PALAUREX 78 by AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD

The provided text describes a 510(k) summary for a dental casting alloy named PALAUREX 78, seeking to establish its substantial equivalence to a legally marketed device, Jelenko Freedom Plus. It is not a study proving a device meets acceptance criteria in the typical sense of a clinical or performance study with defined performance metrics like sensitivity, specificity, or reader improvement. This document is a pre-market notification to the FDA, demonstrating that a new device is as safe and effective as a predicate device.

Therefore, the requested information elements such as "sample size for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance" are not applicable to this type of submission. This submission focuses on comparing the new device's technological characteristics (composition and physical/mechanical properties) to a legally marketed predicate device.

Here's the information that can be extracted from your input, framed within the context of substantial equivalence rather than traditional acceptance criteria:

1. Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this 510(k) submission are not explicit numerical thresholds for clinical performance (like accuracy metrics). Instead, the acceptance criterion is demonstrating substantial equivalence to the predicate device, Jelenko Freedom Plus, by showing similar technological characteristics and an expectation of similar biological effect and intended use. The "reported device performance" is a comparison of these characteristics.

Characteristic	Acceptance Criterion (Predicate Device: Jelenko Freedom Plus)	Reported Performance (New Device: PALAUREX 78)
Composition (weight%)
% Au	2	2
% Pd	78.4	77.8
% Cu	8	13
% In	6	-
% Ga	5	7
% Ru	< 1	0.2
Noble Content Metal	High (80%)	High (80%)
Physical and Mechanical Properties
Melting Point Range (Solid.) (°C)	1170	1150
Melting Point Range (Liquid) (°C)	1300	1190
Hardness (Vickers 5/30) Soft	265	330
Hardness (Vickers 5/30) Hard	Not specified	380
Yield Strength (MPa) Soft	565	780
Yield Strength (MPa) Hard	Not specified	850
Elongation (%) Soft	30	12
Elongation (%) Hard	Not specified	2
CTE (x10^-6/°C)	13.9	14.3
Density (g/cm³)	10.8	10.6

Discussion from the document:

"The noble content metal is high (80%) in both alloy, with almost identical breakdown to the respective elements."
"Palaurex 78 has two base metal elements, Cu and Ga; Freedom Plus has In as well."
Conclusion: "On the basis of the identical major elements and high noble metal content similar biological effect may be expected from both alloys."

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

Sample Set: Not applicable in the context of a clinical test set. The "test set" here refers to the actual alloy samples of PALAUREX 78 that were subjected to the specified physical and mechanical tests. The exact number of samples tested for each property is not disclosed, but it would have been sufficient to perform the tests as per the cited standards (ANSI/ADA 5 and ISO 9693).
Data Provenance: The device manufacturer, Aurex Precious Metal Industries (PTY)-LTD., is based in the Republic of South Africa. The testing would have been conducted to international standards (ANSI/ADA 5 and ISO 9693), implying a laboratory setting for material characterization. This is a retrospective analysis of the material's properties based on standardized lab tests.

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

Not Applicable. Ground truth, in the sense of expert consensus on clinical findings, is not relevant for this material characterization submission. The "ground truth" for the material properties (e.g., melting point, hardness) is established by the standardized test methods themselves (ANSI/ADA 5 and ISO 9693) which are internationally recognized protocols for material characterization. Compliance with these standards is considered the "truth."

4. Adjudication method for the test set

Not Applicable. Adjudication methods like '2+1' or '3+1' are used for resolving discrepancies in expert interpretations of clinical data. This submission relies on objective, quantifiable material properties measured according to established standards, not subjective interpretations.

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 is a submission for a dental casting alloy, not an AI-powered diagnostic device or a system involving human readers.

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

Not Applicable. This is a dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance claims (compounds, mechanical and physical properties) is derived from standardized laboratory testing methods (ANSI/ADA 5 and ISO 9693). These standards define how to measure these properties precisely and objectively.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this material property comparison. Machine learning or AI models, which typically require training sets, are not involved.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918

SEP - 5 1997

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510 (k) Summary

Trade name: Common name: Classification name: Class ification number:

PALAUREX 78 Dental casting alloy Gold based alloys and precious metal alloys for clinical use EJT

Legally marketed device: Jelenko Freedom Plus Description of the device: Low gold palladium based casting alloy Intended use of the device: Type IV restoration with porcelain veneering

Summary of the technological characteristics

Test methods applied: as in ANSI/ADA 5 and ISO 9693

Comparison of composition:

ALLOY		COMPOSITION (weight%)
	Name	Au	Pd	Cu	In	Ga	Ru
Legal	Freedom Plus	2	78.4	8	6	5	x
New	Palaurex 78	2	77.8	13		7	0.2

x is less than 1 %

Comparison of physical and mechanical properties

ALLOY	Melting point range (°C)		Hardness (Vickers 5/30)		Yield strength (MPa)		Elongation (%)		CTE (x10-6/°C)	Density (g/cm3)
Name	solid.	liquid	soft	hard	soft	hard	soft	hard
Legal Freedom Plus	1170	1300	265		565		30		13.9	10.8
New Palaurex 78	1150	1190	330	380	780	850	12	2	14.3	10.6

Discussion

The noble content metal is high (80%) in both alloy, with almost identical breakdown to the respective elements.

Palaurex 78 has two base metal elements, Cu and Ga: Freedom Plus has In as well.

Conclusion

On the basis of the identical major elements and high noble metal content similar biological effect may be expected from both alloys.

TÜV
CERT

Aurex Precious Metal Industries (Pty) Limited (Reg.No. 88/04891/07) Mone .. Samore and Rotinoro of Denning Motors for Dontal Toustlars

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SEP - 5 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY)-LTD. P.O. Box 509 ... Edenvale 1610 Republic of South Africa

K972954 Re: Palaurex 78 Trade Name: Requlatory Class: II EJT Product Code: Dated: June 13, 1997 Received: June 20, 1997

Dear Mr. Davis:

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 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

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Page 2 - Mr. Davis - -

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 requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: PALAUREX 78

Indications For Use:

Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Supper Rioner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospita! Devices 510(k) Numbe

Prescription Use Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.