(136 days)
The STORZ DP4801, DP4800, and DP4801VP surgical accessory packs contain a vitrectory probe and attached tubing set to be used in conjunction with the STORZ PREMIERE® or DAISY® Microsurgical Systems in the performance of posterior vitrectomy.
The STORZ DP4801, DP4800, and DP4801VP surgical accessory packs contain a vitrectory probe and attached tubing set to be used in conjunction with the STORZ PREMIERE® or DAISY® Microsurgical Systems in the performance of posterior vitrectomy.
The provided text describes a Premarket Notification (510(k) Summary of Safety and Efficacy for STORZ Instrument Company's DP4801, DP4800, and DP4801VP posterior vitrectomy packs. This document is a regulatory submission for medical devices, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria in the typical sense of a performance evaluation study for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and studies proving the device meets those criteria, especially in terms of clinical performance or AI-related metrics, is not applicable or present in this document.
However, I can extract information related to the device characteristics and the comparison to predicate devices, which implicitly serve as acceptance criteria for regulatory clearance based on substantial equivalence.
Here's an attempt to answer the questions based only on the provided text, noting where information is not available:
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A table of acceptance criteria and the reported device performance
In the context of a 510(k) submission, "acceptance criteria" are generally the characteristics of the predicate device that the new device must match or be equivalent to. The "reported device performance" is the new device's characteristics. The document presents this directly in the "DEVICE COMPARISON CHART".
DEVICE CHARACTERISTIC Acceptance Criteria (Predicate Devices: Storz MVS3201, DP4400, DP4400VP PACK) Reported Device Performance (Storz DP4801, DP4800, DP4801VP PACK) Pack Contents Vitrectomy Probe with Tube Set Vitrectomy Probe with Tube Set and Collection Cassette (and Deluxe Accessories for DP4800) Indication For Use Anterior Vitrectomy Posterior Vitrectomy Ophthalmic Surgical System to be Used STORZ PREMIERE®, Protegé, and DAISY® Systems STORZ PREMIERE® and DAISY® Systems Probe Cutting Mechanism Type Guillotine Guillotine Probe Drive Mechanism Type Pneumatic Pneumatic Does Probe Cutter Open When Turned Off As A Safety Measure? YES YES Probe Needle Size 20 Gauge 20 Gauge Patient Contact Materials Type 304 Stainless Steel Type 304 Stainless Steel Instructions For Use Included in Pack? YES YES Labeled For Single Patient Use Only? YES YES Labeled Per 21CFR §801.109(b)? YES YES Provided Sterile? YES YES Packaging PETG Tray with TYVEK Lid PETG Tray with TYVEK Lid Note: The "Indication For Use" is explicitly different (Anterior vs. Posterior Vitrectomy), which is often a key point in 510(k) reviews requiring further justification, but the document claims substantial equivalence. The pack contents also differ, but are presented as acceptable variations.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a "test set" in the context of a performance study with patient data. It is a comparison of device characteristics. Therefore, this information is not applicable/provided.
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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)
As there is no "test set" or clinical performance evaluation described, there are no experts establishing ground truth for a test set. This information is not applicable/provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
As there is no "test set" or clinical performance evaluation described, there is no adjudication method. This information is not applicable/provided.
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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
This document describes surgical accessory packs, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI-related effectiveness is discussed. This information is not applicable/provided.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes surgical accessory packs, not an algorithm. Therefore, no standalone algorithm performance is discussed. This information is not applicable/provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No clinical performance study requiring "ground truth" is described in this document. The "ground truth" for this 510(k) submission relates to the physical and functional characteristics of the devices being compared, as documented by the manufacturer. This information is not applicable/provided in the context of clinical outcomes.
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The sample size for the training set
This document describes surgical accessory packs and does not involve AI or machine learning models that would require a "training set." This information is not applicable/provided.
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How the ground truth for the training set was established
As there is no training set, this information is not applicable/provided.
§ 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.