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510(k) Data Aggregation
(146 days)
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
The CAPSTONE PTC™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.
CLYDESDALE PTC™ Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE PTC™ Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.
The CAPSTONE PTCTM and CLYDESDALE PTC™ Spinal Systems consist of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CAPSTONE PTC™ and CLYDESDALE PTC™ Spinal Systems will be available in all the same sizes as the predicate systems. The CAPSTONE PTC™ and CLYDESDALE PTC™ System implants (subject devices) and the CAPSTONE® and CLYDESDALE® Spinal System implants (predicate devices), are both made from PEEK material with tantalum markers. The only difference in the subject and predicate devices is the subject devices also have a commercially pure titanium coating. In addition, the predicate and subject devices are both convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the MEDTRONIC Sofamor Danek CAPSTONE PTCTM and CLYDESDALE PTC™ Spinal Systems:
This document is a 510(k) Summary for a medical device seeking substantial equivalence to previously cleared devices. It describes non-clinical testing performed to demonstrate that the new devices (which incorporate a titanium coating) are as safe and effective as their uncoated predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Standard | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|---|
| Coating Microstructure | ASTM F1854 | Conform to standards for porous coatings on medical implants (e.g., porosity, pore size). | Testing performed; implies conformity. |
| Shear Fatigue Testing | ASTM F1160 | Withstand specified shear and bending fatigue loads for calcium phosphate and metallic coatings. | Testing performed; implies performance within acceptable limits. |
| Static Shear Testing | ASTM F1044 | Exhibit sufficient static shear strength for calcium phosphate and metallic coatings. | Testing performed; implies performance within acceptable limits. |
| Tensile Testing | ASTM F1147 | Demonstrate adequate tensile strength for calcium phosphate and metallic coatings. | Testing performed; implies performance within acceptable limits. |
| Abrasion Testing | ASTM F1978 | Exhibit appropriate abrasion resistance for metallic thermal spray coatings. | Testing performed; implies performance within acceptable limits. |
| Static Compression | ASTM F2077 | Withstand specified static compression loads for intervertebral body fusion devices. | Testing performed; implies performance within acceptable limits. |
| Dynamic Compression | ASTM F2077 | Withstand specified dynamic compression loads for intervertebral body fusion devices. | Testing performed; implies performance within acceptable limits. |
| Static Compression Shear | ASTM F2077 | Withstand specified static compression shear loads for intervertebral body fusion devices. | Testing performed; implies performance within acceptable limits. |
| Dynamic Compression Shear Fatigue | ASTM F2077 | Withstand specified dynamic compression shear fatigue loads for intervertebral body fusion devices. | Testing performed; implies performance within acceptable limits. |
| Subsidence Testing | ASTM F2267 | Demonstrate acceptable load-induced subsidence under static axial compression. | Testing performed; implies performance within acceptable limits. |
| Static Push-out (Expulsion) Testing | ASTM Draft Standard F04.25.02.02 | Resist expulsion under specified static push-out forces. | Testing performed; implies performance within acceptable limits. |
| Wear Particulate Testing | ASTM F1877 | Exhibit acceptable wear particulate characteristics (size, morphology, quantity). | Testing performed; implies acceptable wear characteristics. |
| Biocompatibility | (Animal testing using canines and CP Ti coated coupons) | No adverse biological reactions; demonstrate tissue compatibility with CP Ti coating. | Animal testing supports biocompatibility, implying no adverse reactions. |
Important Note: This document primarily focuses on demonstrating substantial equivalence through non-clinical performance to existing predicate devices. It does not explicitly state numerical acceptance criteria or specific performance values for the new devices, but rather relies on compliance with established ASTM standards and implicitly, that the new devices perform comparably to or better than the predicate devices tested under the same standards. The conclusion explicitly states the belief that the devices are "substantially equivalent to the predicates," which is the ultimate acceptance criterion for a 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Non-Clinical): The document details various non-clinical mechanical and material tests. For each ASTM standard, there would be a defined sample size (e.g., number of test specimens). However, the document does not explicitly state the specific sample sizes used for each mechanical or material test.
- Data Provenance: The data provenance is laboratory testing (mechanical, material, and in-vivo animal testing). It is not human clinical data, so country of origin and retrospective/prospective distinctions are not applicable in the typical sense. The testing was conducted to U.S. (ASTM) standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For non-clinical, mechanical, and material testing, "ground truth" is established by adherence to universally accepted standards (ASTM standards in this case) and scientific principles, not by expert consensus on subjective interpretations. The expertise lies in the engineers and technicians performing the tests and interpreting the results in accordance with the specified standards.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic performance studies where expert consensus is needed to establish ground truth for a subjective assessment. This document describes objective, non-clinical engineering and material science tests.
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 submission is for an intervertebral body fusion device (an implant), not a diagnostic device or AI software. Therefore, an MRMC study related to human readers improving with AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical implant, not an algorithm or software device.
7. The Type of Ground Truth Used
- Engineering and Material Standards Compliance, and Animal Study Outcomes.
- For the mechanical and material tests (ASTM F1854, F1160, F1044, F1147, F1978, F2077, F2267, F04.25.02.02, F1877), the ground truth is the specified performance criteria within the respective ASTM standards. The device's performance is compared against these objective, quantitative criteria.
- For biocompatibility, the ground truth is established through animal testing outcomes (canines) demonstrating tissue compatibility and the absence of adverse biological reactions to the CP Ti coating.
8. The Sample Size for the Training Set
- Not Applicable. This submission describes mechanical and biocompatibility testing for an implant, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/algorithm, this question is not relevant.
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