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510(k) Data Aggregation
(73 days)
These Systems are intended for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to provide stabilization as an adjunct to 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 skeletally mature patients using allograft 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 previous 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 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, 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 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 and 4.0 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process 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.
OC Fusion System
The Synthes OC Fusion System is intended to provide stabilization as an adjunct to 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, and Synthes Synapse System.
The OC Fusion System is indicated for skeletally mature patients using allograft and/or autograft for the following indications:
· Degenerative disc disease 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
- · Fracture/dislocation
- Atlanto/axial fracture with instability
- · Occipital-cervical dislocation
- · Revision of previous cervical spine surgery
- · Tumors (primary and metastatic)
The use of screws is limited to placement in the occiput. Screws are not intended to be placed into the cervical spine.
The Synapse System is a hook, pedicle screw, and rod spinal system which is designed to provide spinal fixation to allow for stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Synapse System is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Axon System and CerviFix System also included in the indications for use statement are additional hook, pedicle screw, and rod spinal systems. These systems consist of anchors including bone screws, pedicle screws and hooks; interconnection mechanisms including locking screws, set screws, parallel rod connectors, clamps, transverse bars, rod collars and nuts; longitudinal members including rods and rod/plates; and transverse connectors including transconnectors.
The OC Fusion System consists of occipital plates, occipital screws, and rods intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. The OC Fusion System can be used with components from the Synthes CerviFix System including Axon and Synapse components to create a complete occipital-cervical-thoracic spinal construct.
Fixation of the rods included in the Synapse and OC Fusion Systems is achieved by using hooks from one of the aforementioned cleared systems. System components in the Synapse and OC Fusion Systems are implanted with Class I general use surgical instruments.
The provided text describes a 510(k) premarket notification for medical devices, specifically the Synapse System and OC Fusion System, which are spinal interlaminal fixation orthoses. The document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a study that defines and tests against acceptance criteria for a new device's performance characteristics.
Therefore, many of the requested details, such as a table of acceptance criteria with reported device performance, sample sizes for test and training sets, expert qualifications, and ground truth establishment, are not explicitly provided in this type of regulatory submission. This document confirms the material, intended use, and general performance testing (mechanical testing for a specific component) to demonstrate equivalence.
Here's an attempt to answer the questions based on the available information, noting where information is not present:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria for a newly developed performance characteristic nor detailed reported device performance against such criteria. The submission states that the device was evaluated using mechanical testing and found to be "substantially equivalent to or better than the predicate devices." This implies that the 'acceptance criteria' were likely an equivalence or superiority comparison to the predicate device's established performance, rather than specific numerical thresholds for novel performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to or betterment of predicate devices in mechanical testing (static compression bending, dynamic compression bending, dynamic torsion testing). | "Test results and analyses showed that the proposed components to the Synapse and OC Fusion Systems were substantially equivalent to or better than the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes mechanical testing for the OC Fusion System components. It does not specify a sample size (e.g., number of test articles) for this mechanical testing. There is no information provided regarding data provenance (country of origin, retrospective/prospective) as the testing described is in vitro mechanical testing, not human-patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The study described is mechanical testing of physical device components, not an assessment requiring expert interpretation of medical images or patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of ambiguous cases, particularly in imaging, and are not relevant to mechanical performance testing.
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
There is no MRMC study or AI component mentioned in this document. This submission is for physical spinal fixation devices, not a diagnostic or AI-powered medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. There is no algorithm or software device described in this submission.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical testing performed, the "ground truth" would be the direct physical measurements of device strength, fatigue, and other mechanical properties under controlled conditions, compared against the equivalent properties of the predicate devices according to ASTM F2706-08.
8. The sample size for the training set
This is not applicable. There is no training set mentioned as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
This is not applicable. There is no training set.
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(44 days)
These Systems are intended for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to provide stabilization as an adjunct to 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 skeletally mature patients using allograft and/or autograft 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 previous 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 (TI-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 and 4.0 mm/6.0 mm paralle1 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 Synapse System is a hook and pedicle screw spinal system which is designed to provide spinal fixation to allow for stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Synapse System is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Axon System and Cervifix System also included in the indications for use statement are additional hook and pedicle screw spinal systems. These systems consist of anchors including bone screws, pedicle screws and hooks: interconnection mechanisms including locking screws, set screws, parallel rod connectors, clamps, transverse bars, rod collars and nuts; longitudinal members including rods and rod/plates; and transverse connectors including transconnectors. These system components are implanted using class I surgical instruments.
This document describes a 510(k) premarket notification for the Synapse System, specifically focusing on proposed curved rods. It is a submission intended to demonstrate substantial equivalence to previously cleared devices, rather than a study proving performance against acceptance criteria for a novel device.
Therefore, many of the requested categories for a study proving device performance are not applicable (N/A) in this context, as this submission primarily relies on a "rationale" comparing the new components to existing ones, rather than new performance testing.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Conformance: Curved rods manufactured from Ti-6A1-7Nb (TAN), conforming to ASTM F-1295-11 and ISO 5832-11. | The proposed curved rods are manufactured from the same material, titanium aluminum niobium (Ti-6A1-7Nb (TAN)), as the previously cleared Synapse System curved rods. The material conforms to ASTM F-1295-11 and ISO 5832-11. |
| Technological Characteristics: Indications for use, intended use, and technological characteristics (design, material) of proposed curved rods are the same as, or similar to, predicate devices. | The indications for use, intended use and technological characteristics, such as design and material, of the proposed curved rods are the same as, or similar to, those of the predicate devices from the Synapse System, Sierra™ System and Altius™ OCT System. |
| Performance Testing: (Implied: No new performance testing required if substantial equivalence is based on existing data/rationale). | A rationale is provided in place of performance testing for the proposed curved rods. (This indicates that the "performance criteria" were met by demonstrating equivalence rather than actual new testing.) |
2. Sample size used for the test set and the data provenance
- Sample Size: N/A. No new test set involving patient data or specimens was described. The submission relies on a "rationale" for equivalence to predicate devices.
- Data Provenance: N/A. No new data from a test set (e.g., country of origin, retrospective/prospective) is presented. The "performance data" section explicitly states "A rationale is provided in place of performance testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. As no new test set data requiring ground truth establishment was presented, this is not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set requiring expert adjudication was described.
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
- N/A. This device is a spinal fixation orthosis (physical implant system), not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical implant, not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No new ground truth establishment was described, as the submission focused on comparing the new components to established predicate devices based on design, materials, and existing performance data (implied from the predicates).
8. The sample size for the training set
- N/A. No training set for an algorithm was involved; this is a physical medical device.
9. How the ground truth for the training set was established
- N/A. No training set or associated ground truth was established for this submission.
Summary of the Submission's Approach:
The K133698 submission for the Synapse System (specifically, proposed curved rods) is a substantial equivalence (SE) submission. This means the applicant demonstrated that the new device components (curved rods) are as safe and effective as a legally marketed predicate device.
Instead of conducting new performance studies, the manufacturer provided a "rationale" arguing that:
- The materials (Ti-6A1-7Nb (TAN)) are identical to those used in previously cleared components.
- The technological characteristics (design, intended use, indications for use) of the proposed curved rods are the same or similar to predicate devices (Synapse System, Sierra™ System, Altius™ OCT System).
This approach is common in 510(k) submissions where modifications to existing devices are minor and do not raise new questions of safety or effectiveness. The FDA's clearance (as indicated in the letter dated January 16, 2014) confirms their agreement that the device is substantially equivalent to predicates.
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(30 days)
Synthes Synapse System is indicated for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to provide stabilization as an adjunct to 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 skeletally mature patients using allograft and/or autograft 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 previous 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 and 4.0 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.
Synthes OC Fusion System is intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) and screws (T1-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 skeletally mature patients using allograft and/or autograft for the following:
• Degenerative disc disease 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
• Fracture/Dislocation
• Atlanto/axial fracture with instability
• Occipital-cervical dislocation
• Revision of previous cervical spinal surgery
• 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.
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 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-thoracic 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) and screws (T1-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 occipital clamps are manufactured from both commercially pure Titanium, grade 4 and Titanium Aluminum Niobium (Ti-6Al-7Nb).
The plates are manufactured from commercially pure Titanium, grade 2. The two bodies in the plate that serve as rod connection points are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) as are the rods, and occipital screws.
The provided 510(k) summary for the Synthes Synapse 4.0mm System and the Synthes OC Fusion 4.0mm System does not describe a study that involves acceptance criteria and device performance in the way typically associated with AI/ML-enabled medical devices or diagnostic tools.
Instead, this document details a submission for spinal implant systems, where the "acceptance criteria" for clearance are based on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance data. Clinical data was explicitly stated as not needed for these devices.
Therefore, many of the requested points regarding sample size, data provenance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance are not applicable to this type of medical device submission.
Here's the information that can be extracted or deduced from the provided text according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The device's intended use should be equivalent to previously cleared predicate devices. | The Synthes Synapse 4.0mm System and Synthes OC Fusion 4.0mm System have indications for use that are equivalent to already cleared devices like Synthes CerviFix, Synthes Axon, and Synthes OC Fusion Systems. Their intended uses include providing stabilization as an adjunct to fusion for various cervical and occipitocervical conditions (e.g., DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, tumor). |
| Material Equivalence: The device's materials of manufacture should be equivalent to previously cleared predicate devices. | The implants are manufactured from Titanium Aluminum Niobium (TAN) (Ti-6Al-7Nb) ASTM F1295, commercially pure Titanium Grade 4, and commercially pure Titanium Grade 2. These materials are stated to be the same or equivalent to the predicate devices. |
| Design Equivalence: The device's design should be equivalent to previously cleared predicate devices. | The 4.0mm components of both systems are a result of design modifications but are stated to be substantially equivalent to the predicates in design. |
| Function Equivalence: The device's function should be equivalent to previously cleared predicate devices. | The 4.0mm components of both systems are stated to be substantially equivalent to the predicates in function. |
| Anatomic Sites Equivalence: The device's anatomic sites of use should be equivalent to previously cleared predicate devices. | The devices are intended for use in the cervical and/or upper thoracic spine (C1-T3), with specific limitations on screw placement, which aligns with predicate devices. |
| Performance Equivalence: Non-clinical performance demonstrates equivalence. | Non-Clinical Performance and Conclusions: Documentation was provided which demonstrated the [Device Name] System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance, and material of manufacture. |
| No Clinical Data Needed: Clearance did not require clinical studies to demonstrate safety and effectiveness. | Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set in the context of AI/ML or diagnostic performance evaluation was used. The substantial equivalence was based on non-clinical performance documentation, generally referring to mechanical testing, material characterization, and design principle comparisons, rather than a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There was no "ground truth" establishment in the context of diagnostic assessment or expert consensus for a test set. The evaluation was primarily of engineering and material properties, compared against predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method was mentioned or required for this type of submission.
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 device is a spinal implant system, 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 is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable directly. The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate devices based on their prior clearance, and the new devices' ability to meet comparable engineering and material standards. No clinical outcomes data or pathology was used or required for this 510(k) clearance itself.
8. The sample size for the training set
- Not applicable. There was no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There was no "training set" or corresponding ground truth establishment described for this device.
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(100 days)
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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