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The PathLoc SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The PATHLOC SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. This submission adds an additional screw option to the system.

This document is an FDA 510(k) clearance letter for a medical device called the "PathLoc SI Joint Fusion System." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to AI or algorithm performance.

The content of the provided text focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• Regulatory requirements and classifications.
• Description of the device and its intended use (sacroiliac joint fusion).
• Material composition.
• A brief mention of "performance testing" through engineering analysis, stating that added components do not introduce a "new worst case" and don't require additional mechanical testing. This refers to mechanical integrity and safety of the implant itself, not AI performance.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria, as the provided text does not contain this information. The device in question is a physical implant (bone screws), not a software or AI-driven diagnostic or therapeutic device.

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The PathLoc SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The PATHLOC SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136.

• 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 on its own
• Self-tapping flute centers screw for easy insertion

This document is a 510(k) summary for the PathLoc SI Joint Fusion System, a Class II medical device. It's important to understand that a 510(k) submission primarily demonstrates "substantial equivalence" to existing legally marketed devices, rather than proving novel effectiveness or safety through extensive clinical trials.

The provided text focuses on the device's design, materials, and substantial equivalence to predicate devices, but does not contain information regarding studies that prove the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity, which would typically be found for AI/ML-driven devices or diagnostics.

Therefore, I cannot provide a response filling the requested sections as the document describes a traditional mechanical medical device, not one with performance characteristics that would be evaluated with the type of study design you're asking about (e.g., AI/ML performance, diagnostic accuracy etc.).

The document explicitly states:

• "A risk assessment, including FE analysis, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. And the results of the risk assessment were confirmed, and that there were no problems with safety and effectiveness. None of the additional components is the worst case of the PathLoc SI Joint Fusion System and the additional components to be added through this submission do not require additional mechanical testing."
• "Therefore, we substitute mechanical test data of PathLoc SI Joint Fusion System for additional components with the predicate device data (K153656/K181600)."

This indicates that the "performance testing" was primarily a risk assessment and Finite Element (FE) analysis, comparing the new components to previously cleared predicate devices based on mechanical properties and safety, not a clinical study evaluating diagnostic or therapeutic accuracy against a ground truth.

To directly answer your prompt, the information about acceptance criteria and study proving device performance as you've outlined (e.g., sample size, expert ground truth, MRMC study, standalone performance, training set details) is not present in this 510(k) summary because it's not relevant for this type of device submission. This is a mechanical implant, not an AI or diagnostic device that would require such performance evaluations.

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The PathLoc-SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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 on its own
· Self-tapping flute centers screw for easy insertion

The provided document is a 510(k) premarket notification for a medical device called the "PathLoc-SI Joint Fusion System." It describes the device, its intended use, and compares it to a legally marketed predicate device.

Crucially, this document is for a mechanical medical device (bone fixation fastener), not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/SaMD performance metrics (like sensitivity, specificity, AUC, etc.) does not apply.

The performance testing mentioned (ASTM F543-13 Standard and ASTM F2193-14 Standard) relates to the physical and mechanical properties of the bone screws (e.g., torsional strength, axial pullout strength, bending strength). These standards are for assessing the structural integrity and performance of the hardware itself, not for evaluating an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot provide the information requested in the prompt because the available text does not describe an AI/SaMD and thus lacks the relevant data concerning:

1. A table of acceptance criteria and reported device performance (for an AI/SaMD): The document lists mechanical tests, not AI performance metrics.
2. Sample size used for the test set and data provenance: No test set for an AI algorithm is mentioned.
3. Number of experts used to establish ground truth: Not applicable for a mechanical device.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document indicates that the device's substantial equivalence is based on its similarity in design, material, and indications for use to a previously cleared predicate device (K153656), along with adherence to established mechanical testing standards for bone fixation devices.

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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.

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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