Search Results

Hemoblock S (Prescription): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations

Hemoblock S (OTC): To control bleeding of minor lacerations, minor cuts and minor abrasions

The Hemoblock_S (Hemoblock_S (Prescription Use) and Hemoblock_S (OTC Use)) for being placed on the U.S.A Market is single use, hemostatic dressing made of Chitosan and Cotton. This device is called to Hemoblock Gauze on the Republic of Korea Market.

Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Hemoblock_S acts as a mechanical barrier against bleeding by turning into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Hemoblock_S is provided in two different types to accommodate a variety of treatment regions, according to being based on the whether strap yan which is consisted with Nylon and handle for remove a device into any wound, with following;

• Gauze(N) Type: There is not strap yarn part on the Hemoblock_S
• Gauze(S) Type: There is strap yarn part on the Hemoblock_S

The Hemoblock_S is individually packaged in a foil pouch and is Irradiation sterilized in accordance with ISO 11137 Series.

The provided text does not contain information about the acceptance criteria and performance of a device based on a study; instead, it is a 510(k) premarket notification summary for a hemostatic dressing called "Hemoblock S". The document details the device's characteristics, its comparison to a predicate device, and non-clinical testing performed (biocompatibility, sterilization, shelf-life, and general performance tests like appearance, dimension, tensile strength, absorption, X-ray impermeableness, and in vitro blood clotting test). It also mentions an animal study for hemostatic testing.

There is no mention of a study involving a test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or specific acceptance criteria with reported device performance in the context of diagnostic accuracy or AI assistance. The performance tests mentioned are related to the physical properties and sterilization of the dressing, not its diagnostic or assistive capabilities for human readers.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information regarding acceptance criteria and study results for device performance in the context of the questions asked.

Ask a specific question about this device

The CORE-INJECTOR is to be used in conjunction with an endoscope to perform endoscopic injections, such as the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.

The CORE-INJECTOR, the disposable endoscope injection needle is a disposable device for injecting medicine and medical supplies into a mucous membrane or blood vessel to stop the bleeding or for hardening the vessel during endoscopic procedure. The device consists of a stainless steel needle attached to sheath and handle where a syringe with solution for injection can be attached. It is available in various sizes and working lengths. The needle sizes are 23 gauge and the needle length is 4.0mm. The working length includes 1,200mm, 1,600mm, 1,800mm, 2,300mm. The operating time is less than 1 hour. it contacts with mucosa of the human digestive tract. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10°). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

The provided document describes the non-clinical performance testing for the CORE-INJECTOR device to demonstrate its substantial equivalence to a predicate device. It does not contain information about a comparative effectiveness study (MRMC) or a standalone (algorithm-only) study for a medical imaging AI device. The device in question is an endoscope injection needle, not an AI or imaging device. Therefore, many of the requested fields are not applicable.

Here's the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The CORE-SNARE is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.

The CORE-SNARE is a disposable device for cuts out and removes the tissues such as polyps after entering a site to be treated during endoscopic procedures. The device consists of Snare-loop connected with catheter tube and Catheter tube pass through operating channel of endoscope and Handle connected with snare through the catheter tube. It is available in various sizes and working lengths. Users can choose an Oval or a Crescent or Diamond type based on their preference and the characteristic of the loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion. When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10t%). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

The provided document is a 510(k) premarket notification for a medical device called CORE-SNARE. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria in the context of an AI/ML powered device.

Therefore, the document does not contain the information requested in your prompt regarding:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes, data provenance, expert ground truth establishment, or adjudication methods for an AI/ML test set.
• MRMC studies or standalone AI performance.
• Training set details for an AI/ML algorithm.

The document primarily details the non-clinical performance testing to demonstrate the physical, electrical, and material safety and effectiveness of the CORE-SNARE, which is an electrosurgical snare for polyp removal.

Here's what the document does provide regarding its "acceptance criteria" and "study":

Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

The "acceptance criteria" in this context are the limits and standards the physical device must meet during various non-clinical tests to be considered safe and effective and substantially equivalent to the predicate. The "study" refers to the bench testing performed.

Ask a specific question about this device

The CORE-SPORT is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

The CORE-SPORT, an surgical instrument that provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery, and consists of a Port-Assay and a Retractor.

Port-Assay consists of several ports of various sizes. Port-Assay consists of 3 or 4 ports and 5 and/or 12 mm sized ports.

The proposed product is packed in Tray & Tyvek following EO Sterilization (SAL 10°). The device is supplied sterile for single-use and shall be not reused or re-sterilized.

Based on the provided text, the device in question is CORE-SPORT, a surgical instrument for minimally invasive laparoscopic surgery. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, the performance data presented is primarily bench testing and comparative testing against self-defined criteria, rather than clinical studies involving human patients or complex AI algorithms requiring ground truth establishment by experts.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify specific sample sizes for each test. It generally states that tests were "conducted" or "performed." For device performance, the data provenance is from bench testing and comparative testing within a laboratory setting. The company is INCORE CO., LTD. from Republic of Korea. The studies described are pre-market testing for regulatory submission, and therefore are inherently prospective in their design (intended to evaluate the device against pre-defined criteria).

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

This document describes a medical device (surgical port), not an AI-assisted diagnostic device. Therefore, the concept of "ground truth established by experts" (e.g., radiologists interpreting images) is not applicable in the context of these described performance tests. The "ground truth" for these tests is based on objective physical measurements, adherence to industry standards (e.g., ISO, USP, ASTM), and the predefined acceptance criteria for mechanical and material properties. There is no mention of human expert readers for "test sets" in the diagnostic sense.

4. Adjudication Method for the Test Set (e.g., 2+1, 3+1, none)

Since this is not an AI diagnostic study relying on human interpretation for "ground truth," there is no adjudication method described or necessary. The "adjudication" is essentially the device passing or failing against the established objective metrics and standards.

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 MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic AI devices where human performance with and without AI assistance is being evaluated. The CORE-SPORT is a physical surgical instrument, not an AI or diagnostic tool.

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

Again, this question is primarily relevant for AI algorithms. The "standalone performance" described here refers to the device's physical and material properties and its function (e.g., air leak, tensile strength). The tests are designed to show the device's inherent capabilities and safety without human intervention in its functionality, but the evaluation is performed by human testers against these criteria.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed on COR-SPORT is based on:

• Industry Standards: ISO 11135 (sterility), ISO 10993 (biocompatibility), USP 38 (extraction), ASTM F1980 (accelerated aging).
• Engineering Specifications and Bench Test Parameters: Pre-defined force limits (10N for tensile strength), pressure maintenance values (15mmHg for 30 seconds for air leak), and size parameters (30mm for cavity access).
• Absence of Adverse Events: "No defects," "no evidence of microbial growth," "no friction, crash, damage."

8. The Sample Size for the Training Set

The concept of a "training set" applies to machine learning or AI models. Since CORE-SPORT is a physical medical device, there is no training set in this context. The manufacturing process and quality control would be based on established engineering principles and production runs, not data training.

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

As there is no training set for a physical medical device, this question is not applicable.

Ask a specific question about this device

It is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for
(1) Endoscopic marking
(2) Hemostasis for
(a) Mucosal/sub-mucosal defects

The endoscope clip is a metallic mechanical device used in endoscopy in order to close two mucosal surfaces without the need for surgery and suturing. Its function is similar to a suture in gross surgical applications, as it is used to join together two disjointed surfaces, but, can be applied through the channel of an endoscope under direct visualization. The endoscope clip has found use in treating gastrointestinal bleeding (both in the upper and lower GI tract), in preventing bleeding after therapeutic procedures such as polypectomy, and in closing gastrointestinal perforations.

The Handle Slider and the coil are connected, and the clip are connected. When the Handle Slider is moved backward, the coil connected to the Handle Slider is pulled back, and the clip is also pulled back and the clip is closed as the clip enters the Clip Body. After the clip is completely closed, the clip will no longer be pulled back and when the threshold is reached, the Disconnection connector part will eventually break. As a result, the delivery device and the clip are completely separated, and the clip remains alone to maintain hemostasis.

The provided text is a 510(k) summary for a medical device called "CORE-CLIP," a disposable endoscope clip. It aims to demonstrate substantial equivalence to a predicate device. However, the document does NOT contain the specific details required to answer all parts of your request, especially regarding acceptance criteria, performance metrics, and the full scope of a comparative effectiveness study as one might expect for an AI/CADe device. This device is a mechanical one, and the non-clinical and animal testing focus on its mechanical and biological safety and performance rather than AI algorithm performance.

Therefore, for the questions related to AI/CADe systems (e.g., sample sizes for training/test sets, ground truth establishment methods, expert qualifications, MRMC studies, standalone performance), the information is not present as it is not an AI-powered device.

Here's an analysis of the provided text based on your questions, with N/R (Not Reported) or N/A (Not Applicable) where the information is not relevant or present for this type of mechanical device submission:

Acceptance Criteria and Device Performance (Based on available information for a mechanical device)

Given that this is a mechanical device, the "acceptance criteria" discussed are for its mechanical and biological safety and performance, not for an AI algorithm's diagnostic accuracy. The document states that the "results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the device "meets the acceptance criteria" by performing comparably to the predicate and adhering to relevant standards.

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

The document mentions several non-clinical tests performed, and the acceptance criteria are implicitly the successful completion and meeting of standards within these tests. The reported device performance is that it met these standards.

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

• Test Set Sample Size: For the non-clinical bench tests (e.g., rotation, open/close, tensile strength, clamping retention time), specific numerical sample sizes are N/R. These tests would typically involve a specific number of units, but the report only states "The mechanical properties tests were performed by being based on each product different properties and dimensions."
• Data Provenance:
  • Country of Origin: The submitter is INCORE Co., Ltd., Republic of Korea. The testing was conducted by them or their contracted labs.
  • Retrospective or Prospective: These are non-clinical, benchtop, and animal tests, not human retrospective/prospective clinical studies. They are specifically performed for this submission.

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

• N/A. This information is for AI/CADe systems where human experts establish ground truth for image interpretation. For a mechanical device, performance is typically assessed against engineering specifications, material standards, and functional requirements.

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

• N/A. This applies to human expert adjudication for image interpretation in AI 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:

• N/A. This is a mechanical device, not an AI software.

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

• N/A. This is a mechanical device, not an AI algorithm.

7. The type of ground truth used:

• For the non-clinical tests: The "ground truth" is defined by established engineering and biological standards (e.g., ISO, ASTM, AAMI, USP, in-house predicate-based standards).
• For the animal test: The "ground truth" for adhesion safety and hemostatic performance would be direct observation and measurement in the animal model.

8. The sample size for the training set:

• N/A. This is for AI algorithms. This device does not have a "training set."

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

• N/A. This is for AI algorithms.

Ask a specific question about this device

The CORE-Trocar is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.

The CORE-Trocar has a port to insert endoscopic instruments during endoscopic procedures. It consist of a cannula and a obturator. The Trocar is available in nine (9) models(IC-TC02, IC-TC02S, IC-TC03, IC-TC03S, IC-TC05S, IC-TC05S, IC-TC08, IC-TC10, IC-TC12) and the models are divided into six (6) types according to the kinds of diameter Type : 2mm Type(IC-TC02, IC-TC02S), 3mm Type(IC-TC03, IC-TC03S), 5mm Type(IC-TC05, IC-TC05S), 8mm Type(IC-TC08), 10mm Type(IC-TC10) and 12mm Type(IC-TC12). The cannula assembly have seals(main, secondary), a valve and a stopcock. The obturator has non-bladed tip. Sterilization is done with EO gas and Sterilization Assurance Level(SAL) 10-6. The seals prevent loss of CO2 pneumoperitoneum pressure when instruments are inserted or withdrawn.

The provided text is a 510(k) summary for the CORE-Trocar device and describes acceptance criteria and performance data from various tests. However, it does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/human-in-the-loop performance evaluation or a standalone AI algorithm performance study. It focuses on the mechanical, biological, and physical/chemical properties of the trocar itself.

Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document as they pertain to the performance evaluation of AI/ML-based medical devices, which the CORE-Trocar is not.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Reported Device Performance

The device underwent various non-clinical performance bench tests and comparative tests against a predicate device.

Ask a specific question about this device