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.

Device Description

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.

AI/ML Overview

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:

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).
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.
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).
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical instrument adaptor.
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.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the word "storz" in white letters against a black background. The font is bold and sans-serif. The letters are slightly distressed, giving the image a vintage or worn look.

Premarket Notification Storz Instrument Company

964743

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following information is submitted in accordance with the requirements of 21 CFR § 807.92:

Contact Person: Patrick G. Balsmann, Regulatory Affairs Associate Storz, 3365 Tree Court Industrial Bldv., St. Louis, MO 63122-6694 Phone: (314) 225- 5051, ext. 5538.

Date Prepared: January 9, 1997.

Proprietary Name: Storz E8010 ErgoTecTM/Premiere® Adaptor.

Common/Usual Name: Adaptor for ophthalmic microscissors driver handpiece and interchangeabe instrument tips.

Classification Name: Instrument, vitreous cutting and aspirating (86HQE).

Device Description/Intended Use: 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. An illustration of the the Storz E8010 ErgoTec™/Premiere® Adaptor is included in the device instructions which are attached.

Predicate Device: The Storz D7108 Microscissors Handpiece, as it utilizes the new Storz E8010 ErgoTec™/Premiere® Adaptor and Storz ErgoTec Instrument Tips, is similar in design, function, and composition to the Storz CX7100 and CX7150 Microscissors Handpieces (K961310) and the existing Storz Microscissors Handpiece (K960061).

Predicate Comparison: A chart comparing characteristics of the Storz D7108 Microscissors Handpiece, as it utilizes the new Storz E8010 ErgoTecTMPremiere® Adaptor and Storz ErgoTec Instrument Tips, to those of the predicate devices, is attached.

Submitted by:

Patrick G. Balsmann Regulatory Affairs

STORZ® INSTRUMENT COMPANY, 3365 Tree Court Industrial Blvd., St. Louis, MO 63122-6694 (314) 225-5051 FAX (314) 225-7365

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Image /page/1/Figure/0 description: The image shows the logo and contact information for Storz Instrument Company. The logo is on the left side of the image, and the address is St. Louis, MO 63122-6694. On the right side of the image, the text "ErgaTec™/Premiere® Adapter - E8010 User Instructions" is present. The image appears to be from a user manual or product information sheet.

Image /page/1/Figure/1 description: The image shows three separate components of a surgical instrument. The first component is the ErgoTec Tip Assembly, which includes a protective tip guard. The second component is the ErgoTec Adapter E8010. The third component is the Scissor Handpiece D7108.

The Storz E8010 ErgoTec * /Premiere® Adaptor allows the ErgoTec * Vitreoretinal Instrument System tips to be used with the Storz D7108 Microscissors Handpiece. The adaptor features an anterior rotation knob which allows the tip to be adjusted into optimal alignment.

NOTE: Refer to the Premiere® Microsurgical System owner's manual for instructions on use of the Storz D7108 Microscissors Handpiece.

Preparation for Use

A. Hold the handpiece firmly and thread the adaptor to the handpiece by grasping the posterior end of the adaptor and turning it clockwise onto the handpiece until secure.
B. With the plastic protective tip guard in place, hold the rotation knob of the adaptor firmly and securely attach the tip to the adaptor/handpiece assembly by threading the tip clockwise onto the assembly.
C. Remove the protective tip guard by grasping the guard at the tip end and pulling it downward from the lip toward the adaptor/ handpiece assembly.

Disassembly of Instrument

A. Reinstall the protective tip guard in opposite manner of removal. Hold the rotation inob of the adaptor firmly and unscrew the tip by turning counterclockwise being careful to protect the tip from damage.
B. Hold the handplece firmly and unscrew the adaptor by grasping the posterior end and turning countercolckwise.

Cleaning and Sterilization Instructions

A. For the ErgoTec ™ Tip, follow the cleaning and sterilization which came with the tip.
The adaptor should be removed from the handpiece for cleaning. 8.
C. Clean outer surfaces with mild detergent solution and water.
1. Thoroughty rinse with warm (30-40°C) distilled or deignized water.
E. The adaptor should be installed on the handpiece for sterilization.

The minimum requirements for sterilization are:

Standard Gravity Steam Sterilization (Preferred method). Place the handpiece in a . clean open tray, wrapped or unwrapped. Sterilize for 30 minutes at 121° C. (250° F.).
. Flash Sterilization. Place the unwrapped handpiece in a clean open tray. Sterifize for 10 minutes at 132° C. (270° F.).
High Vacuum Sterilization. Place the wrapped handpiece in a clean open tray. . Sterilize for a minimum of 3 minutes at 134° C. -01+3°

CAUTION: Allow the adapter/handpiece assembly to cool at least 20 minutes before handling.

039005451 Rev. A

Plastic Protective

Tip Guard

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K964743

Storz E8010 ErgoTec™/Premiere® Adaptor Device Comparison Chart

Device Characteristic	Storz D7108 Microscissor HP (with newStorz ErgoTec™/Premiere® Adaptor)	Storz D7108 Microscissor HP (withoutStorz ErgoTec™/Premiere® Adaptor)	Storz CX7100 & CX7150Microscissors HP's
510(k) #	Current. K964743	# K960061	# K961310
Intended Use	Cutting and manipulation of posteriorintraocular tissue.	Cutting and manipulation of posteriorintraocular tissue.	Cutting and manipulation of posteriorintraocular tissue.
RecommendedMicrosurgical System	Storz Premiere® Microsurgical System.	Storz Premiere® Microsurgical System.	Storz Millennium™ Microsurgical System.
System Components	Storz D7108 Microscissor Handpiece;Storz D7106 Microscissor Drive Tube;Storz E8010 ErgoTec™/Premiere®Adaptor;Storz ErgoTec™ Vitreoretinal InstrumentTips.	Storz D7108 Microscissor Handpiece:Storz D7106 Microscissor Drive Tube:Grieshaber Microscissors Tips.	Storz CX7100 Vertical Cut Handpiece;Storz CX7150 Proportional CutHandpiece;Storz ErgoTec™ Vitreoretinal InstrumentTips.
Microscissor ActivationMechanism	Pneumatic.	Pneumatic.	Electrical.
Detachable Tips?	Yes.	Yes.	Yes.
Rotatable Tips?	Yes.	Yes.	Yes.
Reusable Tips?	Yes.	Yes.	Yes.
Tip Materials?	420 Stainless steel.	Stainless steel.	420 Stainless steel.
Compatible With Single& Multi-Cut Modes?	Yes.	Yes.	Yes.
Footpedal Control?	Yes.	Yes.	Yes.

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1898

Regulation Number and Section

§ 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.