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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 <3cm
• Bleeding ulcers
• Arteries<2mm
• Polyps<1.5cm in diameter
• Diverticula in the colon
• Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection
• 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel.

4. As a supplementary method, closure of digestive tract luminal perforations<20mm that can be treated conservatively.

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 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 <3cm
• Bleeding ulcers
• Arteries<2mm
• Polyps<1.5cm in diameter
• Diverticula in the colon
• Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection

3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel.
4. As a supplementary method, closure of GI tract luminal perforations<20mm that can be treated conservatively.

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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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 <3cm
• · Bleeding ulcers
• · Arteries<2mm
• Polyps<1.5cm in diameter
• · Diverticula in the colon
• · Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection
• 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel
• 4. As a supplementary method, closure for GI tract luminal perforations<20mm that can be treated conservatively.

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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Weck® Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size, type and material of the clip based upon their experience, judgment and needs.

Weck® Metal Ligating Clips are single-use, non-absorbable, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. Each product line possesses a unique design necessary for compatibility with its appropriate Weck® ligating clip applier. The clips are available in a range of sizes, allowing the end user to ligate a wide range of vessels and tissue structures. Weck® Metal Ligating Clips are manufactured from medical grade titanium, tantalum or stainless steel alloys and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.

Accessories to the Weck® Metal Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.

The Weck® Metal Ligating Clips are non-absorbable, non-active implantable devices used for vessel or tissue ligation in general surgical procedures. The clips are made from medical-grade titanium, tantalum, or stainless steel alloys.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "Non-clinical performance testing" was conducted, but specific sample sizes for this testing are not provided.
• Data Provenance: The studies were non-clinical performance testing conducted by the manufacturer, Teleflex Medical, Incorporated, to support a 510(k) submission to the FDA in the USA. This is considered prospective, manufacturer-conducted testing for regulatory approval.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. The ground truth for this device (MR Conditional claim, material compliance, and substantial equivalence) was established through non-clinical performance testing and comparison to existing predicate devices, rather than expert interpretation of medical images or data.

4. Adjudication Method

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of data where consensus among experts is needed. This submission relies on objective engineering and material testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic aids or AI systems that assist human readers in tasks like image interpretation, and the Weck® Metal Ligating Clips are a physical implantable device.

6. Standalone Performance Study

• Yes, a standalone study was done in the sense that the device's "MR Conditional" performance was tested independently of human intervention. The "Non-clinical performance testing" was conducted on the device itself to determine its behavior in an MR environment. However, this is not "algorithm only" performance as often seen in AI/software substantial equivalence discussions, but rather direct device performance testing.

7. Type of Ground Truth Used

• Engineering and Material Standards: The ground truth for the "MR Conditional" claim was based on established engineering standards (ASTM F2503-08) and FDA guidance for medical devices in MR environments.
• Comparison to Predicate Devices: The ground truth for overall safety and effectiveness was established by demonstrating substantial equivalence to previously cleared predicate devices (K982313 and K841547), implying that if the new device performs similarly to devices already deemed safe and effective, it is also safe and effective.
• Biological Compatibility: Patient-contacting materials compliance with ISO10993-1 provides ground truth for biocompatibility.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance data is based on physical testing of the device itself.

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

• Not applicable, as no training set was used.

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