(158 days)
The Intended Use and the Indications for Use are identical for our SHIELDED Trocar and the other, older Trocar versions.
Our SHIELDED Trocar adds one feature to the old commonly known Trocar: It does not expose any sharp edges, except when it is pushed through the abdominal wall to gain surgical access. Then, inside of the body cavity, it automatically and immedeately re-entors it's SHIELDING MODE by covering the cutting edge with a springloaded, blunt Obturator.
While assembled this new Trocar never allows accidental cutting of a patient or operating room personel. Disassembly of this instrument is only required for cleaning and sterilization.
Our SHIELDED Trocar represents a combination between common old Trocars and the SHECRNA function of Veress needles: A springloaded blunt Obturator devic· always covers the sharp cutting edge.
The provided text describes a medical device, the "SHIELDED Trocar with springloaded Obturator" (K960347), and makes claims about its safety and effectiveness. However, it does not contain the information requested regarding acceptance criteria and a detailed study proving the device meets those criteria, as typically found in comprehensive medical device submissions.
Here's a breakdown of why the requested information cannot be extracted from the given text:
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A table of acceptance criteria and the reported device performance: The text states the device was "in detail compared to other, older 'Trocars" and that "the performance and effectiveness of our SHELDED Trocar is identical to older Trocar models." It also mentions it "provides safety for patients and operating room personnel." However, no specific, quantifiable acceptance criteria (e.g., success rates, force measurements, tissue damage metrics) are defined, nor are specific performance metrics reported in a tabular format. The claims are qualitative and comparative rather than quantitative against defined thresholds.
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Sample size used for the test set and the data provenance: The text mentions "Comparative Bench testing with animal tissue." It does not specify the number of animals used, the number of tests performed, or the type/species of animal. Data provenance (country of origin, retrospective/prospective) is not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is entirely absent. There is no mention of experts establishing a ground truth for any testing.
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Adjudication method for the test set: Not mentioned.
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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. The device is a physical surgical instrument, not an AI or diagnostic imaging device that would involve human "readers" or an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used: For the "Comparative Bench testing with animal tissue," the "ground truth" would likely be direct observation of the device's function, tissue penetration, and absence of accidental exposure. However, the text does not explicitly define what "ground truth" was used or how it was established.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes the features and intended use of a shielded trocar and states that bench testing on animal tissue showed identical performance to older models. However, it lacks the detailed quantitative data, explicit acceptance criteria, specific study design parameters (like sample sizes, expert involvement, and ground truth methodologies), and statistical analyses typically associated with a robust study proving device performance against defined criteria.
The "Performance Testing" section is very brief, stating only: "Comparative Bench testing with animal tissue enabled us to conclude that the performance and effectiveness of our SHELDED Trocar is identical to older Trocar models." This is a conclusion, not a detailed description of the study itself.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.