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The Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC®) Surgical System is intended for suprapubic bladder catheterization (cystostomy) and drainage. The catheter should not be allowed to remain indwelling for more than 29 days.

The T-SPeCTM Surgical System is, in effect, a sterile suprapubic catheter and accessory kit consisting of a) a suprapubic catheter; b) a catheter punch instrument used to create a cystostomy and place the suprapubic catheter; and c) a piston syringe to fill the catheter balloon after placement.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC™) Surgical System:

1. Table of Acceptance Criteria and Reported Device Performance

A critical point to note is the absence of specific, quantitative acceptance criteria and their corresponding reported performance values within this 510(k) summary. The summary states that "various bench performance studies have been performed" but does not detail the specific criteria or the results of those studies. The primary "acceptance criterion" articulated is the demonstration of "substantial equivalence" to predicate devices based on non-clinical data.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not mention a "test set" in the context of clinical or performance data for an AI/algorithm-based device.

• Sample Size for Test Set: Not applicable as no clinical or AI-specific performance testing is detailed.
• Data Provenance: Not applicable. The submission explicitly states, "No clinical performance testing was performed." The equivalence is based on non-clinical bench studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Number of Experts: Not applicable. As no clinical performance testing or "test set" requiring expert ground truth was conducted, no experts were used for this purpose.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since no clinical performance testing requiring a "test set" with expert review was conducted, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. The provided text does not mention any MRMC comparative effectiveness study. This is not an AI/software as a medical device (SaMD) submission where such studies would be typical.
• Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: No. The device is a "Surgical System" consisting of physical medical instruments (catheter, punch instrument, syringe), not a standalone algorithm or software. Therefore, the concept of "algorithm only" performance is not relevant to this submission.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of clinical or AI performance. The "ground truth" for this device's safety and effectiveness relies on established engineering principles, material science, and performance testing benchmarks for similar physical medical devices (e.g., integrity of materials, sterility, functionality of mechanical components). The "ground truth" is essentially conformance to design specifications and recognized standards for physical medical devices, as demonstrated by bench testing.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a submission for a physical medical device, not an AI/machine learning model. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for a physical device.

Summary of the Study:

The study proving the device meets its "acceptance criteria" (which in this case is primarily substantial equivalence to predicate devices for safety and effectiveness) consists of non-clinical bench performance studies.

The 510(k) summary explicitly states: "No clinical performance testing was performed. Substantial equivalence for the subject device is based on the aforementioned non-clinical bench studies."

These bench studies covered:

• Suprapubic Catheter design and performance.
• Catheter accessory design and performance.
• Biocompatibility.
• Sterilization Validation & Shelf Life.

The detailed results and specific acceptance parameters of these bench studies are not provided in the 510(k) summary (which is common for these summaries). The FDA's decision to clear the device implies that the non-clinical data was sufficient to demonstrate substantial equivalence to legally marketed predicate devices for the stated intended use.

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