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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

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.

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Indications for use of the SD Trans-Osseous Fastening fractured bone fragments together while the fracture heals. This fastener is specifically useful in fastening split fractures, such as found in tibial buttress fractures.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "SD Trans-Osseous Fastener." This type of letter generally concerns regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as would be found in a clinical study report or a premarket approval (PMA) application.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Specifically:

1. A table of acceptance criteria and the reported device performance: Not present. The letter is a clearance for marketing, not a performance report.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
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: This device is a trans-osseous fastener, a mechanical implant, not an AI diagnostic or assistance tool. Therefore, an MRMC study with AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
8. The sample size for the training set: Not applicable for a physical medical device.
9. How the ground truth for the training set was established: Not applicable for a physical medical device.

The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for 510(k) clearance. This means that the device is deemed as safe and effective as a legally marketed device that existed prior to May 28, 1976 (or has been reclassified). The document is a regulatory approval, not a scientific study detailing performance metrics.

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