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The SPIDER® Flexible Blunt Dissector and Band Passer is indicated for use with the SPIDER® single port device (SPIDER® Surgical Platform) during laparoscopic surgery to dissect tissue layers, to pull tubing and to generally assist in the placement of gastric bands.

Device Description

The SPIDER® Flexible Blunt Dissector and Band Passer device is a surgical instrument used to facilitate laparoscopic surgery. It is intended for use with the SPIDER® Single Port Device or other laparoscopic access device that facilitates the use of rigid and/or flexible instrumentation. The SPIDER® Flexible Blunt Dissector and Band Passer instrument has a flexible shaft with an articulating distal tip is blunt to allow tissue dissection between tissue layers and the articulation is actuated via a proximal ratcheted handle. The blunt tip includes a shallow slot to grab sutures as applicable. It also includes a non-electrical retractable loop (grasping loop) for grasping and pulling tubing, sutures, or tissue. The instrument is provided sterile and is a single use, disposable device.

AI/ML Overview

Here's an analysis of the provided text regarding the SPIDER® Flexible Blunt Dissector and Band Passer device, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or a direct "reported device performance" against those criteria in a table format. However, it describes various tests performed and their conclusions, which can be interpreted as meeting implicit acceptance criteria for safety and effectiveness.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance:
- Articulation angle	Evaluated during bench studies.
- Strength	Evaluated during bench studies.
- Function of the blunt tip (tissue dissection)	Evaluated during bench studies and simulated use (chicken tissue), and in a cadaver model. Performed as intended.
- Function of the loop (grasping/pulling tubing, sutures, bands)	Evaluated during bench studies and simulated use (chicken tissue), and in a cadaver model. This technological feature was tested in simulated use bench studies and in a cadaver model to demonstrate that it fulfills its intended use with regard to grabbing and pulling bands. Performed as intended.
- Reliability/Durability (cycle testing)	Evaluated during bench studies. Remained functional following cycle testing.
- Compatibility with SPIDER® Single Port Device	Tested under simulated use conditions with the SPIDER® laparoscopic device. Performed as intended.
Sterility:
- Sterility Assurance Level (SAL)	Achieved 1x10⁻⁶ SAL (Gamma sterility testing performed for the Flexible Instruments Family, which includes this device).
- Maintenance of sterility during shelf life	Sterile barrier packaging tested for the Flexible Instruments family and found to maintain sterility during shelf life testing.
Biocompatibility:
- Non-toxic, non-irritating, non-sensitizing	Studies concluded the instruments are non-toxic, non-irritating, and non-sensitizing in accordance with ISO 10993-1.
Clinical Performance/Equivalence:
- Performance of blunt dissection in laparoscopic procedures	Pre-clinical testing in a cadaver model study demonstrated the device compares to standard laparoscopic instruments and predicate devices.
- Performance of band positioning in laparoscopic procedures	Pre-clinical testing in a cadaver model study demonstrated the device compares to standard laparoscopic instruments and predicate devices. This specifically refers to the mechanical loop's function which, despite being a technological difference, was proven to fulfill its intended use in simulated use bench studies and a cadaver model.
Overall Safety and Effectiveness:	Concluded to be as safe and effective as predicate devices, with the same intended use and similar performance, raising no new safety or effectiveness issues.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical sample size for the individual tests (e.g., number of devices for functional testing, number of cadavers). It refers generally to "bench studies," "simulated use conditions," and "a cadaver model study."
Data Provenance:
- Bench Studies: Laboratory setting.
- Simulated Use: Likely laboratory or controlled environment using "tissue samples (chicken tissue)."
- Pre-clinical Study: "Cadaver model study."
- The origin of the data (country) is not explicitly stated, but the submission is to the US FDA by a company based in Durham, NC, so it's likely US-based or compliant with US standards.
- All data appears to be prospective for the purpose of demonstrating the device's performance for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number or qualifications of experts involved in establishing ground truth for the test sets. For the "cadaver model study," it implies clinical relevance by stating the device "compares to that of standard laparoscopic instruments and predicate devices," likely requiring evaluation by individuals with surgical or anatomical expertise, but this is not explicitly stated.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test sets. The results appear to be direct observations and measurements from the various studies.

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

There is no mention of an MRMC comparative effectiveness study or any AI component in this device. This device is a surgical instrument (blunt dissector and band passer), not an AI-assisted diagnostic or operative imaging system.

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

Not applicable. As mentioned above, this device is a physical surgical instrument, not an algorithm or software. Therefore, no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Direct observation and measurement: For functional aspects like articulation angle, strength, and cycle testing.
Biological/Physiological Standards: For biocompatibility (ISO 10993-1) and sterility (1x10⁻⁶ SAL).
Performance against "intended use" in simulated and anatomical models: The ability to "dissect tissue layers, to pull tubing and to generally assist in the placement of gastric bands" using chicken tissue and cadavers.
Comparison to predicate devices: Performance was assessed relative to established and legally marketed laparoscopic instruments.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is a physical medical device.

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