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510(k) Data Aggregation
(127 days)
Spyder Medical's Ostial Sprit Cannulae is indicated for use in delivery of cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass surgery.
The Ostial Sprit Cannulae is a single use, disposable medical device. It consists of three main components all of which are based on common thermoplastics. The majority of the device consists of a vinyl tube provided for in three varying sizes in diameter; 6, 9 & 10.5 Fr, as well as, two varying degrees of rigidity; standard and flexible. Proximally, the device is anchored with a vinyl female luer connector. Distally, the device terminates in a pre-shaped vinyl cuff purposely positioned over a thru hole within the tubing for purposes of receiving the perfused cardioplegia solution. The cuff is provided for in five varying diameters of 4, 5, 6, 7 & 8 mm. The device is provided for in either a straight or distally angled configuration. Technologically, cardioplegia solution is infused at the proximal end exiting the distal end. During infusion, the cuff receives perfusate within its inner lumen maintaining its shape/rigidity.
This document is a 510(k) summary for the Ostial Sprit Cannulae, a medical device for delivering cardioplegia solution during cardiopulmonary bypass surgery. However, it does not contain the specific detailed information typically found in acceptance criteria and study reports for AI/software devices. The entire document focuses on demonstrating substantial equivalence to a predicate device for a physical medical product based on non-clinical performance evaluations.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device adherence to them in the context of an AI/software device. The information below reflects what is available in the provided text, which is limited to the non-clinical performance evaluation of a physical device.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the "acceptance criteria" are implied by comparing the subject device's performance to the predicate device, aiming for substantial equivalence. No explicit numerical acceptance criteria are listed.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Evaluation: | ||
| Fluid performance (pressure loss) | Performance substantially equivalent to or better than predicate | "subject device outperformed the predicate device as it sustained lower levels of pressure for the same given flow rates." |
| Mechanical hemolysis | Biologically insignificant differences compared to predicate | "no biologically significant differences in the blood parameters between Spyder Medical's Ostial Sprit Cannulae and its predicate device. The percent hemolysis... were considered substantially equivalent and biologically insignificant." |
| Integrity Testing: | ||
| Leak/burst analysis | Acceptable and substantially equivalent to predicate | "considered acceptable and substantially equivalent to its predicate device." |
| Tensile strength (luer-tubing bond) | Acceptable and substantially equivalent to predicate | "considered acceptable and substantially equivalent to its predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non-clinical performance evaluation" and "clinical simulation of fluid perfusion." This suggests laboratory-based testing rather than patient data.
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified, but implied to be laboratory/simulation data ("non-clinical performance evaluation," "clinical simulation"). Not from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this physical device's performance is derived from direct measurement and observation during functional and integrity testing, not from expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical evaluation of a physical device, not an AI/software assessment requiring expert adjudication.
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
Not applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on direct physical measurements and laboratory-simulated functional tests (e.g., pressure loss, hemolysis measurements, leak/burst tests, tensile strength tests) of the device against a predicate.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/software device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/software device requiring a training set.
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