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The Marionette™ SA is intended for use by surgeons for grasping, dissection, and tissue cutting during laparoscopic surgical procedures.

The Marionette™ SA is a manually operated, articulating mechanical surgical device. It is primarily composed of stainless steel, anodized aluminum and Delrin. The instrument provides for the one handed control (left or right hand) of the positioning/repositioning of an instrument that includes the ability to change disposable/reusable tips for grasping, dissection, and tissue cutting during laparoscopic surgical procedures. The device is sold non-sterile to the hospital institution to be cleaned and sterilized on site prior to each use. Some accessories that support the device are sold sterile and are single use components.

The provided 510(k) summary for the Marionette™ SA (K072811) does not contain details about acceptance criteria, device performance, or human subject studies with ground truth data.

This document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device. For devices like the Marionette™ SA, which are manual surgical instruments (graspers, scissors, dissectors), the regulatory submission often relies on a comparison of design, materials, manufacturing processes, and intended use to existing legally marketed devices. Performance testing typically involves bench testing, biocompatibility, and sterilization validation, rather than clinical efficacy studies with specific acceptance criteria that would generate the kind of data requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based solely on the provided text.

Here's what I can extract from the provided document:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. It's highly probable that any performance testing conducted would have been bench testing or internal validation, rather than clinical studies with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as no human subject study with ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as no human subject study with ground truth establishment is described.

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 MRMC study was mentioned. This device is a manual surgical instrument, not an AI-assisted diagnostic or interpretive device.

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

• Not applicable. This device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable as no human subject study with ground truth establishment is described.

8. The sample size for the training set

• Not applicable as no machine learning or AI component is described.

9. How the ground truth for the training set was established

• Not applicable as no machine learning or AI component is described.

Summary of what the document does provide:

• Intended Use: The Marionette™ SA is intended for use by surgeons for grasping, dissection, and tissue cutting during laparoscopic surgical procedures.
• Device Description: A manually operated, articulating mechanical surgical device primarily composed of stainless steel, anodized aluminum, and Delrin. It provides one-handed control and the ability to change disposable/reusable tips.
• Substantial Equivalence: The device claims substantial equivalence in application and function to the Endolink True Movement System (K043541), Cambridge Laparo-Angle (K061425), and Microline Re-New laparoscopic instrument (K962119). This is the primary basis for its clearance, implying that its performance characteristics are considered comparable to these predicate devices based on design and intended use, not necessarily through clinical trials directly comparing performance metrics.

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The Statarius™ is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 5-12mm during diagnostic and therapeutic surgical procedures.

The Statarius™ is a manually operated, mechanical surgical device. It is primarily composed of stainless steel and anodized aluminum. The instrument provides for the one handed control for the positioning/repositioning of an endoscope during surgical procedures. The Statarius™ eliminates the need for the surgeon or assistant to continuously hold an endoscope during surgical procedures.

The provided document is a 510(k) summary for the Statarius™ Endoscope Holder, which is a manually operated, mechanical surgical device. It is primarily composed of stainless steel and anodized aluminum and is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 5-12mm during diagnostic and therapeutic surgical procedures.

The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Armand Endoscope Holder, K5050051).

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device