(83 days)
The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures.
The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460 and K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures.
This document is a 510(k) summary for a medical device (Storz DP5100 Anterior Collection Cassette Pack) and does not contain information about studies related to device performance against specific acceptance criteria in the way you've described (e.g., accuracy, sensitivity, specificity for an AI/diagnostic device).
The context of this document is a regulatory submission demonstrating substantial equivalence to existing predicate devices, rather than a clinical performance study with predefined acceptance criteria for a diagnostic or AI-driven medical device.
Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader studies because these details are not present in the provided text.
The document primarily focuses on:
- Device Description and Intended Use: What the device is and what it's for.
- Predicate Device Comparison: Showing how the new device is "substantially equivalent" to already-cleared devices, primarily through comparing physical characteristics, materials, sterilization, and intended use.
This comparison chart (provided in your input) is the "study" that proves the device meets the "acceptance criteria" of being substantially equivalent to predicate devices. The "acceptance criteria" here are met by demonstrating that the modified device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicates.
In summary, none of the specific points you asked for regarding acceptance criteria for device performance, sample sizes, ground truth, or MRMC studies are applicable to this type of 510(k) submission document.
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UG 6 1996
Premarket Notification Storz Instrument Company
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: Regulatory Affairs Associate
Date Prepared: May 9, 1996
Proprietary Name: Storz DP5100 Anterior Collection Cassettte Pack
Common/Usual Name: Ophthalmic microsurgical system accessory pack for anterior segment surgical procedures.
Classification Name: System, Phacofragmentation (86 HQC).
Device Description/Intended Use: The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures.
Predicate Device: The modified Storz DP5100 is substantially equivalent to the existing Storz DP5100 Ambulatory Surgery Center (ASC) Collection Cassette Pack (K894278, K921758), and to the Storz DP4101 Basic Irrigation / Aspiration Pack (K953078).
Predicate Comparison: A chart comparing the Storz DP5100, as modified, to the predicate devices, demonstrating substantial equivalence, is attached,
Submitted by:
Lindsey Swearingen
Audrey Swearingen Storz Instrument Company
STORZ * 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694 (314) 225-5051 FAX (314) 225-7365
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DEVICE COMPARISON CHART
Storz DP5100 Anterior Collection Cassette Pack
| Device | Storz DP5100, modified | Storz DP5100, existing | Storz DP4101 |
|---|---|---|---|
| Intended Use | Collection of Aspirant duringAnterior Segment OphthalmicSurgery | Collection of Aspirant duringAnterior Segment OphthalmicSurgery | Delivery of Irrigant andCollection of Aspirant duringAnterior Segment OpthalmicSurgery |
| Components | Anterior Collection Cassette,Instruction Sheet | Anterior Collection Cassette | I/A Tubing, Test Chamber,Anterior Collection Cassette,Instruction Sheet |
| Single Patient Use? | Yes | Yes | Yes |
| Cassette Material | Phillips K-Resin® | LEXAN™ | Phillips K-Resin® |
| Provided Sterile? | Yes | Yes | Yes |
| SterilizationMethod | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Packaging | Tyvek® and PET/PE Pouch,Six pouches per Box | Tyvek® and PET/PE Pouch,Six pouches per Box | High-impact Polystyrene TrayWith Tyvek® Lid,Six Packs per Box |
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§ 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.