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510(k) Data Aggregation
(145 days)
HTx disposable hysteroscope system is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
The HTx Disposable Hysteroscope System is a single use hysteroscope endoscope intended for gynecology procedure applications. It includes a disposable cannula module, a reusable imaging system, a medical grade display and optional software for processing patient management. The disposable cannula contains a miniature complementary metal-oxide-semiconductor (CMOS) camera, a light-emitting diode (LED) illumination module, and a channel for fluid and device. The cannula connects directly to the image system via an image cable. The cannula also contains three (3) buttons for video recording, picture taking, and light-emitting diode (LED) brightness control. The image system connects to a medical grade display module via DVI port. The external patient management software runs on an external PC that connects with the image system via LAN cable.
This document is a 510(k) premarket notification for the AcuVu HTx Disposable Hysteroscope System, indicating that the device is a Class II medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (AcuVu GDT-1000, K180096) rather than detailing a clinical study with specific acceptance criteria and performance metrics for an AI-powered device.
Therefore, many of the requested categories for AI-specific studies are not applicable or cannot be extracted from this document, as the HTx Disposable Hysteroscope System, as described, does not appear to be an AI-powered device in the sense of an algorithm for diagnostic or prognostic purposes. It is a traditional medical imaging device (hysteroscope) for viewing the cervical canal and uterine cavity.
Here's an attempt to answer the questions based on the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with numerical performance metrics for a diagnostic or AI algorithm. Instead, it lists various non-clinical tests performed to ensure the device meets safety and functional requirements. The "acceptance criteria" can be inferred as compliance with the listed standards and demonstrating acceptable results in the tests.
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11135:2014 (Ethylene Oxide Sterilization) | Validation performed in accordance with ISO 11135:2014. (Implies successful sterilization and packaging) |
| Biocompatibility | FDA guidance "Use of International Standard ISO 10993-1," "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Specific tests: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017), Material Mediated Pyrogenicity (ISO 10993-11:2017). | Results demonstrated the subject device is non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic, and non-pyrogenetic. |
| Electromagnetic Compatibility/Electrical Safety | IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2 | Device was tested and found to be compliant with these standards. |
| Optical Performance | ISO 8600-1:2015 (General requirements), ISO 8600-3:2019 (Determination of Field of View and Direction of View), IEC 62471:2006 (Photobiological safety), IEC 60601-2-18:2009 (Endoscopic equipment specific requirements). Specific parameters mentioned in comparison table: FOV > 115 degrees, DOV: HTx 60: 12 Degrees, HTx40: 8 degrees, Image resolution: 400x400 (160,000) pixels. | Optical performance (direction of view, field of view, distortion/resolution, luminous flux, color performance, photobiological safety), optical safety, and thermal safety testing were conducted in accordance with the listed standards. The functional comparison table states: FOV>115 degrees (Same as predicate), DOV: HTx 60: 12 Degrees, HTx40: 8 degrees (Different DOV from predicate, which was 0 degree). Image resolution: 400x400 (160,000) pixels (Same as predicate). This implies the performance meets the requirements set by these standards and comparison to the predicate device. |
| Software | FDA's 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Device (for a Moderate Level of Concern device) | Software documentation provided in support of the subject device as per the guidance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes technical and performance testing of a physical medical device (hysteroscope), not a clinical study on a patient population with a "test set" of data in the AI sense. No patient sample sizes or data provenance (country, retrospective/prospective) are mentioned. The testing involves laboratory verification and validation activities.
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. As noted above, this is not an AI-powered diagnostic device undergoing a clinical study with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document does not describe a clinical study requiring an adjudication method for 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
Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance. This document concerns a hysteroscope, which is an imaging device, not an AI algorithm assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For the technical and performance testing described, the "ground truth" is measured against engineering specifications and international standards (e.g., optical properties, sterility, biocompatibility).
8. The sample size for the training set
Not applicable. This device does not use an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use an AI algorithm that requires a training set and associated ground truth.
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