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The device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. Closure of Gl tract lumenal perforations less than 20mm that can be treated conservatively.

The Single Use Hemoclip is a sterile, single use device that consists of metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis and endoscopic marking in the gastrointestinal tract. The device is provided sterile (EO). The large clip opening design meets various clinical treatment demands. It can be opened and closed repeatedly and can achieve repositioning. The 360 rotatable design is convenient for clinical use. lt consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

The provided document is a 510(k) summary for a medical device (Single Use Hemoclips) and does not describe a study involving acceptance criteria and device performance in the context of AI or software. Instead, it details the substantial equivalence of the subject device to a predicate device through non-clinical bench testing.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to device performance, sample sizes, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training set details, or how ground truth was established for a study because this information is not present in the given text.

The document focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA.

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The Disposable Hemoclip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

1. Endoscopic marking
2. Hemostasis for:
   • Mucosal/sub-mucosal defects

The Disposable Hemoclip is the key and common accessory in the diagnosis and treatment procedure of digestive endoscope. As a single use instrument, the disposable hemoclip does not allow to be used by twice, and cannot be separated by components except to be used as well. It is also a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle and tube. The delivery system is constructed using stainless steel and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1600mm, 1800mm, 2100mm and 2300mm working lengths.
The clip is made of stainless-steel material and deployed from the delivery system during use. The clip jaws are designed that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy.

The provided text is a 510(k) Summary for a medical device called "Disposable Hemoclip (AF series)". It describes the device, its intended use, a comparison with a predicate device, and the non-clinical data used to demonstrate substantial equivalence.

However, the document does not contain information about:

• A table of acceptance criteria and the reported device performance in the sense of predefined thresholds for clinical efficacy or accuracy. Instead, it lists various non-clinical tests performed.
• Sample sizes used for a "test set" in a clinical study because no clinical studies were performed.
• Data provenance, number of experts, adjudication methods, or MRMC studies, as these relate to clinical data which is explicitly stated as N/A.
• Standalone algorithm performance or details about ground truth for training data, as this is a physical medical device, not an AI/software device.

Therefore, many of the requested items cannot be provided from the given input.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present "acceptance criteria" in the format of specific thresholds for clinical performance (e.g., sensitivity, specificity, accuracy) because it relies on non-clinical testing for substantial equivalence. Instead, it lists various non-clinical tests performed to demonstrate that the subject device performs similarly to the predicate device. The "reported device performance" is essentially that the device "met all design specifications" and that "test results demonstrate substantial equivalence between the subject device and the predicate device" for each test.

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

• Test Set Sample Size: Not applicable. The submission relies on non-clinical (bench) testing, not clinical studies with patients or human data to form a "test set" in the context of clinical performance.
• Data Provenance: The non-clinical tests were conducted internally or by contract labs following recognized standards.

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

• Not applicable. No clinical studies were conducted, and therefore no ground truth was established by medical experts for a test set.

4. Adjudication method for the test set

• Not applicable. No clinical studies requiring adjudication were performed.

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 medical device (hemoclip), not an AI/software device, and no MRMC studies were performed.

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 non-clinical tests was established by adhering to recognized international and FDA standards (e.g., ISO, ASTM, USP) for biocompatibility, sterilization, shelf life, and mechanical properties. The performance of the predicate device also served as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

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

• Not applicable, for the same reason as above.

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The Disposable Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

1. Endoscopic marking
2. Hemostasis for
   • Mucosal/sub-mucosal defects

The Disposable Hemoclip consists of one pre-loaded clip and delivery system for single patient use only. Disposable Hemoclip is provided in sterile. The clip is made of stainless steel with good superelasticity performance. The clip is pre-loaded in end of the Spring tube part through its deformation and it is deployed from the delivery system during use.The clip is engineered such that they can be opened and closed up to many times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. The delivery system consists of a handle and delivery catheter. The delivery system will allow for the device to rotate at the distal end.

The provided text describes a 510(k) premarket notification for a medical device, the Disposable Hemoclip. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a detailed clinical study demonstrating improved patient outcomes or diagnostic accuracy.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria for software or AI-driven diagnostic devices.

Specifically, the document states:

• "No Clinical Study is included in this submission." This means there is no study that evaluates the device's performance in a clinical setting against specific metrics like sensitivity, specificity, or reader improvement with AI assistance.
• The "acceptance criteria" listed for the device relate to non-clinical performance data (e.g., appearance, size, hardness, open/close performance, rotation performance, releasing force, clipping force, peeling force, connection firmness, dimensional verification, and MR safety testing), and compliance with ISO standards (ISO 10993, ISO 11135-1, ISO 10993-7). These are engineering and material specifications, not performance metrics for diagnostic accuracy or clinical effectiveness in the way an AI/software device would have acceptance criteria.
• The device being discussed is a physical medical instrument (a disposable hemoclip), not a software or AI device. Hence, there are no concepts like "ground truth for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," or "training/test set sample sizes" in the context of an AI/diagnostic algorithm.

In summary, this document is not relevant for describing the acceptance criteria and study proving a device meets those criteria for an AI/software-driven diagnostic device. It details a substantial equivalence claim for a physical medical instrument.

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It is indicated for Endoscopic clip placement within the Gastromtestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of:
(1) Endoscopic marking
(2) Hemostasis for
(a) Mucosal/ sub-mucosal defects

The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system include: metal cap, spring sheath, pulling wire component, coating layer, protective tube, core rod, and slider. The clip include: clip components and sleeve, and it is deployed from the delivery system during use. The hemoclip can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. The device is available in four clip opening widths, which are 9mm, 11mm, and the device effective length is available in 1600mm, 1800mm, 2600mm, 2600mm.

The provided text describes a 510(k) submission for a Disposable Endoscopic Hemoclip (K222146) and compares it to a predicate device (K182556). The submission focuses on demonstrating substantial equivalence through non-clinical testing rather than clinical trials or AI/algorithm performance. Therefore, many of the requested details about acceptance criteria, clinical studies, and AI performance cannot be found in the provided document.

Here's a breakdown of the available information:

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

The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it lists the results of various non-clinical (bench) tests and biological evaluations, aiming to show compliance with standards and equivalence to the predicate. The "performance" is generally described as "passed" or "complies with standards."

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

The document explicitly states: "No clinical study is included in this submission." All tests described are non-clinical (bench tests, biocompatibility, sterilization, packaging, MR safety). Therefore, there is no "test set" in the context of clinical data, sample size for clinical evaluation, or data provenance from a retrospective or prospective study.

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 clinical studies or human-in-the-loop performance evaluations were conducted or reported.

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

Not applicable, as no clinical studies or human-in-the-loop performance evaluations were conducted or reported.

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 medical device (hemoclip), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

For the non-clinical tests conducted, the "ground truth" would be the specific requirements and specifications defined by the relevant ISO and ASTM standards. For example, for a tensile strength test, the "ground truth" is a defined force threshold that the device must withstand. For sterilization, it's achieving a SAL of 10^-6. These are objective measures against predefined engineering and biological standards.

8. The sample size for the training set

Not applicable, as no clinical studies or AI/algorithm development (with a training set) were conducted or reported.

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

Not applicable, as no clinical studies or AI/algorithm development were conducted or reported.

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Disposable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of:

1. Endoscopic marking, 2 ) Hemostasis for: Mucosal/sub-mucosal defects

The clip is pre-installed at the front of the chuck releaser, the chuck releaser is delivered by the conveyor duct through the endoscope to the Gastrointestinal (GI) tract system finds the bleeding site, thumb ring releases the chuck, so that the clip clamps the bleeding site to stop the bleeding.

The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the HC series. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed no more than five times prior to deployment, aiding in repositioning of the clip at the lesion site.

There are 30 models of Disposable Hemoclip.The main structure and material of each specification model are completely consistent. The outer tube of the plastic wrap type has one more layer of plastic than that of the ordinary type. The material is PE, but the other is the same.

This document describes the premarket notification for the "Disposable Hemoclip" (K213217) and its substantial equivalence to a predicate device. The information details non-clinical tests conducted to demonstrate the device meets acceptance criteria.

1. Table of acceptance criteria and the reported device performance:

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

   • Sample size: The document does not explicitly state the numerical sample size for each performance test. It refers to "a piece of 10cm*10cm isolated pig stomach tissue" for certain tests (e.g., Release the performance, Clamping force, Repositionability, Hemoclip assembly mechanical integrity) and "sample block comparison" for surface roughness. For other tests like reducing substances, extractable metal content, pH, evaporation residue, and UV absorbance, it references using specific volumes of test solutions (e.g., "0.2g sample", "1ml of water", "10mL of the test solution", "25mL of the test solution", "50 mL of the test solution"). The biological tests (cytotoxicity, skin sensitization, acute systemic toxicity, pyrogens, sub-acute systemic toxicity) would have their own sample sizes as per the ISO standards cited, but these are not provided in this summary.
   • Data provenance: The data is based on non-clinical testing conducted by the manufacturer, Beijing ZKSK Technology Co., Ltd., in China. The tissue model used in several tests is "isolated pig stomach tissue," indicating an ex-vivo or in-vitro animal tissue model. All results are from laboratory tests performed on the device itself or its materials, not human clinical trials. Thus, the data provenance is retrospective (tests already performed) and from the manufacturer's facility in China.

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

   • Not applicable. This submission is for a medical device (hemoclip) and relies on objective, quantifiable performance and biocompatibility testing against established standards, not on expert-adjudicated ground truth like in diagnostic imaging with AI. The "ground truth" here is derived directly from the physical properties of the device and its interaction with test materials, measured according to recognized test methodologies and standards.

4. Adjudication method for the test set:

   • Not applicable. As described above, the evaluation is based on objective measurements and adherence to specific numerical or qualitative criteria (e.g., "Meet the requirements", specific values for chemical tests, visual observation of functionality), not on human expert adjudication.

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 manual endoscopic tool, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

   • Not applicable. This is not an algorithm-only device. It is a physical medical device. The "standalone" performance testing refers to the device's inherent mechanical, material, and functional properties as evaluated in the non-clinical tests.

7. The type of ground truth used:

   • The "ground truth" for the non-clinical tests is established by:
     • Standardized measurement methodologies: Testing performed according to recognized international and national standards (ISO, ASTM, USP).
     • Objective performance criteria: Specific quantitative thresholds (e.g., force values, concentration limits, roughness parameters) and qualitative observations (e.g., smooth rotation, no separation, no cytotoxicity) defined in the acceptance criteria.
     • Material properties and chemical analysis results: Direct measurements of material hardness, chemical residues, extractables, pH, and UV absorbance.
     • Functional demonstrations: Observing the device's ability to open, close, clamp, release, and rotate as intended with a tissue model (isolated pig stomach tissue).

8. The sample size for the training set:

   • Not applicable. This submission concerns a physical medical device, not an AI model requiring a training set.

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

   • Not applicable, as no training set was used.

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The Hemoclip is indicated for endoscopic clip placement within the digestive tract for the purpose of:

• 1. Endoscopic marking,
• 2. Hemostasis for:
• Mucosal/sub-mucosal defects

Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube. Release part consists of Spring End, Spring hose near clip end, Connect end, Plastic Coated Spring Tube / Spring Tube and Handle part. EO Sterilization and use for single use only. For our proposed Hemoclip, the release part could connect and release the clips repeatedly.

We include 5 series for this submission, 55501series, 55502 series, 55504 series and 55505 series. 55501 series and 55502 series are models consist of release part and clip part, and the release part and clip part are already combined, no additional separate clips include, 55501series and 55502 series are reloadable, the release part could connect and release clips repeatedly. 55503 series are models only consist of separate clip part, and the release part of 55501, 55502, 55503 and 55504 series can connect with the separate clip (55503 series) repeatedly. 55504 and 55505 series are models consist of one preloaded Hemoclip (consist of release part and clip part, and the release part and clip part are already combined) and additional separate clips, 55504 series and 55505 series are reloadable, the release part can connect separate clips and release clips repeatedly.

The provided text describes a 510(k) summary for a medical device called Hemoclip. This document does not pertain to an AI/ML device, therefore, the requested information regarding acceptance criteria and study details for such a device is not applicable. The Hemoclip is a medical device for endoscopic clip placement and its clearance is based on substantial equivalence to a predicate device, not on AI/ML performance metrics.

Specifically, the document states:

• No Clinical test is included in this submission. (Section 5.9)
• The performance data provided relates to non-clinical performance (shelf life validation, packaging validation, biocompatibility, and sterility) to meet design specifications and show substantial equivalence to the predicate device (Section 5.8).

As such, I cannot extract the acceptance criteria, study details, human reader performance, standalone algorithm performance, or ground truth information relevant to an AI/ML device from this document.

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The Single Use Hemoclip Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: (1) endoscopic marking, (2) hemostasis for (a) mucosal / sub-mucosal defects

The proposed device Single Use Hemoclip is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

The provided text describes a 510(k) premarket notification for a medical device (Single Use Hemoclip) and demonstrates its substantial equivalence to predicate devices. However, the document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered medical device, which the provided prompt seems to be specifically asking for.

The acceptance criteria typically outlined in AI/ML medical device submissions (as per the prompt's structure) would include metrics like sensitivity, specificity, AUC, and performance targets against "ground truth" established by experts. The provided document instead focuses on equivalence testing for a physical medical device (a hemoclip), detailing mechanical and biological testing to ensure its safety and performance.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance: Because the document does not define such criteria or report AI/ML performance metrics.
2. Sample size and data provenance for the test set: Not applicable for a physical device.
3. Number of experts and qualifications for ground truth: Not applicable for a physical device.
4. Adjudication method for the test set: Not applicable for a physical device.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for a physical device.
6. Standalone (algorithm-only) performance: Not applicable as there is no algorithm.
7. Type of ground truth used: Not applicable.
8. Training set sample size: Not applicable.
9. How ground truth for training set was established: Not applicable.

The "Performance data" section in the document (Page 8, Item 7) lists bench tests conducted on the Single Use Hemoclip, which are relevant for a physical device, but not for an AI/ML driven one:

• Dimensional verification
• Mechanical Integrity of Clip Assembly
• Clamping Strength Testing
• Tensile Strength Testing
• Release Force Testing
• Rotation Testing

The conclusion states that "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent." This is the "proof" for this specific device, based on physical and material properties, not AI/ML performance.

In summary, the provided document relates to the 510(k) clearance of a physical medical device and thus does not contain the information requested about AI/ML device acceptance criteria and performance studies.

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The Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

1. Endoscopic marking,
2. Hemostasis for:

• Mucosal/sub-mucosal defects

Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube. Release part consists of Spring End, Plastic Coated Spring Tube / Spring Tube and Handle. EO Sterilization and use for single use only.
For 510 family, the grooves on the frap tube allow the released clip could be removed by snare loops. If the clip has been deployed, but its position is not satisfactory, or it affects the field of vision, we can remove it.

The provided text is a 510(k) summary for a medical device called "Hemoclip." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way an AI/ML device submission might.

Therefore, many of the requested elements for an AI/ML device study (like sample size for test/training, number of experts, adjudication methods, MRMC studies, and detailed ground truth establishment) are not applicable or not present in this document. This document describes a traditional medical device clearance, not an AI/ML product.

However, I can extract information related to the acceptance criteria and performance data that is provided for this traditional device.

Here's an attempt to answer your request based on the provided text, while noting where information is not available due to the nature of the submission (traditional medical device vs. AI/ML):

Device: Hemoclip (Endoscope Clipping Device)
Type of Device: Traditional Medical Device (Class II)

1. Table of Acceptance Criteria and the Reported Device Performance

The submission states, "The Hemoclip meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device."

While specific numeric acceptance criteria values are not provided in this summary, the document does list the performance tests conducted, implying these tests were used to demonstrate adherence to design specifications and substantial equivalence.

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

• Sample Size: Not specified in the provided summary. Performance testing was "non-clinical bench test."
• Data Provenance: Bench test data. No country of origin or retrospective/prospective distinction is relevant for these types of bench tests.

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

• Not Applicable. For mechanical and biocompatibility testing of a physical medical device, "experts" in the sense of medical professionals establishing ground truth for diagnostic purposes are not relevant. Testing is primarily objective and based on engineering and material science standards.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication is typically for resolving discrepancies in human expert labeling or diagnosis in AI studies. For physical device performance testing, adjudication methods are not typically used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not Applicable. This is a traditional medical device, not an AI-assisted diagnostic device. No human-in-the-loop study involving medical image readers was conducted or is relevant for this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a physical medical device (a Hemoclip), not a software algorithm.

7. The Type of Ground Truth Used

• For the performance data, the "ground truth" is defined by the design specifications and international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterility, and implied engineering specifications for mechanical properties). There is no "true positive/negative" ground truth as would be established for a diagnostic device.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. As there is no training set, there's no ground truth to establish for it.

Summary for the Hemoclip K211787 Submission:

This 510(k) submission for the Hemoclip is for a traditional physical medical device used for endoscopic clip placement. The "acceptance criteria" revolve around established engineering design specifications, biocompatibility standards (ISO 10993), and sterility standards (ISO 11135). The "study" proving it meets these criteria consisted of non-clinical bench testing. The data presented demonstrates substantial equivalence to a legally marketed predicate device (K172727) by showing that differences do not raise new questions of safety or effectiveness. The concept of "ground truth" as applied to AI/ML diagnostics (expert consensus, pathology, outcomes) does not apply here; rather, the device's performance is objectively measured against predetermined engineering and material standards.

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Single Use Rotatable and Repositionable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking 2) Hemostasis for: Mucosal/sub-mucosal defects

The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site.

The provided document is an FDA 510(k) premarket notification for a medical device called the "Single Use Rotatable and Repositionable Hemoclip." This type of submission aims to demonstrate that a new device is "substantially equivalent" (SE) to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA).

As such, the document does not describe a study that proves the device meets specific acceptance criteria in the manner of a clinical trial for an AI/algorithm-based device. Instead, it focuses on demonstrating equivalence through non-clinical testing and comparison to predicate devices.

Therefore, many of the requested details about acceptance criteria, test set sizes, expert involvement, and ground truth establishment (which are typical for AI/algorithm performance studies) are not applicable to this 510(k) submission.

Here's a breakdown of the information that is available and what is not for this specific product, structured to address your points as much as possible:

Acceptance Criteria and Device Performance (Not applicable in the context of an algorithm or AI performance)

This device is a mechanical medical instrument (hemoclip), not an AI or algorithm-based device. Therefore, the "acceptance criteria" here refer to meeting design specifications and demonstrating performance comparable to predicate devices through bench testing (mechanical and biocompatibility). There are no performance metrics like sensitivity, specificity, or accuracy for an AI.

Table of Acceptance Criteria and Reported Device Performance (as per non-clinical testing for a mechanical device):

Study to Prove Device Meets Acceptance Criteria

The "study" refers to the non-clinical testing described, not a clinical trial or AI performance study.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated numerically for each non-clinical test (e.g., how many clips were tested for clamping strength). However, the general statement "Performance test was performed on both the proposed device and predicate device" implies a sufficient number of samples were tested to robustly compare performance and draw conclusions of no significant difference.
   • Data Provenance: The tests were conducted internally by Anrei Medical (Hangzhou) Co., Ltd. in the People's Republic of China, as indicated by the sponsor's identification. This is non-clinical laboratory data.
   • Retrospective or Prospective: These are laboratory bench tests conducted prospectively to gather data for the submission.

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

   • Not Applicable. This is a mechanical device. Ground truth, in the context of an AI device, refers to expert labeling of medical images or other data. For a mechanical device, "ground truth" is measured physical properties or biological responses to materials (e.g., measuring clamping force, observing cell growth in cytotoxicity tests, or confirming sterility). These are objective measurements against established standards, not expert consensus on interpretations.

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

   • Not Applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for AI/imaging devices. For mechanical performance and biocompatibility tests, results are derived from objective measurements and laboratory protocols, not human adjudication between different interpretations.

4. 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. This is a mechanical device, not an AI or imaging device. Therefore, MRMC studies are not relevant.

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

   • Not Applicable. As a mechanical device, there is no "algorithm only" performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Objective Measurements Against Standards. The "ground truth" for this device's performance is established by objective physical and biological tests according to recognized international and national standards (e.g., ISO, ASTM, USP). For example:
     • Biocompatibility: Established biological reactions (e.g., no cytotoxicity via cell culture tests).
     • Mechanical Properties: Measured physical forces (e.g., tensile strength in Newtons, clamping force).
     • Sterility: Absence of microbial growth, reaching a specific SAL.
     • Shelf Life: Data demonstrating stability of materials/performance over time.

7. The sample size for the training set:

   • Not Applicable. This is a mechanical device, not an AI requiring a "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. There is no training set for this type of device.

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The hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

• 1. Endoscopic marking
• 2. Hemostasis for
• · Mucosal/sub-mucosal defects

The Hemoclip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1650mm, 1950mm and 2300mm working lengths. The clip consists of a stainless steel capsule, and clip arms, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The hemoclip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.

The provided document, a 510(k) Summary for the Hemoclip, does not contain information about acceptance criteria for device performance based on diagnostic metrics (e.g., sensitivity, specificity) derived from a study involving human readers or ground truth established by experts.

Instead, this document focuses on establishing substantial equivalence for a medical device (Hemoclip) through a series of bench tests and comparison to predicate devices, without involving clinical trials or diagnostic performance studies in the way one might expect for AI/Software as a Medical Device (SaMD) clearances.

Therefore, many of the requested categories cannot be answered from the provided text.

Here's what can be extracted:

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

The document lists several bench tests that were performed. The acceptance criteria are implicitly "passing" for each test.

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

This information is not provided in the document. The tests mentioned are bench tests, not clinical studies involving patient data.

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)

This information is not applicable/provided. Ground truth by medical experts (e.g., radiologists) is typically established for diagnostic performance studies, which were not conducted for this device clearance.

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

This information is not applicable/provided. Adjudication methods are typically used for establishing ground truth in clinical/diagnostic studies.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No Clinical test is included in this submission." This device is a mechanical medical instrument, not an AI/SaMD.

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

No, a standalone performance study was not done. This device is a mechanical medical instrument, not an AI/SaMD.

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

This information is not applicable/provided. The "ground truth" for the bench tests would be defined by engineering specifications and physical test standards (e.g., a force gauge measurement, a caliper measurement), not medical ground truths like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable/provided. There is no mention of a "training set" as this device is not a machine learning or AI product.

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

This information is not applicable/provided. There is no mention of a "training set" or its ground truth establishment.

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