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The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices are indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery.

The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with a deployment mechanism. The bag is supplied pre-loaded in the introducer assembly and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment of the bag with the use of the biasing arms.

The provided FDA 510(k) clearance letter for the DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (K250411) does not contain information related to software, artificial intelligence (AI), diagnostic performance, or studies involving human readers or ground truth for diagnostic accuracy.

The document describes a medical device, a specimen retrieval system, and its non-clinical testing to demonstrate substantial equivalence to a predicate device. The information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment is not applicable to a submission for a physical surgical device like this.

Therefore, I cannot populate the requested table or answer the specific questions related to AI-driven diagnostic studies based on the provided text.

Here's a summary of what is available regarding acceptance criteria and studies, framed according to the nature of this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" and "device performance" are primarily related to its physical characteristics, functionality, and safety as compared to a predicate device, rather than diagnostic accuracy.

Given that this is a 510(k) for a physical medical device (a specimen retrieval system) and not an AI/software-as-medical-device, the following points are not applicable as they pertain to AI/diagnostic studies:

2. Sample sizes for test set and data provenance: Not applicable. No test set of diagnostic data was used.
3. Number of experts used to establish ground truth & qualifications: Not applicable. No ground truth for diagnostic accuracy was established.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. No human readers were evaluated for improvement with AI assistance.
6. Standalone (algorithm only) performance: Not applicable. There is no algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. There is no training set for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable.

The "studies" conducted for this device were non-clinical performance and biocompatibility tests to demonstrate the device's physical and material safety and functionality, and its substantial equivalence to a legally marketed predicate device.

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The Disposable Monopolar Laparoscopic Tips and Reusable Handles are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.

The Disposable Monopolar Laparoscopic Tips and Reusable Handles are sterile packaged single use monopolar attachments intended for use in combination with the Reusable Handle. It is designed to include graspers, dissectors, forceps, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue.

The Disposable Monopolar Laparoscopic Tips are offered in a working diameter of 5 mm with various jaw patterns including scissors, graspers, forceps and dissectors.

The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. The shaft of the handle is 34 cm in length and is made from stainless steel covered with an external insulation. Handles are offered in ratcheting configurations and are intended to be connected to the sterile disposable tips. Once connected the rotation knob provides 360 degrees of rotation for the instrument shaft and jaws. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.

The provided document is a 510(k) premarket notification for a medical device (Disposable Monopolar Laparoscopic Tips and Reusable Handles). It describes the device, its intended use, and substantial equivalence to a predicate device.

However, the document does not contain information about:

• Acceptance criteria for a study, beyond the general statement that nonclinical testing "met all design specifications and are substantially equivalent to the predicate device."
• A study proving the device meets acceptance criteria in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). The "study" mentioned here is nonclinical testing to ensure electrical performance and thermal spread are comparable to the predicate device, not a diagnostic accuracy study.
• Sample sizes for test sets (in the context of algorithm evaluation).
• Data provenance, number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, type of ground truth, training set sample size, or how training ground truth was established. These questions are highly relevant to the evaluation of AI/ML-based medical devices, which this product is not.

The document describes a traditional medical device (electrosurgical instruments) and demonstrates substantial equivalence through nonclinical testing, primarily focused on electrical safety, biocompatibility, sterilization, and basic performance parameters like thermal spread in tissue. It explicitly states, "There were no clinical trials performed on these devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance for an AI/ML device, nor can I answer the specific questions related to the study design for such a device, as this information is not present in the provided text.

The information that is provided regarding "tests" can be summarized as:

Nonclinical Tests Performed:

• Biocompatibility Testing: Conforms to ISO 10993 standards (Parts 1, 5, 7, 10, 11).
• Medical Electrical Equipment Safety Testing: Conforms to IEC 60601 series standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18).
• Aging Study
• Autoclave Sterilization Validation
• Ethylene Oxide Sterilization: Per ISO 11135:2014.
• Performance Studies: Designed to test appearance, dimensions, corrosion resistance, operational forces, cutting efficacy, and thermal effects on tissue.
• Electrical Performance: Followed FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," requiring testing on three different tissue types (e.g., Kidney, Muscle as shown in tables) at minimum, default, and maximum generator power to simulate thermal spread.

Table 1 & 3: Thermal Damage Results (Example provided for Kidney and Muscle Tissue)

Summary and Limitations based on the provided text:

1. Acceptance Criteria and Reported Device Performance: General statement that "Results showed an equivalent thermal spread under the same conditions across the different tissue types and power settings" compared to the predicate. The thermal damage tables provide measured performance for the subject device. Specific numerical acceptance criteria (e.g., "thermal spread must be

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The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.

The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are sterile packaged single use monopolar attachments intended for use in combination with the Reusable Handle. It is designed to include graspers, dissectors, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue.

The Disposable Monopolar Laparoscopic Shafts are offered in working diameters of 3 to 5 mm and lengths between 20 to 45 cm. The shaft is made from aluminum covered with a fluorinated ethylene polypropylene external insulation. The shaft is attached to the handle using the locking knob and a stainless-steel drive rod which connects to the jaws and interacts with the handle activation rod.

The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. Handles are offered in ratcheting and non-ratcheting configurations and are intended to be connected to the sterile disposable shaft. Once connected the rotation knob provides 360 degrees of rotation for the instrument shaft and jaws. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.

This is a 510(k) premarket notification for a medical device (Disposable Monopolar Laparoscopic Shafts and Reusable Handles), which focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical effectiveness through novel acceptance criteria and studies. Therefore, many of the requested categories are not directly applicable or explicitly detailed in the provided document in the way they would be for a de novo device or a device requiring clinical trials.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are generally based on demonstrating equivalence to the predicate device's performance in specific non-clinical tests. The document doesn't present a formal table of acceptance criteria with specific numerical targets. Instead, it describes comparative testing against the predicate.

• Equivalent cut performance (no slipping, overall cut length, scissor opening) across different mediums compared to the predicate device. | "Testing showed the Disposable Monopolar Laparoscopic Shafts and Reusable Handles devices performed equivalent to the predicate product." |
  | Electrical Performance:
• Equivalent thermal spread across different tissue types and power settings (minimum, default, maximum generator power) compared to the predicate device. | "Results showed an equivalent thermal spread under the same conditions across the different tissue types and power settings." (Testing followed FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued August 15, 2016, requiring testing on three different tissue types at minimum, default, and maximum generator power). |
  | Safety and Biocompatibility:
• Conformance to relevant ISO standards (e.g., ISO 10993 for biocompatibility, ES60601-1, IEC 60601-2-2, IEC 60601-2-18 for electrical safety). | "Conforms to ISO 10993"
  "[Testing was] performed in accordance with... ANSI AAMI ES60601-1:2005/(R)2012... IEC 60601-2-2:2017... IEC 60601-2-18:2009." (Specific quantitative results for these are not provided, but conformance implies meeting the standards' requirements). |
  | Sterilization:
• Validation of Ethylene Oxide sterilization to SAL of 10^-6. | "Sterilized using Ethylene Oxide for single patient use in accordance with ISO 11135 to an SAL of 10^-6."
  "Ethylene Oxide Sterilization Validation per ISO 11135:2014..." |
  | Aging Study:
• Performance maintained after accelerated aging. | An "Aging Study" was performed, implying successful completion, though specific results are not detailed. |
  | Autoclave Sterilization Validation (for Reusable Handle):
• Validation of autoclave sterilization process. | An "Autoclave Sterilization Validation" was performed, implying successful completion, though specific results are not detailed. |

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not explicitly state the sample sizes used for the non-clinical tests (e.g., number of devices tested for cut performance, number of thermal spread measurements). This information is typically found in detailed test reports, not usually in the 510(k) summary itself.
• Data Provenance: The data provenance is from non-clinical bench testing. The country of origin of the data is not specified, but it would typically be from a testing laboratory (either in-house or third-party) adhering to international standards. The data is prospective in the sense that the tests were conducted specifically for this 510(k) submission to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable here. "Ground truth" established by experts is relevant for studies involving diagnosis, image interpretation, or clinical outcomes. The studies for this device are non-clinical bench tests comparing physical and electrical properties to a predicate device. The "ground truth" is established by the direct physical measurements and compliance with engineering and safety standards.

4. Adjudication method for the test set

Not applicable, as this is related to expert review or clinical trial data, which is not part of this 510(k) submission for non-clinical testing.

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. MRMC studies are typically used for diagnostic imaging devices involving human interpretation of data, often with AI assistance. This device is a surgical instrument, and no such study was conducted or required. The document explicitly states: "There were no clinical trials performed on these devices."

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

This question is geared towards AI-enabled devices. The device described (Monopolar Laparoscopic Shafts and Reusable Handles) is a physical surgical instrument and does not incorporate an algorithm or AI. Therefore, this is not applicable.

7. The type of ground truth used

As mentioned in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly applicable to this type of non-clinical device testing. For the non-clinical tests performed:

• Mechanical and Electrical Performance: The "ground truth" is based on direct physical measurements (e.g., cut length, thermal spread measurement under magnification) conducted in a controlled laboratory environment against the performance of a legally marketed predicate device.
• Safety and Biocompatibility: The "ground truth" is defined by compliance with recognized international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety).

8. The sample size for the training set

Not applicable. This device is a physical surgical instrument and does not involve machine learning or a "training set" in the computational sense.

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

Not applicable, for the same reason as point 8.

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