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The SPIDER® Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.

The SPIDER® Flexible Monopolar Instruments are surgical instruments used to facilitate laparoscopic surgery. The instruments are a part of the SPIDER® Flexible Surgical Instruments family. They are intended for use with the SPIDER® Single Port Device. The instruments may be used with or without electrocautery. The flexible electrocautery instruments are pre-sterilized, single use, disposable devices. The devices have a ring handle with ratchets where applicable, a rotation knob for rotating the shaft and distal tips, an electrocautery post for cable connection to an electrosurgical generator, a flexible shaft, and distal tips to manipulate tissue. The instruments may be used without connecting to a power source. However, when connected by a standard cable to an electrosurgical generator, the instruments may be used for cutting and coagulation of tissue. The instrument set includes: Flexible graspers for grasping tissue, Flexible shears for cutting tissue, Flexible dissectors for dissecting tissue.

The provided document describes the K122299 510(k) Summary for the SPIDER® Flexible Monopolar Surgical Instruments. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding AI-specific studies and detailed performance metrics is not directly applicable or available in this document.

However, I can extract the relevant information from the document regarding the device's testing and acceptance.

Device: SPIDER® Flexible Monopolar Surgical Instruments (Flex Monopolar Graspers, Wavy Ratcheted; Flex Monopolar Graspers, Serrated Ratcheted; Flex Monopolar Maryland Dissectors; Flex Monopolar Shears)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size:
  • Functional Testing: Not specified.
  • Sterility: Not specified (refers to a "dose audit study" an ISO standard, but specific counts not given).
  • Sterile Barrier/Shelf Life: Not specified.
  • Biocompatibility: Not specified.
  • Electrical Safety: Not specified.
  • Preclinical Swine Study: Not specified.
• Data Provenance:
  • Preclinical Swine Study: Conducted internally ("tested... in a preclinical swine study"). This would typically be considered prospective and controlled.
  • Other tests (Functional, Sterility, Biocompatibility, Electrical Safety, etc.): Performed in-house or by accredited labs as part of the device development and verification process. No geographical origin or retrospective/prospective nature is specified, but these are generally considered prospective verification tests.

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

• This document describes a medical device (surgical instruments), not an AI/algorithm-based diagnostic or imaging device where "ground truth" is established by human experts for test sets.
• The preclinical swine study involved evaluation of performance, likely by veterinarians, surgeons, or device engineers, but the specific number or qualifications are not mentioned. Their role was to observe and confirm device performance, not to establish ground truth for a diagnostic outcome.

4. Adjudication Method for the Test Set:

• Not applicable as this is a physical surgical instrument and not a diagnostic or AI system requiring adjudication of results or classifications against a ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done as this is not an AI/imaging device. The study performed was a preclinical animal study to evaluate instrument performance.
• The document implies a comparison to predicate devices, stating "When compared to the predicate devices, the SPIDER® Flexible Monopolar Instruments do not incorporate any significant technological differences that affect safety and efficacy," justifying why clinical data was not deemed necessary. This is a functional and design comparison, not an impact on human reader performance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Not applicable, as this is a physical surgical instrument. The device is always used with a human surgeon.

7. Type of Ground Truth Used:

• For this type of device, "ground truth" refers to the confirmed physical, mechanical, and biological properties and performance characteristics of the instrument. This was established through:
  • Direct Measurement/Verification: Functional tests, dimensional checks, electrical tests (HIPOT, dielectric), biocompatibility assays.
  • Standardized Protocols: Adherence to ISO standards for sterility, packaging, and biocompatibility.
  • Preclinical Observation: Direct observation and assessment of performance in a live animal model (swine study) by qualified personnel (likely veterinarians/surgeons).

8. Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no "training set" in the context of this device. The development process would involve iterative design, prototyping, and testing against design specifications, but not data-driven training in the AI sense.

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