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The MaxiFlex Semi Flex Scopes are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. Device may be re-used and re-sterilized by the EtO sterilization process up to 3 times

The Maxi-Flex Semi Flex Scopes™ is flexible endoscope that allows operator-controlled deflection of the distal end or tip of the scope. The devices will be made available in lengths (25 cm and 65 cm), each length with a working channel. With a Maxi-Flex accessory a 'Y Port' the working channel may be utilized as an irrigation channel.

The provided text describes a 510(k) premarket notification for the "Maxi-Flex Semi-Flex Scopes" device. The acceptance criteria and the study proving the device meets those criteria are primarily related to its reusability after sterilization.

Here's an analysis of the requested information:

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

*Note: There is a discrepancy between the "Testing" section which states "four (4) EtO sterilization cycles without any degradation" and the "Indications for Use Statement" which specifies "up to 3 times." The FDA's letter mentions "for the indications for use stated in the enclosure," which would imply the 3 times limit is the accepted one for marketing.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: The document mentions "four (4) EtO sterilization cycles" as the test to prove reusability. It does not explicitly state how many individual Maxi-Flex Semi-Flex Scopes were subjected to these cycles. It's implied that at least one device was tested.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted internally by Maxi-Flex, LLC as part of their submission. It's a prospective test specifically for this submission.

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

This information is not provided in the document. The testing described is a performance/durability test of the scope itself, not a diagnostic device requiring expert interpretation of results. It likely involved engineering and quality control personnel within Maxi-Flex, LLC, rather than medical experts to establish a "ground truth" in the clinical sense.

4. Adjudication method for the test set

This information is not applicable/provided. The testing was a direct measurement of the device's ability to withstand sterilization cycles without degradation, not a subjective clinical assessment requiring adjudication.

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. This is a medical device (endoscope), not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

This information is not applicable/provided. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this performance test was defined by the original design specifications of the device. The test aimed to show that the device, after multiple sterilization cycles, still met these predefined engineering and functional specifications.

8. The sample size for the training set

This information is not applicable/provided. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

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

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The MaxiFlex Semi Flex Scopes™.are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures

Not Found

I am sorry, but this document is a 510(k) premarket notification letter from the FDA to Technology Delivery Systems, Inc. regarding their MaxiFlex-Semi Flex Scope.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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The MaxiFlex - Fiberoptic Energy Delivery System is designed to deliver lase energy to perform: general surgical, dermatological, intraoral soft tissue, orthopaedic, maxillo-facial, and cosmetic surgery. The MaxiFlex fiber is intended for energy delivery for ablating, incising, excising, vaporization and coagulation of soft tissues within the medical/surgical specialties noted above using a contact fiber optic based laser system.

The device is suitable for use for all applications for which the laser output unit is cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.

The delivery fiber cables, consist of multi-mode, single core optical fibers available in 200, 400, and 1000um diameters. The standard SMA 905 fiber connector terminates one end of the delivery fiber, which is attached to the SMA union at the rear panel of the laser box. The fiber is stripped of its protective jacket in accordance with the laser manufacturers instructions and is cleaved to provide laser radiation output.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MaxiFlex Fiberoptic Energy Delivery System:

This document is a 510(k) premarket notification for a medical device seeking substantial equivalence to already legally marketed devices. It's important to understand that 510(k) submissions generally do not involve new clinical studies or elaborate performance testing to establish novel acceptance criteria. Instead, they demonstrate that a new device is as safe and effective as a predicate device through comparison of features, materials, and intended use.

Therefore, the concept of "acceptance criteria" in this context is primarily about demonstrating that the MaxiFlex Fiberoptic Energy Delivery System's features, functional specifications, and intended uses are substantially equivalent to those of the identified predicate devices without raising new questions of safety or effectiveness. The "study" proving this is essentially the comparative analysis presented in the document itself.

Here's the breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The "study" presented here is a premarket notification (510(k)) submission's comparative analysis for substantial equivalence. It does not involve a traditional clinical efficacy study with quantitative patient outcomes.

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

• Test Set Sample Size: Not applicable in the context of a 510(k) substantial equivalence submission for this type of device. There isn't a "test set" of patient data in the sense of a clinical trial. The "test" is the comparison of the new device's specifications and intended use against those of legally marketed predicate devices.
• Data Provenance: The data provenance comes from the publicly available specifications and intended uses of three predicate devices: StrateFire, InnovaQuartz, and one labeled "SE?". These are legally marketed devices in the United States. The data about the MaxiFlex device is provided by the manufacturer (Technology Delivery Systems, Inc.). This is a retrospective comparison against existing device information.

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

• Number of Experts: Not explicitly stated or applicable in the traditional sense. The "ground truth" for a 510(k) comparison is regulatory clearance of the predicate devices and the technical specifications provided by their manufacturers (and the applicant for the new device). FDA reviewers (medical officers, engineers, etc.) with relevant expertise are the ones who assess the substantial equivalence.
• Qualifications of Experts: FDA scientific and regulatory staff are the "experts" who determine if the device is substantially equivalent to predicates based on the provided technical and descriptive information. Their qualifications would include relevant scientific and medical backgrounds (e.g., engineering, medical physics, clinical specialties).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no qualitative assessment of a test set by multiple experts requiring adjudication. The comparison is based on objective technical specifications and intended uses as detailed in the submission. The FDA makes the final determination of substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to assess human reader performance (e.g., radiologists interpreting images) with and without AI assistance, which is not relevant for a surgical fiberoptic energy delivery system in a 510(k) submission.

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

• Standalone Performance Study: No, a standalone performance study (algorithm only) was not done. This device is a physical instrument (fiberoptic cable) for delivering laser energy, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used here is the established regulatory clearance and publicly available specifications/intended uses of the predicate devices. The manufacturer of the MaxiFlex device asserts that its device is equivalent to these legally marketed devices in terms of its characteristics and intended applications. The FDA then verifies this assertion based on the submitted documentation.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. As this is not an AI/machine learning device, there is no "training set" in that context. If interpreted as internal testing data for the MaxiFlex fiber itself, this document does not specify any sample sizes for design verification or validation testing. A 510(k) relies on comparison to predicates and adherence to recognized standards, rather than new extensive clinical trials for devices of this nature.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for an AI/ML algorithm involved. For the predicate devices, their "ground truth" (i.e., their safety and effectiveness) was established through their own regulatory clearance processes, which might have involved different types of testing or comparisons depending on their original classification and pathway to market.

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