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The NiTi Compression Anastomosis Ring (CAR) is intended for use throughout the alimentary tract for the creation of end-to-end, end-toside and side-to-side anastomoses in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi Compression Anastomosis Ring is passed from the body.

The Compression Anastomosis Ring (CAR) device is a sterile single use device. The CAR provides a simple method for the creation circular compression anastomosis of the alimentary tract. After a period of 7-10 days, a compression-induced necrosis of the tissue sides underneath the ring occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.

This document is a 510(k) summary for the Compression Anastomosis Ring (CAR) and does not contain any information regarding acceptance criteria or a study proving device performance against such criteria. It details the device's classification, predicate device, intended use, and substantial equivalence claim based on validations and performance testing, including animal studies.

Therefore, I cannot provide the requested information.

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The NiTi Compression Anastomosis Ring (CAR) is intended for use throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi Compression Anastomosis Ring is passed from the body.

The Compression Anastomosis Ring (CAR) device is a sterile single use device. The CAR provides a simple method for the creation circular compression anastomosis of the alimentary tract. After a period of 5-10 days, a compression-induced necrosis of the tissue sides underneath the ring occurs and the whole device, together with the necrosed tissue that was compressed by the ring, detaches and is naturally expelled with the stool.

The provided document, a 510(k) summary for the Compression Anastomosis Ring (CAR), does not contain specific acceptance criteria or a detailed study description with performance outcomes. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against predefined criteria.

However, based on the information provided, here's what can be extracted and what is missing:

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

This information is not available in the provided document. The 510(k) summary states, "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act." Therefore, specific acceptance criteria and detailed device performance metrics (e.g., success rate of anastomosis, incidence of leakage, time to expulsion of the device) are not presented in this document.

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

The document mentions "validations and performance testing results, including animal studies" (Section {2}). However, it does not specify the sample size for any test set or the provenance of this data. It's only stated that these studies were conducted by NiTi Medical Technologies Ltd.

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 available in the provided document. The summary only refers to "animal studies" as part of the performance testing, but no details regarding expert involvement or ground truth establishment are given.

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

This information is not available in the provided document.

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

This information is not applicable/available. The device is a surgical implant (Compression Anastomosis Ring), not an AI-assisted diagnostic tool.

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

This information is not applicable/available. The device is a physical surgical implant, not an algorithm.

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

Given the mention of "animal studies," the ground truth likely involved observational outcomes and possibly pathological examination of the anastomoses in the animal subjects. However, the specific type and methodology are not detailed in this document.

8. The sample size for the training set

This information is not applicable/available. The device is a physical surgical implant, not a machine learning model that requires a training set.

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

This information is not applicable/available. The device is a physical surgical implant, not a machine learning model.

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The NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) is intended to be used to facilitate side-to-side anastomosis of the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi Clip is wassed from the body. The LapCAC is indicated for open, minimally invasive or laparoscopic procedures.

The Laparoscopic Compression Anastomosis Clip (LapCAC) device is a sterile single patient use device. The LapCAC provides a simple method for the creation of side-to-side compression anastomosis of the alimentary tract in open, minimally invasive and laparoscopic procedures. The LapCAC device is comprised of two components: Clip Reload double ring clip that is inserted into the two cut segments and performs the required compression on the tissue, and Applier/Handle with which the Clip is introduced into the treated area. The LapCAC device has an extended 35 or 45 cm. long shaft and is designed to pass through a 12 mm standard trocar. After a period of 7-10 days, a compression-induced necrosis of the tissue undernouth the was compressed by the rings, detaches and is naturally expelled with the stool.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner one might expect for an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity).

The document is a 510(k) summary for a medical device called the "Laparoscopic Compression Anastomosis Clip (LapCAC)". This device is a surgical CLIP, not an AI/ML diagnostic or assistive technology. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, MRMC studies, and training/test set sample sizes are not applicable to the content provided.

The 510(k) process for this type of device relies on demonstrating "substantial equivalence" to predicate devices, primarily through comparison of intended use, technological characteristics, and performance testing often related to biological safety and mechanical functionality, rather than diagnostic accuracy.

Summary based on the provided text:

• Acceptance Criteria and Reported Device Performance: Not applicable/not provided in the context of diagnostic performance metrics for an AI/ML device. The document states a belief of substantial equivalence based on "performance testing results," but the specific criteria or results of these tests (e.g., mechanical strength, biocompatibility, deployment success rate) are not detailed.

• Sample size used for the test set and the data provenance: Not applicable. The device is a surgical clip, not a software algorithm tested on a dataset.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

• Adjudication method: Not applicable.

• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.

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

• The type of ground truth used: Not applicable.

• The sample size for the training set: Not applicable.

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

What is present in the document is information related to regulatory clearance for a hardware medical device:

• Device Name: Laparoscopic Compression Anastomosis Clip (LapCAC)
• Intended Use: To facilitate side-to-side anastomosis of the alimentary tract, yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient, the clip is passed from the body. Indicated for open, minimally invasive, or laparoscopic procedures.
• Classification: Class II device, product code FZP, Regulation No. 21 C.F.R. § 878.4300 (Implantable Clip).
• Predicate Devices: CAC, Compression Anastomosis Clip (K033324, K041751) and Universal Stapler System (K892233, K913802).
• Performance Standards: "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act."
• Substantial Equivalence: Applicant "believes that the Laparoscopic Compression Anastomosis Clip (LapCAC) is substantially equivalent to the predicate device cited above without raising new safety and/or effectiveness issues," based on "performance testing results." (However, the details of these tests are not provided in this summary.)

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The NiTi HandSTC has applications throughout the alimentary tract in surgeries for resection, transaction, and the creation of anastomoses.

The NiTi HandSTC is a palm size linear cutter and stapler whose main parts are housed together enabling one hand operation by sequential pressing on the device lever.

The HandSTC applies 56 titanium staples in a line approximately 60mm long. The unformed staples are "U" shape which closed to form "B" shape. When the device is open the distance between the cartridge and the anvil is 4 cm.

The HandSTC device is supplied with one cartridge and can be reloaded for a total of 8 firings

The reloads are available in two sizes:

Blue- unformed staple leg height is 3.5 mm, staple dimension when closed is 1.5 mm. This cartridge closes to a gap of 0.8 mm and it is used for standard tissue and gastrointestinal applications.

Green- unformed staple leg height is 4.5 mm, staple dimension when closed is 2.0 mm. This cartridge closes to a gap of 1.3mm and it is used for gastrointestinal tract and thick tissues such as stomach and rectum applications.

This document is a 510(k) summary for the HandSTC medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document focuses on establishing substantial equivalence to predicate devices, which is a regulatory pathway for demonstration of safety and effectiveness, rather than performance against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. The document states: "Based on validations and performance testing results, NiTi Medical Techologies Ltd. believes that the HandSTC is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues." However, the details of these validations and performance testing results, including acceptance criteria and study designs, are not included in this summary.

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The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate side-to-side anastomosis of the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTi CAC is not applicable through Trocars in laparoscopic procedures.

The Compression Anastomosis Clip (CAC) device is a sterile single use device. The CAC provides a simple method for the creation of side-to-side compression anastomosis of the alimentary tract. The CAC device is comprised of two components:

• Clip double ring clip that is inserted into the two cut segments of the tissue to be anastomosed and performs the required compression on the tissue.
• Applier with which the Clip is introduced into the treated area.
  After a period of 7-10 days, a compression-induced necrosis of the tissue sides underneath the rings occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.

The provided text does not contain information about acceptance criteria for device performance, nor details of a study that proves the device meets such criteria. The document is a 510(k) summary for a Compression Anastomosis Clip (CAC), primarily focusing on:

• Applicant and Contact Information
• Trade Name and Classification
• Predicate Devices
• Intended Use
• Device Description
• Substantial Equivalence Claims
• FDA 510(k) Clearance Letter
• Indications for Use Statement

The "Substantial Equivalence" section mentions "validations and performance testing results, including animal studies," but it does not elaborate on what these results were, what acceptance criteria were used, or the specifics of the studies.

Therefore, I cannot provide the requested table and study details. The input document does not contain this information.

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The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate colonic side-to-side anastomosis yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTI CAC is not applicable through trocars in laparoscopic procedures.

The Compression Anastomosis Clip (CAC) device is a sterile single use device. The CAC provides a simple method for the creation of side-to-side compression anastomosis of the intestine. The CAC device is comprised of two components: CLIP - DOUBLE RING CLIP THAT IS INSERTED INTO THE TWO CUT SEGMENTS OF THE INTESTINE AND PERFORMS THE REQUIRED COMPRESSION ON THE TISSUE. APPLIER - WITH WHICH THE CLIP IS INTRODUCED INTO THE TREATED AREA. After a period of 7-10 days, a compression-induced necrosis of the intestine sides underneath the rings occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.

This looks like a medical device submission, specifically a 510(k) summary for a Compression Anastomosis Clip (CAC). I will extract the information you requested based on the provided text.

It's important to note that the provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices and describes the device's design and intended use. It mentions "comparative animal and clinical studies" in the "Substantial Equivalence" section, but it does not provide details about those studies, their acceptance criteria, or their results within the provided text. Therefore, much of the requested information cannot be found in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The provided 510(k) summary does not detail specific acceptance criteria or performance metrics derived from studies for the CAC device itself. It states that "validations and performance testing results, including comparative animal and clinical studies" were used to establish substantial equivalence, but the actual data, success/failure criteria, or performance outcomes are not reported here.

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

• Cannot be provided. The document states "comparative animal and clinical studies" were conducted, but it does not specify the sample sizes for these studies, nor does it detail their design (retrospective/prospective) or data provenance (country of origin).

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 / Cannot be provided. This question typically applies to studies where expert interpretation (e.g., image reading) is a primary outcome. For a surgical device like an anastomosis clip, "ground truth" would likely be established through surgical observation, pathological examination of tissue healing, and patient follow-up, rather than expert interpretation of a "test set" in the traditional sense of diagnostic devices. The document does not describe how ground truth was established for its comparative studies, nor does it mention any experts involved in such a process.

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

• Not applicable / Cannot be provided. Similar to point 3, this question is typically relevant for diagnostic studies involving multiple readers. The nature of the studies for a surgical clip (animal and clinical studies focusing on surgical outcomes like anastomotic integrity, healing, and device expulsion) would not typically involve an adjudication method as 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 question is specific to AI-assisted diagnostic devices. The Compression Anastomosis Clip is a surgical device, not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to this device.

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

• Not applicable. This question is specific to AI/algorithmic performance. The Compression Anastomosis Clip is a physical surgical device, not an algorithm.

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

• Cannot be determined from the provided text. While it's highly probable that ground truth in the "comparative animal and clinical studies" would involve outcomes data (e.g., anastomotic leakage rates, healing, patency, device expulsion success) and potentially pathology (histological assessment of tissue healing), the document does not explicitly state what type of ground truth was used.

8. The sample size for the training set

• Not applicable / Cannot be provided. A "training set" is relevant for machine learning algorithms. This device is a physical surgical instrument, not an AI model.

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

• Not applicable / Cannot be provided. As above, "training set" and "ground truth for the training set" are concepts related to machine learning and AI, which are not applicable to this physical medical device.

Summary of what is present:

The 510(k) summary provides:

• Device name, applicant, contact, and date.
• Classification information (Class II, implantable clip, FZP).
• Predicate devices used for comparison (Valtrac Biofragmentable Anastomosis Ring, Proximate™ Linear Cutter and Stapler, U-Clip™, Murphy's Button).
• Intended Use statement: "The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate colonic side-to-side anastomosis yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTI CAC is not applicable through trocars in laparoscopic procedures."
• Device Description: A sterile, single-use device comprised of a double ring clip and an applier, designed to create side-to-side compression anastomosis. It explains the mechanism of action (compression-induced necrosis and natural expulsion after 7-10 days).
• A general statement about substantial equivalence being based on "validations and performance testing results, including comparative animal and clinical studies." However, the details of these studies are not provided in this summary.

This document serves as a regulatory filing to establish substantial equivalence for market clearance, rather than a detailed publication of device performance study results.

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