the Training Set
This information is not applicable as this is a mechanical performance study, not a machine learning study that would have a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of mechanical testing.
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