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510(k) Data Aggregation
(145 days)
The Synthes Navigable Pedicle Preparation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion.
The Navigable Pedicle Preparation Instruments are manual surgical instruments which are designed to interface with already-cleared surgical navigation systems. Instruments in this system may be pre-calibrated to already-cleared surgical navigation systems, or may be manually calibrated to already-cleared surgical navigation systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general manual functions within the orthopaedic surgical environment.
This is a 510(k) summary for a set of surgical instruments, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth for an AI device is not applicable and cannot be extracted from the provided text.
The document describes the Synthes Navigable Pedicle Preparation Instruments, which are manual surgical instruments designed to interface with existing surgical navigation systems.
Here's a breakdown of the relevant information provided:
1. Acceptance Criteria and Reported Device Performance (Non-AI/ML):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet performance requirements for intended use | "The Navigable Pedicle Preparation Instruments met the performance requirements, providing assurance of device performance for their intended use." |
| No safety or effectiveness issues | "No safety or effectiveness issues were raised by the performance testing." |
2. Sample size used for the test set and data provenance (Not applicable for AI/ML):
The document mentions "usability testing" as a validation activity in the "Performance Data" section. However, it does not specify sample sizes for test sets, data provenance (e.g., country of origin), or whether the data was retrospective or prospective, as these details are typically associated with clinical studies or AI/ML performance evaluations, not characterization of manual surgical instruments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable for AI/ML):
This information is not provided because the validation involved usability testing of manual instruments, not the establishment of ground truth for an AI/ML algorithm.
4. Adjudication method (Not applicable for AI/ML):
This concept is not relevant to the validation 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 (Not applicable for AI/ML):
No MRMC study was conducted as this device is not an AI/ML system or a reading assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable for AI/ML):
This is not applicable as the device is a set of manual surgical instruments.
7. The type of ground truth used (Not applicable for AI/ML):
Ground truth as it relates to AI/ML performance is not relevant here. The validation focused on the functional performance and usability of the physical instruments.
8. The sample size for the training set (Not applicable for AI/ML):
There is no "training set" in the context of manual surgical instrument validation, as this is a concept associated with AI/ML model development.
9. How the ground truth for the training set was established (Not applicable for AI/ML):
This is not applicable for the reasons stated above.
In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of manual surgical instruments through non-clinical performance testing (usability testing). It does not contain the detailed information related to AI/ML device validation, such as specific acceptance criteria for algorithm performance, sample sizes for test/training sets, expert involvement in ground truth establishment, or comparative effectiveness studies of AI assistance. The document explicitly states: "Clinical data was not needed for the Navigable Pedicle Preparation Instruments."
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(133 days)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.
Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.
This is an addition to Synthes' existing non-cervical spinal fixation devices intended for are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The additional locking cap in this submission is manufactured of cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).
The provided text describes a 510(k) Summary for a medical device called the "Synthes Matrix System," which is an addition to an existing line of non-cervical spinal fixation devices. The document explicitly states that clinical data and conclusions were NOT needed for this device. This means that the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not available in this document because a clinical study was not performed or deemed necessary for this 510(k) submission.
The acceptance criteria and proof of meeting them are based on non-clinical performance data (bench testing), which demonstrated equivalence or superiority to predicate devices.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence or superiority to predicate devices in mechanical properties | Bench testing results demonstrate that Synthes Matrix performs equivalently or superiorly to the above-mentioned predicates in static compression bending, static torsion, and dynamic compression bending (in accordance with ASTM F1717-11a). |
| Compliance with relevant ASTM standards | The testing was conducted in accordance with ASTM F1717-11a (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (for Posterior Spinal Implant Constructs)). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. (Refers to mechanical testing specimens, not human subjects or a data set for an AI model).
- Data Provenance: Not applicable in the context of human data. The data comes from bench testing of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts: Not applicable. Ground truth for mechanical testing is established by engineering specifications and direct measurement, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. This is mechanical bench testing, not a clinical study requiring adjudication of diagnostic outcomes.
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. This device is a spinal implant, not an AI or diagnostic imaging device. No human reader studies were performed or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (spinal implant), not an algorithm or AI.
7. The type of ground truth used
- Ground Truth: For mechanical testing, the ground truth is based on the physical properties and performance characteristics defined by engineering standards (e.g., ASTM F1717-11a) and compared against the performance of legally marketed predicate devices.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.
In summary, this 510(k) submission relied on non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices, and explicitly stated that clinical data was not required. Therefore, all questions pertaining to clinical study design, human data, expert review, and AI model specifics are not addressed by the provided document.
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(30 days)
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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(426 days)
The Scout Vessel Guard System is indicated as a cover for vessels during anterior vertebral surgery.
The Synthes Scout Tack Fixation is a method of fixation of the Scout Vessel Guard to bone. The single-use Scout Tack implant is made of a titanium alloy (TAN, per ASTM F1295-05, "Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)," January 1, 2005). It has a low profile head. The tack is inserted by light impaction through the Scout Vessel Guard into lumbar vertebral bone. The Scout Tack implant can be used as an alternative to, or a complement to, suturing the Scout Vessel Guard in place.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Device Performance |
|---|---|
| Pullout Strength (compared to suture fixation and predicate devices) | Performed equivalently to or superior to predicate devices (Synthes Arch Fixation System, Replication Medical EnGuard Vessel Guard, Covidien Autosuture Tacker System) and suture fixation. |
| Dynamic Mechanical Testing (compared to suture fixation) | Performed equivalently to or superior to suture fixation. |
| Dynamic Biomechanical Testing (compared to suture fixation) | Performed equivalently to or superior to suture fixation. |
| Usability (cadaver lab testing) | Demonstrated equivalent usability to predicate devices and suture fixation. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each test (pullout, dynamic mechanical, dynamic biomechanical, and usability). However, it implies that the tests involved sufficient samples to draw conclusions about equivalence or superiority.
The data provenance is not explicitly stated as "country of origin," but the testing was conducted by Synthes, an American company. The tests are described as "non-clinical," and the phrase "cadaver lab testing" suggests a controlled, pre-clinical environment. The study is retrospective in the sense that it evaluates the device's performance against established predicate devices and methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the number of experts used or their specific qualifications for establishing ground truth in the non-clinical tests. For usability testing in cadaver labs, it is implied that surgeons or trained professionals evaluated the device, but their number and specific qualifications (e.g., years of experience, specialty) are not provided.
4. Adjudication Method for the Test Set:
The document does not describe a formal adjudication method. The evaluation of test results (e.g., pullout strength measurements, mechanical properties) would typically involve engineering analysis and comparison against pre-defined thresholds or predicate device performance. For usability, it's likely a qualitative assessment by the testing personnel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The tests described are non-clinical, mechanical, and biomechanical evaluations, along with cadaver lab usability, not studies involving multiple human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical device (tack fixation) and not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests was based on direct measurements of mechanical properties (e.g., pullout strength, dynamic response) and observations of usability in a cadaver model, compared against the performance of established predicate devices and traditional fixation methods (suturing). There is no "pathology" or "outcomes data" ground truth as this is a pre-clinical evaluation.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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(52 days)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to Synthes USS 5.5 mm rod systems.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.
Synthes USS
6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
5.5 mm Rod System: Matrix, MIRS
5.0 mm Rod System: USS Small Stature
CerviFix
3.5 mm Rod Systems: CerviFix, Axon, Synapse
4.0 mm Rod System: Synapse
This is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium). posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The new sagittal screw that is the subject of this submission is similar to the already-cleared polyaxial screw and is manufactured of TAN (Titanium-6 Aluminum-7 Niobium Alloy per ASTM F1295 - 05 ). These screws restrict head angulation to the direction parallel to the rod slot (typically the cranial/caudal direction).
The provided text describes a 510(k) summary for the Synthes Matrix System, a medical device for spinal fixation, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria.
Therefore, many of the requested categories for AI/algorithm performance and study design are not applicable as this document pertains to a medical device submission, not an AI or software study.
However, I can extract the relevant information regarding performance data and acceptance criteria based on the provided text.
Here's a breakdown of the requested information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as numerical thresholds for specific performance metrics in the context of an AI study. Instead, it refers to the device demonstrating "equivalently or superiorly" to predicate devices.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Equivalent or superior to predicate devices (as per ASTM F1717-11a) | Performs equivalently or superiorly to predicate devices in static compression bending, static torsion, and dynamic compression bending. |
2. Sample size used for the test set and the data provenance
Not Applicable (N/A) - This document describes non-clinical bench testing for a physical medical device (spinal fixation system), not a study with a test set of data (images, clinical records, etc.) for an AI algorithm. The performance data is from mechanical bench testing, not a clinical data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - Ground truth as defined for an AI study (e.g., expert consensus on image interpretation) is not applicable here. The "ground truth" for mechanical testing would be the physical properties and performance metrics measured using established engineering standards.
4. Adjudication method for the test set
N/A - This concept is relevant for studies involving human judgment or interpretation (like image reading). For mechanical bench testing, data is typically collected directly from instruments and analyzed against engineering standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A - This is an AI-specific study type. The document describes a physical medical device and its mechanical testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This refers to AI algorithm performance. The Synthes Matrix System is a physical implantable device.
7. The type of ground truth used
For the non-clinical performance data, the "ground truth" (or reference standard) inherently comes from established engineering standards and physical measurements obtained during mechanical bench testing. Specifically, it adheres to ASTM F1717-11a, an American Society for Testing and Materials standard for spinal implant constructs.
8. The sample size for the training set
N/A - This document does not describe the development or testing of an AI algorithm, and therefore there is no "training set."
9. How the ground truth for the training set was established
N/A - As there is no training set for an AI algorithm, this question is not applicable.
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(77 days)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.
Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5mm tapered rods, the Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Synthes USS 5.5 mm rod systems.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.
The Synthes USS Connector is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are rod-to-rod connectors which can connect spinal rods of 5.5mm diameter. The rod-to-rod connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05).
This document describes the 510(k) summary for the Synthes USS Connector, a spinal fixation device. It details the device's intended use, indications for use, and performance data.
Here's an analysis of the provided information, framed as acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence (Overall Safety & Effectiveness): | The Synthes USS Connector is considered "substantially equivalent" to predicate devices. |
| Mechanical Performance (Static Compression Bending): Device withstands static compression bending. | Non-clinical testing according to ASTM F1717-10 was conducted, which includes static compression bending. The results presumably demonstrated performance equivalent to predicate devices, thus meeting this (implied) criterion. |
| Mechanical Performance (Dynamic Compression Bending): Device withstands dynamic compression bending. | Non-clinical testing according to ASTM F1717-10 was conducted, which includes dynamic compression bending. The results presumably demonstrated performance equivalent to predicate devices, thus meeting this (implied) criterion. |
| Mechanical Performance (Static Torsion): Device withstands static torsional forces. | Non-clinical testing according to ASTM F1717-10 was conducted, which includes static torsion. The results presumably demonstrated performance equivalent to predicate devices, thus meeting this (implied) criterion. |
| Material Biocompatibility: Materials are safe for implantation. | The device is comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05), which is a commonly used and accepted biocompatible material for spinal implants. |
Study used to prove device meets acceptance criteria:
The study proving the device meets the acceptance criteria is described as non-clinical testing conducted according to ASTM F1717-10. This standard covers "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for the non-clinical testing (e.g., number of connectors tested). It only mentions "non-clinical testing."
Data Provenance: Not applicable, as this was non-clinical (mechanical) testing, not human-subject or clinical data.
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 mechanical testing is established by engineering standards and measurements, not by expert consensus.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically used for subjective assessments (e.g., image interpretation) or clinical outcomes, not for objective mechanical 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
No MRMC comparative effectiveness study was done. This document describes a spinal implant, not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical spinal implant, not an algorithm.
7. The type of ground truth used
The ground truth used for mechanical performance testing is the specifications and requirements outlined in ASTM F1717-10. The acceptance criterion for mechanical performance is that the device demonstrates mechanical characteristics (strength, fatigue resistance) that are "substantially equivalent" to predicate devices, as measured against the forces described in the ASTM standard.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for the mechanical testing of a physical medical device. This is not an AI/ML product.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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(100 days)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 5.5/6.0mm extension connectors, Matrix can be linked to the Synthes USS 6.0mm rod systems. 6.0/6.0mm extension connectors can be used to link all Synthes USS 6.0mm rod systems to one another.
When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.
In addition, Synthes USS 6.0mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.
The Synthes USS Line Extension is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are in-line extension connectors which can connect spinal rods of the same or different diameters. The in-line extension connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05).
The document describes the K113149 510(k) submission for the Synthes USS Line Extension (connectors), which are non-cervical spinal fixation devices.
Here's an analysis of the provided text with respect to your questions:
1. Table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Compression Bending | Substantially equivalent to predicate devices (Synthes USS, K962608; Synthes USS, K963045; Synthes Click'X, K992739; Synthes Click'X, K031175; Synthes USS Illiosacral and Polyaxial, K082572; Synthes Matrix System, K092929; Synthes Matrix System, K100634; Synthes Matrix System, K100952; Synthes 6.0 CoCr and CP Ti-3 Rods, K103287) | The testing determined that the Synthes USS Connector is substantially equivalent to the predicate devices. |
| Static Torsion | Substantially equivalent to predicate devices | The testing determined that the Synthes USS Connector is substantially equivalent to the predicate devices. |
| Dynamic Compression Bending | Substantially equivalent to predicate devices | The testing determined that the Synthes USS Connector is substantially equivalent to the predicate devices. |
Explanation: The acceptance criteria are implicitly met if the "non-clinical testing according to ASTM F1717-10 - static compression bending, static torsion, and dynamic compression bending - to determine that the Synthes USS Connector is substantially equivalent to the predicate devices identified" was successful. The document states that the testing was conducted "to determine" this, and the FDA's clearance implies the substantial equivalence was demonstrated.
2. Sample sized used for the test set and the data provenance
The document does not explicitly state the specific sample sizes (number of devices tested) for the non-clinical tests. It refers to "non-clinical testing according to ASTM F1717-10". ASTM F1717-10 is a standard for testing spinal implant constructs, and it would specify the required number of samples for each test type. The data provenance is non-clinical, meaning it's from laboratory testing rather than human subjects. The country of origin for the data is not specified, but the firm (Synthes Spine) is located in West Chester, PA, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is based on the physical properties and performance measured against a standard (ASTM F1717-10), not on expert consensus or human interpretation.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert review of medical images or patient outcomes, not for mechanical bench 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
This question is not applicable. MRMC studies are relevant for AI-powered diagnostic or interpretive devices that assist human readers (e.g., radiologists). This submission concerns a physical medical device (spinal connectors), not a diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
The ground truth used for these non-clinical tests is the performance metrics defined by the ASTM F1717-10 standard and the performance characteristics of the identified predicate devices. The new device's performance is compared against these established benchmarks to demonstrate substantial equivalence.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of mechanical bench testing for spinal implants. Training sets are relevant for machine learning or AI models.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as #8.
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(70 days)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Matrix or MIRS can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Matrix System or MIRS.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.
Synthes MIRS is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium). This system is comprised of polyaxial reduction screws, rods, and locking caps. This system is intended to facilitate minimally invasive spinal reduction. The components of this system are manufactured of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05), Titanium (Ti-4 per ASTM F67-06) and cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).
Here's a breakdown of the acceptance criteria and study information for the Synthes MIRS device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Compression Bending | Equivalent or superior to predicate devices (ASTM F1717-10) | Performs equivalently or superiorly to the above-mentioned predicates |
| Static Torsion | Equivalent or superior to predicate devices (ASTM F1717-10) | Performs equivalently or superiorly to the above-mentioned predicates |
| Dynamic Compression Bending | Equivalent or superior to predicate devices (ASTM F1717-10) | Performs equivalently or superiorly to the above-mentioned predicates |
Note on Acceptance Criteria: The document directly states that the device "performs equivalently or superiorly to the above-mentioned predicates" for each test. This implies that the acceptance criteria were defined as achieving at least equivalence to the performance of the specified predicate devices when tested according to ASTM F1717-10.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. The document focuses on bench testing, not clinical studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the study was non-clinical bench testing. There was no ground truth based on expert clinical assessment.
4. Adjudication Method for the Test Set
This information is not applicable as the study was non-clinical bench testing. There was no clinical ground truth requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical data and conclusions were not needed for this device."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to this device. The Synthes MIRS is a pedicle screw spinal system, a physical medical device, not a software algorithm that performs diagnostic or assistive tasks.
7. Type of Ground Truth Used
The "ground truth" for this non-clinical study was the bench testing standards (ASTM F1717-10) and the performance of legally marketed predicate devices. The goal was to demonstrate mechanical equivalence or superiority.
8. Sample Size for the Training Set
This information is not applicable as the study was non-clinical bench testing. There was no "training set" in the context of an algorithm or machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the study was non-clinical bench testing.
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(108 days)
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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(186 days)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 5.5/6.0mm parallel connectors, Matrix can be linked to the Synthes USS 6.0mm rod systems. 6.0/6.0mm parallel connectors can be used to link all Synthes USS 6.0mm rod systems to one another.
When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5mm tapered rods, the Matrix System can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.
In addition, Synthes USS 6.0mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.
The Synthes USS is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are snap-on parallel connectors which can connect spinal rods of the same or different diameters. The snap-on parallel connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05) and Nitinol (per ASTM F2063-05).
This document is a 510(k) summary for the Synthes Universal Spine System (USS), a medical device. It does not contain information about the acceptance criteria and the study proving the device meets said criteria as typically found in submissions for AI/ML-powered devices.
Here's why and what's missing:
- Device Type: The Synthes USS is described as non-cervical spinal fixation devices, including pedicle screws, hooks, and connectors. These are mechanical implants, not an AI/ML-powered or software-driven diagnostic or therapeutic device.
- Regulatory Pathway: A 510(k) submission for this type of mechanical implant primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through material testing, mechanical testing, and an assessment of design and performance characteristics, rather than clinical efficacy studies often associated with AI/ML devices.
- Missing Information: Consequently, the document does not include any of the requested information points because they are not applicable to this type of device submission:
- No acceptance criteria table for AI performance metrics.
- No information about sample sizes for test sets, data provenance, or ground truth establishment by experts for AI.
- No adjudication methods, MRMC studies, or standalone algorithm performance data.
- No training set information or ground truth establishment for training data.
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