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Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease ( defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion. The system is composed of modular polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, sublaminar band cerclages, band connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.

The provided text is an FDA 510(k) clearance letter for a medical device called the "MASADA Modular Spinal Fixation System." This document is a regulatory approval, not a scientific study report describing the performance of an AI/ML device. Therefore, it does not contain the information requested regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML system.

The "Non-clinical Test Summary" explicitly states: "An engineering analysis determined that no new worst case conditions have been introduced since the previously cleared submission (K231694)." and the "Clinical Test Summary" explicitly states: "No clinical studies were performed."

This means the clearance was based on substantial equivalence to predicate devices through design, materials, and engineering analysis, rather than new performance data from a clinical or AI/ML-specific study.

Therefore, I cannot provide the requested table and details about acceptance criteria and study findings for an AI/ML device based on the given input.

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The EGPS Navigated Instruments are indicated for use during the preparation and placement of Astura Medical screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The EGPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for precisely locating anatomical structures and for the special position of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. Use of the EGPS Navigated Instrument System is limited to use only with the Olympic and Masada spinal fixation systems (Olympic K153446, Olympic MIS K182239, Masada K231694).

Astura Medical EGPS Navigated Instruments are non-sterile, reusable instruments including a drill and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of associated Astura Medical screw implants. The instruments are manufactured from stainless steel per ASTM F899.

The provided text is a 510(k) summary for the Astura Medical EGPS Navigated Instruments. It does not describe a study involving an AI/Machine Learning device or a diagnostic device that would have typical acceptance criteria and a study design as outlined in your request.

Instead, this document pertains to a Class II surgical instrument (Stereotaxic Instrument) that is intended for use with a pre-existing robotic navigation platform. The FDA's review for this type of device typically focuses on substantial equivalence to a predicate device, which involves demonstrating similar performance, design, materials, and indications for use.

Therefore, most of the specific points in your request regarding acceptance criteria for device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable to this submission, as it's not a diagnostic AI/ML device.

However, I can extract the relevant information concerning the non-clinical tests that were performed to demonstrate substantial equivalence for this surgical instrument.

Here's the closest interpretation of your request based on the provided text:

Device: EGPS Navigated Instruments

Device Type: Surgical Instrument (Stereotaxic Instrument) for spinal surgery, used with a robotic navigation platform.

Nature of FDA Submission: 510(k) Premarket Notification, seeking substantial equivalence to a predicate device.

Absence of AI/ML Study Data: The document explicitly states "No clinical studies were performed" and the "Non-clinical Test Summary" only lists "Comparative dimensional analysis of subject instruments with predicate." This indicates that the device's acceptance was based on non-clinical engineering and design verification, not on clinical performance metrics typically associated with AI/ML or diagnostic devices.

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

The document does not present specific quantitative acceptance criteria or detailed performance metrics in the format of a clinical performance study for an AI/ML device. Instead, it relies on demonstrating equivalence through design and material comparisons.

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The non-clinical test involved "Comparative dimensional analysis," which refers to comparing the manufactured subject instruments to the specifications or dimensions of the predicate, likely involving engineering measurements rather than a "sample set" of patient data.
• Data Provenance: Not applicable. The "data" here would be engineering measurements and material specifications, not patient data from a specific country or collected retrospectively/prospectively.

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 the context of AI/ML, refers to validated clinical outcomes or expert labels. For a surgical instrument, "ground truth" would relate to engineering specifications and manufacturing tolerances, which are established by design engineers and quality control personnel, not typically clinical experts for labeling.

4. Adjudication method for the test set

• Not applicable. There was no "test set" of clinical data requiring expert adjudication.

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 is a surgical instrument, not an AI/ML diagnostic or assistive technology that would be subject to an MRMC study.

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

• Not applicable. This device is not an algorithm. It is a physical instrument intended for use by a surgeon, assisted by a separate robotic navigation platform.

7. The type of ground truth used

• The "ground truth" for this device's acceptance is based on engineering specifications, material standards (ASTM F899), and documented design equivalence to the predicate device. There is no clinical "ground truth" in the typical sense of pathology or outcomes data for this specific submission.

8. The sample size for the training set

• Not applicable. There is no AI/ML training set involved.

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

• Not applicable. There is no AI/ML training set involved.

In summary, this 510(k) submission for the EGPS Navigated Instruments is for a physical surgical device, not a software-based AI/ML diagnostic tool. Therefore, the questions related to clinical study design for AI/ML devices are not relevant to this document. The manufacturer demonstrated substantial equivalence primarily through non-clinical comparative analysis of the instrument's design, materials, and intended use with its predicate.

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The DOMINION Expandable Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-Tl) and the thoracolumbar spine (T1-L5). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the cervical spine (C2-T1), DOMINION spacers are in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissues in the cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. When used in the thoracolumbar spine (T1-L5), DOMINION spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The system is intended to be used with supplemental fixation that has been cleared by the FDA for use in the thoracolumbar spine (i.e. posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The Dominion Expandable Corpectomy system is a modular system comprised of Expandable Columns, Modular Endplates, and optional screws. The primary purpose of the Expandable Column is to provide mechanical support to the anterior column of the spine after a vertebral corpectomy is performed. The primary function of the Modular Endplates is to provide attachment points for the Expandable Column to the vertebral endplates. The screws are an optional device that can provide enhanced fixation to the vertebral endplates when desired. The system contains Inserters which allow the insertion and expansion of the Expandable Columns.

The document provided is a 510(k) premarket notification for a medical device (DOMINION Expandable Corpectomy System) and does not describe a study involving humans or AI for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document because it is not relevant to this type of device submission.

Here's a breakdown of what can be inferred from the document and why other points cannot be addressed:

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

The document lists several non-clinical tests that were performed, which inherently have acceptance criteria. However, the specific acceptance criteria values (e.g., minimum compression strength, maximum torsion deformation) and the reported device performance values (the actual measurements from the tests) are not detailed in this summary. It only states that the following analyses were conducted:

The summary states, "Astura Medical considers the DOMINION Expandable Corpectomy Spacer to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use." This implies that the non-clinical tests demonstrated performance comparable to or better than the predicate devices, thereby meeting relevant acceptance criteria established for such devices.

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

This information is not provided in a 510(k) summary for non-clinical (mechanical) testing. Sample sizes for mechanical tests are typically dictated by testing standards (e.g., ASTM standards) rather than patient data. Data provenance like country of origin or retrospective/prospective is not applicable to mechanical performance testing.

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 is not applicable as the device is a spinal implant, and the "ground truth" for its performance is established through mechanical testing against engineering standards, not through expert human interpretation of medical images or patient data.

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

Not applicable. Mechanical test results are objective measurements and do not typically require adjudication by experts in the same way clinical or diagnostic studies do.

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

The document explicitly states: "No clinical studies were performed." Therefore, an MRMC comparative effectiveness study was not done. This device is not an AI-powered diagnostic tool.

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

Not applicable. This is not an AI algorithm.

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

For this medical device, the "ground truth" for its safety and effectiveness is established through the adherence to recognized international and national mechanical testing standards (e.g., ASTM F2077, ASTM F2267) and the comparison of its performance to legally marketed predicate devices. It is based on engineering principles and material science, not clinical outcomes or expert consensus in a diagnostic sense.

8. The sample size for the training set

Not applicable. This device is not an AI system that requires a "training set."

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

Not applicable. As above, this device is not an AI system.

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Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease ( defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediative patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolessent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma surgery, used in sublaminar or facet wiring techniques.
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions.
  The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The MASADA Modular Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of modular polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, sublaminar band cerclages, band connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.

This document is an FDA 510(k) clearance letter for the MASADA Modular Spinal Fixation System. It does not describe an AI medical device or any study proving a device meets acceptance criteria related to AI performance. Therefore, I cannot provide the requested information.

The document primarily focuses on:

• Device name: MASADA Modular Spinal Fixation System
• Regulatory classification: Class II, Thoracolumbosacral Pedicle Screw System, Spinal Interlaminar Fixation Orthosis, Bone Fixation Cerclage, Orthopedic Stereotaxic Instrument.
• Intended Use/Indications for Use: Immobilization and stabilization of the posterior, non-cervical spine, including an articulated "Navigated Instrument System" for guiding surgical placement using imaging (CT, MR, fluoroscopy). Also includes a Sublaminar Band System.
• Substantial Equivalence: Comparison to predicate devices (OLYMPIC Posterior Spinal Fixation System, OLYMPIC Navigated Instruments, OLYMPIC Deformity Band System, Globus CREO Stabilization System).
• Non-clinical testing: Static Compression Bending, Dynamic Compression Bending, Static Torsion, Tulip Dissociation (all mechanical tests according to ASTM standards).
• Clinical testing: Explicitly states "No clinical studies were performed."

The request asks for details specific to an AI/ML powered device, including:

1. Table of acceptance criteria and device performance (AI metrics).
2. Sample size and data provenance for a "test set" (implying data used for AI evaluation).
3. Number and qualification of experts for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details (human reader improvement with AI).
6. Standalone (algorithm only) performance.
7. Type of ground truth (e.g., pathology, outcomes data).
8. Training set sample size and ground truth establishment for training.

None of this information is present in the provided text because the MASADA Modular Spinal Fixation System is a physical surgical implant and instrument system, not an AI/ML-driven diagnostic or therapeutic device. The "Navigated Instrument System" component uses existing imaging modalities (CT, MR) and a Medtronic StealthStation® System for anatomical localization, which is a computer-assisted surgical navigation system, but not an AI-powered device that processes medical images for diagnostic or prognostic purposes to which AI-specific acceptance criteria and studies would apply.

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The REUNION SI Joint System is indicated for skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Reunion Sacroiliac (SI) Joint Fusion System is a screw system designed to provide fixation across the sacroiliac joint to promote fusion. The screws are accompanied by a modular screw head that provides additional fixation points to the bone. A secondary screw option is a compression screw that does not affix to the modular heads. The system is supported by a comprehensive set of instruments to install the screw implants within the system.

The provided text is a 510(k) summary for the REUNION Sacroiliac Joint Fusion System. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/algorithm-based diagnostic or screening tool.

Therefore, the requested information regarding acceptance criteria, linked study designs, ground truth establishment, expert adjudication, or MRMC studies for an AI device is not applicable to this document.

Here's why and what information is available in the provided text:

• Device Type: The REUNION Sacroiliac Joint Fusion System is a physical medical device (a screw system for bone fixation), not an AI/algorithm.
• Approval Pathway: It's being approved via a 510(k) pathway, which primarily requires demonstrating substantial equivalence to a legally marketed predicate device, often through mechanical and material testing, rather than clinical performance trials to prove a specific numerical measure of diagnostic accuracy.
• "Clinical Test Summary": The document explicitly states "No clinical studies were performed" (page 5), reinforcing that the evaluation was not based on human clinical performance data against a specific acceptance criterion.

Based on the provided text, I cannot answer the questions regarding acceptance criteria and a study proving the device meets those criteria, as these concepts, in the context described (e.g., AI/algorithm performance), are not present or relevant to this 510(k) submission.

The acceptance criteria for this type of device (a physical implant) would typically be met through:

• Material compatibility and strength: Demonstrated by tests like those listed (Torsional Properties, Driving Torque, Axial Pullout Strength, Static/Dynamic Cantilever Bending) according to relevant ASTM standards. The "acceptance criteria" here would be meeting the specified mechanical property ranges or failure modes outlined in those standards, and showing equivalence to the predicate devices.
• Design and manufacturing controls: Adherence to Quality System (QS) regulation (21 CFR Part 820).
• Labeling requirements.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical tests summarized on page 5:

• Torsional Properties (ASTM F543)
• Driving Torque (ASTM F543)
• Axial Pullout Strength (ASTM F543)
• Static Cantilever Bending (ASTM F2193)
• Dynamic Cantilever Bending (ASTM F2193)

These tests are designed to show that the device performs mechanically as intended and is substantially equivalent to predicate devices. However, the document does not enumerate specific numerical acceptance criteria for these tests or explicitly state the reported device performance against those numerical criteria in a table within the provided text. It merely states that "The REUNION Sacroiliac Joint Fusion System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances."

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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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The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
-Spinal trauma surgery, used in sublaminar or facet wiring techniques.
-Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. -Spinal degenerative surgery, as an adjunct to spinal fusions.
The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The OLYMPIC Deformity Band System is a system designed to stabilize a vertebrae during the fusion process. The system is composed of sublaminar bad cerclages and band connectors. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.

This is a medical device, not an AI/ML device. The provided text outlines the 510(k) summary for the OLYMPIC Deformity Band System, a temporary orthopedic implant, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML model.

Therefore, I cannot provide the requested information. The document focuses on mechanical and material testing for a physical implant, not on the performance metrics of an AI system.

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The EL CAPITAN Anterior Lumbar Interbody Fusion 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). EL CAPITAN system implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The EL CAPITAN spacer and plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws.

When used with anchors only the zero plate may be used and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

Hyperlordotic interbody devices (>20° lordosis), Oblique interbody devices and EL CAPITAN 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 EL CAPITAN X spacer may only be used with titanium alloy screws.

The EL CAPITAN Anterior Lumbar Interbody Fusion 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). The Spacers are a modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights, and the plates are offered in multiple fixation types and sizes 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 provided text describes the EL CAPITAN Anterior Lumbar Interbody Fusion device and its substantial equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about a study proving the device meets specific acceptance criteria based on performance in a clinical or diagnostic context.

The document discusses the regulatory clearance (K222554) of an intervertebral body fusion device and summarizes the non-clinical tests performed to demonstrate substantial equivalence to predicate devices. However, this is not a study that proves a device meets acceptance criteria in the sense of a clinical performance study with defined metrics for accuracy, sensitivity, or specificity. Instead, it's a regulatory summary demonstrating mechanical and material equivalence.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as they are not applicable to the type of information presented.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not in terms of performance metrics like accuracy, sensitivity, or specificity as would be relevant for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the successful completion of the non-clinical tests listed, demonstrating mechanical and material equivalence to predicate devices. The "reported device performance" is that it passed these tests.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. The tests are non-clinical (mechanical, material, etc.), not based on a "test set" of patient data for performance evaluation.
• Data Provenance: Not applicable. These are laboratory test results, not clinical data from patients.

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 the context of expert consensus or pathology is relevant for clinical or diagnostic studies. For these non-clinical mechanical tests, the "ground truth" is defined by the ASTM standards and engineering principles. The tests themselves provide the data.

4. Adjudication method for the test set

• Not applicable. There is no expert adjudication process for these non-clinical mechanical tests as there would be for subjective clinical assessments. The results are objective measurements against defined 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

• No, an MRMC comparative effectiveness study was not done. The device is an intervertebral body fusion device, not a diagnostic tool or AI-assisted system for human readers.

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

• Not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

• Not applicable in the conventional sense (expert consensus, pathology, outcomes data). For these non-clinical mechanical tests, the "ground truth" is implied by the established ASTM standards and measurable physical properties.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm requiring a training set.

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

• Not applicable. This device is not an AI algorithm.

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The El Capitan Anterior Lumbar Interbody System 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 radiosraphic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). El Capitan System implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (0) months of non-operative weatment prior to treatment with an intervertebral cage.

The EL CAPITAN Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When used with anchors only the zero plate may be used and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

Hyperlordotic interbody devices (>20° lordosis) and the Oblique interbody devices must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine.

The El Capitan Anterior 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). The Spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights, and the plates are offered in multiple fixation types and sizes 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 provided text is a 510(k) Summary for the EL CAPITAN Anterior Lumbar Interbody Fusion System. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by non-clinical testing. It explicitly states that no clinical studies were performed. Therefore, information regarding acceptance criteria derived from a clinical study, sample sizes for test/training sets, expert qualifications, or adjudication methods cannot be extracted from this document.

However, the document does list non-clinical tests that were conducted to establish substantial equivalence. These tests serve as the basis for the device meeting performance acceptance criteria in a non-clinical context.

Here's a breakdown of the requested information based on the provided text, with explicit notes about what is not available:

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

The document lists the types of non-clinical tests performed, and states that the results "indicate that the El Capitan implants are equivalent to predicate devices." This implies that the acceptance criteria for these tests were met by demonstrating equivalence to the legally marketed predicate devices. Specific quantitative acceptance criteria or detailed numerical performance results are not provided in this summary.

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

This information is not available as the summary explicitly states "No clinical studies were performed." The non-clinical tests would involve physical device samples, but the number of samples used for each test is not specified. The provenance of the test data would be the laboratory where the non-clinical mechanical testing was performed, but this is not mentioned.

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 as no clinical studies were performed and thus no human expert-established ground truth was required for the presented non-clinical equivalence testing.

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

This information is not applicable as no clinical studies involving human interpretation or adjudication were performed.

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 as no clinical studies, especially those involving AI assistance or human readers, were performed.

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

This information is not applicable. The device described is a physical interbody fusion system, not an algorithm or AI device.

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

For the non-clinical tests, the "ground truth" is established by adherence to recognized ASTM standards (e.g., F2077, F1717, F2267) and by comparing the performance results to established performance characteristics of the predicate devices. This represents a laboratory-based, standard-driven performance benchmark rather than a medical ground truth (like pathology or outcomes data).

8. The sample size for the training set

This information is not applicable as no clinical studies were performed, and therefore, no training set for a clinical algorithm was used.

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

This information is not applicable as no clinical studies were performed, and therefore, no training set for a clinical algorithm was used.

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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.

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.

Here's an analysis of the provided text regarding the SIRION Lateral Lumbar Interbody Fusion device:

The provided document is a 510(k) summary for the SIRION Lateral Lumbar Interbody Fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria through clinical performance.

Based on the provided text, a table of acceptance criteria and reported device performance for a clinical study to prove performance against specific metrics is not available. The document explicitly states: "No clinical studies were performed."

Instead, the submission relies on non-clinical testing and a comparison to predicate devices to establish substantial equivalence.

Here's what can be extracted from the document regarding testing and comparisons:

1. Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing and Equivalence):

Note: The document only states "The results of these evaluations indicate that the Sirion implants are equivalent to predicate devices." It does not provide specific numerical acceptance criteria or detailed results from these non-clinical tests.

2. Sample Size for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable. No clinical test set was used, as "No clinical studies were performed."
• Data Provenance: The non-clinical testing (FEA and Mechanical) was conducted internally or by a contracted lab for Astura Medical. The data provenance details (e.g., country of origin, retrospective/prospective) are not specified in the summary but would be part of the full 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not applicable. No clinical test set was used, and therefore no ground truth established by experts for performance evaluation.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No MRMC comparative effectiveness study was done. The document explicitly states "No clinical studies were performed."

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

• Not applicable. This device is a physical medical implant, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" would be established by validated engineering standards (ASTM F2077, ASTM F2267, etc.) and direct physical measurements and observations during testing (e.g., expulsion force, deformation under load). This is a technical ground truth based on established engineering principles and standardized test methods.

8. The Sample Size for the Training Set:

• Not applicable. There is no mention of a "training set" in the context of an AI/ML algorithm, as this is a physical medical device. The "training" for this type of device development involves established engineering design principles, material science, and manufacturing processes.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as no training set for an AI/ML algorithm is mentioned.

Summary of the K202495 Submission:

This 510(k) clearance for the SIRION Lateral Lumbar Interbody Fusion device is based on demonstrating substantial equivalence to previously cleared predicate devices (Sirion Lateral Lumbar Interbody Fusion K192006, Half Dome K152512, K163481, K172947, K182877, and ATEC ALIF and LLIF Spacer System K182746). The equivalence is supported by non-clinical testing (FEA for static/dynamic compression and shear, subsidence, and mechanical expulsion testing) which showed the new device to be comparable. No clinical studies were performed or required for this 510(k) clearance. The acceptance criteria are therefore implicit in the demonstrated equivalence to existing legally marketed devices and adherence to relevant ASTM standards for mechanical performance.

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