The Sterile Bioplate ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

Device Description

The Bioplate ZIP® Craniotomy Fixation System consists of two circular caps, in a parallel configuration that is connected by an internal, serrated post. The devices will be available in several sizes with cap diameters in the range of 12mm to 20mm to be used for varying cranial closure techniques. The device will be packaged and provided Sterile ( by gamma radiation)

AI/ML Overview

This document describes a 510(k) premarket notification for a modified design of the Bioplate ZIP® Craniotomy Fixation System. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of device performance as one might expect for a diagnostic or AI-based device. Instead, this is a traditional medical device submission focused on substantial equivalence to predicate devices for regulatory clearance.

Therefore, many of the requested categories about acceptance criteria, study design, and ground truth are not applicable to this type of submission. The provided text does not contain any performance data from a clinical or analytical study in the way these questions are typically posed for AI/diagnostic devices.

Here's an assessment based on the provided text, indicating where information is present versus where it's absent or not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for performance metrics. The underlying acceptance criterion for this type of submission is "substantial equivalence" to predicate devices regarding safety and efficacy.
Reported Device Performance: No performance metrics (e.g., accuracy, precision, sensitivity, specificity) are reported. The submission focuses on demonstrating that the modified design's technical characteristics are "substantially equivalent" to predicate devices and raise "no new issues of safety and efficacy."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. There is no mention of a "test set" or data provenance in the context of device performance evaluation. The submission relies on a comparison of technical characteristics and intended use.

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. There is no "ground truth" establishment in the context of a performance study for this device type within this document. Regulatory review is done by FDA reviewers.

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 for performance evaluation.

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 physical implant (craniotomy fixation system), not an AI or diagnostic tool involving "human readers" or "AI assistance."

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

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

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

Not applicable. As there's no performance evaluation in the traditional sense, there's no "ground truth" specified for such an evaluation. The "truth" for this submission is that the device's technical characteristics and intended use are similar enough to previously cleared devices.

8. The sample size for the training set

Not applicable. There is no "training set" for this type of physical device submission.

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

Not applicable.

Summary based on the provided text:

This 510(k) submission (K082175) for the modified Bioplate ZIP® Craniotomy Fixation System describes a physical device intended to reattach a cranial bone flap. The "study" (or rather, the regulatory approach) detailed here is a demonstration of substantial equivalence to predicate devices (K070901, K013050, K020088).

The "acceptance criteria" and "study" are implicitly tied to the FDA's declaration of substantial equivalence. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies that the provided information regarding the device's technological characteristics and intended use adequately demonstrated that it did not raise new questions of safety or efficacy compared to the predicate devices.

The document does not elaborate on specific engineering tests or biocompatibility assessments that would typically be part of such a submission, only that the "technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." These underlying tests would form the basis for proving that the device itself meets its design specifications and is safe, but the submission summary does not provide their details.

Summary

{0}------------------------------------------------

AUG 1 3 2008

Summary of Safety and Effectiveness VI.

Submitter's name, address, telephone number and contact person:

Bioplate, Inc. 3643 Lenawee Avenue Los Angeles, CA, 90016 (310) 815-2100 (310) 815-2126 (fax)

Contact Person: Jesus Farinas

Trade name of Device:

Modified design of the Bioplate ZIP® Craniotomy Fixation System (K013050, K020088)

Common Name:

Bone Fixation Plates

Device Classification:

Class 2, 21 CFR 882-5330 GXN

Predicate Devices:

(1) Bioplate, Inc. The Bioplate ZIP® Craniotomy Fixation System (K070901)
(2.) Bioplate, Inc. The Bioplate ZIP® Craniotomy Fixation System (K013050)
(3.) Bioplate, Inc. Device Modification of the Bioplate ZIP® Craniotomy Fixation System_(K020088)

{1}------------------------------------------------

Description of the Device:

Intended Use of the Device:

The Bioplate ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

Comparison of the device's technological characteristics with those of the predicate devices

All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2008

Bioplate, Inc. % Mr. Jesus T. Farinas Director, OA/RA 3643 Lenawee Avenue Los Angeles, California 90016-4310

Re: K082175

Trade/Device Name: Bioplate ZIP® Craniotomy Fixation System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: July 31, 2008 Received: August 1, 2008

Dear Mr. Farinas:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Mr. Jesus T. Farinas

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Mulhearn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for use

K082175 510(k) Number (if known)

Device Name: Modified plate design for Bioplate ZIP® Craniotomy Fixation System.

Indication for Use:

Prescription Use AND/OR × (Part 21 GFR-801 Subpart D)

Over-The Counter Use (21 GFR 801 Subpart C)

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

Concurrence of the CDRH, Office of Evaluation (ODE)

eubare bucumo for mxa

(Division Sign-Off) Page 1 of Division of General, Restorative, and Neurological Devices

510(k) Number K082175

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).