The Peregrine OptiPort Vitrectomy Probe is a single use, 20 GA guillotine style cutter for use during ophthalmic surgery. Approximately 6' in length and provided sterile, it consists of the following. At the proximal end, a female and male luer connector attached to the resective ends of dual PVC tubing. A colored stripe is added to one of the tubes to establish it as the half used for aspiration. A Delrin Handpiece with a 20 GA stainless steel needle at the distal end. The mechanics to operate the vitrectomy probe extend through the inner lumen of the stainless shaft and may be activated pneumatically.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called the "Peregrine OptiPort Vitrectomy Probe." It does not contain information about acceptance criteria or a study proving the device meets them in the way described in your request.

Here's why and what information is available:

510(k) Premarket Notifications: These submissions aim to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its safety and effectiveness through clinical trials with specific acceptance criteria. The focus is on comparison and similarity, not on novel performance testing against predefined metrics.
"Substantial Equivalence Comparison" Section: This section directly addresses the core of a 510(k). It compares the Peregrine OptiPort Vitrectomy Probe to the H.S. International Shapiro Cutter Vitrectomy Probe (the predicate device) based on features like intended use, driver type, cutting action, shaft size, port size, insertion method, and reusability. The implicit "acceptance" in a 510(k) is that the new device shares enough characteristics with the predicate that it can be considered equally safe and effective without requiring new clinical performance studies.

Therefore, I cannot populate the table or answer most of your detailed questions about acceptance criteria, efficacy studies, sample sizes, ground truth, or expert involvement because this type of information is generally not part of a 510(k) summary focused on substantial equivalence.

However, I can provide the following based on the document's content:

Summary of Device Information from the 510(k) Notification:

1. Table of Acceptance Criteria and Reported Device Performance:

Formal acceptance criteria and a study demonstrating performance against these criteria are NOT present in this 510(k) submission. The submission focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a performance study against specific acceptance criteria. The implicit "acceptance" is that the device is substantially equivalent to the predicate.

Characteristic/Feature	Peregrine OptiPort Vitrectomy Probe	H.S. International Shapiro Cutter Vitrectomy Probe (Predicate)	Fulfilled/Met (Based on Substantial Equivalence Claim)
Intended Use	Vitreous Removal	Vitreous Removal	Met (Identical)
Driver Type	pneumatic driver	pneumatic driver	Met (Identical)
Cutting Action	guillotine cutting action	guillotine cutting action	Met (Identical)
Shaft Size	20 GA stainless steel shaft	20 GA stainless steel shaft	Met (Identical)
Port Size	.035mm port at distal tip	.034mm port at distal tip	Met (Very similar, considered equivalent)
Insertion	through 1mm incision	through 1mm incision	Met (Identical)
Usage	single use	single use	Met (Identical)
Handle	ergonomic handle	ergonomic handle	Met (Similar design principle)

2. Sample size used for the test set and the data provenance:

Not applicable. This document does not describe a performance test set or clinical study with a sample size. The "test" is a comparison to a predicate device, not an independent assessment of performance on a data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no "test set" and no ground truth established by experts for performance in this 510(k) submission. FDA reviewers evaluate the substantial equivalence claim.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set or expert adjudication process 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 device is a surgical instrument (vitrectomy probe), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. No ground truth data of this type is presented or required for a 510(k) focused on substantial equivalence of a surgical tool. The "ground truth" for the submission is the legally marketed predicate device and its known characteristics.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable.

Additional Relevant Information from the Document:

Sterility: The device will be ETO Sterilized, and the method used to validate the sterilization cycle is the AAMI Overkill Method. This is a crucial "acceptance criteria" for sterility, and the method for validation is stated.
Predicate Device: H.S. International Shapiro Cutter Vitrectomy Probe (Product# HS32-803).
Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This decision is the "acceptance" for the 510(k) process.

Summary

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APR 3 0 1998

January 30, 1998

K9803999

Premarket Notification [510(k)] Summary

Submitter: Peregrine Surgical Ltd. 4050D Skyron Drive Dovlestown, PA 18901 Phone: (215) 348-0456 (215) 348-5526 Fax:

Official Correspondent: Amy Hessenthaler

Trade Name: Peregrine OptiPort Vitrectomy Probe

Common Name: Vitrectomy Guillotine Cutter

Registration Number: 2529392

Classification: Class II

Class Name: Not Known

Panel: Ophthalmic

Product Code: 86 HQE

Device Description: The Peregrine OptiPort Vitrectomy Probe is a single use, 20 GA guillotine style cutter for use during ophthalmic surgery. Approximately 6' in length and provided sterile, it consists of the following. At the proximal end, a female and male luer connector attached to the resective ends of dual PVC tubing. A colored stripe is added to one of the tubes to establish it as the half used for aspiration. A Delrin Handpiece with a 20 GA stainless steel needle at the distal end. The mechanics to operate the vitrectomy probe extend through the inner lumen of the stainless shaft and may be activated pneumatically. (see Appendix B)

Statement of indications for use. - For removal of vitreous and vitreal membranes during opthalmic surgery.

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Substantial Equivalence Comparison

PeregrineOptiPort Vitrectomy Probe	H.S. InternationalShapiro Cutter VitrectomyProbe
Application for 510(K)Product# 505.10	Manufactured by H.S. InternationalProduct# HS32-803
Vitreous Removal	Vitreous Removal
pneumatic driver	pneumatic driver
guillotine cutting action	guillotine cutting action
20 GA stainless steel shaft	20 GA stainless steel shaft
.035mm port at distal tip	.034mm port at distal tip
insertion through 1mm incision	insertion through 1mm incision
single use	single use
ergonomic handle	ergonomic handle

The Peregrine OptiPort Vitrectomy Probe is identical in principle to the ophthalmic guillotine cutters marketed today. The materials used in its manufacture are similar, if not in most comparisons identical.

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Sterility

The Device will be ETO Sterilized.

The method used to validate the sterilization cycle is AAMI Overkill Method

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1998

Mr. Todd Richmond Peregrine Surgical Ltd. 4050D Skyron Drive Doylestown, PA 18901

Re: K980399

Trade Name: Peregrine OptiPort Vitrectomy Probe Regulatory Class: II Product Code: 86 HQE Dated: January 30, 1998 Received: February 2, 1998

Dear Mr. Richmond:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: . General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Todd Richmond

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl forentthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510K Number (if known): K980399

Device Name: Peregrine OptiPort Vitrectorny Probe

Indications for Use:

For removal of vitreous and vitreal membranes dering ophthalmic surgery.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _______xx

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Over-The-Counter Use

Everett T. Boom

(Division Sign-Off) Division of Ophthalmic D 510(k) Number

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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.