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510(k) Data Aggregation
(224 days)
The Pitkar Spinal Pedicle Screw System is intended for non-cervical posterior and anterolateral fixation of the spine 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/or sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (i.e., fracture or dislocation); 4. Spinal Stenosis; 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); 6. Tumor; 7. Pseudoarthrosis and/or failed previous fusion
The subject system (Pitkar Spinal Pedicle Screw) attaches to the spine through screw, rod, and crosslink components. Furthermore, the system is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. All implants are manufactured from Ti-alloy per ASTM F136.
This submission is for a medical device (Pitkar Spinal Pedicle Screw System), not a software or AI device. Therefore, the requested information on acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable and is not present in the provided text.
The document describes the regulatory review and clearance of a Pitkar Spinal Pedicle Screw System, a physical medical device. The clearance is based on its substantial equivalence to existing legally marketed predicate devices.
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical mechanical and material testing, not clinical trials or AI/software performance studies.
Here's a breakdown of what is available in the document regarding how the device meets its "acceptance criteria" (which in this case are related to safety and performance through substantial equivalence):
Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for this physical device are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant ASTM standards for mechanical performance.
1. Table of Acceptance Criteria and Reported Device Performance
There is no specific table of "acceptance criteria" with numerical performance metrics provided in the document for the device itself. Instead, the performance is demonstrated by:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | "The technological design features of the subject system (Pitkar Spinal Pedicle Screw System) are substantially equivalent to the primary predicate (K043578), additional predicates (K082572, K060648, K190471, K180226, and K201457), and reference device (K192619)." |
| Mechanical Performance (demonstrated against applicable standards) | "The device performance of Pitkar Spinal Pedicle Screw System has been demonstrated against applicable standards ASTM F1717- Standard Test Methods For Spinal Implant Constructs In A Vertebrectomy Model:" |
- Static Compression Bending Test
- Dynamic Compression Bending Test
- Static Torsion Test
"The submitted mechanical testing data demonstrates that the proposed device is substantially equivalent to that of the predicate device for the desired indications." |
| Material Composition | "All implants are manufactured from Ti-alloy per ASTM F136." |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. For a physical device, this would typically refer to the number of device samples tested in laboratory settings, not patient data sets. The provenance would be the testing facility.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
Not applicable for this type of device submission. Ground truth here is established by engineering and materials science principles and adherence to standards.
4. Adjudication Method for the Test Set:
Not applicable for this type of device submission. Adjudication methods are typically for clinical data or expert reviews, not mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:
Not applicable. This is a physical implant device, not a software algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this device's safety and effectiveness is established through:
- Mechanical Testing Results: Performance against established ASTM standards (ASTM F1717 for static compression bending, dynamic compression bending, and static torsion).
- Material Compatibility and Specifications: Conformance to ASTM F136 for Ti-alloy.
- Substantial Equivalence: Comparison of design features, intended use, indications for use, and function to existing cleared predicate devices.
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no "training set" in the context of this physical device.
In summary, the provided document is a 510(k) clearance letter for a Class II spinal implant device. The "proof" it meets "acceptance criteria" lies in demonstrating substantial equivalence to predicate devices and adherence to relevant ASTM mechanical testing standards.
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