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The Posterior Lumber System Multi-Axial Screw DESCO 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 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 spondylothesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The 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.

As a special 510(k) submission, the predicate device to which we are claiming equivalence is our own product, Sintea Biotech's Posterior Lumbar System (K020085). This 510(k) submission represents a modification to the predicate, in which the locking cap threads are modified and additional size diameter screws are added to the already cleared Posterior Lumbar System.

This document is a 510(k) premarket notification for a medical device called the "Posterior Lumbar System Multi-Axial Screws - DESCO" by Sintea Biotech, Inc. It's a review by the FDA determining substantial equivalence to predicate devices, rather than a study proving acceptance criteria for a new AI/software device.

Therefore, the provided document does not contain any of the requested information regarding acceptance criteria or a study proving a device meets acceptance criteria for an AI/software product. The document pertains to a traditional medical device (pedicle screws) and its regulatory clearance process, where "substantial equivalence" is the key determination, not performance against specific acceptance criteria in the context of an AI study.

Specifically, there is no information on:

1. A table of acceptance criteria and reported device performance for an AI/software.
2. Sample sizes or data provenance for a test set.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
5. Standalone algorithm performance.
6. Type of ground truth used (e.g., pathology, outcomes data) in the context of an AI study.
7. Sample size for a training set.
8. How ground truth for a training set was established.

The document primarily focuses on the device's indications for use and its substantial equivalence to previously cleared devices (K020085 and K043355), with a modification to locking cap threads and the addition of new screw sizes. The "Performance Data" section explicitly states to "Please see 510(k) submission for the Sintea Biotech's Multi-Axial Screws System, K043355," indicating that any relevant performance testing would be documented in that predicate device's submission, and would likely involve mechanical or biocompatibility testing for a physical implant, not software performance.

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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-SI 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.

The PLS Sunflower II screws are available with the same material, shape, fillet, diameters and length of PLS Sunflower screws (K043355). They have the same characteristics as PLS Sunflower Multi-axial screws with the exception that the Sunflower II holds both 5mm and 5.5mm diameter rods instead of only 5mm rods, both sizes fall under an already FDA cleared range.

The locking mechanism of the PLS Sunflower II is the same as the PLS Sunflower Multiaxial screw (K043355) with the exception of the external ring in the locking cap. The external ring in the SUNFLOWER locking cap did not contribute to the mechanical stability of the system, therefore, its absence in the Sunflower II Screw will make the system easier to use intraoperatively.

The PLS Multi-axial Sunflower II screws are made of the same material as the PLS Multi-axial Sunflower screws. The somatic thread is the same as the thread of the PLS standard screws. The lengths and diameters of the multi-axial screws are the same as the lengths and diameters of the PLS standard screws. The design of this screw allows for up to 25 degrees of angulation in any direction to accommodate different anatomic conditions.

The provided text describes a 510(k) submission for a medical device, the Sintea Biotech Posterior Lumbar System Sunflower II Multi-axial Screw. Such submissions focus on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to establish acceptance criteria and device performance in the same way a PMA (Pre-Market Approval) would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical trial with performance metrics. Instead, it relies on demonstrating equivalence through design modifications and biomechanical testing, as well as adherence to standards.

Here's a breakdown of why the requested information is not present and what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not found: The document refers to "Biomechanical studies" but does not provide specific acceptance criteria or quantitative performance results in a table. It only states that these studies "demonstrate that the device system is safe, effective, and suitable for use as a spinal fixation device system."
• The 510(k) process for this type of device typically relies on mechanical testing to ensure the modified device meets the same performance standards as the predicate, not on clinical performance metrics like sensitivity, specificity, or surgical outcomes with specific acceptance thresholds.

2. Sample Size Used for the Test Set and Data Provenance:

• Not found: No clinical test set or data provenance (country of origin, retrospective/prospective) is mentioned, as this is not a clinical study report. The "test set" in this context would implicitly refer to the specimens used in biomechanical testing, but details are not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable/Not found: This pertains to clinical studies involving human interpretation or pathology. Since this is a hardware modification submission, such expert ground truth for a test set is not relevant.

4. Adjudication Method for the Test Set:

• Not applicable/Not found: See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable/Not found: This type of study evaluates human reader performance, often with AI assistance. This document is about a mechanical implant, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance:

• Not applicable/Not found: This concerns AI algorithms. The device is a physical implant.

7. Type of Ground Truth Used:

• Not applicable/Not found: For a medical implant, the "ground truth" related to its performance is typically established through a combination of engineering design principles, material testing, and biomechanical studies, rather than expert consensus, pathology, or outcomes data in a clinical trial setting for a 510(k) submission.

8. Sample Size for the Training Set:

• Not applicable/Not found: This is relevant for machine learning models. The device is a mechanical implant.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable/Not found: See point 8.

What the document does provide in relation to proof of meeting criteria:

• Predicate Device Equivalence: The primary "proof" is the demonstration of substantial equivalence to a legally marketed predicate device (Sintea Biotech's own Posterior Lumbar System Multi-axial Screw).
• Modification Justification: The modification (holding 5mm and 5.5mm rods, and removal of an external ring) is described as being within the scope of already cleared sizes and not affecting mechanical stability.
• Biomechanical Studies: The document explicitly states: "Biomechanical studies conducted on the Sintea Biotech Posterior Lumbar System Sunflower II multi-axial screw implant construct demonstrate that the device system is safe, effective, and suitable for use as a spinal fixation device system." However, no specific results, methods, or acceptance criteria from these studies are detailed in the provided text.
• Compliance with Standards: The company "intends to comply with all voluntary Performance Standards applicable to the Sintea Biotech Posterior Lumbar System. At the present time, various performance standards such as ASTM, ISO, QSR/GMP and in-house SOP standards are used." This implies that the biomechanical studies would be designed to meet the requirements of these standards.
• Special Controls: The device must comply with specific special controls, including:
  • Compliance with material standards
  • Compliance with mechanical testing standard
  • Compliance with biocompatibility standard
  • Specific labeling requirements

In summary, for K060513, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to a predicate device and adherence to recognized industry standards and FDA special controls, supported by internal biomechanical testing (for which details are not provided in this excerpt). It's crucial to understand that a 510(k) notification, especially a "special" one for modifications, doesn't require the same depth of clinical evidence and acceptance criteria reporting as a PMA.

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