Search Results
Found 3 results
510(k) Data Aggregation
(28 days)
CAPSURE PS SYSTEM
The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) in skeletally mature patients. The CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.
The predicate CapSure® PS System consists of a selection of non-sterile, single use, titanium alloy screws and connectors, and titanium alloy and cobalt chrome rod components that are assembled to create a rigid spinal construct. The components of the predicate CapSure® PS System are attached to the non-cervical spine of skeletally mature patients in order to stabilize the spine during fusion of vertebral bodies, and are intended to be removed after spinal fusion is achieved.
This document describes a 510(k) premarket notification for a medical device called the CapSure® PS System, a pedicle screw spinal system. The submission seeks clearance for additional components to an already cleared system. As such, the information provided focuses on the substantial equivalence to a predicate device rather than on novel acceptance criteria and a detailed clinical study demonstrating performance against those criteria as would be required for a de novo submission or a new device with significant technological differences.
Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as detailed study information often associated with AI/software devices, cannot be fully generated. This document pertains to a hardware medical device (pedicle screw system), and therefore, the type of "acceptance criteria" and "study" are different from what one might expect for a software or AI-based device.
However, I can extract the available information related to performance data and the rationale for claiming substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from testing) | Reported Device Performance / Rationale |
|---|---|---|
| Mechanical Performance | Static Compression | "The modified implants were compared to constructs previously tested in static compression... in accordance with ASTM F1717." |
| Static Torsion | "The modified implants were compared to constructs previously tested in... static torsion... in accordance with ASTM F1717." | |
| Dynamic Compression | "The modified implants were compared to constructs previously tested in... dynamic compression in accordance with ASTM F1717." | |
| Safety and Effectiveness | Substantial Equivalence | "An engineering rationale determined that the proposed implants do not represent a new worst case and were therefore determined to be substantially equivalent to the predicate devices." |
| No new issues of safety or effectiveness | "Based on the indications for use, technological characteristics and comparison to a predicate, the subject CapSure® PS System... does not present any new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of human subjects or a large dataset often associated with AI/software studies. Instead, it refers to "modified implants" and "constructs previously tested." This implies an engineering test setup with a limited number of physical components for mechanical testing. No specific number is given.
- Data Provenance: Not applicable in the context of clinical data or country of origin. The data provenance is from mechanical testing conducted in accordance with ASTM F1717. The document does not specify where these tests were performed, but given the manufacturer is US-based and seeking FDA clearance, it's presumed to be from a reputable testing facility, likely within the US, or a recognized international body. The tests are "retrospective" in the sense that the modified implants are compared to "constructs previously tested" rather than new testing being exclusively performed for the new components (though some testing was likely done to ensure the comparison is valid).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a hardware medical device; the "ground truth" is established by adherence to recognized mechanical testing standards (ASTM F1717) and engineering principles, not through expert consensus on medical images or clinical outcomes in the same way an AI device would. The "experts" involved would be mechanical engineers and test technicians responsible for performing and interpreting the mechanical tests.
4. Adjudication Method for the Test Set
- Not Applicable. As this is mechanical testing of hardware, there is no expert adjudication process in the manner of multiple medical professionals independently reviewing cases and reaching a consensus. The "adjudication" is based on whether the devices meet the specified parameters of the ASTM F1717 standard and if the engineering rationale for substantial equivalence is sound.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant for evaluating the performance of AI/software in a clinical context (e.g., how AI assistance impacts human readers' diagnostic accuracy). This document pertains to a physical implantable device, so an MRMC study was not conducted or required for this type of submission.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- No. This is a hardware device. There is no standalone algorithm to evaluate.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance is the mechanical test results obtained by following recognized industry standards (ASTM F1717) for spinal implant performance, alongside an engineering rationale demonstrating that the updated components do not negatively impact these established performance characteristics and are equivalent to the predicate.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no training set for this hardware device.
Ask a specific question about this device
(28 days)
MODIFICATION TO CAPSURE PS SYSTEM
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.
The CapSure® PS System consists of a selection of non-sterile, single use titanium alloy rod, screw, and cross connector components that are assembled to create a rigid spinal construct. The components of the CapSure® PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.
This purpose of this submission is to gain clearance for the addition of the LP Cross Connector component to the CapSure® PS System. The LP Cross Connector is a non-sterile, single use, titanium allow device which can be used with the CapSure® PS System for added stability. The LP Cross Connector is available in lengths ranging from 38mm to 81mm.
This document is a 510(k) summary for the CapSure® PS System, a pedicle screw spinal system. It does not describe an AI/ML device or present a study comparing AI performance against acceptance criteria. Therefore, most of the requested information cannot be extracted.
However, I can provide what is available regarding the device and its equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical study comparing the device to a predicate. Instead, the "acceptance criteria" here refers to demonstrating substantial equivalence to existing legally marketed predicate devices through mechanical testing.
| Acceptance Criteria Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The device (CapSure® PS System with LP Cross Connector) must demonstrate substantial equivalence to its predicate devices (CapSure® PS System K083743, K083353) in terms of intended use, technological characteristics, and safety/effectiveness, particularly through mechanical testing. | "mechanical testing demonstrated that the CapSure® PS System is equivalent to the predicate CapSure® PS System. The differences between the CapSure® PS System and the predicate device do not raise any new questions of safety or effectiveness. Thus, the CapSure® PS System is substantially equivalent to its predicate device." The FDA concurred with this assessment, stating "We have reviewed your Section 510(k) premarket notification...and have determined the device is substantially equivalent...to legally marketed predicate devices." This implies that the device met the implicit acceptance criteria for mechanical performance that allowed it to be considered equivalent to its predicates. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a 510(k) summary for a physical medical device (pedicle screw system), not an AI/ML device requiring a test set of data. The "study" mentioned is mechanical testing. Details about the sample size (number of constructs tested) and data provenance for this mechanical testing are not provided in this summary.
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. For mechanical testing of a physical device, ground truth is established by engineering standards and measurements, not by expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no test set in the context of clinical data requiring expert adjudication.
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 is not applicable. This document pertains to a physical spinal implant device, not an AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be the established engineering standards, material properties, and biomechanical parameters against which the device's performance was measured. No clinical ground truth from patient data (expert consensus, pathology, or outcomes) is mentioned in the context of this 510(k) summary for the equivalence determination.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is a physical medical device, not an AI/ML system.
Ask a specific question about this device
(28 days)
CAPSURE PS SYSTEM
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.
The CapSure® PS System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the CapSure® PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.
This purpose of this submission is to gain clearance for the addition of an optional Cross Connector component to the CapSure® PS System. The Cross Connector is a non-sterile, single use, titanium allow device which can be used with the CapSure® PS System for added stability. The Cross Connector is available in lengths ranging from 35mm to 100mm.
The provided documentation does not contain information regarding the acceptance criteria, device performance tables, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The document is a 510(k) summary for the CapSure® PS System, a pedicle screw spinal system, and its optional Cross Connector component. It primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than reporting on the performance of an AI/ML-based device against specific acceptance criteria.
Therefore, I cannot fulfill your request with the information provided.
Ask a specific question about this device
Page 1 of 1