The PowrSyringe Injector is a single use manual hand-held piston syringe with handles to inject fluids into, or aspirate fluid from, the body including use in angiography. The PowrSyringe Injector handles allow the user to push the blunger into the barrel when the user squeezes the handles. Users may open the PowrSyringe Injector's handles to aspirate fluid back into the barrel.

The PowrSyringe Injector safety features include:

Clear barrel for visualization of air bubbles. a
I Minimum dead space between the plunger and barrel with the handles are fully squeezed.
트 Handle design to prevent the plunger from being pulled out of the barrel during aspiration.

AI/ML Overview

Despite the request for reporting acceptance criteria and study details, the provided text does not contain any information about a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for a medical device called "PowrSyringe Injector," which is a piston syringe. The key takeaway from the document regarding performance is that the device demonstrates substantial equivalence to predicate devices through non-clinical testing. This means it's compared to already legally marketed devices and shown to be similar in terms of function and safety, rather than undergoing a study to meet novel acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or expert involvement because this information is not present in the provided text.

Here's a breakdown of why each requested point cannot be addressed:

A table of acceptance criteria and the reported device performance: No specific quantitative acceptance criteria or reported performance metrics are mentioned for the PowrSyringe Injector in the context of a "study" to prove its performance. The document only states that "Bench and animal performance testing to confirm functionality in the intended use and equivalence to predicate device is included." This implies comparative testing, not testing against predefined, quantifiable acceptance criteria.
Sample sizes used for the test set and the data provenance: No test set sample sizes are provided. The only "data" mentioned is from "Bench and animal performance testing," without details on the number of units tested. Data provenance is not specified beyond "Non-Clinical Testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no mention of a clinical or standalone study with a "test set" requiring ground truth establishment, this information is absent.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there's no test set or expert evaluation described.
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 manual piston syringe, not an AI-powered diagnostic tool. The concept of "human readers" and "AI assistance" doesn't apply.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study generating "ground truth" is described. The "ground truth" for substantial equivalence would generally be the performance and safety profiles of the predicate devices.
The sample size for the training set: Not applicable, as this device doesn't involve machine learning or a "training set."
How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document focuses on demonstrating substantial equivalence through non-clinical testing against predicate devices, which is a different regulatory pathway than providing detailed performance studies against specific acceptance criteria for a novel device or AI product.

Summary

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5. 510(k) Summary

SEP 2 1 2007

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided.

Device Information

Trade Name:	PowrSyringe Injector
Common Name:	Piston Syringe
Classification Name:	FMF Syringe, Piston

Predicate Devices

The PowrSyringe Injector is substantially equivalent to multiple previous cleared piston syringes and angiographic syringes.

Device Description

The PowrSyringe Injector safety features include:

Clear barrel for visualization of air bubbles. a
I Minimum dead space between the plunger and barrel with the handles are fully squeezed.
트 Handle design to prevent the plunger from being pulled out of the barrel during aspiration.

Intended Use

The PowrSyringe Injector is a piston syringe to inject fluids into, or aspirate fluids from, the body including use in angiography.

Comparison to Predicate Devices

Data is provided to demonstrate the PowrSyringe Injector is substantially equivalent to previous cleared devices and does not introduce any new safety risks. Substantial equivalence is based on equivalence in indications for use, intended use, patient contact, materials, design, function, performance, sterilization, and safety.

Non-Clinical Testing

Bench and animal performance testing to confirm functionality in the intended use and equivalence to predicate device is included.

Clinical testing

Not applicable.

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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 consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

SEP 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pinyons Medical Technology, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street North West Buffalo, Minnesota 55313

Re: K072318

Trade/Device Name: PowrSyringe Injector Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 5, 2007 Received: September 6, 2007

Dear Mr. Job:

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.

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Page 2 - Mr. Job

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.

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Snute Y. Michine Ound.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indication for Use Statement

510(k) Number:

K472318

Device Name:

PowrSyringe Injector

Indications for Use:

The PowrSyringe Injector is a piston syringe to inject fluids into, or aspirate fluids from, the body including use in angiography.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Chas V. m

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _ Kanall

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).