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The Resects Tissue Resection Device is intended for intrauterine use by physicians trained in hysteroscopy to resect and remove tissue, including focal lesions such as endometrial polyps.

The Resectr device is a non-powered manual hysteroscopic surgical instrument used to resect and remove tissue under direct visualization. The device is supplied sterile for single use only. The device is offered in two sizes (5F and 9F) for compatibility with hysteroscopes with a 1.65mm or 3.0mm working channel respectively. The Resectr devices consist of a handle that is manually squeezed and released to actuate a blade within the resecting window to resect and remove target tissue. The devices are provided assembled with a vacuum tube port for use with a suction source. As tissue is resected, it is evacuated through the length of the device and out the vacuum tube port.

The provided document is a 510(k) Summary for the Resectr™ Tissue Resection Device. It describes the non-clinical performance data and conclusion drawn from this data to demonstrate substantial equivalence to a predicate device. However, it does not include specific acceptance criteria values or detailed results of a study to prove the device meets these criteria in the format requested (i.e., a table comparing acceptance criteria to reported device performance). It also does not mention any studies involving human readers or AI.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be extracted:

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

   • The document states: "All testing performed met the predefined acceptance criteria." However, the document does not specify what those predefined acceptance criteria were for each test, nor does it provide the reported device performance values.
   • It lists performance tests conducted, but not the acceptance criteria or results.

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

   • This information is not provided in the document. The document refers to "samples aged at T=0 and T=3 years accelerated aging" for mechanical testing, but not specific sample sizes for each test.

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/provided. The studies described are non-clinical (biocompatibility, sterilization, package integrity, mechanical performance). There is no mention of experts establishing ground truth for a test set in the context of diagnostic or interpretive performance.

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

   • This information is not applicable/provided for the same reasons as point 3.

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/provided. The document describes a medical device for tissue resection, 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/provided. The device is a manual surgical instrument, not an algorithm.

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

   • This information is not applicable/provided in the context of diagnostic ground truth. The "ground truth" for the non-clinical tests would have been established by validated testing methods and specifications (e.g., a specific tensile strength value that must be met, a specific sterility assurance level).

8. The sample size for the training set

   • This information is not applicable/provided. The device is a physical instrument, not an AI model requiring a training set.

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

   • This information is not applicable/provided for the same reason as point 8.

Summary of available information from the document:

The study conducted was a series of non-clinical tests performed on the Resectr™ Tissue Resection Device to demonstrate its safety and effectiveness and support a determination of substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size: Not explicitly stated, though it mentions "samples aged at T=0 and T=3 years accelerated aging" for mechanical testing.
• Data provenance: Not explicitly stated, but assumed to be from Boston Scientific's internal testing facilities, likely in the US (given the company's location). The data is retrospective in the sense that it was generated prior to submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable; these were non-clinical engineering and biological tests, not medical diagnostic studies requiring expert consensus as ground truth.

4. Adjudication method for the test set:
* Not applicable.

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 medical device, not an AI system.

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

7. The type of ground truth used:
* For biocompatibility: established by standardized biological testing methods.
* For sterilization: established by standardized sterility assurance level (SAL) methods.
* For package integrity: established by standardized ASTM test methods and specifications.
* For mechanical performance: established by pre-defined engineering specifications and test methods.

8. The sample size for the training set:
* Not applicable; this is a physical medical device.

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

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