Search Results

The A-Lap™ set has application for use in the creation and maintenance of an operative cavity such as the gynecologic, general, urologic and thoracic procedures. The set may be used in procedures to create and maintain a port of entry and for temporary retracting of tissue.

The A-Lap™ retractor has application for use in the creation and maintenance of an operative cavity such as the gynecologic. general, urologic and thoracic procedures. The device may be used in procedures requiring temporary retracting of tissue.

The EZaxess is intended for use in creating and for maintaining a port of entry in gynecologic, general, urologic and thoracic procedures.

The A Lap™ set is laparoscopic surgical device compose of two components:

A-Lap™ Retractor - a surgical retraction instrument used to move, retain or hold back internal organs in the operative region during laparoscopic surgery. The device purposes is to widen the access area to the treatment site (the surgical field), to grasp and retract the surrounding tissues, to maintain the resultant size of the access area and to secure the retracted tissue or organs by holding it away from the surgical site. The retraction is achieved by a 12 cm X 12 cm polyester mesh connected to stainless steel wires.

EZaxess - a laparoscopic port included a 170 mm long and 10mm in diameter bladeless trocar and flexible cannula (10cm long and 10mm in diameter). The device is used to create and maintain a port of entry during laparoscopic surgery. The A Lap™ set is intended to be use for various laparoscopic surgical procedures, such as gynecologic, general, urologic and thoracic procedures. It is fully disposable and is intended for single use only.

Here's an analysis of the provided text regarding the A-Lap™ Set, A-Lap™ Retractor, and EZaxess devices, focusing on acceptance criteria and the study that proves the devices meet them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance metrics. Instead, it refers to general compliance with standards and equivalence to predicate devices. The "performance" is primarily assessed through design analysis, in vitro, and in vivo data to confirm safety and effectiveness, and substantial equivalence.

Based on the text, the implicit acceptance criteria and reported performance relate to:

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

The 510(k) summary does not specify the sample sizes used for the in vitro or in vivo tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The term "in vivo data" suggests that some studies were conducted on living subjects, but details are absent.

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

This information is not provided in the document. The filing does not describe a process involving experts establishing ground truth for performance metrics, as it is a device intended for surgical retraction/access and not an diagnostic AI device.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable in the context of this type of device submission. Adjudication methods are typically relevant for diagnostic studies where expert consensus is needed to establish a definitive diagnosis.

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

No, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument (retractor and trocar), not an AI-assisted diagnostic tool or a device that impacts "human reader" performance.

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

No, a standalone algorithm performance study was not performed. This is a physical surgical device, not an algorithm or AI.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic AI devices (e.g., pathology, outcomes data) is not directly applicable here. For this surgical device, the "ground truth" for proving safety and effectiveness would be established through a combination of:

• Compliance with Biocompatibility Standards: ISO 10993-1.
• Engineering Design Analysis: Demonstrating the device's adherence to design specifications and mechanical integrity.
• In vitro testing: Likely bench testing for flexibility, mechanical strength, and mesh compliance to ensure the device performs as intended in a simulated environment.
• In vivo data: This would typically involve animal studies or potentially human clinical data (though not explicitly detailed here) to demonstrate safe and effective organ retraction and port creation without adverse events.
• Substantial Equivalence: Comparison to the known safe and effective performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/algorithm-based device that requires a training set.

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

This information is not applicable as this is not an AI/algorithm-based device and does not have a training set or associated ground truth in that context.

Ask a specific question about this device