(14 days)
Instrumed Laparoscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic closed and minimally invasive procedures.
Instrumed Laparoscopes provide illumination and visualization in diagnostic procedures and in conjunction with laparoscopic instruments (accessories) operative laparoscopic procedures
This document describes a 510(k) premarket notification for Instrumed Laparoscopes and Accessories. The submission claims substantial equivalence to a predicate device, the Gimmi Laparoscope (K012660). Therefore, the study details you are asking for, which typically involve demonstrating performance against defined acceptance criteria, are not directly presented as they would be for a novel device requiring such proof.
Instead, the submission relies on demonstrating technical similarity and that the Instrumed instruments are "absolutely safe and effective for its intended use and do not raise any questions regarding safety and effectiveness" based on performance data conducted on the Instrumed instruments. However, the specific details or content of this "performance data" are not provided in this summary.
Given the nature of a 510(k) submission seeking substantial equivalence to a predicate device, a formal study demonstrating a device meets a specific set of acceptance criteria with detailed statistical analysis and power calculations, as you might expect for a new technology, is generally not required in the same way. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Therefore, many of the specific questions about sample size, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable or not explicitly provided in this summary document focused on substantial equivalence.
Here's an attempt to address your questions based on the provided text, indicating when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (Summary Statement) |
|---|---|
| Equivalence in Design and Technical Characteristics to Gimmi Laparoscope (K012660) | The Instrumed product is similar to the Gimmi product in terms of design and technical characteristics. The Laparoscope and the respective laparoscopic instruments are identical to the Gimmi products. |
| Equivalence in Materials Used to Gimmi Laparoscope (K012660) | The Instrumed product is also similar to the Gimmi products in terms of the used material. |
| Safety and Effectiveness for Intended Use | "The presented data that was conducted on the Instrumed instruments shows in its results that the Laparoscope and the laparoscopic instruments are absolutely safe and effective for its intended use and do not raise any questions regarding safety and effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "presented data that was conducted on the Instrumed instruments."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. A formal expert-driven ground truth establishment for a test set is not described as part of this substantial equivalence claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (laparoscopes and accessories), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. The "performance data" would likely have involved engineering tests, material testing, and potentially some form of clinical observation or simulated use, but the nature of the "ground truth" (e.g., benchmark values, successful function, lack of adverse events) is not detailed.
8. The sample size for the training set
- Not applicable/Not specified. This is not a machine learning or AI device that would typically have a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not specified as there is no "training set" described.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.