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MultAport Cannulas: The MultAport reusable cannula is used with an AccuPort Seal or Orbital Reducer Seal and Trocar Spike for creating a point of entry for laparoscopic instruments into the abdominal cavity.

AccuPort 5-12mm Seal: The AccuPort Seal is a single-use device used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments with diameters ranging from 5mm to 12mm.

Orbital Reducer Seal: The Orbital Reducer is a single used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments of equal and smaller size.

The "candidate device" is a reusable, stainless steel Cannula and disposable, single-use reduction seal system that threads into the Cannula. The reducer system is composed of silicon rubber, thermoplastic rubber, and plastics. Accessories: Cannulas & Reduction Systems

The provided text is a 510(k) summary for a medical device (Cannula, Reducer and Accessories) and does not contain the information requested to describe acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document focuses on:

• Identifying the submitter, contact person, and date prepared.
• Naming the device and its common name.
• Listing predicate devices.
• Describing the device and its accessories.
• Stating its intended use.
• Claiming substantial equivalence to predicate devices based on comparable technological characteristics (materials and mode of action).
• Mentioning conformance to voluntary standards but noting no mandatory existing performance standards.
• Presenting the FDA's clearance letter for marketing the device.
• Detailing the Indications For Use for the MultAport Cannulas, AccuPort Seal, and Orbital Reducer Seal.

There is no mention of:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is typical for predicate device submissions from this era (1998), which often relied on comparative analysis to existing devices rather than extensive clinical studies with specified performance metrics in the 510(k) summary itself. The clearance is based on "substantial equivalence" to legally marketed predicate devices, implying that if the predicate devices were safe and effective, and the new device is sufficiently similar, it also meets those standards.

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