Search Results
Found 1 results
510(k) Data Aggregation
(332 days)
The Spinal Simplicity Posterior Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:
· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- · spondylolisthesis;
- · trauma (i.e., fracture or dislocation); and/or
- tumor.
The Posterior Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).
The Posterior Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include several spiked grips at the ends of each Plate for attachment to the spinous processes. The Posterior Fusion Plate device is available in multiple sizes to accommodate varying patient anatomy. The Posterior Fusion Plate is made from Ti6Al4V and Ti6Al4V ELI. The HA Posterior Fusion Plate has an additional hydroxyapatite coating on the distal regions of the device.
The document provided is a 510(k) summary for a medical device called the "Posterior Fusion Plate." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new AI/software-based device. Hence, most of the requested information regarding acceptance criteria, specific study designs for performance metrics, ground truth, and reader studies is not explicitly available in this document as it pertains to a different type of device and regulatory submission.
However, I can extract the information that is present and indicate where the requested information is not applicable or not provided in this specific context.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (from the document) |
|---|---|
| Mechanical Performance (based on ASTM F1717 standards): | "The data demonstrate that the subject Posterior Fusion Plate device presents substantially equivalent mechanical performance compared to the predicate device." Specific quantitative criteria and results for each test (Static Axial Compression, Static Torsion, Dynamic Axial Compression) are not provided in this summary but the overall conclusion of meeting substantial equivalence is stated. |
| Surgical Insertion Technique Suitability: | "Cadaveric device insertion data was presented to demonstrate the suitability of the surgical insertion technique for the device's listed indications. The data demonstrate that the device may be inserted with minimal risk of spinous process fracture." |
| Device Function and Performance (Surgeon-involved): | "Data from a surgeon-involved cadaveric implantation study was presented to demonstrate suitable device function and performance." (No specific quantitative criteria or outcomes are detailed for this study in the summary). |
| Clinical Safety (Risk of failure to deploy, spinous process fracture, neurological injuries): | "Survey data from surgeons outside the United States who have implanted the device was also presented and show that none of the surgeons observed any instances of failure to deploy the device wings, spinous process fracture, or neurological injuries." |
| Clinical Safety (Risk of device migration, dislodgement, spinous process fracture): | "Clinical data were presented to demonstrate that the risk of device migration, dislodgement, and spinous process fracture were sufficiently low." (No specific quantitative data or acceptance thresholds are provided, just the conclusion of "sufficiently low"). |
| Bacterial Endotoxin: | "Bacterial endotoxin testing will be performed on all batches of sterile packed devices." (This is a statement of a future process, implying a standard acceptance criterion that must be met for each batch). |
2. Sample Size Used for the Test Set and Data Provenance
- Mechanical Testing (ASTM F1717): Not specified. These are typically in-vitro lab tests, not using human data.
- Cadaveric Insertion Data: Not specified. This would be a prospective study, likely conducted in a controlled lab setting.
- Surgeon-involved Cadaveric Implantation Study: Not specified. Prospective, controlled lab setting.
- Survey Data from Surgeons:
- Sample Size: Not specified (number of surgeons).
- Data Provenance: "outside the United States," retrospective from the perspective of the survey, gathering past observations.
- Clinical Data (migration, dislodgement, fracture):
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The term "clinical data" implies human patient data, but details are lacking.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Mechanical Testing: No human experts establish ground truth for these physical tests. Standards like ASTM F1717 define the methodology.
- Cadaveric Insertion Data: The "minimal risk of spinous process fracture" would likely be judged by the testing personnel and/or surgical experts involved in the study. The number and qualifications are not specified.
- Surgeon-involved Cadaveric Implantation Study: Similar to above, "suitable device function and performance" would be assessed by the involved surgeons. The number and qualifications are not specified.
- Survey Data: The "ground truth" (observations of failures) relies on the reporting surgeons themselves. Their qualifications are implied as surgeons who implant the device, but specific experience levels are not detailed.
- Clinical Data: While "clinical data" is mentioned, the method for establishing "ground truth" for risks like migration, dislodgement, and fracture (e.g., by independent medical reviewers, imaging, etc.) is not detailed, nor are the number or qualifications of experts.
4. Adjudication Method for the Test Set
Not specified for any of the studies mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this document describes a physical medical device (spinal implant), not an AI/software device that would typically undergo an MRMC study comparing human readers with and without AI assistance. Therefore, this section is not applicable, and no effect size for human readers improving with AI is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical implant, not an algorithm or AI.
7. The Type of Ground Truth Used
- Mechanical Testing: Defined by physical measurements and adherence to ASTM standards.
- Cadaveric Data: Observations of physical outcomes (e.g., presence/absence of fracture) during surgical simulation.
- Survey Data: Self-reported observations by implanting surgeons.
- Clinical Data: Observations of clinical outcomes (e.g., migration, dislodgement, fracture) in patients. Whether this involved expert consensus, pathology, or direct outcome data is not specified.
8. The Sample Size for the Training Set
This concept is primarily relevant for AI/machine learning models. Since this is a physical medical device, there isn't a "training set" in the AI sense. The design and manufacturing process would involve internal testing and refinement, but not a formally labeled "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as above.
Ask a specific question about this device
Page 1 of 1