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The MINI LAP Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to manipulate other soft internal tissues.

The MINI LAP Instruments are a family of minimally invasive devices. The devices penetrate soft tissue to access certain areas of the human anatomy. The devices are used to manipulate other soft internal tissues. Prior to insertion, the physician must depress the safety button and retract the instrument into the needle. The needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the jaws of the instrument will open. The device includes a self-activating safety that prohibits the jaws from returning to their fully retracted position while in use, which acts as a blunt shield for the sharp needle tip. The device is provided in the following configurations: 250mm Length with Retractor Fan Clamp Type and 250mm Length with Retractor Rake Clamp Type. The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.

The provided text describes a 510(k) submission for the MINI LAP Retractors, a family of minimally invasive surgical devices. The submission focuses on demonstrating substantial equivalence to a predicate device (Mini Lap Instruments - K070686), rather than presenting a de novo study with explicit acceptance criteria and performance data for a new, unproven device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device meeting those criteria.

Specifically:

1. Table of acceptance criteria and reported device performance: Not present. The submission emphasizes substantial equivalence, not specific performance metrics against predefined acceptance criteria for a novel device.
2. Sample size for the test set and data provenance: Not present. No clinical study data is reported for a test set.
3. Number of experts and qualifications for ground truth: Not present. No ground truth establishment is described as no study data is presented.
4. Adjudication method for the test set: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not present. No human-in-the-loop study is described.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI/software device.
7. Type of ground truth used: Not applicable as no study data is presented.
8. Sample size for the training set: Not applicable as no training set for an algorithm is mentioned.
9. How ground truth for the training set was established: Not applicable.

The "Performance Data" section states: "We believe the addition of these two jaw configurations are a minor expansion to a product family that already has 510(k) clearance. The subject device is composed of biocompatible materials and the sterilization process has been validated." This indicates that the performance justification relies on bench testing (biocompatibility, sterilization validation) and the argument of substantial equivalence to an already cleared device, rather than a new clinical or comparative effectiveness study with specific performance outcomes.

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