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510(k) Data Aggregation
(58 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Do not introduce new issues of safety/effectiveness | Risk assessment and FE analysis confirmed no new safety/effectiveness issues. |
| Additional components are not worst-case | Confirmed that additional components are not the worst case. |
| Substantially equivalent to predicate | Overall technology characteristics lead to conclusion of substantial equivalence to predicate (K210035). |
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.
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(30 days)
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 Elatus 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 aqunct 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 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, 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 Elatus 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 Elatus 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 is a 510(k) summary for the Paeon Anterior Cervical Plate System and Elatus Lumbar Plate System. It describes the devices, their indications for use, and claims substantial equivalence to previously cleared predicate devices.
**However, this document does not describe:
- Acceptance criteria in terms of performance metrics for an AI/ML powered device.
- A study proving the device meets specific acceptance criteria using a test set of data.
- Details about sample sizes, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment for data-driven performance evaluation.**
This document is a regulatory submission for spinal intervertebral body fixation orthoses, which are physical medical devices (implants for spinal fusion), not AI/ML-powered software devices. The "performance testing" section explicitly states that "The additional components added in this submission do not require additional mechanical testing." and refers to substituting mechanical test data from predicate devices. This is typical for physical devices demonstrating substantial equivalence based on material, design, and manufacturing process similarity to existing devices.
Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI/ML-based device from the provided text. The questions posed in the prompt (e.g., "Number of experts used to establish the ground truth", "MRMC comparative effectiveness study", "standalone (i.e. algorithm only without human-in-the-loop performance)") are relevant to the evaluation of AI/ML software as a medical device, which is not what this document pertains to.
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(143 days)
ABTross ALIF Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. ABTross ALIF Expandable Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral 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.
The ABTross ALIF Expandable Cage System is interbody fusion devices. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And cages are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The cage can be expanded in height using the system instrument after being inserted in the unexpanded state. The cages have serrations on the superior endplate and inferior endplate surfaces area to contact vertebrae bone endplate. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g., posterior pedicle screw and rod systems, anterior or lateral plate systems, and anterior screw and rod systems). All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances.
The provided text describes the regulatory filing for the ABTross ALIF Expandable Cage System, a medical device for spinal fusion. It details the device's indications for use, materials, and comparative analysis with predicate devices. However, the document does not contain the specific information requested regarding acceptance criteria for a device performance, the study that proves it meets those criteria, or details related to AI/MRMC studies.
The document focuses on demonstrating substantial equivalence to existing devices cleared by the FDA, primarily through bench testing of mechanical properties. It does not present clinical study data or performance metrics in the format of acceptance criteria.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or AI/MRMC study results, as this information is not present in the provided text.
The text does mention:
- Performance Data: "Performance testing was performed to demonstrate that the subject ABTross ALIF Expandable Cage System is substantially equivalent to other predicate devices."
- Tests Conducted: Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, static expulsion test (ASTM draft F-04.25.02.02), and static subsidence test (ASTM F 2267-04).
- Result of Tests: "Bench testing to evaluate the mechanical properties of the ABTross ALIF Expandable Cage System showed a higher or similar mechanical value than predicate marketed devices."
- Ground Truth Type: Not explicitly stated, but the "higher or similar mechanical value" suggests that the "ground truth" for the mechanical tests would be the established acceptable mechanical properties or performance of the predicate devices according to the ASTM standards.
- Training Set Sample Size/Ground Truth: This information is not applicable and hence not provided as the evaluation is based on mechanical bench testing against predicate performance, not a machine learning model.
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(80 days)
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.
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent or superior to predicate devices (K210035, K200793) in static compression bending and static torsion (specifically for worst-case configurations). | The subject devices are stated to be identical to the predicate devices. A risk assessment, including ASTM F1717 testing for static compression bending and static torsion, was conducted to confirm that additional components (sizes) do not introduce new safety or effectiveness issues. The manufacturer explicitly states, "None of the additional sizes is the worst case of the Paeon Posterior Cervical Fixation System. Therefore, we substitute mechanical test data of additional components of Paeon Posterior Cervical Fixation System with the predicate device (K210035)." This implies that the performance of the new sizes is considered acceptable by being within the safety margin established by the worst-case predicate. |
| Material Biocompatibility: Materials used are biocompatible and equivalent to those in predicate devices. | The materials used for all systems (Ti-6Al-4V ELI titanium alloy (ASTM F136) and Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537) for Paeon Posterior Cervical Fixation System) are explicitly stated to be the same materials used in the predicate devices (K210035). |
| Functional Equivalence: Performs the intended function (e.g., stabilization, fusion adjunct) similarly to predicate devices. | The document states: "The design feature, indications for use and manufacturing process for the subject devices are substantially equivalent to the predicate devices." and "Subject devices are shown to be substantially equivalent to the predicate devices in indications for use, design, same manufacturing process, function and materials used." This implies functional equivalence. |
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.
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(58 days)
XYPAN Expandable Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. XYPAN Expandable Lumbar Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The XYPAN Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.
- -XYPAN-XT Expandable Cage is to be implanted via transforaminal and posterior approach.
- -XYPAN-XTP Expandable Cage is to be implanted via Anterior to Psoas approach.
- XYPAN-XL Expandable Cage is to be implanted via lateral approach. -
The provided text is a 510(k) summary for the XYPAN Expandable Lumbar Cage System, a medical device for intervertebral body fusion. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.
The 510(k) summary explicitly states: "Engineering rationales and comparisons between the subject and predicate devices were used to leverage previously conducted performance testing." This means that no new performance study was conducted for the XYPAN Expandable Lumbar Cage System itself to prove it meets acceptance criteria. Instead, its performance is considered substantially equivalent to a previously cleared device (the predicate device) based on similar design, materials, and intended use.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them directly from this document.
However, I can extract information related to the device and the basis for its clearance:
Device Information:
- Device Name: XYPAN Expandable Lumbar Cage System
- Regulation Number: 21 CFR 888.3080
- Regulation Name: Intervertebral Body Fusion Device
- Regulatory Class: Class II
- Product Code: MAX
- Indicated Use: Intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, with or without up to Grade 1 spondylolisthesis or retrolisthesis. To be used with autogenous and/or allogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment.
- Material: Titanium 6AL-4V Alloy (ASTM F136)
- Predicate Device: AccelFix Lumbar Interbody Fusion Cage System (K190708) from L&K Biomed Co., Ltd.
Basis for Substantial Equivalence (as per the document):
- Identical Indications for Use
- Identical Materials of manufacture
- Identical Structural support mechanism
Because the document relies on substantial equivalence and engineering rationales to a predicate device rather than a new performance study with specific acceptance criteria, most of your requested points cannot be answered directly from the provided text.
Specifically:
- A table of acceptance criteria and the reported device performance: Not provided, as no new performance study was described.
- Sample size used for the test set and the data provenance: Not applicable, as no new test set study was described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 device is a physical implant, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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