(33 days)
FOR USE IN INSTALLING SURGICAL DRAINS
The EuTrochar is a trocar used for the installation of surgical drains. The EuTrochar has a handle, the "Deployer" to facilitate gripping, to improve accuracy of drain placement and to keep fingers away from the sharp point. Trocars have been used for more than a hundred years to create an incision in soft tissue for surgical drain tubing. Like other drain installation trocars, this instrument is a highly polished stainless steel rod of small diameter, normally 4 to 6mm in diameter and about 160mm long. One end of the rod is very sharply pointed and the other end has a hose barb for affixing tying. The rod is curved between the two ends so that it looks like a giant sailmaker's needle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EuTrochar device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety: No hazard to prospective patient | "No failures were experienced." "The conclusions of each tester were that there had been no failure and that the devices did not present a hazard to a prospective patient..." |
| Safety: No hazard to surgical personnel | "...nor to surgical personnel." |
| Functionality: Successful use by outside surgeons and support personnel | "Special Devices developed a Trials Protocol, which we consider a "bench trial." Employing plastic sheet as ersatz tissue, a series of EuTrochars and several Deployers were used in trials. No failures were experienced." |
| Functionality: Accurate drain placement | "The EuTrochar has a handle, the "Deployer" to facilitate gripping, to improve accuracy of drain placement..." (Claim, not explicitly tested as a quantifiable criterion in the study description, but implied by the "no failures" outcome.) |
| Functionality: Keeping fingers away from sharp point | "The Deployer is different from the predicate drain installation trocars in that the protective cover "Sheath" is not removed by the surgeons' hand... With the Deployer opened, there is ample clearance tissue to fit between the sharp point of the EuTrochar and the Receiver target. Holding the Deployer by the handles, the surgeon and associates are clear of the sharp point..." |
| Functionality: Easy release from Receiver | "The EuTrochar, protected by the Sheath, is easily released from the Receiver." |
| Functionality: Cutting from tubing and discarding | "It is cut from the tubing and discarded into the hazardous waste depository." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: "Many drain installations were performed on dead animal tissue." and "Employing plastic sheet as ersatz tissue, a series of EuTrochars and several Deployers were used in trials."
- Sample Size:
- Animal Tissue: Not explicitly stated, but described as "Many." This indicates a qualitative assessment rather than a statistically robust sample size.
- Plastic Sheet ("Bench Trial"): Not explicitly stated how many "series of EuTrochars" or "several Deployers" were used, nor the number of trials total.
- Data Provenance:
- Country of Origin: United States (based on the company address and FDA submission).
- Retrospective or Prospective: The "bench trial" and tests on animal tissue were conducted prospectively by the device manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated. The text mentions "Technicians in Special Devices" and later "outside surgeons and support personnel" for the "bench trial." It's unclear how many individuals constituted "technicians" or "outside surgeons."
- Qualifications of Experts:
- Technicians: "Technicians in Special Devices performed exhaustive tests..." - No specific qualifications (e.g., years of experience, specific medical expertise) are provided beyond being "technicians."
- Outside Surgeons: "ascertain that the hardware could be used successfully by outside surgeons and support personnel..." - No specific qualifications are provided for the "outside surgeons."
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The phrase "The conclusions of each tester were that there had been no failure..." suggests individual assessments by "each tester" rather than a formal adjudication process (like 2+1 or 3+1 consensus). It appears to be based on direct observation and qualitative assessment by the individuals performing the tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The studies described are focused on the safety and basic functionality of the EuTrochar in a standalone context, not on its comparative effectiveness in improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance assessment was effectively done. The EuTrochar is a manual surgical instrument, not an algorithm. The "tests with prototype hardware using both plastic tissue and animal tissue" and the "bench trial" evaluate the device's standalone mechanical safety and functionality, without comparing its performance to human (surgeon) performance or evaluating human performance with and without the device. The device itself is the "standalone" element being tested.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Qualitative Observation/Expert Assessment: The "ground truth" for the tests appears to have been based on direct observation of the device's function, ease of use, and whether "failures were experienced" or if it "presented a hazard" by the "technicians" and "outside surgeons" involved in the trials.
- Functionality/Safety Outcomes: The primary outcomes were successful installation of drains, lack of failures, and absence of hazards.
8. The Sample Size for the Training Set
- Not applicable. The EuTrochar is a mechanical surgical instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "prototype hardware" and "series of EuTrochars and several Deployers" used in testing would represent the specific instances of the device being evaluated, not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is not an AI/ML device, so there is no training set or associated ground truth establishment for a training set.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.