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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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The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.

The DANNIK Disposable Monopolar Laparoscopic Instruments are sterile single-use devices consisting of a handle, rotator knob and shaft. The handle activates the instrument jaws and scissor blades. The rotator knob provides 360 degrees of rotation for the instrument shaft and jaws. The shaft includes an external insulation that runs from the rotator knob to the instrument jaws and is provided in working diameters of 3 to 5 mm and lengths up to 33 cm. 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 text describes a 510(k) premarket notification for a medical device, specifically the DANNIK Disposable Monopolar Laparoscopic Instrument.

However, the content does not include any information about acceptance criteria or a study proving that the device meets those criteria, as typically seen for AI/ML-based medical devices or devices requiring extensive performance evaluations. The submission is a "Special 510(k) Summary" which indicates a modification to a previously cleared device (from 5mm to 3mm working diameter). This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data for acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and performance study from this document. The document explicitly states:

• "There were no clinical trials performed on these devices." (Page 5, Section 8. CLINICAL TESTS)
• "NONCLINICAL TESTS: Risk analysis was conducted to assess the impact of the change on the subject device using internal design control procedures. Assessments were completed for the risk associated with Electromagnetic Energy as related to the basic safety and essential performances as detailed in IEC 60601-1 and appropriate collateral and/or particular standards. Dimensional Analysis and verification of the shaft flexural strength was completed, which showed that the devices met the same requirements as the predicate device." (Page 4, Section 7. NONCLINICAL TESTS)

This indicates that the modifications were assessed through non-clinical testing (dimensional analysis, flexural strength, risk analysis related to electrosurgical safety) to demonstrate equivalence, and not through a study with acceptance criteria measuring specific performance metrics for diagnosis or treatment effectiveness in a clinical setting against a predefined ground truth.

To directly answer your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available or specified in the document. The filing focuses on demonstrating that the new 3mm diameter version meets the same physical/electrical safety requirements as the 5mm predicate.
2. Sample sized used for the test set and the data provenance: Not applicable in the context of a clinical study. The non-clinical tests involved dimensional analysis and verification of shaft flexural strength; samples would be drawn from manufacturing lots for these tests, but specific sample sizes are not detailed beyond "showed that the devices met the same requirements as the predicate device." No patient data or clinical data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established as no clinical trials or diagnostic performance studies were performed.
4. Adjudication method for the test set: Not applicable.
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 device is not an AI/ML diagnostic or assistive 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.
7. The type of ground truth used: Not applicable in a clinical sense. The "ground truth" for the non-clinical tests would be the established engineering specifications and safety standards (e.g., IEC 60601-1 for electrosurgical devices) that the predicate device also met.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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The DANNIK Specimen Retrieval System is in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery via extracorporeal manual morcellation.

The DANNIK Specimen Retrieval System is contraindicated for laparoscopic power morcellation during gynecologic procedures. The DANNIK Specimen Retrieval System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.

The DANNIK Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with and without a deployment mechanism. The bag 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 the bag with the use of the biasing arms.

The DANNIK Specimen Retrieval System is comprised of a flexible plastic bag with and without a deployment mechanism.

The bag is made from polyurethane and/or rip-stop nylon 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 bags come in sizes from 50 to 3000 mL.

The deployment mechanism consists of a push-pull rod and introducer assembly. The push-pull rod consists of a handle, shaft and biasing arms and is made from a combination of Stainless Steel, Nitinol, ABS, and PC. The introducer assembly consists of a tube and is made from ABS and/or PC. The deployment mechanism allows easy insertion through the cannula and full deployment the use of the metallic biasing arms. Introducers range from 5 to 15 mm in diameter.

This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.

Here's a breakdown of the acceptance criteria and study information for the DANNIK Specimen Retrieval System, based on the provided document:

This document describes a 510(k) premarket notification for a medical device. It's important to note that 510(k) clearances are for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials with defined acceptance criteria for disease detection/diagnosis. The "acceptance criteria" here therefore refer to the performance benchmarks against the predicate device in non-clinical settings.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "sample size" for a clinical test set in the traditional sense, as this was a non-clinical bench testing submission. The testing involved comparing the DANNIK Specimen Retrieval System to the predicate device, the Espiner Tissue Retrieval System (K111845), using various bench tests.

• Test Set: Non-clinical bench testing of the DANNIK Specimen Retrieval System.
• Data Provenance: The testing was conducted to demonstrate substantial equivalence to a legally marketed predicate device. The document does not specify the country of origin for the data, but it is for a US FDA submission, implying the tests were conducted under US regulatory guidelines or accepted international standards. The testing is retrospective in the sense that it compares features to an already marketed device, but the actual tests on the DANNIK device would be considered part of a prospective testing plan for the submission.

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

Not applicable. For a 510(k) submission based on non-clinical bench testing, expert consensus for ground truth as seen in diagnostic device studies is typically not required. The "truth" for these tests is defined by established engineering standards and performance specifications for medical devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical ground truth established by experts requiring an adjudication method. The assessment of performance against the predicate was based on objective-bench testing parameters.

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 device is a physical specimen retrieval system, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was performed.

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

Not applicable. This device is a physical specimen retrieval system and does not involve any algorithms or AI for standalone performance evaluation.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering specifications and performance characteristics of the DANNIK Specimen Retrieval System.
• Performance data from the predicate device (Espiner Tissue Retrieval System, K111845) which served as the benchmark for demonstrating substantial equivalence.
• International standards such as ISO 11135 (sterilization) and ISO 10993 (biocompatibility), and ISO 11607 (packaging).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve machine learning or AI, so there is no concept of a "training set" for an algorithm.

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

Not applicable, as there is no training set for an algorithm.

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The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.

The DANNIK Disposable Monopolar Laparoscopic Instrument consists of Handle which activates the instruments jaws and scissor blades, Rotator knob that provides 360 degrees rotation , both handle and rotation knob are made of ABS thermoplastic, and a Shaft made from Medical grade Stainless Steel and insulated with high-density polyethylene PE. 5mm in diameter with a working length of 33cm. RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with appropriate ground electrode.

This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.

The provided text describes the DANNIK Disposable Monopolar Laparoscopic Instrument, which is a medical device. The document does not describe a study that uses acceptance criteria in the context of an AI/ML powered medical device, but rather provides information related to the 510(k) premarket notification process for a physical medical instrument.

Therefore, many of the requested elements for an AI/ML powered device, such as sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or cannot be extracted from this document.

However, I can extract information about the non-clinical tests performed, which could be considered analogous to "acceptance criteria" in a broad sense for a physical device, and how the device meets them through testing.

Here's the information that can be extracted, framed as closely as possible to your request, with an explicit note where the information is not applicable to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This document pertains to the 510(k) clearance of a physical medical instrument, not an AI/ML powered device. The "tests" mentioned are non-clinical engineering evaluations, not studies with test sets in the AI/ML context.

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

Not applicable. The evaluations were performed by "Design Engineers." Specific numbers or detailed qualifications are not provided beyond this title. Ground truth in the AI/ML sense (e.g., expert consensus on image interpretation) is not relevant here.

4. Adjudication method for the test set

Not applicable. This concept (e.g., 2+1, 3+1) is for reconciling discrepancies in expert opinions for AI/ML ground truth, which is not relevant to the non-clinical engineering evaluations 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

Not applicable. This is not an AI/ML powered device, and no MRMC study was conducted or reported.

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

Not applicable. This is not an AI/ML powered device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is implied to be engineering specifications, performance standards (like ISO 10993, ISO 11135-1), and functionality requirements validated through direct testing by design engineers. There is no "ground truth" as typically defined for AI/ML models (e.g., pathology, expert consensus).

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

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The DANNIK Titanium Ligation Clips is designed for the intended use of ligating blood vessels .The Clip has been specially designed to insure occlusion of vessels and prevent any slippage once applied. The clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary.

Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The DANNIK Titanium Ligation, clip can be left in vivo without sequela as it is biologically inert.

The DANNIK Titanium Ligation Clips are exclusively made of titanium and supplied in four different sizes: small, medium-large, and large. Packaged in cartridge of six clip units.

The titanium used meets all requirements for A.S.T.M. specifications F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and ISO 5832-2-93 and 10993 "Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium".

This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.

The provided text describes a 510(k) premarket notification for a medical device: the DANNIK Titanium Ligation Clip. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through new clinical trials.

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/machine learning performance metrics (e.g., sensitivity, specificity, reader improvement with AI assistance). The "acceptance criteria" and "study" described in the prompt are typical for AI/ML device submissions, but not for a physical device like a ligation clip, where the focus is on material properties, mechanical performance (e.g., clamping force, corrosion resistance), and biocompatibility.

Based on the provided text, here's what can be extracted about the device and its testing:

1. A table of acceptance criteria and the reported device performance:
   The document does not present a formal table of explicit acceptance criteria with quantitative performance metrics for AI/ML. Instead, it states:

   Acceptance Criteria (Implied)	Reported Device Performance
   Appearance	"PASS"
   Dimension	"PASS"
   Surface Roughness	"PASS"
   Hardness	"PASS"
   Toughness	"PASS"
   Clamping (Retention) Performance	"PASS"
   Corrosion Resistance	"PASS"
   Other technical standard requirements of Dannik compared to predicate	"meets"

2. Sample sizes used for the test set and the data provenance:
   The document mentions "performance studies and bench testing" and "non-clinical tests." It does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These are typically physical tests on a sample of manufactured clips.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable in the context of AI/ML ground truth. The tests were evaluated by the "Design Engineer." Qualifications of the Design Engineer are not specified beyond their title.

4. Adjudication method for the test set:
   Not applicable in the context of AI/ML ground truth. The results were simply reported as "PASS."

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
   No, an MRMC study was not done. This type of study is relevant for AI/ML diagnostic devices, not for a titanium ligation clip.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
   The "ground truth" for the performance of the ligation clips appears to be based on physical measurements and material science standards (e.g., ASTM F-67 95, ISO 5832-2-93, ISO 10993) and comparison to the predicate device's known performance characteristics. For biocompatibility, it "Conforms to ISO 10993."

8. The sample size for the training set:
   Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable.

Summary of Device Performance and Equivalence:

The DANNIK Titanium Ligation Clip's safety and effectiveness were demonstrated through:

• Substantial Equivalence: Comparison to legally marketed predicate devices (Vitalitec International Inc Implantable Titanium Hemostatic Clip K981645 and Weck Metal Ligating Clips K132658) in terms of:
  • Intended Use: Ligation of blood vessels for hemostasis or radiographic marking.
  • Device Description: Titanium ligation clips.
  • Clip Material: Titanium meeting ASTM F-67 95 Grade I and ISO 5832-2-93 and 10993 standards.
  • Sterilization: Ethylene Oxide (ETO) conforming to ISO 11135-1.
  • Prescription Only Use: Yes.
  • Biocompatibility: Conforms to ISO 10993.
• Non-Clinical Bench Testing: Evaluation of physical and mechanical properties including appearance, dimension, surface roughness, hardness, toughness, clamping (retention) performance, and corrosion resistance. All tests resulted in "PASS."
• No new technologies: The document states that "There are no new technologies being added to this device from the predicate, in terms of finished device functions."
• No Clinical Trials: "No Clinical trials performed on the DANNIK Titanium Ligation Clips." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data.

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The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, and tissue debris from the surgical site

The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris from the surgical site.

The system consists of a hand piece equipped with two trumpet style valves, a probe and connecting lines of tubing, one set designated to attach to supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.

This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.

The provided document is a 510(k) summary for the DANNIK Laparoscopic Suction Irrigation System. It outlines the device's characteristics and its substantial equivalence to a predicate device. However, it does not contain acceptance criteria or study details in the format requested for AI/algorithm performance evaluation.

This document describes a medical device (a physical instrument), not an AI/software device. Therefore, many of the requested fields, such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable in this context.

Based on the document, here's what can be extracted and what cannot:

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

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not a software or AI product that uses test sets of data. The "test set" here refers to the device itself being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for a physical device is its manufacturing specifications and performance standards, established through engineering design and testing, not expert consensus on medical images or patient data. The document mentions evaluation by a "Design Engineer."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for establishing ground truth in medical imaging or clinical data for AI models.

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 a physical surgical tool and does not involve human readers or AI assistance in the context of diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" is defined by established engineering and manufacturing standards, and the performance of the predicate device. This is confirmed through bench testing rather than clinical outcomes or pathological analysis.

8. The sample size for the training set: Not applicable. There is no "training set" for a physical device in this context.

9. How the ground truth for the training set was established: Not applicable.

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