Search Results

The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices are indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery.

The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with a deployment mechanism. The bag is supplied pre-loaded in the introducer assembly and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment of the bag with the use of the biasing arms.

The provided FDA 510(k) clearance letter for the DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (K250411) does not contain information related to software, artificial intelligence (AI), diagnostic performance, or studies involving human readers or ground truth for diagnostic accuracy.

The document describes a medical device, a specimen retrieval system, and its non-clinical testing to demonstrate substantial equivalence to a predicate device. The information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment is not applicable to a submission for a physical surgical device like this.

Therefore, I cannot populate the requested table or answer the specific questions related to AI-driven diagnostic studies based on the provided text.

Here's a summary of what is available regarding acceptance criteria and studies, framed according to the nature of this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" and "device performance" are primarily related to its physical characteristics, functionality, and safety as compared to a predicate device, rather than diagnostic accuracy.

Given that this is a 510(k) for a physical medical device (a specimen retrieval system) and not an AI/software-as-medical-device, the following points are not applicable as they pertain to AI/diagnostic studies:

2. Sample sizes for test set and data provenance: Not applicable. No test set of diagnostic data was used.
3. Number of experts used to establish ground truth & qualifications: Not applicable. No ground truth for diagnostic accuracy was established.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. No human readers were evaluated for improvement with AI assistance.
6. Standalone (algorithm only) performance: Not applicable. There is no algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. There is no training set for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable.

The "studies" conducted for this device were non-clinical performance and biocompatibility tests to demonstrate the device's physical and material safety and functionality, and its substantial equivalence to a legally marketed predicate device.

Ask a specific question about this device

The DANNIK Specimen Retrieval System is in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery via extracorporeal manual morcellation.

The DANNIK Specimen Retrieval System is contraindicated for laparoscopic power morcellation during gynecologic procedures. The DANNIK Specimen Retrieval System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.

The DANNIK Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with and without a deployment mechanism. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment the bag with the use of the biasing arms.

The DANNIK Specimen Retrieval System is comprised of a flexible plastic bag with and without a deployment mechanism.

The bag is made from polyurethane and/or rip-stop nylon and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The bags come in sizes from 50 to 3000 mL.

The deployment mechanism consists of a push-pull rod and introducer assembly. The push-pull rod consists of a handle, shaft and biasing arms and is made from a combination of Stainless Steel, Nitinol, ABS, and PC. The introducer assembly consists of a tube and is made from ABS and/or PC. The deployment mechanism allows easy insertion through the cannula and full deployment the use of the metallic biasing arms. Introducers range from 5 to 15 mm in diameter.

This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.

Here's a breakdown of the acceptance criteria and study information for the DANNIK Specimen Retrieval System, based on the provided document:

This document describes a 510(k) premarket notification for a medical device. It's important to note that 510(k) clearances are for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials with defined acceptance criteria for disease detection/diagnosis. The "acceptance criteria" here therefore refer to the performance benchmarks against the predicate device in non-clinical settings.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "sample size" for a clinical test set in the traditional sense, as this was a non-clinical bench testing submission. The testing involved comparing the DANNIK Specimen Retrieval System to the predicate device, the Espiner Tissue Retrieval System (K111845), using various bench tests.

• Test Set: Non-clinical bench testing of the DANNIK Specimen Retrieval System.
• Data Provenance: The testing was conducted to demonstrate substantial equivalence to a legally marketed predicate device. The document does not specify the country of origin for the data, but it is for a US FDA submission, implying the tests were conducted under US regulatory guidelines or accepted international standards. The testing is retrospective in the sense that it compares features to an already marketed device, but the actual tests on the DANNIK device would be considered part of a prospective testing plan for the submission.

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

Not applicable. For a 510(k) submission based on non-clinical bench testing, expert consensus for ground truth as seen in diagnostic device studies is typically not required. The "truth" for these tests is defined by established engineering standards and performance specifications for medical devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical ground truth established by experts requiring an adjudication method. The assessment of performance against the predicate was based on objective-bench testing parameters.

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 device is a physical specimen retrieval system, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was performed.

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

Not applicable. This device is a physical specimen retrieval system and does not involve any algorithms or AI for standalone performance evaluation.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering specifications and performance characteristics of the DANNIK Specimen Retrieval System.
• Performance data from the predicate device (Espiner Tissue Retrieval System, K111845) which served as the benchmark for demonstrating substantial equivalence.
• International standards such as ISO 11135 (sterilization) and ISO 10993 (biocompatibility), and ISO 11607 (packaging).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve machine learning or AI, so there is no concept of a "training set" for an algorithm.

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

Not applicable, as there is no training set for an algorithm.

Ask a specific question about this device

The DeRoyal Laprador Specimen Retrieval System is a sterile device intended to be used for collection of tissue, organs, and calculi during laparoscopic surgical procedures.

The DeRoyal Laprador Specimen Retrieval System consists of a handle, a cylindrical tube, a string, and a ripstop nylon bag. The system deploys and retracts the nylon bag, which encloses tissue specimens for retrieval during laparoscopic surgical procedures. The device is designed for introduction and use through appropriately sized trocars. The device is sterilized by ethylene oxide.

Here's a breakdown of the acceptance criteria and the study information for the DeRoyal Laprador Specimen Retrieval System, based on the provided text:

Acceptance Criteria and Device Performance

A table of acceptance criteria and reported device performance is not explicitly detailed with quantitative outcomes in the provided document. The document states that "All tests were performed on the DeRoyal Laprador Specimen Retrieval system, the predicate device, and an additional competitor, Applied Medical Specimen Retrieval System (K100959). The proposed device passed all design verification tests and performed comparable to at least one competitor device, thus demonstrating it meets performance specifications and functions safe and effectively."

However, we can infer the types of performance criteria that were assessed:

Note: The document does not provide specific numerical thresholds for "passing" or detailed comparative metrics (e.g., "bag burst resistance was X Newtons, which exceeded the predicate's Y Newtons"). It only states that the device "passed all design verification tests" and "performed comparable to at least one competitor device."

Study Information

Due to the nature of this document (a 510(k) summary for a specimen retrieval system), the type of study described is a bench testing study for device performance and comparison. It is not a clinical study involving human subjects or AI algorithms. As such, many of the requested fields are not applicable in this context.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated how many units of each device (DeRoyal, Anchor, Applied Medical) were tested for each criterion. The document refers to "bench testing" without detailing the number of units.
   • Data Provenance: The testing was conducted internally or by a contracted lab for DeRoyal Industries, Inc. This is a prospective test in the sense that the new device was built and then tested, but not a prospective clinical trial. The country of origin of the testing itself is not explicitly stated but can be inferred to be associated with DeRoyal's operations (USA or Dominican Republic based on company locations listed).

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

   • Not applicable. This was a bench test of physical device performance, not a diagnostic or interpretive task requiring expert medical opinion to establish ground truth.

3. Adjudication method for the test set:

   • Not applicable. This was a direct measurement/performance test, not a subjective assessment requiring adjudication.

4. 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 medical device; there is no AI component or human reader interpretation involved in its direct function.

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

   • Not applicable. This is a physical medical device without an algorithm component.

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

   • The "ground truth" for this study was the pre-defined performance specifications for each characteristic (e.g., a specific pressure leak rate limit, a minimum puncture resistance). The device either met these objective physical parameters or it did not.

7. The sample size for the training set:

   • Not applicable. There is no AI model or training set involved.

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

   • Not applicable.

Ask a specific question about this device

The Unimax Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

The Unimax Specimen Retrieval System is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Unimax Specimen Retrieval System is supplied in a dispending tube for ease of insertion through a standard 10, 11 or 12mm trocar sheath.

This is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML device performance and studies are not applicable.

Here's an analysis of the provided text regarding the Unimax Specimen Retrieval System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K103510) is a 510(k) premarket notification for a medical device. For such devices, acceptance criteria are typically established through a series of non-clinical tests to demonstrate safety and effectiveness. The document refers to "pre-defined acceptance criteria" but does not explicitly list these criteria or their specific values. Instead, it states that the device "meets the requirements of its pre-defined acceptance criteria."

The performance is described relative to a predicate device (Applied Medical Resources Corporation Specimen Retrieval System, K100959), asserting "substantial equivalence."

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

The document mentions "a series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests" but does not specify the sample sizes used for these test sets. The data provenance is generally "bench testing" and "in vitro and in vivo preclinical tests," which are types of lab or animal studies, not human clinical trial data. There's no indication of country of origin for the internal testing data, but the submitter's address is in Taipei, Taiwan. The studies were prospective in the sense that they were conducted specifically to support this 510(k) submission.

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

This information is not provided in the document. For non-clinical tests on a medical device like this, ground truth is typically established against engineering specifications, material standards, and biological safety standards (like ISO 10993). It is not usually established by human expert consensus in the way it would be for an AI diagnostic tool.

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical and objective, based on measurements against predefined criteria and standards rather than human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI image analysis or diagnostic tools, not for a physical specimen retrieval system. Therefore, an effect size of human improvement with AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No, a standalone algorithm study was not done. This device is a physical surgical tool and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests (physical, mechanical, biocompatibility) would be based on established engineering specifications, material science standards, and accepted biological safety standards (e.g., ISO 10993). For instance, a tensile strength test would have a pre-defined ground truth for the minimum acceptable strength. Biocompatibility would be evaluated against the absence of adverse biological reactions as defined by ISO standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML system that requires a "training set."

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

Not applicable. (See point 8).

Ask a specific question about this device

The Applied Medical Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

The Applied medical specimen Retrieval System is a disposable receptacle used to collect and extract tissue, organs and calculi during laparoscopic procedures. It consists of a flexible polymer bag and an introducer structure that fits through a trocar port. Extracorporeal activation of the introducer handle ejects the flexible bag which automatically opens in preparation for receipt of the specimen. The device is constructed of various polymers and stainless steel. It is packaged in a Tyvek/Mylar peel pouch and a product shelf pack. The shelf pack will be sterilized using gamma irradiation per AAMI/ISO guidelines. Sterility Assurance Level will be 10°.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Applied Medical Specimen Retrieval System (K100959):

Overall Assessment:

The provided document is a 510(k) summary for a medical device. For this type of submission, the "acceptance criteria" are not typically presented as quantitative performance metrics that the device must meet to be considered "accepted." Instead, the key acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device. This substantial equivalence is primarily shown through a comparison of technological characteristics and, crucially, through non-clinical testing that confirms the new device's safety and effectiveness compared to the predicate.

The "study" described is not a typical clinical trial or a performance study that generates specific statistical metrics like sensitivity, specificity, or accuracy that would be used to meet predefined quantitative acceptance criteria. Instead, it's a comparative non-clinical testing program designed to show that the new device performs similarly to the predicate.

Acceptance Criteria and Reported Device Performance

Additional Information on the Testing ("Study")

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state the numerical sample size (e.g., number of test specimens, number of devices tested) for the functionality, robustness, and bag strength tests. It only refers to "test methods" and "test results."
   • Data Provenance: The testing was conducted by Applied Medical. It is non-clinical/bench testing, not involving human subjects. The country of origin of the data is not specified but assumed to be the United States, given the company's location and FDA submission. It is by definition a prospective test of the newly manufactured device.

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

   • Not applicable. This was a non-clinical, bench testing study. "Ground truth" in the clinical sense (e.g., expert diagnosis) is not relevant here. The ground truth for performance was established by engineering specifications and comparative testing against the predicate device.

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

   • Not applicable. As a non-clinical bench test, there was no expert adjudication process for establishing a "ground truth" outcome. Test results were likely directly measured against predetermined engineering criteria or predicate device performance.

4. 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 device is a specimen retrieval system, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was conducted or relevant.

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

   • Not applicable. This is a physical medical device, not a software algorithm.

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

   • For the non-clinical testing, the "ground truth" was established by:
     • Engineering specifications and design requirements: For functionality, robustness, and bag strength.
     • Predicate device performance: The "ground truth" for acceptable performance was essentially defined by the performance characteristics of the legally marketed predicate device (K060051), as the goal was to demonstrate substantial equivalence.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this device. This is a physical medical device, not a machine learning model.

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

   • Not applicable. As no training set was used.

Ask a specific question about this device

The Applied Medical Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

The Applied Medical Specimen Retrieval System is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch, which is standard packaging material for Applied's products. The packaged product is then placed in an outer product shelf pack. The Applied Medical disposable Specimen Retrieval System will be sterilized using Cobalt 60 Gamma Radiation, AAMI/ISO Guideline for Radiation Sterilization will be utilized to provide a Sterility Assurance Level of 106.

This document is a 510(k) Summary for a medical device called the "Specimen Retrieval System" by Applied Medical Resources Corporation. It describes the device's intended use and indicates that it has been found to be "substantially equivalent" to predicate devices.

Based on the provided text, a detailed study proving the device meets acceptance criteria in the way you've described for AI/diagnostic devices is not available or applicable. The document focuses on regulatory clearance for a physical medical device, not a diagnostic algorithm.

Here's a breakdown of why many of your questions cannot be answered from this document, and what limited information is available:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The primary acceptance criterion mentioned is for biocompatibility: "The Specimen Retrieval System has been found non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices."
• Reported Device Performance:
  • Biocompatibility: Non-irritant (per ISO 10993, Part I).
  • Sterilization: Will be sterilized using Cobalt 60 Gamma Radiation, meeting AAMI/ISO Guideline for Radiation Sterilization to provide a Sterility Assurance Level of 10⁻⁶.
  • Clinical Utility: Stated to be equivalent to predicate devices in "design methodology, principle of operation and clinical utility," and introduces "no new safety or effectiveness issues." This is a regulatory statement for substantial equivalence, not a performance metric from a clinical study.

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

• Not applicable / Not provided. The document does not describe a "test set" in the context of diagnostic performance data. The ISO 10993 testing would involve specific biological samples, but the size or provenance of these are not detailed here.

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 / Not provided. This device is a physical tool; there is no "ground truth" to be established by clinical experts in the manner you're describing for a diagnostic device.

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

• Not applicable / Not provided.

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. This is a physical specimen retrieval system, not an AI or diagnostic tool. MRMC studies are not relevant here.

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

• No. This is a physical device, not an algorithm.

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

• Not applicable. The "ground truth" for this device relates to its physical and biological properties (e.g., sterility, biocompatibility, structural integrity for its intended use), which are confirmed through engineering and biological testing, not clinical "ground truth" as you'd define for a diagnostic.

8. The sample size for the training set.

• Not applicable / Not provided. There is no "training set" for this type of device.

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

• Not applicable / Not provided.

Summary of what the document does provide regarding device evaluation:

The evaluation described in this document is for a Class II medical device (Endoscope and accessories, Product Code: GCJ) seeking 510(k) clearance based on substantial equivalence to existing predicate devices.

The "study" that proves the device meets the acceptance criteria primarily consists of:

• Biocompatibility Testing: According to ISO 10993, Part I, demonstrating the device is non-irritant. (The scope and "sample size" for this specific test are not given).
• Sterilization Validation: A commitment to use Cobalt 60 Gamma Radiation and adhere to AAMI/ISO Guideline for Radiation Sterilization to achieve a Sterility Assurance Level of 10⁻⁶. This implies that sterilization validation studies (which involve a specific "sample size" of devices and test organisms) would have been performed or are planned, but the details are not in this summary.
• Comparison to Predicate Devices: The core of 510(k) clearance is demonstrating that the new device is "substantially equivalent" in design, principle of operation, and clinical utility, and introduces "no new safety or effectiveness issues." This is a regulatory comparison rather than a separate clinical study with specific performance metrics.

In essence, this document is a regulatory submission for a physical medical device, not a performance study for a diagnostic or AI-driven system, hence the lack of information pertaining to many of your questions.

Ask a specific question about this device