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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 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 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 is a 510(k) summary for the "Single Use Hemoclip" device. It outlines the device's characteristics, indications for use, and comparison to predicate devices, along with performance data. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study that proves the device meets them, particularly for AI/human reader performance.

This document focuses on the substantial equivalence of a medical device (a hemoclip) to previously cleared devices based on physical and mechanical properties, not on the performance of a diagnostic AI algorithm that would typically involve acceptance criteria related to sensitivity, specificity, or human reader studies.

Here's an analysis of what information is present and what is missing from the provided text:

Information Present:

• Device Name: Single Use Hemoclip
• Predicate Devices: Sterile Repositionable Hemostasis Clipping Device (K152001) and SureClipTM Repositionable Hemostasis Clip (K161463).
• Bench Tests Performed:
  • Appearance
  • Dimensional verification
  • Clamping Strength Testing
  • Release Force Testing
  • Open and Close Mechanical Integrity of Clip Assembly
  • Tensile Strength Testing
  • Rotation Testing
• Conclusion from Bench Tests: "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent."
• Clinical Study: "No clinical study is included in this submission."
• Ground Truth for Manufacturing/Bench Testing: Implied by ISO standards (ISO 10993, ISO 11135-1, ISO 10993-7) and the specific bench tests (e.g., dimensional verification would involve measuring against design specifications).

Information Missing (and why it's missing from this specific document type):

The majority of your questions are relevant to the evaluation of a diagnostic AI device or a device where human interpretation or a specific performance metric (like accuracy, sensitivity, specificity) is key to its safety and effectiveness. This document describes a physical medical device (a hemoclip) and its physical and mechanical performance. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/diagnostic algorithm are not directly applicable here.

Here's why many of your specific questions cannot be answered from this document:

1. Table of acceptance criteria and reported device performance (for AI): Not applicable. The "performance data" listed are for mechanical integrity and dimensions, not diagnostic accuracy.
2. Sample size used for the test set and data provenance (e.g. country of origin, retrospective/prospective): Not applicable for an AI test set. The "tests" were bench tests on the physical device. The relevant "sample size" would be the number of devices tested for each bench test, which is not detailed here. No patient data is involved.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical device's mechanical properties is based on engineering specifications and measurement standards, not expert reader consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size: No. Clinical studies were not conducted, and this is not a diagnostic device requiring human reader evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the ground truth would be the engineering design specifications and industry standards for mechanical performance (e.g., how much force the clip should withstand, its dimensions). This is implied by the listed ISO standards.
8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) pertains to a physical medical device (a hemoclip) and its substantial equivalence based on bench testing of mechanical and physical properties. The framework of acceptance criteria and study design you've described (particularly questions 2-6 and 8-9) is primarily relevant to diagnostic AI/machine learning devices or clinical studies involving diagnostic accuracy or human interpretation, which are not detailed or applicable in this specific regulatory submission for this type of device.

The "acceptance criteria" for this device would be its ability to meet the specified mechanical and dimensional requirements, demonstrating equivalence to the predicate devices, as shown by the listed bench tests. The full details of these bench tests (e.g., the number of clips tested for clamping strength, the specific force values) are not provided in this summary but would be part of the full 510(k) submission.

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