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The ENDOCOLLECT Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.

The ENDOCOLLECT Specimen Retrieval Bag ("ENDOCOLLECT") is a disposable device used as a receptacle for the collection and extraction of tissue specimens during laparoscopic surgery and is intended to be used with an endoscopic trocar. ENDOCOLLECT is comprised of a flexible plastic bag with a large, easily accessible opening, a spring finger, deployment shaft, shaft handle, and an insertion tube. In the fully deployed condition, the specimen bag opening is maintained during the retrieval of a specimen. When the specimen is placed in the bag, the bag is closed with the cinch cord and the device may be removed from the body.

This FDA 510(k) summary does not describe a study involving AI or human readers, therefore, much of the requested information is not applicable. The device in question is a medical tool, the ENDOCOLLECT Specimen Retrieval Bag, used in laparoscopic procedures to capture organs or tissue. The 510(k) submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, not on AI performance or human reader studies.

Here's a breakdown of the applicable information:

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

The document does not provide a specific table of acceptance criteria with numerical performance metrics for an AI device. Instead, it lists the types of non-clinical bench testing conducted to demonstrate that the device meets established specifications and consistently performs for its intended use. The "reported device performance" is a general statement that "The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the ENDOCOLLECT Specimen Retrieval Bag meet the established specifications necessary for consistent performance during its intended use."

The categories of testing performed are:

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 applicable as the document describes non-clinical bench testing of a physical medical device, not a study involving a "test set" of data for an AI algorithm.

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 as the document describes non-clinical bench testing of a physical medical device, not an AI algorithm requiring expert-established ground truth.

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

This information is not applicable as the document describes non-clinical bench testing of a physical medical device, not an AI algorithm requiring adjudication of a test set.

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

There was no MRMC comparative effectiveness study done. The device is a specimen retrieval bag, not an AI-assisted diagnostic tool. No comparison to human readers with or without AI assistance is relevant or reported.

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

This information is not applicable as the document is about a physical medical device, not a standalone AI algorithm.

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

This information is not applicable as the document describes non-clinical bench testing of a physical medical device. The "ground truth" for such testing is typically based on pre-defined engineering specifications and industry standards rather than medical consensus or pathology.

8. The sample size for the training set

This information is not applicable as there is no training set mentioned in the context of this device.

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

This information is not applicable as there is no training set mentioned in the context of this device.

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The ENDOCOLLECT Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.

The ENDOCOLLECT Specimen Retrieval Bag ("ENDOCOLLECT") is a disposable device used as a receptacle for the collection and extraction of tissue specimens during laparoscopic surgery and is intended to be used with an endoscopic trocar. ENDOCOLLECT is comprised of a flexible plastic bag with a large, easily accessible opening, a spring finger, deployment shaft, shaft handle, and an insertion tube. In the fully deployed condition, the specimen bag opening is maintained during the retrieval of a specimen. When the specimen is placed in the bag, the bag is closed with the cinch cord and the device may be removed from the body.

This document is an FDA 510(k) clearance letter for a medical device called the "ENDOCOLLECT Specimen Retrieval Bag." It details the regulatory process and the determination of substantial equivalence to a predicate device.

Based on the provided text, the device in question is a physical medical device (specimen retrieval bag) and not an AI/software-based medical device. Therefore, many of the requested points related to AI/MRMC studies, ground truth establishment, and training/test sets are not applicable to this submission.

The document primarily focuses on the nonclinical performance testing to demonstrate the device's safety and effectiveness compared to a legally marketed predicate device.

Here's an analysis of the provided information in the context of the requested points, noting where information is not applicable due to the nature of the device:

Device Type: ENDOCOLLECT Specimen Retrieval Bag (a physical, disposable device for laparoscopic tissue retrieval). This is NOT an AI/software device.

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

The document does not provide a direct table of specific numerical acceptance criteria and reported performance values. Instead, it offers a summary of the types of nonclinical bench testing conducted:

Overall Conclusion: "The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the ENDOCOLLECT Specimen Retrieval Bag meet the established specifications necessary for consistent performance during its intended use."

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

• Sample Size: Not explicitly stated for each test. The testing is described as "Nonclinical Bench Testing," implying laboratory-based tests of physical specimens of the device.
• Data Provenance: Not specified, but generally, bench testing would be conducted in a controlled lab environment. Given the applicant's address (Providence, RI, USA), it's likely conducted in the USA.
• Retrospective/Prospective: Not applicable. These 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)

Not applicable. The "ground truth" for a physical device like this is established through engineering and material science testing against predefined specifications, not human expert consensus on interpretations of images or data. Usability validation might involve human evaluators, but they wouldn't be establishing "ground truth" in the diagnostic sense.

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

Not applicable. This concept is relevant for studies involving human interpretation or consensus, such as clinical trials or image labeling. Bench testing relies on objective measurements against engineering specifications.

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 device, not an AI/software device, and no MRMC study was conducted or required. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence to the predicate device."

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

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

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

For this physical device, the "ground truth" is defined by engineering specifications and validated testing methods. For example:

• Force and Volume Testing: The "ground truth" is the measured force or volume achieved by the device, compared against a target specification.
• Puncture Testing: The "ground truth" is whether the device withstands a specified puncture force without failure.
• Biocompatibility Testing: The "ground truth" is established by standard biological safety tests demonstrating the materials are non-toxic and biocompatible according to recognized standards (e.g., ISO 10993).

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model that requires a training set.

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

Not applicable. See point 8.

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The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.

The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, steel sheet, plug, inner sleeve, outer sleeve, pull ring, outer introducer handle, joint, tightening line, pick rod and inner introducer handle. The device is available in a series of models: RJRB-50, RJRB-100, RJRB-120, RJRB-150, RJRN-200, RJRB-250, RJRB-300, RJRB-320, RJRB-420. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use

This document is a 510(k) premarket notification for a "Disposable Specimen Retrieval Bag" and does not describe an AI/ML medical device. Therefore, it does not contain information about acceptance criteria for an AI device, a study proving an AI device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document is for a physical medical device and is primarily focused on demonstrating "Substantial Equivalence" to a previously marketed predicate device based on non-clinical performance and biocompatibility tests.

The device is a physical medical device, not an AI medical device. Therefore, the requested information regarding AI device acceptance criteria, studies, and related data is not applicable and not present in the provided text.

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The AEON™ Retrieval Bag is a sterile single use device that can be used for the encapture and removal of an organ, tissue, or fluid from the body cavity during laparoscopic surgery.

The AEON™ Retrieval Bag, is a sterile, disposable, single-use, individually-packaged polymeric sack with laparoscopic introducer system that is designed to facilitate the removal of tissues or organs in the process of laparoscopic surgery.

The system consists of a sack connected to a laparoscopic introducer system. The introducer system comprises an elongated rod for laparoscopic insertion, flexible arms to allow deployment of the sack in the surgical cavity, and a drawstring to facilitate sack closure and extraction.

The provided text describes the AEON Retrieval Bag, a medical device for laparoscopic surgery, and its 510(k) submission to the FDA. However, the document does not contain information about the acceptance criteria and the study that proves the device meets specific performance criteria.

Instead, it states:

• "Nonclinical tests were conducted with the AEON™ Retrieval Bag to verify that the proposed device is safe and effective, performs as intended, and meets all design specifications. Devices are tested for bag material/seal strength, bag material/seal leak integrity, and bag resistance to breakage in simulated removal testing. Real time shelf life testing was also performed."
• "This submission does not include data from Clinical Studies."

Therefore, I cannot provide the requested table, sample sizes, expert details, or other study-specific information because it is not present in the given text. The document focuses on regulatory approval based on substantial equivalence to a predicate device and non-clinical testing without detailing specific acceptance criteria or study results for those tests.

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The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.

The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, opening support, outer introducer shaft, outer introducer handle, inner introducer handle, string and pull loop. The device is available in a series of models. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use.

The provided text describes a 510(k) premarket notification for a Specimen Retrieval Bag. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria for a novel medical device.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted because such a study was not presented in this document.

Here's what can be extracted and what cannot:

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

The document provides a comparison of the proposed device against a predicate device, focusing on technological characteristics and compliance with general standards. It does not explicitly state "acceptance criteria" for a study to prove performance but rather lists the tests performed to demonstrate substantial equivalence to the predicate.

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 does not provide details on the sample sizes used for the non-clinical tests or the data provenance. It only states that "performance tests were performed on both proposed device and predicate device."

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 and not provided. The study is a non-clinical, bench-testing evaluation designed to demonstrate substantial equivalence, not a clinical study involving human readers or expert ground truth for interpretation.

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

This information is not applicable and not provided, as there was no clinical study or expert adjudication 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

No MRMC or clinical study was done. The document explicitly states: "No clinical study is included in this submission."

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

This concept is not applicable as the device is a physical specimen retrieval bag, not an AI algorithm. The tests performed are non-clinical, bench tests.

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

For the non-clinical performance tests, the "ground truth" would be the established scientific and engineering principles and the performance of the predicate device, as well as compliance with recognized standards (e.g., ISO, ASTM). It's not a clinical "ground truth."

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set." The device is a physical medical device, not an AI or machine learning model that requires training data.

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

Not applicable as there is no training set mentioned.

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The specimen retrieval bag has application for safe, convenient removal of tissue specimens such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, small sections of bowel and other tissue structures.

The ReliaCatch™ 10mm Specimen Retrieval Bag and ReliaCatch™ 12mm Specimen Retrieval Bag consist of a long cylindrical tube and a rip-stop nylon bag that encapsulates and contains specimens for removal from the body cavity. The device contains a handle used to retract and deploy the bag. The specimen bag is designed for introduction and use through all appropriately sized trocar sleeves.

The provided text describes a 510(k) premarket notification for the ReliaCatch Specimen Retrieval Bag, comparing it to a predicate device. However, it does not contain the detailed acceptance criteria for the device's performance, nor does it present a study proving the device meets specific acceptance criteria in a structured manner.

The document primarily focuses on establishing substantial equivalence to a predicate device based on device description, intended use, and a general summary of performance data. It lists types of performance tests conducted but does not provide the quantitative acceptance criteria or the specific results.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or training set information. This information is not present in the provided document.

The document states:

• "Summary of testing includes description of test methods, sample size, acceptance criteria, and pass/fail results. Objective acceptance criteria were defined for each test."
• "Performance testing included: Leak Rate Evaluation, Trocar Insertion Force, Trocar Removal Force, Pouch Deployment Force, Pouch Retraction Force, Pouch Cinch Force, Pouch Burst Pressure, Human Factors/Usability"

This indicates that such information exists but is not detailed within this FDA letter or the included 510(k) summary.

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The Beacon Bag Specimen Retrieval Bag System consists of a family of impervious bags that are sterile, single use, disposable devices having applications as a receptacle for the safe encapture and removal of tissue specimens, organs and calculi during laparoscopic surgical procedures that can be used alone or with a dedicated introducer system.

The Beacon Bag Specimen Retrieval Bags are comprised of an introducer tube with a blunt tip, flexible fiber reinforced plastic bag with a large, easily accessible opening. With the blunt tip the instruments can be introduced percutaneously to the intended surgical site directly through an opening in the abdomen or through a conduit cannula/trocar for sizes under 16 mm, after which the working portion of the instrument can be deployed. The deployment systems consists of either a push/pull rod with thumb ring (similar to a syringe), finger ring handle, or a back handle and a push button with an internal push rod, all instruments have a blunt tip nose used for direct insertion into the abdomen. In the fully deployed condition, the bag opening is maintained in an open position by metallic rings. A suture with a slipknot and perforations of the bag under where the bag is attached to the rings facilitates closure of the specimen bag after the specimen has been collected into the bag, the suture or purse string is connected to an external part (string ring).. The specimen bag has a series of perforations around the perimeter so when the purse string suture is pulled and the bag starts to cinch and separates from the metallic rings, this is accomplished by pulling the external string ring.

The larger sized Beacon Bag Specimen Retrieval Bags, 16mm and 20mm come with a side access tube which allows for additional access into the bag without compromising the integrity of the bag opening to visualize the specimen inside the bag. This is accomplished by using a 5 mm or less sized instruments and scopes to be introduced directly into the bag for additional visualization and manipulation where required.

The provided text describes a 510(k) premarket notification for the Beacon Bag Specimen Retrieval Bag System. This is a medical device clearance document, not a clinical study report for an AI model. Therefore, the document does not contain the information requested regarding acceptance criteria and study proving an AI device meets those criteria.

Specifically, the document discusses:

• Acceptance Criteria for a Physical Device: The document states "The Beacon Bag Specimen Retrieval Bag utilizes technologies that are currently found in legally marketed predicate devices. Based upon testing and comparison with the predicate devices, the Beacon Surgical Specimen retrieval bag system presents no additional adverse indications or results. We have found that the Beacon Bag Specimen Retrieval Bag system does not present any new risks to the patient and that it is safe and performs within its design specifications." This indicates the acceptance criteria are related to safety, performance within design specifications, and equivalence to predicate devices, which are typical for traditional medical devices.
• Study Proving Device Meets Criteria: The document mentions "The devices components being utilized from the predicate device K111845 have been subjected to and passed a variety of bench tests along with sterilization and aging. Additionally, the critical functions of the device have been tested for verification under protocol's BS-0101 and BS-0102 and have met the stated requirements." This refers to bench testing for a physical medical device, not a study involving AI model evaluation.

Therefore, I cannot provide the requested information in the form of the table and the detailed study parameters because the source material does not describe a study related to an AI device's performance against acceptance criteria. The document is for a physical specimen retrieval bag, not an AI or software as a medical device.

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The GENICON Single-Use Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.

The GENICON Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easily accessible opening, a push-pull rod with thumb ring handle, finger rings, string and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim. A string with a closure suture facilitates closure of the specimen bag after the specimen has been collected. This device is packaged and sterlized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.

The provided document is a 510(k) summary for the GENICON Specimen Retrieval Bag. It details the device's description, indications for use, and a statement about nonclinical tests supporting substantial equivalence to predicate devices. However, it does not contain the specific acceptance criteria or a detailed study report that proves the device meets those criteria, as typically found in a clinical trial or performance study report. The document mentions "Bench Testing and Clinical Evaluation performed (ref. TR-12022-A and CLEV-032-A)," but the details of these tests are not provided in this regulatory submission.

Therefore, for aspects requiring detailed study information, the answer will reflect that the information is "Not Available in the provided text."

Here's an attempt to answer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly list quantitative acceptance criteria or detailed device performance metrics from a study. It only states that "Successful results support a determination of substantial equivalence" for general operation, seal strength peel, and puncture resistance. Without access to TR-12022-A and CLEV-032-A, specific criteria and performance values cannot be extracted.

2. Sample Size for the Test Set and Data Provenance

• Sample size used for the test set: Not available in the provided text. The document mentions "Bench Testing and Clinical Evaluation," but no sample sizes are given for either.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not available in the provided text.

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

• Number of experts: Not available in the provided text.
• Qualifications of those experts: Not available in the provided text.

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

• Adjudication method: Not available in the provided text.

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

• MRMC comparative effectiveness study: Not applicable. This device is a physical specimen retrieval bag, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

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

• Standalone performance study: Not applicable. This device is a physical medical instrument, not a software algorithm.

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

• Type of ground truth: Not available in the provided text. For bench testing, ground truth would likely be established by objective physical measurements according to specified test methods. For clinical evaluation, it would typically relate to the device's ability to safely and effectively retrieve specimens in a surgical setting, which could involve surgical observations, successful specimen retrieval without complications, and potentially pathology results of retrieved specimens. However, the document does not specify.

8. The Sample Size for the Training Set

• Sample size for the training set: Not applicable/Not available. This device is a physical specimen retrieval bag, and the concept of a "training set" is usually associated with machine learning algorithms, which is not applicable here. Even if a design verification/validation process involved iterative testing, the term "training set" as used in AI contexts does not apply.

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

• How the ground truth for the training set was established: Not applicable/Not available, as the concept of a "training set" for a physical device is not relevant in the context of this summary.

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The Mediflex device is a laparoscopic tissue retrieval bag model 24003-MF. The sterile bag is a single use disposable device used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures.

The Mediflex device model 24003-MF is for endoscopic retrieval of tissue. It consists of a sterile pouch bag wrapped in coated paper inside a Tyvek peel pouch that is a single use, disposable and durable device. The pouch bag is made of polyurethane coated polyamide. It is suitable for collection and extraction of tissue through 10, 11 or 12mm cannula during laparoscopic surgical procedures. The sterile pouch bag construction is suitable for function and made for opening and closure during the surgical retrieval process. The outer Tyvek peel pouch is marked with the device identification.

This document describes a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a predicate device rather than "prove" performance against acceptance criteria in the manner of a novel device study. Therefore, the questions related to AI studies, multi-reader multi-case studies, and ground truth for training sets are not applicable here.

Here's an analysis based on the provided text, focusing on how the device demonstrates equivalency rather than meeting specific performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device, K033842 Nubert, and relevant safety and performance standards. The "reported device performance" for the Mediflex 24003-MF is its characteristic comparison to the predicate.

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The MGB LAPBAG sterile retrieval bag for Endoscopic surgery is intended to be used for:

• -General surgery
• Abdominal surgery - .
• Gynecological surgery -
• Thoracic minimally invasive procedures. -

The Specimen Retrieval Bag is indicated for use in endoscopic procedures to allow tissues or debris to be removed from the abdominal cavity.

Not Found

I am sorry, but the provided document does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to MGB Endoskopische Geräte GmbH Berlin regarding their MGB Disposable Retrieval Bag/LAPBAG. It confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, study methodologies, or ground truth details.

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