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510(k) Data Aggregation
(143 days)
The IOB Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures. It may be used with or without a removable light source.
The IOB disposable vaginal speculum consists of up and under plastic blades and handle with three different sizes (smail, medium and large). The speculum is used by medical professionals to visualize interior of vagina and cervix during patient examination.
The provided 510(k) summary does not contain the level of detail typically found in a clinical study report for AI/CADe devices. This device is a disposable speculum, a physical medical instrument, not an AI/CADe system. Therefore, the information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not directly applicable in the same way it would be for a software-based diagnostic tool.
However, I can extract the relevant information regarding performance and acceptance based on the content available for this physical device.
1. Table of Acceptance Criteria and Reported Device Performance
For this physical device, acceptance criteria relate to its physical properties, manufacturing, and biological safety, rather than diagnostic accuracy metrics like sensitivity or specificity. Performance is primarily about functionality and equivalence to a predicate device.
| Category | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Suitable for limited contact duration (per FDA G95-1 and ISO 10993-1 requirements for cytotoxicity, irritation, and sensitivity). | "Biocompatibility testing (cytotoxicity, irritation and sensitivity) according to ISO 10993 for a limited contact device was demonstrated to be suitable for the intended use of the product." |
| Functional Performance | Able to survive stresses encountered during use without failure; performs equivalently to the predicate device. | "Bench testing was performed by simulating actual usage comparing the device with the predicate speculum. The testing results show that the new device performs equivalent to the predicate device. Both bench testing and stability study show that the device is able to survive stresses encountered during use without failure." |
| Material | Constructed from commonly used medical-grade polystyrene. | "The new device is constructed using polystyrene that is commonly used by the medical device industry for like and similar devices." (Implies meeting industry standards for material suitability). |
| Intended Use | Same as predicate device (dilate vagina, expose interior of vagina and exterior of cervix). | "The IOB Disposable Speculum has the same technological characteristics and indications for use as the predicate device." "The IOB Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures." |
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 applicable and not provided in the document. The device is a physical speculum; its testing involved "bench testing" and "stability study" simulating usage, not a clinical "test set" with patient data in the typical sense of a diagnostic algorithm.
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 is not applicable and not provided. "Ground truth" in the context of this device's testing would relate to physical performance metrics (e.g., structural integrity, ease of use), not diagnostic interpretation by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations of diagnostic data, which is not what was performed for this physical device.
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 is not applicable. An MRMC study is relevant for evaluating the impact of AI/CADe systems on human reader performance for diagnostic tasks. This device is a physical instrument, not an AI/CADe system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical speculum and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for performance would likely be based on:
- Biocompatibility Standards: Adherence to ISO 10993 standards.
- Engineering Specifications: Meeting pre-defined physical strength, flexibility, and dimensional requirements.
- Predicate Device Comparison: Functional equivalence observed during simulated usage against the predicate device.
8. The sample size for the training set
This is not applicable. The concept of a "training set" refers to data used to train an AI algorithm. This device is a physical instrument.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a physical device.
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