Ocu-Guard™ and Supple Ocu-Guard™ are indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the Implant. Ocu-Guard and Supple Ocu-Guard allow for tissue ingrowth through the vascularization process and protect the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard and Supple Ocu-Guard also allow for muscle reattachment to facilitate motility of the implant.

Device Description

Ocu-Guard™ Orbital Implant Wrap and Supple Ocu-Guard™ Orbital Implant Wrap. Both products are composed of bovine pericardium, cross-linked (tanned) with glutaraldehyde.

Ocu-Guard and Supple Ocu-Guard will be available in configurations ranging from 4cmx4cm to 10cmx16cm.

Ocu-Guard and Supple Ocu-Guard will also be available as a "pre-formed" wrap. The "pre-formed" wrap will be available in configurations which will fit implant spheres ranging from 14 mm to 22 mm in size.

AI/ML Overview

This 510(k) submission (K973552) for Ocu-Guard™ and Supple Ocu-Guard™ Orbital Implant Wrap does not contain detailed acceptance criteria or a specific study proving the device meets stated acceptance criteria in a format directly comparable to modern AI/ML device submissions. Instead, it relies on a demonstration of substantial equivalence to predicate devices. Therefore, the requested output in the format of acceptance criteria and device performance based on a standalone study cannot be fully extracted.

However, based on the provided text, we can infer the principles of acceptance and the types of studies performed to support the claim of substantial equivalence.

Here's an interpretation of the document in the requested format, with explanations where direct information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Inferred)	Specific Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary from Submission)
Configuration (Sizes)	Substantially equivalent to predicate device sizes.	"The sizes of Ocu-Guard and Supple Ocu-Guard are substantially equivalent to those sold by the predicate device."
Extension of Indications	No new questions of safety and effectiveness for use as an orbital implant wrap compared to predicate material (ePTFE).	"Extension of these indications to include use as an orbital implant wrap does not pose new questions of safety and effectiveness." This is supported by the historical use of processed bovine pericardium in similar prosthetic applications.
Physical/Mechanical Properties	Properties important for performance as an orbital implant wrap are substantially equivalent to the predicate device.	"The physical and mechanical properties important for performance as an orbital implant wrap are substantially equivalent between Ocu-Guard/ Supple Ocu-Guard and the predicate device."
Biocompatibility	Long history of biocompatibility, consistent with clinical experience and testing.	"Processed bovine pericardium has a long history of biocompatibility. Peri-Guard has been marketed since 1982 with no indication of biocompatibility problems. The biocompatibility testing summarized herein is consistent with this clinical experience."
In Vivo Performance (Rabbit Ocular)	Similar function to Peri-Guard and donor sclera in vivo.	"The rabbit ocular implant study shows that Peri-Guard and donor sclera appear to function in a similar manner, in vivo." (Note: The device being reviewed, Ocu-Guard, is a newer variant of Peri-Guard).
In Vivo Performance (Canine Implant)	Similar performance to ePTFE in vivo.	"A canine implant study shows that Supple Peri-Guard and ePTFE perform in a similar manner, in vivo." (Note: Supple Peri-Guard is a predicate for Supple Ocu-Guard).
Clinical Performance	Safe and effective, and substantially equivalent to the predicate device.	"Preliminary clinical data indicates that our bovine material performs in a safe and effective manner, and in a substantially equivalent fashion to the predicate device."

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

Rabbit Ocular Implant Studies: Sample size is not specified. Likely retrospective, as it refers to a "study" without details on its design or start/end dates for this specific 510(k). Data provenance: Not specified (but likely within the US given the submission to FDA).
Canine Implant Studies: Sample size is not specified. Likely retrospective. Data provenance: Not specified.
Clinical Report: "Preliminary clinical data" is mentioned, sample size not specified. Likely retrospective from existing clinical use of the bovine material (Peri-Guard and Supple Peri-Guard). Data provenance: Not specified.

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

This document does not describe "ground truth" in the context of expert consensus as relevant to AI/ML devices. The "truth" here is established through pre-clinical (animal) studies and preliminary clinical observations by researchers/clinicians, which are then evaluated by the FDA for substantial equivalence. No specific number or qualification of experts establishing ground truth in this manner is provided.

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

Not applicable. The studies mentioned (animal, preliminary clinical) are experimental observations rather than assessments requiring adjudication of interpretations of data by multiple human readers.

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 submission predates the widespread use of sophisticated AI in medical devices and does not involve human readers interpreting images with or without AI assistance. The focus is on the material's biological and physical performance.

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

Yes, in a sense, the animal studies (Rabbit Ocular Implant, Canine Studies) and the biocompatibility testing can be considered "standalone" evaluations of the device material's performance independent of human intervention in its function. These studies assess the biological and physical properties of the material itself.

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

The "ground truth" for demonstrating substantial equivalence is primarily derived from:

Histopathological or gross observation in animal studies (e.g., tissue integration, inflammatory response).
Biocompatibility testing results (standard tests for cytotoxicity, sensitization, irritation, etc.).
Mechanical and physical testing results of the material characteristics.
Clinical observations/outcomes data from the "preliminary clinical data" and "history of safety and effectiveness" for the predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm requiring a training set. The "history of safety and effectiveness" and predicate device data can be conceptualized as a vast "experience base" rather than a formally labeled training set.

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

Not applicable, as no training set for an algorithm is involved. The "ground truth" for the historical data of processed bovine pericardium (Peri-Guard, Supple Peri-Guard) would have been established through extensive preclinical and clinical use, including pathology, clinical outcomes, and long-term safety monitoring over two decades (since 1982).

Summary

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K9 735522
Dec. 14, 1992

มุทรศึก: เพลง เอริย์ เป็นที่ 2014 เมื่อวันที่ 1982 ราคม

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

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Applicant Name & Address:	Bio-Vascular, Inc.2575 University AvenueSt. Paul, MN 55114-1024Fax: (612) 642-9018
Contact:	Julie ShermanRegulatory Affairs AssociatePhone: (612) 603-3803
Alternate Contact:	Barb AtzenhoeferRegulatory Affairs ManagerPhone: (612) 603-3795
Date Prepared:	September 18, 1997
Trade Name:	Ocu-Guard™ Orbital Implant WrapSupple Ocu-Guard™ Orbital Implant Wrap
Common or Usual Name:	Implant, Eye Sphere (Accessory)
Device Classification Name:	Implant, Eye Sphere (Accessory)
Substantial Equivalence:	Oculo-Plastik ePTFE Sheet Covering for OcularImplant (K934834)Peri-Guard (K821532, K833021, K842066 andK961811)Supple Peri-Guard (K921895, K923657 andK961810)

Device Description:

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Ocu-Guard™ Orbital Implant Wrap and Supple Ocu-Guard™ Orbital Implant Wrap. Both products are composed of bovine pericardium, cross-linked (tanned) with glutaraldehyde.

Ocu-Guard and Supple Ocu-Guard will be available in configurations ranging from 4cmx4cm to 10cmx16cm.

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Statement of Intended Use:

Ocu-Guard and Supple Ocu-Guard are intended for the wrapping of orbital implants used in enucleation procedures.

Summary/Comparison of Technological Characterisitics:

We maintain that Ocu-Guard and Supple Ocu-Guard are substantially equivalent to the predicate devices and that the extended indication for use as an orbital implant wrap does not pose new questions of safety and effectiveness. This claim is based on the following elements.

Configuration 1.

The sizes of Ocu-Guard and Supple Ocu-Guard are substantially equivalent to those sold by the predicate device.

Extension of Indications (Labeling) 2.

Processed bovine pericardium and the material used in the predicate device (ePTFE) have a history of being used in similar prosthetic applications. The material used in Ocu-Guard and Supple Ocu-Guard are already indicated for material closure, soft tissue repair, peripheral vascular repair, dural repair and lung and bronchus resection. As summarized below and discussed earlier, we have shown that extension of these indications to include use as an orbital implant wrap does not pose new questions of safety and effectiveness.

3. Physical/Mechanical Properties

The physical and mechanical properties important for performance as an orbital implant wrap are substantially equivalent between Ocu-Guard/ Supple Ocu-Guard and the predicate device.

Biocompatibility 4.

Processed bovine pericardium has a long history of biocompatibility. Peri-Guard has been marketed since 1982 with no indication of biocompatibility problems. The biocompatibility testing summarized herein is consistent with this clinical experience.

5. Rabbit Ocular Implant Studies

The rabbit ocular implant study shows that Peri-Guard and donor sclera appear to function in a similar manner, in vivo.

6. Canine Studies

A canine implant study shows that Supple Peri-Guard and ePTFE perform in a similar manner, in vivo.

7. Clinical Report

Preliminary clinical data indicates that our bovine material performs in a safe and effective manner, and in a substantially equivalent fashion to the predicate device.

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History of Safety and Effectiveness 8.

Peri-Guard and Supple Peri-Guard processed bovine pericardium have been used widely as an implant material for well over two decades and has been shown to be safe and effective in a variety of medical applications.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 6 1997

Ms. Julie A. Sherman Regulatory Affairs Associate Bio-Vascular, Inc. 2575 University Avenue St. Paul. MN 55114-1024

Re: K973552

Trade Name: Ocu-Guard™ and Supple Ocu-Guard™ Orbital Implant Wrap Regulatory Class: II Product Code: 86 MTZ Dated: September 18, 1997 Received: September 19, 1997

Dear Ms. Sherman:

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 premarker 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 - Ms. Julie A. Sherman

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 lorential

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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510(k) Number (if known): K973552

Device Name:

Ocu-Guard™ Orbital Implant Wrap Supple Ocu-Guard™ Orbita! Implant Wrap

Indications for Use: Ocu-Guard™ and Supple Ocu-Guard™ are indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the Implant. Ocu-Guard and Supple Ocu-Guard allow for tissue ingrowth through the vascularization process and protect the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard and Supple Ocu-Guard also allow for muscle reattachment to facilitate motility of the implant.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Don Calogero DRL

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K97355.2

Prescription Use
Per 21 CFR 801.109

Over-The-Counter Use

Regulation Number and Section

§ 886.3320 Eye sphere implant.

(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.