The X-ray MPS system is an intraoral receiver of the X-ray energy used by the dentist r ne A Tay NT & Systemler as vity. The MPSe sensor consists of 3 pieces: an X-ray to image toom an X-ray sensor driver and a power supply.

The Progeny MPSe Intraoral X-ray System consists of the following main components:
Sensor
X-Ray sensor driver
Power Supply

AI/ML Overview

The provided text is a 510(k) summary for the Progeny MPSe Intraoral Dental X-ray Sensor, submitted in 2004. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with acceptance criteria and performance data in the format requested.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can summarize what is available:

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria for performance metrics like sensitivity, specificity, or image quality, nor does it present a formal table of reported device performance against such criteria. Instead, it relies on a comparison table of characteristics to demonstrate substantial equivalence to predicate devices.

Characteristic	Predicate Device (Schick CDR, VisioDent RSV, Durr Vista Ray, Trophy RVG)	Progeny MPSe	Acceptance Criteria (Implied)
Product Name	CDR, RSV, Vista Ray, RVG	MPSe	(Matching general class)
Number of sensors	2-3	2	Comparable number
Sensor size [mm]	Ranges (e.g., 31x22 to 45x32)	35x26, 41x31	Comparable size ranges
Technology	CMOS, CCD	CCD	Comparable technology
Interface to PC	USB, EPP	Ethernet, WLAN	Functional connectivity
Dynamic Range	4096:1	65536:1	Comparable or better
Distance between Device & PC [m]	5, 5 or 30	Unlimited*	Functional distance
Sensor Cable length [m]	2, 2.5	2	Comparable length
Indications for Use	Intraoral receiver of X-rays in dental radiography	Intraoral receiver of X-rays in dental radiography	Equivalent indications
Safety and Effectiveness	Assumed safe and effective for predicates	Determined safe and effective	Equivalent safety and effectiveness

The "Unlimited" for "Distance between Device & PC" refers to the IEEE802.3 Standard (Ethernet), implying no practical limit within a network.

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

Not applicable. This document is a 510(k) submission focused on substantial equivalence through comparison of design and indications, not a clinical study report with a test set of patient data.

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

Not applicable. No ground truth establishment for a test set of clinical data is described.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication 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 document predates widespread AI integration in dental X-ray systems and does not describe an MRMC study.

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

Not applicable. This document describes a physical X-ray sensor system, not an algorithm.

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

Not applicable. No ground truth is established as there is no clinical data analysis in this document. The "ground truth" for the device's characteristics is based on its engineering specifications and design.

8. The sample size for the training set

Not applicable. This document describes a physical device, not a machine learning model, so there is no training set mentioned.

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

Not applicable. See point 8.

Summary from the document:

The Progeny MPSe Intraoral Dental X-ray Sensor, through its 510(k) submission, demonstrates substantial equivalence to existing predicate devices (Schick Technologies Inc. CDR, VisioDent RSV, Durr Dental Vista Ray, Trophy RVG). The argument for equivalence is based on shared indications for use, materials, design, and operational/functional features, as detailed in a comparison table. The document emphasizes that the MPSe System is determined to be safe and effective when used as labeled, similar to its predicate devices. No formal clinical study with performance acceptance criteria or a dedicated test set with human readers and ground truth is presented in this 510(k) summary.

Summary

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Image /page/0/Picture/2 description: The image shows a close-up of handwritten text, with the characters "K04182" prominently displayed at the top. Below this, there appears to be additional cursive writing, though it is somewhat blurred and less distinct. The overall impression is that of a document or label with a combination of alphanumeric identification and handwritten notes.

510 (k) Summary

AUG - 9 2004

As required by CFR section 807.92(c)

General Information I.

July 2, 2004 Date:
Progeny Inc. Applicant: 1407 Barclay Blvd. Buffalo Grove, IL 60089
E. M. Dolan Contact Person:
847.850.3800, ext. 240 Telephone:
847.459.5175 Fax:

II. Names:

Device Name:

Trade Name:	MPSe
Common Name:	Progeny MPSe
Classification Name:	Unit, X-ray Intraoral

III. Predicate Devices

Schick Technologies Inc. CDR VisioDent RSV Durr Dental Vista Ray Trophy RVG

IV. Product Description

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ing

The Progeny MPSe Intraoral X-ray System consists of the following main components:

Sensor X-Ray sensor driver Power Supply

Accessories and Part Numbers

X-ray sensor: By the number of the pixel array the CCD X-ray sensors that can be used with the MPSe driver are two. Number 1 has a matrix of 912 x 1368 (1.25 million pixels) and number 2 has 1250 x 1640 (2.05 million pixels).

X-ray sensor driver: The driver module is a stand-alone or wall mounting It ray sellow a to a network storage device or display at a local display if the option is available.

Power Supply: This is a medical certified unit that has 110-240V AC input and 12V output. Power Supplies that are also acceptable include medical certified power supply units with the output range of 6V to 26V .

Other Devices

The intraoral X-ray Sensor is intended for use in a Local Area Network in communication with storage devices such as Personal Computers or Laptops that are connected to the local network.

Indications for Use / Rationale for Substantial Equivalence V.

The MPSe System is to be used as an intraoral receiver of X-rays in Dental radiography.

The MPSe shares the same indication for use, materials, design, operational and functional features and is therefore substantially equivalent to the predicate devices listed in section III of this summary.

There are several major independent manufacturers of Intraoral Diagnostic Radiographic Systems on the US market. One is the Trophy Radiologie RVG. The 510(k) number is K950533. The classification of the Trophy Radiologie device is listed as product code EAP.

The other currently marketed device is the Schick Technologies CDR. The 510(k) number is K933455. The classification of the Schick Technologies CDR is listed as product code EAP.

Labeling for the currently marketed devices is included in section 2 of this document.

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Image: Progeny Logo	Progeny, Inc. MPSe 510(k)	7.2.04

There are several major independent manufacturers of Digital Intra Oral X-ray systems. I here are several major maopendo listed the most popular products from Schick In the comparison table below are not and Trophy in comparison to the Progeny MPSe digital X-ray system.

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Image /page/3/Picture/1 description: The image shows the word "progeny" in a serif font. The word is in lowercase letters. To the left of the word is a black graphic that looks like a stylized letter.

Comparison Table:

Characteristic	SchickTechnologiesInc.	VisioDent	DurrDental	Trophy	Progeny Inc.
Product Name	CDR	RSV	Vista Ray	RVG	MPSe
Numbersensors	3	2	2	2	2
Sensor size[mm]	31 x 2237 x 2443 x 30	39 x 2542 x 32	25 x 3632 x 42	41 x 2545 x 32	35 x 2641 x 31
Technology	CMOS	CCD	CCD	CCD	CCD
Interface toPC	USB	USB	EPP	USB	Ethernet,WLAN
DynamicRange	4096:1	4096	4096:1	4096:1	65536:1
DistancebetweenDevice & PC		5	5 or 30		Unlimited*
Sensor Cablelength [m]	2	2	2.5	2	2

Regarding IEEE802.3 Standard

Safety and Effectiveness Information VI.

In these safety instructions the word "system" refers to the Progeny MPSe and its accessories.

Read Instructions First: Please read and follow the safety and operating instructions before operating the system.
Retain Instructions: Keep the safety and operating instructions in a safe place for future reference.
Obey All Warnings: Warnings and cautions on the system and in safety and operating instructions must be adhered to.

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1821

Following Instructions: If you have difficulty following or understanding the instructions in this booklet, call your dealer or supplier.

orogeny

Cleaning: Unplug the system Power Cord from the wall outlet before cleaning. Do not spray any aerosol or non-aerosol sprays into the control unit or power supply. If not sprey any acreeee as as as and water on a damp cloth. Sterilization or disinfecting should be done only as recommended in the Section "Cleaning and Sterilization."
Moving: Do not place on an unstable surface. A system and cart combination o! Moring: Do noved with care. Quick stops, excessive force, and uneven surfaces may should be me rea will cart combination to overturn. Locate your system on a secure platform and avoid jarring the system while in operation.

platform and a relea Jarring with an external DC power supply, and a three-wire grounding type plug (a plug having a third pin for grounding). The 3pronged plug must be operated only from standard 3-prong grounded wall outlets. If promoted plag man of the type of power supply to your office, consult your local power company.

Company.
The Power Supply will accept AC inputs in the range of 100-240 Volts, 50 or 60 Hz. In order to connect to the electrical power in a specific area, a detachable cord set with its' power plug approved for the particular AC receptacle must be used. This must be a Class I, 3-Wire, grounded connection.

Power Cord and Handpiece Cable Protection: The power cord and handpiece o. I o read on a car a d a that they are not likely to be walked on, pinched or kinked by items placed upon or against them. This may damage the cords and prevent the system from working properly. Pay particular attention to plugs and the point from which the cords exit the system.
Lightning: For added protection of this system during a lightning storm or when it is left unattended and unused for long periods of time, disconnect it from the wall outlet. This will prevent damage to the system due to lightning and power line surges.
Servicing: Except for the replacement of light bulbs, do not attempt to service this system yourself. Opening or removing covers may expose you to dangerous voltage or other hazards and may damage the system and void the warranty.
Ventilation: Openings in the system cabinet are provided to ensure proper ventilation. These openings must remain unobstructed at all times. Use caution when stacking the system near other equipment to ensure the normal operating temperature is not exceeded. Do not install this product into a closed rack or cabinet. Never place objects in or near openings in the cabinet.

CAUTION:

Never place the system on a soft surface that might block the ventilation openings in the bottom of the control unit.

Fluids: Keep fluids away from the system to avoid damage resulting from inadvertent spills.
Storage: Store the unit in temperatures of 10-40° C (50-104° F), humidity 0-90%.

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7.2.04

Flammable Anesthetics: This equipment is not suitable for use with flammable anesthetics.

anesments.
15. Mode of Operation: The mode of operation is continuous intermittent.

Mode of Operation: The mode of of protection is ordinary for this equipment.
Degree of Protection: The degree of protection is ordinary for this equipment.
Degree of I rotection: The dogres on inned protection from electric shock from
Auxmary Lquipment. 10 minute only to medical grade auxiliary equipment. icakage currents, it is important to e a statement: "Any TV, VCR, Printer, etc. must comply with the requirements on EN60601."
Damage Requiring Service: Disconnect the system from the wall outlet and 16. Damage Roquiering of Inc. under any of the following conditions:

(a) If the power cord or handpiece cable is damaged.

ogeny

(b) If liquid has been spilled onto, or objects have fallen into the system.

(0) If the system does not operate normally even if you follow the operating (C) it the system does not those controls that are covered by the operating instructions. Instructions: Adjustment or operation may result in damage and may require extensive work to restore the system to its normal operation.

(d) If the product has been dropped or the cabinet has been damaged.

(e) If the system exhibits a distinct change in performance.

CAUTION:

CAUTION.
Do not attempt to remove the covers or service this product yourself. Dangerous Do not attempt to romovie the ode. Only the internal battery can be serviced in the voltages and hazards oney Replacement section for battery replacement. There are no other field serviceable parts inside your system. Refer all servicing to Progeny Inc.

Conclusion VII.

The Progeny MPSe System is determined to be substantially equivalent to the predicate 110 Trogery Mr 80 Byeathick Technologies CDR, The VisioDent RSV, The Durr Dental Vista Ray, and the Trophy RVG. The MPSe System is safe and effective when the device is used as labeled.

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Image /page/6/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines, giving it a modern and abstract appearance.

Food and Drug Administra 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2004

Mr. E. M. Dolan Director of Quality Progeny, Inc. 1407 Barclay Blvd. BUFFALO GROVE IL 60089 Re: K041831

Trade/Device Name: Progeny MPSe Intraoral Dental X-ray Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: July 2, 2004 Received: July 19, 2004

Dear Mr. Dolan:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Scenon 310(t) promation is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstated for use stated in the encrosure, to tegally mance to the Medical Device Amendments, or to commerce proct to May 20, 1770, the claciness with the provisions of the Federal Food, DNA devices that have been recuassince in accordance wall of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval o You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, thatket the detect, cauge requirements for annual registration, listing of general controls provisions of the rest 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 If your device is classifical controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may may be subject to such additional controls. Lincolney of the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I same 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 that FDA has made a determination that your active concessfiel. You must comply of the must comply or any Federal statures and regalations administration and listing (2) CFR Pat (2) CFR Pact with an the Act 3 requirements, meading, surfacturing practice requirements as set forth in the 807), labelling (21 CFR Part 820), BOOR Part 820); and if applicable, the electronic product quality Systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to ocgn marketing your any calence of your device to a legally premarket notification. The FDA imallig of substantial equivalities 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 If you desire specific advice for your device on our lasting of the regulation number at the top of the letter:

8xx. Ixxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and come of the regulation entitled, "Masbranding
Office of Compliance at (301) 594-4639. Also, please note their - Other opense Othce of Compliance at (301) 394-4037. This, production of Some the Dinains of Sma by reference to premarket nomication (210) it it it is a brained from the Division of Small
information on your responsibilities under the Act may be obtained from worker (80 information on your responsionities under the Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance in and includers (1800 Manufacturers, International and Collisation - Posicialist - Posicitires - Posts - Posts - Sollardsmamain.html.

Sincerely yours,

Nancy C. Boyden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page of

510(k) Number (if known): K041831
Device Name: Progeny MPse Intra-oral Dental X-ray Senso

Indications For Use:

Statement of Indication for Use:

Intended Use:

The Progety MPSe system is intended to use for acquisition of digital images of intra-The Progeny MPSe system is intended to use for acquisition of expection of growth interest to a computer for display by Ethernet.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pct 21 CFR 801.109)

Over-The-Counter Use

(Optional Formal 1-2-96)

Nancu C. Broadion

(Division Sign-Off) Division of Reproductive. Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.