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510(k) Data Aggregation
(72 days)
The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.
Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scollosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.
The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 and ISO 5832-3.
A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.
The purpose of this submission is to extend to the PASS LP range, with the addition of those new components:
- TULIP GENESIS Non-cannulated Pedicle Screws
- TULIP GENESIS Non-cannulated Iliac Screws
- TULIP GENESIS Cannulated Pedicle Screws
- TULIP GENESIS Cannulated Iliac Screws
- TULIP GENESIS Breakable Setscrew
This document is a 510(k) Pre-Market Notification from the FDA for the PASS LP Spinal System. It is an approval letter and a summary of the device and its intended use, not a study evaluating its performance against acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot provide the requested information as the document does not contain details about:
- Acceptance criteria and reported device performance related to an AI/ML model. This document is for a medical implant (spinal fixation system), not a software device that relies on performance metrics like accuracy, sensitivity, or specificity.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Stand-alone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
- Sample size for a training set.
- How ground truth for the training set was established.
The "Performance Data" section (g) only mentions mechanical testing according to ASTM F1717-18 for static compression bending, static torsion, and dynamic compression bending tests, concluding that the products are "as mechanically sound as other devices commercially available." This refers to the physical properties of the spinal implants, not the performance of an AI or Machine Learning algorithm.
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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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