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510(k) Data Aggregation
(30 days)
SYNTHES SPINE CO.LP
The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P VA should be packed with autogenous bone graft and implanted via an anterior approach.
The Synthes Zero-P VA is a radiolucent and radiopaque intervertebral body fusion device. The Synthes Zero-P VA is composed of a spacer made from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque marker. The marker allows accurate intra-operative radiographic assessment of the position of the implant. The spacer component is preassembled with a mating titanium alloy (Ti-6Al-7Nb: TAN; ASTM F1295) interbody plate. The device is implanted anteriorly by inserting two screws (TAN) through the plate, one screw per vertebral body. The interbody plate incorporates a lock-catch mechanism in each screw hole comprised of a TAV lock-screw and catch, as well as an Elgiloy (ASTM F1058) spring. The screws offered with the Zero-P VA system are 3.7mm in diameter and are currently offered non-sterile. This line extension covers the addition of sterile-packed screws.
The provided document is a 510(k) summary for the Synthes Zero-P VA device, specifically for an extension covering sterile-packed screws. It describes the device, its intended use, and its equivalence to predicate devices. However, this document states that "Non-clinical performance data and conclusions were not needed for this device" and "Clinical data and conclusions were not needed for this device."
Therefore, the information required to answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document. This 510(k) relies on demonstrating substantial equivalence to previously cleared predicate devices without requiring new performance studies for this specific modification (sterile-packed screws).
To fully answer your questions, one would need to refer to the performance data and studies conducted for the original Synthes Zero-P VA device (K112068) and its earlier versions (K093762, K112459), or if such studies were performed for those previous clearances. This document explicitly states that no new performance data was needed for this particular 510(k) submission.
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(108 days)
SYNTHES SPINE CO.LP
The Synthes Zero-P is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P should be packed with autogenous bone graft and implanted via an anterior approach.
The purpose of this submission is to introduce an additional, larger footprint Zero-P spacer, as well as minor modifications to approved labeling.
The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P spacer is composed of PEEK Optima (ASTM F2026-02) with a radiopaque marker (ASTM F136-2a), and a titanium alloy anterior plate and screws (ASTM F F1295-01). The screws are inserted through the plate into the adjacent vertebral bodies and lock securely to the plate using a tapered-thread locking mechanism.
The Synthes Zero-P is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.
The provided text describes a 510(k) summary for the Synthes Zero-P "Large Footprint" intervertebral fusion device.
This document focuses on establishing substantial equivalence to predicate devices based on design and mechanical performance, rather than clinical efficacy studies with specific acceptance criteria as you might see for novel medical diagnostics or AI/ML-driven devices.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to a 510(k) submission for an intervertebral fusion device like the Synthes Zero-P. These types of studies are typically conducted for different types of devices, such as diagnostic imaging software or AI algorithms, where performance is measured against a ground truth and often involves human readers.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Meet or exceed the performance of predicate devices in relevant mechanical tests. | Synthes performed static and dynamic compression shear and torsion testing in accordance with ASTM F2077. The summary states, "The enclosed information demonstrates the subject device is as safe, effective and performs as well as the predicate." This implies that the device met the mechanical performance requirements to be considered substantially equivalent to the predicate devices. Specific quantitative acceptance criteria (e.g., "yield strength > X N") and the exact results are not provided in this summary but would be detailed in the full submission. |
| Material Compatibility: Use materials proven safe and effective for intervertebral fusion devices. | The Zero-P spacer is composed of PEEK Optima (ASTM F2026-02) with a radiopaque marker (ASTM F136-2a), and a titanium alloy anterior plate and screws (ASTM F F1295-01). These are commonly used biocompatible materials in spinal implants, implicitly accepted through their use in predicate devices. |
| Design and Functionality: Comparable indications, fundamental scientific technology, surgical technique, screw fixation, and design to predicate devices. | "The modifications herein presented to Synthes Zero-P device are substantially equivalent to identified predicates, Synthes Zero-P System (K072981); Synthes Zero-P [sterile screws (K093762)]; Medtronic PEEK Prevail (K073285) in indications, fundamental scientific technology, material, mechanical performance, surgical technique, screw fixation and design." |
| Indications for Use: Align with predicate device indications. | The indications for use are clearly stated and align with those for intervertebral fusion devices for degenerative disc disease. This is implicitly accepted by the FDA's clearance of the device as substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable: This device is an implantable medical device, not a diagnostic or AI/ML device that would typically have a "test set" in the sense of clinical data points for performance evaluation against a ground truth. Performance is demonstrated primarily through non-clinical (benchtop) mechanical testing and comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: See point 2. Ground truth in this context would relate to the established mechanical standards (ASTM F2077) and engineering principles for implant design. The "experts" would be the engineers and biomechanical testing professionals performing and interpreting the tests.
4. Adjudication Method for the Test Set
- Not Applicable: See point 2.
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 an implantable device, not an AI-driven diagnostic tool. An MRMC study is not relevant to its clearance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is an implantable device; there is no algorithm or standalone performance study in this context.
7. The Type of Ground Truth Used
- For the non-clinical performance data, the "ground truth" is based on established engineering standards (ASTM F2077) for static and dynamic mechanical testing of intervertebral body fusion devices, and the mechanical performance characteristics of legally marketed predicate devices.
- For material composition, the ground truth is established by ASTM standards for medical-grade PEEK Optima and titanium alloy (ASTM F2026-02, ASTM F136-2a, ASTM F1295-01).
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" for this device. The design, materials, and mechanical properties are based on well-established engineering principles and existing predicate devices, not machine learning or AI models trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: See point 8.
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(110 days)
SYNTHES SPINE CO.LP
The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P VA should be packed with autogenous bone graft and implanted via an anterior approach.
The Synthes Zero-P VA is a radiolucent and radiopaque intervertebral body fusion device. The Synthes Zero-P VA is composed of a spacer made from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque marker. The marker allows accurate intra-operative radiographic assessment of the position of the implant. The spacer component is preassembled with a mating titanium alloy (Ti-6Al-7Nb; TAN; ASTM F1295) interbody plate. The device is implanted anteriorly by inserting two screws (TAN) through the plate, one screw per vertebral body. The interbody plate incorporates a lock-catch mechanism in each screw hole comprised of a TAV lock-screw and catch, as well as an Elgiloy (ASTM F1058) spring. The screws offered with the Zero-P VA system are 3.7mm in diameter.
This document describes the Synthes Zero-P VA device, which is an intervertebral body fusion device. The provided text outlines the device description, indications for use, and a comparison to predicate devices, including performance data. However, this document does not contain information about explicit acceptance criteria for a device's performance with numerical targets or a study validating those criteria in the context of device performance in terms of accuracy or efficacy metrics.
The "Performance Date (Nonclinical and/or Clinical)" section primarily discusses bench testing to demonstrate substantial equivalence to predicate devices in mechanical performance, not clinical outcomes or specific performance criteria like accuracy, sensitivity, or specificity that would be typical for an AI/ML-based device.
Therefore, for the information requested in the prompt:
1. A table of acceptance criteria and the reported device performance:
Based on the provided text, there are no explicit "acceptance criteria" for accuracy, sensitivity, specificity, or similar performance metrics as would be found for an AI/ML-based device. The performance data presented is for bench testing to demonstrate substantial equivalence in mechanical properties.
| Acceptance Criteria (Not explicitly stated for clinical efficacy/accuracy) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate devices (Implied) | Bench testing (ASTM F2077-03 and ASTM F2267-04) for: |
- Static Axial Compression
- Dynamic Axial Compression
- Static Compression Shear
- Dynamic Compression Shear
- Static Torsion
- Dynamic Torsion
- Subsidence
(Conclusions: Substantially equivalent in performance to Synthes Zero-P (K072981), Sulzer BAK™/Cervical IBF (P980048), and Medtronic PEEK Prevail (K073285)). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The document describes bench testing of the physical medical device, not a test set of data for an AI/ML system.
- Data Provenance: Not applicable in the context of clinical data. The performance data is from laboratory bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for an AI/ML system is not relevant for this device's submission which focuses on mechanical equivalence.
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 a physical intervertebral fusion device, not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the bench testing, the "ground truth" would be the engineering specifications and established ASTM standards (ASTM F2077-03 and ASTM F2267-04) that dictate acceptable mechanical performance for intervertebral body fusion devices. This is not "ground truth" in the AI/ML sense.
8. The sample size for the training set:
- Not applicable. The device is not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
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(342 days)
SYNTHES SPINE CO.LP
The Synthes XRL device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synthes XRL device is intended to be used with Synthes supplemental internal fixation systems (e.g., USS, including Matrix and Pangea, and TSLP). The interior of Synthes XRL can be packed with bone (i. e., autograft or allograft). The Synthes XRL device is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Synthes XRL System is an addition to Synthes' existing thoracolumbar vertebral body replacement systems. These implants are designed to replace a collapsed, damaged or unstable vertebral body and provide anterior spinal column support. These additional implants include telescoping cylindrical components with spiked endplates to grip the adjacent vertebral bodies. These devices are manufactured from PEEK (ASTM F1579-02e1 and ASTM D 6262) with titanium (ASTM F 1295) locking rings and stop pins and tantalum (ASTM F 560) radiopaque markers.
Here's a breakdown of the acceptance criteria and study information for the Synthes XRL System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Outcome) |
|---|---|
| Static Axial Compression | Substantially equivalent to predicate devices |
| Dynamic Axial Compression | Substantially equivalent to predicate devices |
| Static Axial Torsion | Substantially equivalent to predicate devices |
| Dynamic Axial Torsion | Substantially equivalent to predicate devices |
| Expulsion | Substantially equivalent to predicate devices |
| VBR Height-Locking Test | Substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set. It mentions "bench testing results," which implies laboratory-based tests of the device itself rather than patient data. Therefore, the data provenance is likely in-vitro testing and not retrospective or prospective patient data. No country of origin for the data is specified beyond it being performed by Synthes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. The testing involved bench testing against established ASTM standards (ASTM F2077 and ASTM F1717). The "ground truth" would be the performance requirements set forth in these standards. The individuals conducting and analyzing these engineering tests would be qualified engineers or technicians, but their specific number and detailed qualifications are not provided.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation. Since this was bench testing, no such adjudication method would have been used. The results would be objectively measured against the ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical data and conclusions were not needed for this device." Therefore, an MRMC comparative effectiveness study was not performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not relevant as the device is a physical vertebral body replacement system, not a software algorithm. The "performance" refers to the mechanical integrity and function of the implant itself.
7. Type of Ground Truth Used
The ground truth used for the device's performance assessment was based on ASTM standards (ASTM F2077 and ASTM F1717), which define the mechanical properties and performance requirements for spinal implants.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here. This device underwent bench testing, not machine learning algorithm development.
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, a training set is not relevant for this type of device and study.
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(90 days)
SYNTHES SPINE CO.LP
The Synthes Antegra-T System is indicated for use via the 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 (LI - Sl) 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, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Synthes Antegra-T System consists of one-level titanium lumbar and sacral plates and cancellous screws with locking heads. The plates attach to the anterior portion of the lumbar and lumbosacral spine (L1-S1). These one-level plates are available in lengths ranging from 37 mm to 53 mm in 2mm increments. The sacral plates have a step on the underside that allows for precise sacral placement. The Antegra-T System uses the bone-screws from the Synthes Antegra System (K063158).
The provided text describes a medical device, the Synthes Antegra-T System, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for a spinal intervertebral body fixation orthosis. The key takeaway from the provided text regarding performance is:
- Non-Clinical Performance and Conclusions: "Bench testing results demonstrate that the Synthes Antegra-T System is substantially equivalent to the predicate devices."
- Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."
This means the device's substantial equivalence was established through bench testing only, comparing it to existing predicate devices. Since clinical data was not required, and no study is mentioned in the provided text, the specific information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) cannot be extracted.
Therefore, for each of the requested points, the answer is that the information is not available in the provided document.
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(141 days)
SYNTHES SPINE CO.LP
The Synthes ArcoFix System is indicated for use, via the lateral or anterolateral surgical approach, in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of the following:
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spondylolysis
• Fracture (including dislocation and subluxation)
• Spinal stenosis
• Deformities (i.e. scoliosis, kyphosis, lordosis whether neuromuscular or related to deficient posterior elements)
• Tumors (neoplastic disease)
• Pseudoarthrosis
• Failed previous fusion.
The Synthes ArcoFix System is an addition to Synthes' existing anterior/anterolateral/lateral thoracolumbar spine systems. The ArcoFix implant consists of an expandable plate and 4 bone screws, all manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same as the predicates.
The provided text describes a 510(k) submission for the Synthes ArcoFix System, a spinal intervertebral body fixation orthosis. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies with acceptance criteria based on performance metrics.
Therefore, the study information requested regarding acceptance criteria and performance with specific metrics like sensitivity, specificity, or reader improvement does not apply to this 510(k) summary. The submission states directly: "Clinical data and conclusions were not needed for this device."
Instead, the submission focuses on non-clinical bench testing to demonstrate substantial equivalence.
Here's a breakdown based on the characteristics of this 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance | Reported Performance |
|---|---|---|
| Non-Clinical Bench Testing for Substantial Equivalence | The Synthes ArcoFix System must demonstrate substantial equivalence in design, function, material, and intended use as compared to the predicate devices (Synthes VentroFix MIS (K031100) and Synthes Anterior Tension Band (ATB) System (K022791)). This typically involves mechanical testing (e.g., static and dynamic compression, bending, torsion), material characterization, and dimensional verification to ensure the new device performs similarly and meets relevant industry standards. | "Bench testing results demonstrate that the Synthes ArcoFix System is substantially equivalent to the predicate devices." (Specific quantitative results are not provided in this summary.) |
Explanation: In a 510(k) for a device like this spinal implant, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through non-clinical testing that simulates the stresses and uses the device would undergo. The success criterion is the demonstration of "substantial equivalence" based on these tests.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided summary. For mechanical bench testing, samples typically include a statistically relevant number of devices or components to account for manufacturing variability and to demonstrate conformance to specifications.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by Synthes Spine. It would be prospective in nature as the testing is specifically performed for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: For non-clinical bench testing of a spinal implant, "ground truth" as it relates to expert consensus on interpretation of clinical data (like images) is not relevant. The "ground truth" or reference for the bench tests would be established by engineering specifications, relevant ASTM or ISO standards, and the performance characteristics of the predicate devices. The experts involved would be engineers and material scientists.
4. Adjudication method for the test set
- Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are typically used for clinical study data where there is subjectivity in interpretation (e.g., image reading). For objective bench testing, the results are typically quantitative measurements, and "adjudication" in the clinical sense is not performed. Test results are compared against predetermined engineering specifications or predicate device performance.
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 type of study is specifically for evaluating the impact of AI systems on human reader performance, usually in diagnostics like radiology. The Synthes ArcoFix System is a medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This question pertains to the performance of an AI algorithm in isolation. The Synthes ArcoFix System is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Specifications and Predicate Performance: For the non-clinical bench testing, the "ground truth" would be defined by established engineering and material science principles, relevant international standards (e.g., ASTM, ISO) for spinal implants, and the known, acceptable performance characteristics of the predicate devices. Compliance with these established criteria constitutes meeting the "ground truth" for non-clinical substantial equivalence.
8. The sample size for the training set
- Not Applicable: Training sets are used in machine learning for AI algorithms. This is a physical medical device; thus, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, this question is not relevant.
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(111 days)
SYNTHES SPINE CO.LP
The Synthes Zero-P is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P should be packed with autogenous bone graft and implanted via an anterior approach.
The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P is composed of a PEEK spacer with a radiopaque marker, a titanium alloy anterior plate and screws. The screws are inserted through the plate into the adjacent vertebral bodies. The screws lock securely to the plate using a tapered-thread locking mechanism. The Synthes Zero-P is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.
This device, the Synthes Zero-P, is an intervertebral fusion device. The provided text indicates that no clinical data was needed for this device. Therefore, a study demonstrating the device meets acceptance criteria via clinical performance data does not exist in this submission as it was not required.
Instead, the performance data cited is non-clinical, specifically "Bench testing results demonstrate that the Synthes Zero-P is substantially equivalent to the predicate devices." This implies that the acceptance criteria for this device were met through demonstrating equivalence in design, function, and materials to already approved predicate devices via non-clinical, benchtop testing, rather than through a clinical study with human subjects.
Given that no clinical study was performed, the following information cannot be provided from this submission:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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(134 days)
SYNTHES SPINE CO.LP
Synthes OC Fusion System is intended to provide stabilization to promote fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System.
Synthes OC Fusion System is indicated for the following: DDD of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, atlanto/axial fracture with instability, occipital-cervical dislocation, revision of previous cervical spine surgery, and tumors (primary and metastatic)
The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.
Synthes Synapse System is indicated for the following: Hooks, Plate/Rods, Plates, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, OC Fusion and Synapse Systems are indicated for the following:
- Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal Stenosis
- Fracture/dislocation
- Atlantoaxial fracture with instability
- Occipitocervical dislocation
- Revision of pervious cervical spine surgery
- Tumor
When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars
The rods, clamps, screws, nuts, variable axis screws, locking screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallel connector.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Synthes OC Fusion System consists of occipital plates, occipital screws, occipital clamps, and rods intended to provide stabilization to promote fusion of the occipital-cervical junction. This system allows an occipital-cervical construct of either the occipital plate and rods or occipital clamps and rods. Rods are connected to the occipital plate or occipital clamps using a locking screw. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System.
The occipital bone screws are available in 4.5mm and 5.0mm diameters in lengths from 4mm to 18mm. Variable angle screw insertion is possible.
The occipital clamps are available in either a one-hole or two-hole configuration. The occipital plate is available in two sizes in either a medial or lateral configuration for a total of four available plates.
The plates are manufactured from commercially pure Titanium, grade 4. The rod connection points (rod clamps) in the plate are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) as are the occipital clamps, rods, and occipital screws.
The Synthes Synapse System consists of cancellous and cortex polyaxial screws, hooks, rods, transverse bars, parallel connectors, transconnectors, and locking screws. These implants are designed for fixation of the cervical, and/or upper thoracic spine (C1 - T3). A complete occipital-cervical-thoracic construct can be created by using components that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes OC Fusion System.
The implants are manufactured from Titanium Aluminum Niobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.
The provided 510(k) summaries (K072434) for the Synthes OC Fusion System and Synthes Synapse System do not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be described for a diagnostic AI device.
Instead, these submissions are for spinal implant systems which demonstrate substantial equivalence to predicate devices through bench testing (non-clinical performance data) and explicitly state that clinical data and conclusions were not needed for these devices due to their nature (they are modifications of existing, already cleared devices).
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies, as these types of studies were not required or performed for these specific 510(k) clearances.
Here's what can be extracted from the provided text based on the request's categories, tailored to the context of these spinal implant devices:
Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for Software/AI, but for Physical Device Equivalence)
The "acceptance criteria" and "reported device performance" in this context refer to the demonstration of substantial equivalence to predicate devices through non-clinical bench testing. The criteria are likely related to mechanical properties, material integrity, and functional performance matching or exceeding the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Device design, function, material, and intended use are substantially equivalent to predicate devices. | "Bench testing results demonstrate that the Synthes OC Fusion System is substantially equivalent to the predicate devices." (For OC Fusion System) |
| "Bench testing results demonstrate that the Synthes Synapse System is substantially equivalent to the predicate device." (For Synapse System) |
1. A table of acceptance criteria and the reported device performance:
As explained above, the "acceptance criteria" here is that the device is substantially equivalent to its predicate. The "reported device performance" is the statement that bench testing confirmed this substantial equivalence. Specific quantitative metrics such as sensitivity, specificity, accuracy, or specific mechanical thresholds are not detailed in these summaries.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. These are physical devices evaluated through bench testing, not data-driven software. The "test set" would refer to the physical samples of the device undergoing mechanical testing. The specific number of samples tested for each mechanical assessment (e.g., fatigue, static strength) is not provided in the 510(k) summary.
- Data Provenance: Not applicable in the context of country of origin or retrospective/prospective data as these relate to clinical or AI data studies. These are non-clinical biomechanical bench tests typically performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. For physical device bench testing, "ground truth" is established by engineering specifications, material science standards, and comparison to predicate device performance. It doesn't rely on expert human consensus in the way an AI diagnostic device would.
- Qualifications of Experts: Not applicable. The validation is based on objective measurements against engineering standards and predicate device data, not expert clinical judgment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in human expert opinions for ground truth establishment in studies involving subjective interpretation (like medical image analysis). For physical device bench testing, results are objective measurements.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. These devices are spinal implants, not AI-powered diagnostic tools intended to assist human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Standalone Performance: No, a standalone algorithm performance study was not done. These are physical medical devices, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the "study" (bench testing), the "ground truth" is the established mechanical performance and material properties of the predicate device(s) and relevant engineering standards. The goal is to demonstrate that the modified device performs equivalently or better.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. These are physical devices; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable. Since there's no training set, there's no ground truth established for it.
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(59 days)
SYNTHES SPINE CO.LP
The SynFixTM-LR is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFixTM-LR can be packed with autograft.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Synthes SynFixTM-LR is a combination radiolucent and radiopaque intervertebral body fusion device. Four screws are inserted through the anteriorly-located plate into the adjacent vertebral bodies. The screws lock securely to the plate using a tapered-thread locking mechanism. The Synthes SynFixTM-LR is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.
The provided text describes a 510(k) premarket notification for the Synthes SynFixTM-LR intervertebral body fusion device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a detailed clinical study with acceptance criteria and performance metrics in the same way an AI/ML device would.
Therefore, many of the requested fields regarding acceptance criteria, study details, expert involvement, and ground truth establishment are not applicable. The information provided focuses on non-clinical (bench) testing to demonstrate mechanical equivalence.
Here's a breakdown of the available information:
-
Table of acceptance criteria and the reported device performance:
Not applicable (N/A). The submission is for an intervertebral body fusion device, not an AI/ML device. The "Performance Date (Nonclinical and/or Clinical)" section states: "Bench testing results demonstrate that the Synthes SynFix™-LR is substantially equivalent to the predicate devices." No specific numerical acceptance criteria or performance metrics are provided in the summary. -
Sample size used for the test set and the data provenance:
N/A. No test set for an AI/ML algorithm is mentioned. The testing was "bench testing." -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. Ground truth establishment by experts is not relevant for bench testing of a physical medical device. -
Adjudication method for the test set:
N/A. Not relevant for bench testing of a physical medical device. -
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:
N/A. This is not an AI/ML device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. This is not an AI/ML device. -
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
N/A. The "ground truth" for this device would be its mechanical and material properties meeting established standards or being equivalent to the predicate device's properties as determined through bench testing. -
The sample size for the training set:
N/A. There is no training set for a physical medical device. -
How the ground truth for the training set was established:
N/A. There is no training set for a physical medical device.
Summary of available information:
- Acceptance Criteria/Performance: The device met the "substantial equivalence" criteria through bench testing. No specific numerical values or acceptance ranges are provided in the summary.
- Study Type: Non-clinical bench testing.
- Clinical Data: "Clinical data and conclusions were not needed for this device." This statement clarifies that no human clinical trials were required for this 510(k) submission.
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(100 days)
SYNTHES SPINE CO.LP
Synthes Synapse System is indicated for the following: Hooks, Plate/Rods, Rods and Screws When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, and Synapse Systems are indicated for the following: Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) Spondylolisthesis Spinal Stenosis Fracture/dislocation Atlantoaxial fracture with instability Occipitocervical dislocation Revision of pervious cervical spine surgery Tumor When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only. Hooks and Rods The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars The rods, clamps, screws, nuts, variable axis screws, locking screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine. The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallel connector. Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.
The Synthes Synapse System consists of cancellous and cortex polyaxial screws, hooks, rods, transverse bars, parallel connectors, transconnectors, and locking screws. These implants are designed for fixation of the cervical, and/or upper thoracic spine (C1 – T3). A complete occipital-cervical-thoracic construct can be created by using components that have been previously cleared within the Synthes CerviFix System and/or the Synthes Axon System. The implants are manufactured from Titanium Aluminum Niobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.
The provided 510(k) summary for the Synthes Synapse System focuses on demonstrating substantial equivalence to predicate devices through design modifications, material commonality, and intended use. The performance data section explicitly states that "Non-Clinical Performance and Conclusions: Bench testing results demonstrate that the Synthes Synapse System is substantially equivalent to the predicate device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
Therefore, the information required to populate most of the acceptance criteria and study design details (especially those related to clinical studies, ground truth, expert review, training data, etc.) is not available in the provided document. The submission relies solely on non-clinical bench testing to demonstrate substantial equivalence.
Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:
Acceptance Criteria and Device Performance Study for the Synthes Synapse System (K070573)
1. Table of Acceptance Criteria and Reported Device Performance
Since clinical data was not required and no specific objective acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, specificity, or mechanical properties) are detailed as "acceptance criteria" in a quantitative sense, this table will reflect the qualitative overarching acceptance criterion of "substantial equivalence" as demonstrated by bench testing.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Overall Equivalence | "Bench testing results demonstrate that the Synthes Synapse System is substantially equivalent to the predicate device." |
| Design Equivalence | Demonstrated through design modifications of the predicate. |
| Function Equivalence | Demonstrated through bench testing. |
| Material Equivalence | Implants manufactured from Titanium Aluminum Niobium TAN (Ti-6Al-7Nb) ASTM F1295, "the same as the predicate device." |
| Intended Use Equivalence | Identified as substantially equivalent to the predicate in intended use. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in terms of number of devices, materials, or specific test configurations. The document only references "bench testing results."
- Data Provenance: Not applicable in the context of clinical data. It refers to non-clinical laboratory bench testing. The country of origin for the testing itself is not stated.
- Retrospective/Prospective: Not applicable, as this refers to a non-clinical bench study, not a human subjects study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth in the context of expert review or clinical diagnosis was established as this was a non-clinical bench study.
4. Adjudication method for the test set
- Not applicable. No human experts or clinical cases were adjudicated.
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 study was not conducted. This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical implant, not an algorithm.
7. The type of ground truth used
- Not applicable. For a non-clinical bench test, the "ground truth" would be established by validated scientific methodologies, engineering specifications, and measurement standards for mechanical properties (e.g., fatigue strength, torsional rigidity, pull-out strength). The document does not specify these individual "ground truths" but concludes overall substantial equivalence.
8. The sample size for the training set
- Not applicable. This involved non-clinical bench testing of a medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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