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510(k) Data Aggregation
(163 days)
panaSIa SI Fusion System
The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The panaSIa SI Fusion device is a threaded, expandable device, designed to stabilize the sacroiliac joint by piercing the adjacent cortical bone when expanded. The device has large fenestrations to allow for uninterrupted graft contact across the SI joint space. The panaSIa SI Fusion implant is a sterile, single patient use, long-term implantable device made of a titanium grade alloy.
The provided FDA 510(k) clearance letter for the "panaSIa SI Fusion System" describes a medical device, specifically a smooth or threaded metallic bone fixation fastener, intended for sacroiliac (SI) joint fusion.
Based on the provided document, the acceptance criteria and the study proving the device meets these criteria are limited in detail. This is typical for a 510(k) clearance for this type of device, which primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than extensive clinical studies or AI algorithm performance validation.
Here's an analysis of the provided information, addressing your points where possible, and noting where information is not present in the document.
Overview of Device and Clearance Type
The panaSIa SI Fusion System is a physical implant (a threaded, expandable device made of titanium grade alloy) used for sacroiliac joint fusion. The FDA clearance is a 510(k), which means the manufacturer demonstrated the device is substantially equivalent to legally marketed predicate devices. This type of clearance typically relies on non-clinical testing (e.g., mechanical performance) and comparison of design, materials, and indications for use, rather than extensive human clinical trials or complex AI performance metrics.
Acceptance Criteria and Study Details (Based on Provided Document)
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device and submission (510(k) for a physical implant), the "acceptance criteria" are not explicitly quantifiable metrics like sensitivity/specificity for an AI algorithm. Instead, they are typically the successful fulfillment of recognized standards and comparative performance to predicates.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Document) | Reported Device Performance (From Document) |
|---|---|---|
| Intended Use Equivalence | Same intended use as predicate devices. | "The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis." - Matches indications for predicate devices. |
| Principles of Operation Equivalence | Similar principles of operation as predicate devices. | "The subject device and the predicate devices have similar principles of operation..." |
| Design Equivalence | Similar design as predicate devices. | "...designs..." |
| Material Equivalence | Similar materials as predicate devices. | "...and use similar materials. The panaSIa SI Fusion implant is a sterile, single patient use, long-term implantable device made of a titanium grade alloy." |
| Performance (Mechanical) Equivalence | Meets or exceeds mechanical testing standards (ASTM F3574) and performs comparably to predicate in relevant tests (e.g., cadaver testing). | "The non-clinical testing data submitted and relied upon to demonstrate substantial equivalence included static and dynamic vertical shear testing per ASTM F3574 and cadaver testing with comparison to the additional predicate device." |
| Safety & Effectiveness | Demonstrates comparable safety and effectiveness to predicate devices. | "The panaSIa SI Fusion System is as safe, as effective, and performs as well as, or better, than the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "cadaver testing," which refers to ex vivo testing of the device. However, it does not specify the sample size (i.e., number of cadavers or test specimens from cadavers) used for this testing.
- Data Provenance: The document does not specify the country of origin of the cadaver data or whether the testing was retrospective or prospective. Given it's cadaver testing, it's inherently a controlled, ex vivo experimental setup rather than a patient-based retrospective/prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable/not provided in this type of 510(k) submission. The "ground truth" for a physical implant's mechanical performance is typically established by engineering standards (like ASTM F3574) and direct measurement, not by expert consensus on image interpretation or clinical outcomes.
4. Adjudication Method for the Test Set
- Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in clinical imaging studies or clinical trials where human interpretation or consensus is required. This information is not applicable/not provided for a mechanical device performance test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers (e.g., radiologists interpreting images). This device is a physical implant; therefore, no MRMC study was done or is relevant for this submission.
6. Standalone (Algorithm Only) Performance Study
- This refers to the performance of an AI algorithm alone, without human intervention. Since this is a physical medical device and not an AI algorithm, a standalone algorithm performance study was not conducted or is not relevant.
7. Type of Ground Truth Used
- For the non-clinical performance testing:
- Mechanical Standards: Adherence to established engineering standards (ASTM F3574 for static and dynamic vertical shear testing).
- Comparative Performance: The performance of the device was directly compared against a predicate device in cadaver models. While not explicitly stated as "ground truth," the predicate device's known performance serves as the benchmark against which the new device is measured.
- No clinical outcomes or pathology ground truth was used for this 510(k) clearance, as it is based on substantial equivalence through non-clinical testing.
8. Sample Size for the Training Set
- This device is not an AI algorithm, so there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by engineering principles, material science, and prior device designs, but not through a formalized data training set as seen in AI development.
9. How the Ground Truth for the Training Set Was Established
- As there is no AI "training set," this question is not applicable.
In summary, the provided FDA 510(k) clearance letter details a non-AI medical device (an SI joint fusion implant). The "acceptance criteria" and "study" proving these criteria are primarily based on:
- Substantial equivalence to legally marketed predicate devices in terms of intended use, principles of operation, design, and materials.
- Non-clinical performance testing, specifically:
- Adherence to ASTM F3574 for static and dynamic vertical shear testing.
- Comparative cadaver testing against an additional predicate device.
The document does not delve into the detailed quantitative results of these tests (e.g., exact maximum shear force sustained), sample sizes of cadavers, or the specific methods of ground truth establishment beyond relying on industry standards and direct comparison. This level of detail for non-clinical testing is typically found within the full 510(k) submission, not the public-facing clearance letter.
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