(69 days)
The Storz E8010 ErgoTec™/Premiere® Adaptor is a new device accessory designed to adapt the Storz ErgoTecTM Vitreoretinal Instrument Tips to the Storz D7108 Microscissors Handpiece for general use in posterior segment vitreoretinal ophthalmic surgery.
The Storz E8010 ErgoTec™/Premiere® Adaptor is composed of stainless steel and serves to allow connection of the existing Storz D7108 Microscissors Handpiece to the existing Storz ErgoTecTM Vitreoretinal Instrument Tips. The adaptor features an anterior rotation knob which allows the tip to be adjusted into optimal alignment.
The provided document is a 510(k) summary for the Storz E8010 ErgoTec™/Premiere® Adaptor. This type of document is for a medical device regulatory submission and focuses on demonstrating substantial equivalence to a predicate device, not on presenting results of a study that establishes acceptance criteria for performance metrics in the way one might see for an AI/ML medical device.
Therefore, the information requested in your prompt (e.g., acceptance criteria, device performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this document as it describes a physical surgical instrument accessory, not a software-based or AI/ML device.
The document primarily provides:
- Device Description and Intended Use: The adaptor allows existing Storz ErgoTec™ Vitreoretinal Instrument Tips to be used with the Storz D7108 Microscissors Handpiece.
- Predicate Device: Storz D7108 Microscissors Handpiece (K960061), and Storz CX7100 and CX7150 Microscissors Handpieces (K961310).
- Predicate Comparison Table: This table compares the characteristics of the new device (Storz D7108 Microscissors HP with the new adaptor) to the predicate devices, highlighting similarities in intended use, materials, mechanism, and compatibility. The purpose of this comparison is to establish substantial equivalence for regulatory approval, not to demonstrate performance against specific numerical acceptance criteria.
To directly answer your prompt based on the provided text, but acknowledging the difference in device type:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for a 510(k) submission): Substantial equivalence to predicate devices in terms of intended use, technological characteristics (materials, design, function), and safety/effectiveness. There are no explicit numerical performance criteria stated for this mechanical adaptor.
- Reported Device Performance: The device performs its intended function of adapting the ErgoTec tips to the D7108 handpiece, allowing for cutting and manipulation of posterior intraocular tissue, similar to the predicate devices. The comparison chart asserts equivalency across numerous features (see provided table in the document).
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Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML algorithm requiring a data test set. Its safety and effectiveness are established through comparison to a legally marketed predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance evaluation is not relevant here. The "ground truth" for a physical device like this is its physical properties, functionality, and established safety/effectiveness (or that of its predicate).
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Adjudication method for the test set: Not applicable.
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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 not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical instrument adaptor.
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The type of ground truth used: Not applicable. For this type of device, the "ground truth" is typically engineering and materials testing, biocompatibility assessments (if new materials), and a demonstration of equivalent function to predicate devices, rather than a clinical "ground truth" for diagnostic accuracy.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.