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510(k) Data Aggregation
(67 days)
The CarboClear® Pedicle Screw System is intended to provide rigid immobilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/ or allogenic bone graft comprised of cancellous and/or corticocancellous bone graff.
The CarboClear® Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The CarboClear® implants include pedicle screws, rods and locking elements. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. The implants include tantalum markers. The implants are supplied sterile, and are intended for single use.
The provided text describes the CarboClear® Pedicle Screw System, a medical device for spinal stabilization, and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set, ground truth, and expert adjudication as might be seen for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria and study methodology for proving device performance through such studies is not available in this document.
However, based on the provided text, here's what can be extracted regarding performance and substantiation:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance in a table format. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate devices in static and dynamic tests. | Performance testing (per ASTM F1717, F1798, F2193, F543, fatigue lateral bending-axial rotation, rod creep tests): "The test results were found to be comparable to those of predicate devices, as applicable, demonstrating substantially equivalent mechanical performance of the subject system." |
| Clinical performance comparable to predicate devices for the specified indications for use. | Clinical data: "Clinical data for the CarboClear® Pedicle Screw System was presented for the target population specified in the indications for use statement, and supports the substantially equivalent performance of the subject system." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of an AI/ML algorithm evaluation. Instead, it refers to "Performance data" and "Clinical data."
- Performance Data (Mechanical Testing): The sample size for mechanical tests (e.g., number of screws, rods tested) is not provided. The data provenance is laboratory testing conducted according to ASTM standards. Country of origin not specified, but the applicant is based in Israel.
- Clinical Data: The sample size for clinical data (e.g., number of patients) is not provided. The provenance (country of origin, retrospective/prospective) is also not specified.
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 information is not applicable to the type of submission described. The document does not describe a study involving expert-established ground truth for a test set, as would be relevant for an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no mention of an adjudication method as it relates to expert review of a test set.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a physical pedicle screw system, not an AI/ML-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance, the "ground truth" is established by adherence to recognized ASTM standards and comparison to predicate device performance. For clinical performance, the "ground truth" would likely be patient outcomes, but the specific type of clinical ground truth (e.g., imaging follow-up, functional scores, fusion rates) is not detailed.
8. The sample size for the training set
This information is not applicable. The device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is not an AI/ML model that requires a training set with established ground truth.
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(334 days)
• The Sintea Posterior Lumbar System is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion.
• The Sintea Biotech Posterior Lumbar System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• The Sintea Biotech Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Not Found
The provided document describes a medical device, the "Sintea Biotech Posterior Lumbar System," and its clearance process through a 510(k) premarket notification. This process assesses substantial equivalence to legally marketed predicate devices, rather than a clinical trial demonstrating new performance claims against acceptance criteria in the way a novel AI device might.
Therefore, many of the typical acceptance criteria and study elements you've requested (like AI performance, ground truth establishment for training sets, expert consensus, MRMC studies, etc.) are not applicable to this type of medical device submission.
However, I can extract information related to the device's design verification and validation, which serves as its "acceptance criteria" in this context, and the study (biomechanical testing) that proves it meets these criteria.
Here's a breakdown based on the provided text:
1. Table of "Acceptance Criteria" and the Reported Device Performance
For this device, the "acceptance criteria" are compliance with established standards and demonstrated equivalence to predicate devices, focusing on safety and mechanical performance.
| Acceptance Criterion (Standard/Requirement) | Reported Device Performance (Summary of Biomechanical Testing) |
|---|---|
| Material Standards: Compliance with material standards (implied by "Special Controls") | The device is made of the "same implant alloy" as predicate devices. |
| Mechanical Testing Standard: Compliance with mechanical testing standards, specifically ASTM standards (implied by "Special Controls" and "Performance Standards") | "Fatigue testing of a 'worst case' system configuration using constructs made of titanium was conducted. The testing demonstrates that when subjected to repeated physiological loads, increased by suitable safety factors, the Posterior Lumbar System overcomes both static and fatigue tests, with occurrences of neither microscopic nor macroscopic failures after five million cycles of a repeated applied force, according to ASTM testing standards." |
| Biocompatibility Standard: Compliance with biocompatibility standard (implied by "Special Controls") | Not explicitly detailed in the summary, but typically part of the material and design evaluation for equivalence. Assumed to be met by using the "same implant alloy" and being substantially equivalent to predicate devices. |
| Labeling Requirements: Compliance with specific labeling statements (as per "Special Controls") | The document outlines specific indications for use and warnings that must be included in the labeling. This is a regulatory compliance criterion rather than a performance one derived from testing. |
| Substantial Equivalence: To legally marketed predicate devices (TSRH Spinal System and Synergy Spinal System) in terms of intended use, indications for use, material, form, function, components, instruments, dimensions, geometry, and features. | "Biomechanical studies conducted on the Sintea Biotech Posterior Lumbar System implant constructs demonstrate that the device system is safe, effective, and suitable for use as a spinal fixation device system." |
| "The devices have the same intended use and indications for use; The devices are made of the same implant alloy; and The devices have similar form, function, components, instruments, dimensions, geometry and features." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of devices/constructs, but the description refers to "constructs made of titanium." The testing was likely performed on a sufficient number of samples to meet ASTM testing requirements and provide statistically significant results for mechanical strength. For mechanical testing, samples are typically physical specimens of the device or its components.
- Data Provenance: The testing was conducted by Sintea Biotech Inc. as part of their submission. It is internal testing performed by the manufacturer to demonstrate compliance with standards. It is prospective in the sense that the tests were designed and conducted specifically to support this regulatory submission. It is not patient data; it's laboratory testing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. This device submission does not involve clinical data or "ground truth" derived from expert interpretation of medical images or patient outcomes in the way an AI diagnostic device would. The "ground truth" here is adherence to engineering standards and comparison to established predicate devices. The "experts" involved would be mechanical engineers and regulatory specialists ensuring compliance with the testing protocols and standards.
4. Adjudication Method for the Test Set
- Not Applicable. There is no "adjudication" in the clinical sense for this type of mechanical testing. The results are quantitative measurements against predefined ASTM standards (e.g., number of cycles survived, load at failure). The outcome is determined by whether the measurements meet the numerical thresholds set by the standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data, often with or without AI assistance. The Sintea Biotech Posterior Lumbar System is an implantable surgical device, not a diagnostic tool requiring human interpretation of medical images for its primary function.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Not Applicable. This device is a passive, implantable medical device, not an algorithm or AI system. Therefore, standalone performance in that context is irrelevant.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance validation is compliance with established mechanical testing standards (ASTM) and demonstrated similarity to legally marketed predicate devices in terms of material, design, and intended use. This is primarily engineering and regulatory compliance ground truth, not clinical or pathological ground truth in the patient sense.
8. Sample Size for the Training Set
- Not Applicable. This device is not an AI algorithm; therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI algorithm or training set, this question is not relevant.
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