(77 days)
These suction handles are used in conjunction with a vacuum-powered, single patient, body fluid suction apparatus. The handles provide a means to aspirate, remove or sample body fluids from a surgical wound or body orifice via vacuum.
The Medi-Vac Flexi-Clear™ Suction Handles are made of polyvinyl chloride in a variety of sizes and are offered sterile.
This is a 510(k) premarket notification for a medical device (Medi-Vac Flexi-Clear™ Suction Handles), not an AI/ML software device. Therefore, the requested information about acceptance criteria, study design, and performance metrics for AI/ML models (e.g., sample size for test sets, expert ground truth, MRMC studies) is not applicable to the provided text.
The document discusses the substantial equivalence of the Medi-Vac Flexi-Clear™ Suction Handles to a predicate device (Argyle® Yankauer Suction Tube) based on characteristics like intended use, size, configuration, materials, and physical properties.
The "Summary of Testing" table outlines the results of biocompatibility tests conducted on the device.
Here's the information that is extractable from the provided text, structured to align with your request where possible, but noting the inapplicability of AI/ML-specific fields:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity Test | No toxic reactions to acute application. | Suction handle does not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | No reactivity observed. | No reactivity was observed. |
| Hemocompatibility | No lysis (hemocompatible). | Suction handles are hemocompatible exhibiting no lysis. |
| Systemic Toxicity | No potential for irritation. | Suction handle does not display potential for irritation. |
| Sensitization | No potential for irritation (sensitization). | Suction handle does not display any potential for irritation. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is summarized under "Summary of Testing" in the provided document. These are standard biocompatibility tests.
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 for these biocompatibility tests. For medical device biocompatibility, samples of the device material are typically used for in vitro or in vivo testing according to ISO 10993 standards. The exact number of samples or biological replicates is not detailed in this summary.
- Data Provenance: Not specified. Biocompatibility testing is generally performed in certified laboratories.
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)
Not applicable. For biocompatibility testing, ground truth is established by standardized laboratory assays and protocols, interpreted by trained laboratory personnel and toxicologists, not by a panel of clinical experts in the same way an AI model's output would be adjudicated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are for expert consensus in diagnostic imaging or similar fields. Biocompatibility test results are typically objective measurements or observations against established criteria.
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 a physical medical device, not an AI/ML diagnostic or assistive software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility testing, the "ground truth" is based on standardized biological responses and endpoints measured according to recognized test methods (e.g., ISO 10993 series). This includes observing cellular responses (cytotoxicity), tissue reactions (intracutaneous reactivity, sensitization), and blood interactions (hemocompatibility), with results interpreted against predefined pass/fail criteria.
8. The sample size for the training set
Not applicable. There is no AI/ML model for which to define a training set. This is a physical medical device.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model for which to define a training set and its ground truth.
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.