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510(k) Data Aggregation
(329 days)
The PathLoc-SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroililtis.
PathLoc-SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The material is Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) approved for medical use.
· Arch Screw will be implanted in patient's bone then autograft will be inserted.
· Locking Screw can be used with washer or can be used solo
· Self-tapping flute centers screw for easy insertion
· Various choice of Screw Length(30,35,40,45,50,55,60,65,70 mm of Length)
This document is a 510(k) summary for the PathLoc-SI Joint Fusion System. It describes a medical device, its intended use, and compares it to already marketed devices to establish substantial equivalence, which is a regulatory requirement for medical devices in the US.
Based on the provided information, I can answer your questions as follows:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it relies on demonstrating that the device is "substantially equivalent" to legally marketed predicate devices in terms of design, material, and indications for use, and through performance testing to established ASTM standards. The "reported device performance" is essentially that the device meets these ASTM standards as part of its substantial equivalence claim.
However, the closest we can get to this information from the provided text is by listing the performance tests conducted and the implicit "acceptance criteria" that the device must pass these tests according to the relevant ASTM standards.
| Acceptance Criteria Category | Specific Test (Standard) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Torsional test (ASTM F543-13) | Passed (implicit, as concluded to be substantially equivalent) |
| Axial pullout test (ASTM F543-13) | Passed * | |
| Driving torque test (ASTM F543-13) | Passed * | |
| Static bending strength (ASTM F2193-14) | Passed * | |
| Fatigue bending strength (ASTM F2193-14) | Passed * |
Note: The document states "Performance Testing was done" (section 8) and concludes that the device is "substantially equivalent" (section 9). This strongly implies the device met the requirements of these standards, though specific numerical results or pass/fail thresholds are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a premarket notification (510(k)) for a medical device. For devices seeking 510(k) clearance, clinical studies with human subjects are often not required if substantial equivalence can be demonstrated through other means, such as mechanical testing and comparison to predicates.
Therefore, no human clinical test set or data provenance is mentioned or appears to have been used in this submission. The "test set" here refers to the physical device components subjected to mechanical testing. The sample size for these mechanical tests (e.g., number of screws tested for torque or bending) is not specified in this 510(k) summary. These tests are typically conducted in a laboratory setting, not with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Given that this submission relies on mechanical performance testing against ASTM standards and comparison to predicate devices, there was no "ground truth" to be established by clinical experts in the sense of diagnosing patient conditions or interpreting medical images. The "ground truth" for the mechanical tests would be the established specifications and methodologies of the ASTM standards themselves, interpreted by engineers or testing specialists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method for human interpretation was used as there was no human clinical test set in this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed. This device is a physical implant (sacroiliac joint fusion system), not a diagnostic imaging or AI-based software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is a physical implant and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As discussed, this submission relies on mechanical and material testing standards (ASTM F543-13, ASTM F2193-14) and comparison to the design and indications for use of legally marketed predicate devices. The "ground truth" for the mechanical tests is the adherence to the published specifications and performance requirements within those ASTM standards.
8. The sample size for the training set
No training set was used as this is a physical medical device, not an AI or machine learning model.
9. How the ground truth for the training set was established
Not applicable, as there was no training set.
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