(117 days)
The TauTona Injector Device is a syringe assist device and is intended for use in the administration of sterile materials / autologous adipose tissue under aseptic conditions in accordance with the best judgment of the clinician. The TauTona Injector Device is intended for use with standard syringes / cannulas.
The TauTona Injector (TTI) Device is a hand-held, sterile, single-use, disposable device and is designed to be used with, off-the-shelf syringes and injection cannulas. The device is used to assist the physician in injection fluids into the body. The clinician connects the TTI device to the pre-filled syringe and a standard re-injection cannula (Size 9, 14G). The device is activated by a trigger mechanism that enables fluid delivery in specific aliquot sizes. The TTI Device is a simple handle that consists of the following components:
- . Pump with an enclosed motor
- Battery pack (12V) .
- . Controller (printed circuit board with software)
- . Dispensing trigger
- . On/off/aliquot size select switch
- . Indicator light
- . Syringe luer connector (female)
- Cannula luer connector (male) .
The provided text describes the TauTona Injector Device, a syringe assist device. However, it does not contain the specific details regarding acceptance criteria for device performance or a detailed study proving the device meets these criteria in the format requested.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria. While it mentions "Design verification testing" and "comparative testing," it does not present the outcomes of these tests in a quantifiable manner or against specific thresholds.
Therefore, most of the requested information cannot be extracted directly from the provided text.
Here's an attempt to answer the questions based on the available information, with clear indications where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (If stated) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document for specific performance metrics. The overall acceptance criterion is likely "substantially equivalent" to predicate devices for intended use, operating principles, and safety/effectiveness profile. | "Design verification testing confirmed that the TauTona Injector Device performs according to the stated intended use." |
| "Test data included in this 510(k) submission demonstrate similar performance of the TauTona Injector device as compared to the predicate devices." | |
| (No quantitative performance metrics or specific thresholds are provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document refers to "Design verification testing," "comparative testing with the cited predicate devices," and "human factors testing," but no details on the origin or nature (retrospective/prospective) of the data are given.
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)
- Number of Experts: Not applicable. This type of device (piston syringe/syringe assist device) typically relies on engineering and functional testing rather than expert-established ground truth for image interpretation or diagnosis.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable to the type of testing described (functional, comparative, human factors).
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images, often with or without AI assistance. The TauTona Injector Device is a mechanical assist device, not an imaging or diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable for this device. The TauTona Injector Device is a mechanical "human-in-the-loop" device by its very nature, designed to assist a physician in injecting fluids. It does not have an "algorithm-only" or "standalone" mode in the context of AI performance. The software validation mentioned refers to the internal control software, not a diagnostic algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated in terms of expert consensus, pathology, or outcomes data, as these are typically associated with diagnostic devices. For this device, "ground truth" would likely be defined by engineering specifications and functional requirements (e.g., precise aliquot delivery, consistent force, biocompatibility compliance, electrical safety standards). These are verified through various tests like "functional testing," "biocompatibility testing," "sterilization validation," "electrical safety and electromagnetic compatibility testing," and "software validation."
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that typically requires a "training set" for diagnostic performance.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI/machine learning model.
Summary of what the document does indicate about performance and testing:
- Testing Types Mentioned:
- Functional testing
- Comparative testing with predicate devices
- Human factors testing
- Biocompatibility testing (ISO 10993)
- Sterilization validation (ISO 11135)
- Electrical safety and electromagnetic compatibility testing (IEC 60601)
- Software validation (per FDA Guidance Document)
- Packaging and shipping validation (ISTA 2A guidelines)
- Conclusion: The device performs according to its intended use and demonstrates "similar performance" to predicate devices, thus establishing substantial equivalence without raising new safety or effectiveness questions.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).