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The Ocelot TDS 1000 is indicated for use during surgical procedures when fragmentation or debridement of soft tissue is desired.

The Ocelot TDS 1000 is a portable, handheld battery-powered device that consists of a Reusable Drive Unit (RDU), a charging station for the RDU, a sterile Disposable Unit (DU) that houses the cutting tool assembly, and an optional application that displays real-time operating data. The Ocelot TDS 1000 is comprised of a unit that mechanically interacts with tissue and an app that provides real-time device operating data. A battery charging unit is provided to recharge the battery.

The provided text, a 510(k) Premarket Notification from the FDA, does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

The document primarily focuses on establishing "substantial equivalence" between the Ocelot TDS 1000 and a predicate device (Tenex Health TX System, K153299). This process relies on comparing technological characteristics, indications for use, and demonstrating similar performance and safety through various tests, rather than setting and meeting specific, quantifiable acceptance criteria.

The sections that do come closest to the requested information are:

• Performance Testing: This lists the types of tests conducted (Software V&V, Bench testing, Comparative Cadaver testing, Comparative simulated irrigation and aspiration).
• Substantial Equivalence Discussion/Conclusion: This states that "Comparative testing demonstrated equivalent performance" and that the device "has demonstrated substantially equivalence in performance, safety and effectiveness compared to the predicate device."

However, the document does not provide:

1. A table of acceptance criteria and reported device performance: It doesn't define specific numerical thresholds for "cutting speed," "fragmentation," or "debridement efficiency" that the device needed to meet, nor does it report the exact numerical performance values achieved. It only states that the performance was "equivalent" or "similar" to the predicate.
2. Sample size, data provenance, ground truth details, or adjudication methods for test sets: This level of detail regarding the studies (e.g., how many cadavers, what type of bovine muscle tissue, where it was sourced, how results were judged) is not present.
3. Details about expert involvement: There's no mention of experts establishing ground truth, their number, or qualifications.
4. MRMC study information: No multi-reader multi-case study is mentioned, nor any human-in-the-loop performance data.
5. Standalone (algorithm only) performance: This device is a surgical instrument, not an AI algorithm, so this concept is not applicable.
6. Training set details: Again, not applicable as this is a physical device, not an AI model requiring a training set.

In summary, based on the provided text, it is not possible to fill out the requested table or detail the study as it would for an AI/software-as-a-medical-device (SaMD) submission. The document is structured to demonstrate substantial equivalence of a physical medical device, not to present a clinical validation study with specific performance metrics and acceptance thresholds.

If this were an AI device, the FDA 510(k) submission would typically include a much more detailed "Performance Data" section with quantitative metrics (e.g., sensitivity, specificity, AUC) and a clear breakdown of the validation study.

Therefore, I cannot generate the requested output based on the information given.

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