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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.

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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.

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