(76 days)
The Storz DP4600 surgical accessory pack contains an Anterior Intraocular Pressure (IOP) Tube Set Assembly. This component is to be used as an accessory to the Storz PREMIERE® (K894278. K921460, and K946227) and Storz DAISY™ (K854508) Microsurgical Systems in the maintenance of intraocular pressure (IOP) during anterior segment ophthalmic surgical procedures.
The DP4600 is a standard irrigation administration tube set with an additional line that connects the irrigation bottle to an air port on the microsurgical system console. Controlled positive air pressure from the system pressurizes the irrigation bottle and delivers the irrigation fluid at the user-selected rate.
This document is a 510(k) summary for a medical device called the "Storz DP4600 Anterior Intraocular Pressure Control Pack." It primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study demonstrating it meets specific acceptance criteria for performance.
Therefore, many of the requested sections (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, training set details) are not applicable or extractable from this particular document, as it describes a regulatory submission for a device accessory, not a clinical performance study with predefined acceptance criteria.
However, I can extract the following information that is present:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of "acceptance criteria" and "reported device performance" in the typical sense of a clinical or technical validation study with quantitative performance metrics. Instead, it presents a comparison chart against predicate devices to demonstrate substantial equivalence. The "performance" being assessed here is in terms of design, intended use, components, and basic operational features, not clinical outcomes or specific quantitative performance thresholds.
Here's how we can interpret the provided chart in the context of "criteria" and "performance" for a substantial equivalence claim:
| Criteria (Feature for Comparison) | Storz DP4600, modified (Proposed Device Performance) | Acceptance (vs. Predicate) |
|---|---|---|
| Intended Use | Controlled Delivery of Irrigation Solution during Anterior Segment Ophthalmic Surgery | Matches predicate DP4600 existing, similar to DP4101 (which also removes aspirant) |
| Components | IOP Tube Set, with irrigation administration line and filtered air line, and Instruction Sheet | Matches predicate DP4600 existing, different from DP4101 (which includes I/A tubing, test chamber, collection cassette) |
| Manual Adjustment of Flow? | Yes | Matches both predicate devices |
| Flow Control Variable | Irrigation Reservoir Pressure | Matches predicate DP4600 existing, different from DP4101 (Irrigation Reservoir Height) |
| Single Patient Use? | Yes | Matches both predicate devices |
| Provided Sterile? | Yes | Matches both predicate devices |
| Sterilization Method | Gamma Irradiation | Matches both predicate devices |
| Packaging | Singly in Tyvek® / PET Pouch, Ten pouches per Box | Different from both predicate devices (which use high-impact polystyrene trays with Tyvek® lids) |
Notes on Interpretation:
- The table above is constructed from the "DEVICE COMPARISON CHART" to highlight how the proposed device (Storz DP4600, modified) compares to its predicates on various attributes.
- "Acceptance" here means demonstrating "substantial equivalence" based on these comparative features, not statistical acceptance of a performance metric against a predefined threshold.
- The primary "study" is the comparison itself, aiming to show that the proposed device is as safe and effective as the legally marketed predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This document does not describe a clinical study or a technical performance test set in the traditional sense. The "test set" is the proposed device being compared to predicates.
- Data Provenance: Not applicable. There is no patient data or test data described.
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 for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is described.
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 is not an AI/imaging device, nor does it describe an MRMC comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" sought here is the established safety and effectiveness of the predicate devices based on their prior 510(k) clearances. The proposed device's "truth" is its substantial equivalence to those well-established devices.
8. The sample size for the training set
- Not applicable. No training set is described as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. No training set is described.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.