The provided 510(k) summary for the Parallax Cranioset, a methyl methacrylate for cranioplasty, does not contain detailed information about specific acceptance criteria or an analytical study. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided information based on your requested categories:

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

The document does not explicitly list quantitative acceptance criteria with reported performance values. It states: "Performance testing demonstrated that Parallax Cranioset is substantially equivalent to Cranioplastic with regard to functional characteristics." This implies that the device met the functional characteristics of the predicate, but specific quantitative metrics are not provided.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Functional Characteristics	Substantially equivalent to predicate
Material composition	Same as predicate

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

The document does not specify a sample size for any "test set" in the context of clinical or analytical performance. It describes "performance testing" but does not detail the methodology. There is no information on data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided. The study focuses on material properties and functional equivalence to a predicate device, not on diagnostic accuracy requiring expert ground truth for a test set.

4. Adjudication method for the test set

This information is not provided.

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

No such study was conducted or described. The device is a material for cranioplasty, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable. The device is a medical material, not an algorithm.

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

Given the nature of the device (methyl methacrylate for cranioplasty), the "ground truth" for demonstrating substantial equivalence would likely involve established material standards and the performance characteristics of the predicate device. This would typically not involve expert consensus, pathology, or outcomes data in the way a diagnostic device would. It would likely involve:

Material composition analysis: Verifying that the composition is the same as the predicate.
Physical and mechanical property testing: Comparing properties like tensile strength, compressive strength, setting time, biocompatibility, etc., against the predicate device and relevant standards.

8. The sample size for the training set

This information is not provided and is not applicable for this type of device. There is no "training set" as it is not a machine learning or AI device.

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

Not applicable, as there is no training set for this device.

Summary of the Study and Equivalence:

The study proving the device meets the acceptance criteria is described as "Non-clinical Test Results: Performance testing demonstrated that Parallax Cranioset is substantially equivalent to Cranioplastic with regard to functional characteristics." The basis for this equivalence is that "The materials contained within Parallax Cranioset are all materials that appear in the predicate device." This suggests a comparative study against the predicate device (Codman Cranioplastic™, Acrylic Cranioplasty Material (K873689)) for material composition and functional characteristics (e.g., mechanical properties, setting properties). The specific details of this testing (e.g., number of units tested, specific tests performed, quantitative results) are not included in this summary. The key "acceptance criterion" was achieving substantial equivalence to the legally marketed predicate device.

Summary

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AUG 3 1 2000

Section 3 - 510(k) Summary

k 99 4022 510(k) Number:

Date Prepared: June 21, 2000

Applicant Information:

Applicant: Parallax Medical, Inc. 453 Ravendale Drive, Suite B Mountain View, CA 94043
Brvan M. Barr Contact: Senior Materials Scientist
(650) 934-6969 Phone: Fax: (650) 934-6965

Device Information:

Trade Name: Parallax Cranioset

Common Name: Methyl methacrylate for cranioplasty

Equivalent Devices:

The subject device is substantially equivalent to Codman Cranioplastic™, Acrylic Cranioplasty Material (K873689).

Intended Use:

Parallax Cranioset is a resinous material for repair of cranial defects.

Comparison to Predicate Devices:

This device has the same intended use and functional characteristics as the predicate device. The materials contained within Parallax Cranioset are all materials that appear in the predicate device.

Non-clinical Test Results:

Performance testing demonstrated that Parallax Cranioset is substantially equivalent to Cranioplastic with regard to functional characteristics.

Summary:

Based on the product performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Mr. Bryan Barr Senior Materials Scientist Parallax Medical, Inc. 453 Ravendale Drive, Suite B Mountain View, California 94043

Re: K994022 Trade Name: Parallax Cranioset Regulatory Class: II Product Code: GXP Dated: June 21, 2000 Received: June 22, 2000

Dear Mr. Barr:

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.

AUG 3 1 2000

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 requirement, 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.

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.

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Page 2 -- Mr. Bryan Barr

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 additionally 607.10 for m This alagilestions on the promotion and advertising of your device, (201) 594-1037. Traditionally, 107-4639. Also, please note the regulation prease contact the Office of Complexion researce notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnes and 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,

Dune R. bochner.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Statement of Indications for Use

Indications for Use

994022 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Parallax Cranioset

Indications for Use:

Parallax Cranioset is a resinous material for repair of cranial defects.

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Concurrence of CDRH, Office of Device Evaluation (ODE (Division Sign-Off) Division of General Restorative Devices 510(k) Number_199 Prescription Use OR Over-The Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).