(90 days)
The Pick Manipulator is a manual tool for aiding the procedural needs of the surgeon during ophthalmic surgery, such as tissue manipulation and membrane delamination.
Hand-held illuminated pick and membrane delamination instrument for ophthalmic surgery.
The Infinitech Bullet® Endo Illuminated Pick Manipulator is a manual tool intended for ophthalmic surgery, specifically for tissue manipulation and membrane delamination. The provided 510(k) summary does not include a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or any quantitative measure of effectiveness.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on device type, intended use, patient contact materials, and manufacturing/sterilization processes. The concept of "effectiveness" mentioned in the summary is broad and stated as: "The instrument is constructed of commonly used materials for ophthalmic surgical instruments and is configured in a common tool geometry." This implies that its effectiveness is assumed based on its similarity to existing, legally marketed devices.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be found in the provided document because the 510(k) pathway for this device did not require such a study to demonstrate performance against explicit acceptance criteria.
Below is the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, there are no explicit quantitative acceptance criteria or detailed performance metrics reported for the Infinitech Bullet® Endo Illuminated Pick Manipulator. The "effectiveness" is stated qualitatively by comparing it to predicate devices. The acceptance was based on "substantial equivalence" to predicate devices.
| Acceptance Characteristic | Predicate Device Information | Infinitech Bullet® Endo Illuminated Pick Manipulator Reported Performance |
|---|---|---|
| Device Type | Peregrine Wide Angle Light Pipe: Manual Wide Angle Fiber Optic Light | |
| Peregrine Pic Manipulator: Manual Manipulator | Manual Manipulator With Wide Angle Fiber Optic Light | |
| Indications for Use | Ophthalmic Surgery (for both predicate devices) | Ophthalmic Surgery (specifically tissue manipulation and membrane delamination) |
| Patient Contact Materials | Peregrine Wide Angle Light Pipe: Surgical Steel, Surgical Fiber Optics | |
| Peregrine Pic Manipulator: Surgical Steel | 304 Stainless Steel, Acrylic & Fluoropolymer | |
| Sterilization Method | Not Known (for both predicate devices) | Validated EtO |
| Packaging | Not Known (for both predicate devices) | Validated Heat Sealed Tyvek |
| Labeling | Not Known (for both predicate devices) | YES (per 21CRF 801.109) |
| Safety | The predicate devices were legally marketed. | "The instrument is constructed of commonly used materials for ophthalmic surgical instruments and is configured in a tool geometry familiar to surgeons. The patient contact materials raise no questions regarding toxicity or biocompatibility." |
| Effectiveness | The predicate devices were legally marketed. | "The instrument is constructed of commonly used materials for ophthalmic surgical instruments and is configured in a common tool geometry." |
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. No clinical or performance study involving a test set with human or patient data is described in the provided document for the purpose of demonstrating device performance against specific metrics. The device's substantial equivalence was based on a comparison of its design and intended use to existing predicate devices.
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. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there was no test set in the context of device performance evaluation.
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 device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual surgical instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in the context of performance evaluation was used or described.
8. The sample size for the training set
Not applicable. This is a manual surgical instrument; there is no training set involved in the context of machine learning or algorithm development.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, the establishment of ground truth for it is not relevant.
§ 886.1945 Transilluminator.
(a)
Identification. A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.(b)
Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.