Search Results

The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.

The ZESPIN SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. The subject submission introduces additional designs and sizes of the arch screw and locking screw.

• Arch Screw will be implanted in patient's bone then autograft will be inserted.
• Locking Screw can be used with washer or can be used on its own
• Self-tapping flute centers screw for easy insertion

The provided text is a 510(k) summary for the ZESPIN SI Joint Fusion System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance as would be seen for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable or present in this document.

However, I can extract what is available regarding performance testing and regulatory conclusions:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria for device performance based on a study, nor does it report specific performance metrics like accuracy, sensitivity, or specificity. Instead, it relies on a "risk assessment, including FE analysis" and comparison to a predicate device.

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

Not applicable. This is a mechanical device submission, not an AI/ML device requiring a test set of data. The "test" here refers to engineering assessments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for AI/ML performance evaluation is not relevant for this type of device submission. The "ground truth" for proving safety and effectiveness relies on engineering principles, materials science, and established regulatory pathways for similar devices.

4. Adjudication method for the test set

Not applicable.

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. This is not an AI/ML-driven diagnostic or assistive device.

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

Not applicable.

7. The type of ground truth used

For this device, the "ground truth" for acceptability is based on:

• Engineering principles and analysis (e.g., Finite Element Analysis - FEA).
• Compliance with material standards (Ti-6Al-4V ELI titanium alloy per ASTM F136).
• Demonstration of substantial equivalence to a legally marketed predicate device (K210035).

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Ask a specific question about this device

The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Paeon Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (TI-T3): traumatic spinal fractures and or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Paeon Posterior Cervical Fixation System is also 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.

The Paeon Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:

• · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• · spondylolisthesis,
• · trauma (i.e. fractures or dislocations),
• · tumors,
• · deformity (defined as kyphosis, lordosis, or scoliosis),
• · pseudoarthrosis,
• · failed previous fusion,
• · spinal stenosis.

The Spinema Lumbar Plate System is indicated for use via the anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated 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), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.

The ZESPIN SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136.

• Arch Screw will be implanted in patient's bone then autograft will be inserted. .
• Locking Screw can be used with washer or can be used on its own ●
• Self-tapping flute centers screw for easy insertion .

Posterior Cervical Fixation System is a top-loading, multiple components, The Paeon posterior (cervical-thoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, set screw, hooks and accessories that can be used via an open surgical approach. The devices are manufactured from titanium alloy per ASTM F136 and cobalt chromium per ASTM F1537.

The Paeon Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, fourlevel fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile.

The Spinema Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made from titanium alloy per ASTM F136. The Spinema Lumbar Plate System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55

This document describes the ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, and Spinema Lumbar Plate System. It is a 510(k) summary submitted by Aegis Spine, Inc. to the FDA. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

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

The document explicitly states that the subject devices are identical to the predicate devices in all characteristics with the exception of additional sizes (which are not worst-case) for the Paeon Posterior Cervical Fixation System. Therefore, the acceptance criteria and performance are inherently tied to the performance of the predicate devices. The primary characteristic assessed for substantial equivalence in this context is mechanical performance and material biocompatibility.

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

• Sample Size for Test Set: Not explicitly stated as a distinct "test set" in the context of clinical or performance data. The evaluation primarily relies on bench testing (ASTM F1717) for mechanical performance and material equivalence, rather than a clinical "test set" of patients. The "sample" in this case refers to the physical devices tested during the validation of the predicate device and the risk assessment of the new components.
• Data Provenance: The mechanical test data "substituted" is from the predicate device (K210035). This suggests that the data originates from previous testing performed for the K210035 submission. The country of origin and whether it was retrospective or prospective is not specified in this document, but it would typically be from mechanical engineering bench testing conducted under controlled laboratory conditions, likely in the country of manufacture or a certified testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable (N/A) for this type of 510(k) submission. The evaluation focuses on bench testing and material equivalence to a predicate device, not on clinical ground truth established by medical experts for a diagnostic or AI-assisted device.

4. Adjudication method for the test set:

• This information is not applicable (N/A). Adjudication methods like 2+1 or 3+1 refer to clinical consensus for ground truth establishment, which is not relevant for this engineering-focused substantial equivalence claim.

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 (N/A). This submission is for mechanical spinal implants, not an AI-assisted diagnostic device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

• This information is not applicable (N/A). As mentioned, this is for mechanical implants, not an algorithm or AI device.

7. The type of ground truth used:

• The "ground truth" in this context is established through laboratory bench testing standards (e.g., ASTM F1717) for mechanical properties, and industry standards for material specifications (e.g., ASTM F136, ASTM F1537) to ensure safety and performance. The comparison is made against the established performance of the legally marketed predicate devices.

8. The sample size for the training set:

• This information is not applicable (N/A). This submission does not involve machine learning or AI models, so there is no concept of a "training set."

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

• This information is not applicable (N/A). As there is no training set, there is no ground truth established for it in this context.

Ask a specific question about this device

The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The MegaCerfix Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The MegaCerfix Posterior Cervical Fixation System is also 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.

The MegaCerfix Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:

• degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• spondylolisthesis,
• trauma (i.e. fractures or dislocations),
• tumors.
• deformity (defined as kyphosis, lordosis, or scoliosis),
• pseudoarthrosis.
• failed previous fusion,
• spinal stenosis.

The Spinema Lumbar Plate System is indicated for use via the anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated 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), pseudoarthrosis, spondylolysis, scolosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

ZESPIN SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136.

• Arch Screw will be implanted in patient's bone then autograft will be inserted. .
• Locking Screw can be used with washer or can be used on its own 0
• Self-tapping flute centers screw for easy insertion o

The MegaCerfix Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, set screw, hooks and accessories that can be used via an open surgical approach. The devices are manufactured from titanium alloy per ASTM F136 and cobalt chromium per ASTM F1537.

The MegaCerfix Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, threelevel, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile.

The Spinema Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made from titanium alloy per ASTM F136. The Spinema Lumbar Plate System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is an FDA 510(k) clearance letter for several orthopedic spinal devices (ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, and Spinema Lumbar Plate System).

The document states:

• "The subject devices are identical to the predicate devices in all characteristics."
• "The ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, and Spinema Lumbar Plate System are identical to the predicates; mechanical testing is not required to establish substantial equivalence."
• "The overall technology characteristics lead to the conclusion that the ZESPIN SI Joint Fusion System. MegaCerfix Posterior Cervical Fixation System. MegaCerfix Anterior Cervical Plate System, and Spinema Lumbar Plate System is substantially equivalent to the predicate devices."

This indicates that the clearance was based on demonstrating substantial equivalence to already cleared predicate devices, rather than presenting a new study with acceptance criteria for a novel device or AI component. Therefore, I cannot fill in the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

Ask a specific question about this device