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The Cannulas and accessories are to be used with a Dexide seal package and spike for creating a point of entry for laparoscopic instruments into the abdominal cavity and maintaining pneumoperitoneum.

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-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.

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

Sealing Cone:
The Sealing Cone is a reusable product designed for use during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum.

Shaft Seal (replacement part for Sealing Cone):
The Sealing Cone is a reusable product designed for used during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum. The shaft seal is designed for use when sealing the cone to the cannula.

The "candidate device" is a reusable, stainless steel Cannula anc disposable, single-use reduction seal system that threads into the Cannula. The reducer system is composed of silicon rubber, thermoplastic rubber, and plastics. The reusable Sealing Cone and its Seal accommodate the cannula to assist the surgical procedure.

This document is a 510(k) summary for the MultAport™ Cannula, Reducer and Accessories. It focuses on the substantial equivalence of this device to a previously cleared predicate device (K981941) rather than presenting a de novo study with detailed acceptance criteria and performance data in the typical sense for an AI/ML medical device.

Therefore, the requested information points (1-9) regarding acceptance criteria and a study proving performance as one might expect for a novel AI/ML diagnostic or prognostic device are not present in this document.

This 510(k) submission establishes equivalence based on:

• Identical Intended Use and Operating Principle: Both the candidate and predicate device are used for creating an entry point for laparoscopic instruments and maintaining pneumoperitoneum.
• Similar Basic Design Principles and Materials: The devices share fundamental design and material compositions.
• Same Shelf Life, Similar Packaging, and Identical Sterilization Instructions: These aspects are also comparable.

Because this is a 510(k) for a physical medical device (cannula, reducer, accessories) claiming substantial equivalence to an existing device, it does not involve AI/ML components, clinical studies for diagnostic accuracy, or performance metrics like sensitivity, specificity, AUC, or the need for ground truth establishment.

In summary, none of the requested information points (1-9) can be extracted from the provided text because the document is a 510(k) for a conventional medical device seeking clearance through substantial equivalence, not a performance study of a novel device (especially not an AI/ML device).

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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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