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MultAchoice Scissor Instrument: The MultAchoice Scissor may be used in a variety of endoscopic procedures. This device is designed for cutting or transecting tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Scissor has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.

MultAchoice Grasper Instrument: The MultAchoice Grasper may be used in a variety of endoscopic procedures. This device is designed for grasping and manipulating tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Grasper has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.

MultAchoice Dissector Instrument: The MultAchoice Dissector may be used in a variety of endoscopic procedures. This device is designed for blunt dissection, temporary grasping, and manipulation of tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Dissector has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.

The MultAchoice™ Instruments are a set of reusable and configurable instruments consisting of a Handle, Insulated Shaft, and Instrument Insert that comprise a Laparoscopic Scissor, Grasper, and Dissector.

The provided text does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

The document is a 510(k) summary for the MultAchoice™ Instruments, which are laparoscopic scissors, graspers, and dissectors. It describes the device, its intended use, and its substantial equivalence to a predicate device. The key difference highlighted is the additional capability of the MultAchoice™ Instruments being reusable, as opposed to the predicate device which was likely single-use.

The FDA's response letter confirms the substantial equivalence determination.

Therefore, none of the requested information regarding acceptance criteria, study design, or performance metrics can be extracted from this text. This particular submission appears to be focused on demonstrating equivalence based on design and intended use, rather than a clinical performance study with specific metrics.

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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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The “candidate device” is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures.
The "candidate device" is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.
The MultApump™ System is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures.

The “candidate device” consists of a Disposable Pump Head, pump motor, clamp & bracket, power supply and power cord(s) for use in laparoscopy. The Disposable Pump Head is a sterile, single-use device, composed of Stainless Steel, glass filled Polypropylene, Medical Grade EPDM, ABS plastic, plastic and flexible PVC tubing. It has an interface dock for attachments of the reusable pump motor. The pump motor, clamp, power supply and power cord are reusable components.

This 510(k) summary does not contain the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria, as typically expected for AI/ML-enabled devices.

The document discusses a traditional medical device (an irrigation pump) and focuses on substantial equivalence to a predicate device based on its intended use and technological characteristics rather than performance metrics from a specific study.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies, as this information is not present in the provided text.

Based on the provided text, here's what can be inferred (and what cannot):

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that the "candidate device has the same technological characteristics as a legally marketed predicate device." It claims comparability based on features, specifications, materials, and mode of action. However, it does not define specific performance metrics or acceptance criteria (e.g., flow rate accuracy, pressure limits, sterile barrier integrity) that would typically be evaluated in a study for this type of device. There are no performance results reported.

2. Sample size used for the test set and the data provenance:

• Sample size: Not applicable/Not specified. This document describes a traditional device notification, not a study involving a test set of data.
• Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not an AI/ML device, and no ground truth establishment by experts for a test set is mentioned.

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

• Not applicable. No test set or adjudication method is described.

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. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• Not applicable. No ground truth is mentioned in the context of a performance study.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device.

Summary of available information from the text provided:

The provided text is a 510(k) summary for a traditional medical device, the MultApump™ System, an irrigation pump used in laparoscopic surgical procedures. The submission focuses on demonstrating substantial equivalence to a predicate device (Davol (Bard) - K961492) based on its intended use and technological characteristics.

The document states:

• The candidate device provides "controlled powered irrigation during laparoscopic surgical procedures."
• It is explicitly stated that "The candidate device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of action are equivalent."

The notification includes an "MANUFACTURER'S STATEMENT OF SUBSTANTIAL EQUIVALENCE" which reiterates the intended use and states that "The candidate device has the same technological characteristics as a legally marketed predicate device."

Crucially, the document does not describe any specific performance study with acceptance criteria, test sets, or data analysis typically associated with evaluating the performance of AI/ML-enabled devices. The clearance (K981940) was granted based on the determination of substantial equivalence to an existing device rather than a detailed performance study with quantifiable metrics.

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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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