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The StarFin device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperioneum for laparoscopic procedures prior to the placement of trocars. The StarFin device is also used for suture capture, externalization and internalization for wound closure after laparoscopic surgery.

The subject device is a single-use, sterile, laparoscopic needle that is used for percutaneous introduction of a hollow stylet into the abdomen for gas insufflation and establishment of pneumoperitoneum prior to abdominal endoscopy and for closure of trocar site wounds with suture threads.

The subject device is equipped with a stainless steel cannular consisting of a beveled needle point for cutting through tissues. Inside the cannula, there is a spring-loaded inner stylet with a rounded blunt tip used for puncture protection. The hollow stainless steel inner stylet provides passing carbon dioxide gas to create pneumoperitoneum. The inner stylet tip is designed for suture capture, passing, externalization, and internalization for wound closure after laparoscopic surgery.

The environment of use is professional healthcare.

The provided text describes the 510(k) premarket notification for the StarFin device, a laparoscopic insufflator and suture passer. However, it does not contain the specific information required to complete the table and answer all the questions regarding acceptance criteria and the study proving the device meets them.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through:

• Comparison of technological characteristics: This highlights similarities and differences in design, materials, and intended use.
• Non-clinical performance data: This includes biocompatibility, sterilization validation, and bench performance tests.

Crucially, it does not include:

• Quantitative acceptance criteria for device performance (e.g., minimum gas flow rate, maximum leak rate).
• Reported device performance against those specific criteria.
• Details about a clinical study, reader study, or other method to prove the device meets acceptance criteria in a real-world or simulated clinical setting with a defined ground truth and statistical analysis. The mention of "simulated use" with qualified surgeons is too brief to extract the requested details.
• Information on sample sizes for test sets, training sets, data provenance, expert qualifications, or adjudication methods for establishing ground truth as would be present in a comprehensive study report.
• Any details about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance, as the device is mechanical, not AI-based.

Therefore, many of the requested fields cannot be populated from the given text.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be fully provided. The document mentions "bench performance tests" including "appearance, size, gas flow rate, gas leak rate, puncture force, suture retention force, stylet pull strength." It states these tests "met stated performance expectations" and were "compared with the predicate devices," but it does not provide the specific quantitative acceptance criteria or the reported performance values for the StarFin device for these parameters.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document refers to "bench performance tests" and "simulated use," but does not specify sample sizes for these tests, nor their provenance.

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)

• Cannot be provided definitively. For the "simulated use," it states it was evaluated by "qualified and trained laparoscopic surgeons." The number of surgeons or their specific qualifications (e.g., years of experience) are not mentioned. There is no explicit "ground truth" establishment described beyond the surgeons' evaluation during simulated use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No adjudication method is mentioned for any of the described tests, including the "simulated use."

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 / Cannot be provided. The StarFin device is a mechanical medical device (laparoscopic insufflator and suture passer), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Cannot be provided. As a mechanical device, there is no "algorithm only" performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Limited information. For the "bench performance tests," the ground truth would be engineering specifications and predicate device performance. For the "simulated use," the implied ground truth is the assessment and opinion of "qualified and trained laparoscopic surgeons" during the simulation. No other formal types of ground truth (e.g., pathology, outcomes data) are mentioned.

8. The sample size for the training set

• Not applicable / Cannot be provided. The device is mechanical. There is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Not applicable / Cannot be provided. As there is no training set for a mechanical device, no ground truth establishment for it is relevant or described.

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