SUNGSHIM® Sterile single use Insulin Syringe is a disposable, single use syringe which consists of a calibrated hollow barrel, plunger, gasket, cap and fixed needle is a fixed and the needle cap is intended to provide physical protection to the needle. The cap is color coded orange for U-100 insulin, same as equivalent insulin syringes. The SUNGSHIM Sterile single is available in 0.5ml/cc and 1ml/cc sizes in gauges 28g to 31g.

AI/ML Overview

The provided document is a 510(k) premarket notification for the SUNGSHIM® Sterile Single Use Insulin Syringe. It focuses on demonstrating substantial equivalence to a predicate device through comparison of features, materials, and performance data based on established standards. This type of document does not typically include information about acceptance criteria and studies in the way you've outlined for AI/ML-based medical devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the context of AI/ML. The acceptance criteria here are related to meeting established standards for insulin syringes and demonstrating substantial equivalence, not statistical performance metrics of an AI algorithm.

Here's why and what information can be extracted:

No AI/ML Component: The device described is a physical insulin syringe. There is no mention of an algorithm, AI, or machine learning in its function or evaluation.
Performance Data Type: The "Performance data" section refers to bench tests against ISO standards, particulate matter tests against USP standards, and biocompatibility tests against ISO and USP standards. These are physical, chemical, and biological tests, not statistical performance metrics of an AI.
"Acceptance Criteria" in this context: For this device, "acceptance criteria" generally refers to meeting the specifications outlined in the referenced standards (e.g., ISO 8537:2007 for sterile single-use syringes, USP <788> for particulate matter, ISO 10993 for biocompatibility). The document states that "The performance tests demonstrated that SUNGSHIM® Sterile single-use Insulin Syringe is as safe, as effective and performs in a substantially equivalent manner to the predicate device." This is the general "reported performance" against these implicit acceptance criteria, but specific numerical results for each criterion are not provided in this summary.

Therefore, I cannot populate the table or answer most of your specific questions because they are geared towards the evaluation of AI/ML devices, which is not what this document describes.

However, I can provide what is available regarding the "performance data" from the document:

1. A table of acceptance criteria and the reported device performance (based on the context of this physical device):

Acceptance Criteria (Standard Compliance)	Reported Device Performance (as stated in document)
ISO 8537:2007 (Sterile single-use syringes, with or without needle, for insulin)	"The performance tests demonstrated that SUNGSHIM® Sterile single-use Insulin Syringe is as safe, as effective and performs in a substantially equivalent manner to the predicate device."
USP <788> (Particulate matter in injections)	"The performance tests demonstrated that SUNGSHIM® Sterile single-use Insulin Syringe is as safe, as effective and performs in a substantially equivalent manner to the predicate device."
ISO 10993-1, -4, -10, -11 & USP 39<85> (Biocompatibility)	"The performance tests demonstrated that SUNGSHIM® Sterile single-use Insulin Syringe is as safe, as effective and performs in a substantially equivalent manner to the predicate device."

Regarding the other points, they are not applicable to this document as it pertains to a physical, non-AI medical device.

Sample size used for the test set and the data provenance: Not applicable. Tests are physical/chemical/biological, not data-driven in the AI sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an insulin syringe is defined by engineering specifications and direct measurements against standards, not expert consensus on data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the AI sense. Ground truth is defined by specified physical/chemical/biological parameters in the standards.
The sample size for the training set: Not applicable (no training set for a physical device).
How the ground truth for the training set was established: Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 12, 2016

Sung Shim Medicare Co., Ltd. c/o Mr. Peter Chung Plus Global 300 Atwood St. Pittsburgh, Pennsylvania 15213

Re: K152803

Trade/Device Name: SUNGSHIM® Sterile Single Use Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 14, 2016 Received: April 20, 2016

Dear Mr. Chung:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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for Erin I. Keith, M.S Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152803

Device Name

SUNGSHIM® Sterile single use Insulin Syringe

Indications for Use (Describe) SUNGSHIM® Sterile single use Insulin Syringe is hypodermic insulin syringe for subcutaneous injection of U-100 insulin. (Unit scale : U-100)

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

മി Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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510(k) Summary (K152803) [as required by 807.92(c)]

1. Applicant

1. Company : Sung Shim Medicare Co.,Ltd.
1. Address : 190, Maesil-ro, Sojeong-myeon, Sejong-si, Korea
1. Tel : 82-32-676-7066
1. Fax : 82-32-676-7063
1. Prepared date : July 12, 2016
1. Contact person : Peter Chung, 412-687-3976
1. Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA

2. Device Information

1. Trade name : SUNGSHIM® Sterile single use Insulin Syringe
1. Common name : Syringe, piston
1. Classification name : Piston syringe
1. Product code : FMF
1. Requlation number : 880.5860
1. Class of device : Class II
1. Panel : General Hospital
1. Model codes : Insulin Syringe 0.5ml/cc, Insulin Syringe 1ml/cc

3. The legally marketed device to which we are claiming equivalence

K070917 Feel-ject Insulin Syringe

4. Device description

5. Intended Use :

SUNGSHIM® Sterile single use Insulin Syringe is hypodermic insulin syringe for subcutaneous injection of U-100 insulin. (Unit scale : U-100)

6. Performance data:

(1) Bench test
Test standard : ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin
(2) Particulate matter in injections Test standard : USP <788> Test item : Particulate matter in injections
(3) Biocompatibility

Category : External communicating device Contact : Blood path, indirect Contact duration : A-limited (≤24h)

Test standard : ISO 10993-1, ISO 10993-4, ISO 10993-10, ISO 10993-10, ISO 10993-11, USP 39<85>

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Test item : Cytotoxicity, In vitro hemolysis, Acute systemic toxicity, Skin sensitization, Intracutaneous reactivity, Endotoxin

The performance tests demonstrated that SUNGSHIM® Sterile single-use Insulin Syringe is as safe, as effective and performs in a substantially equivalent manner to the predicate device.

Manufacturer	Sung Shim Medicare Co.,Ltd.	Feel Tech
510(k) No.	K152803	K070917
Indication for use	SUNGSHIM® Sterile single use InsulinSyringe is hypodermic insulin syringe forsubcutaneous injection of U-100 insulin. (Unitscale : U-100)	The Feel-ject disposable sterile insulinsyringes are intended for injection of U100insulin only.
Product name	Syringe, piston	Syringe, piston
Trade name	SUNGSHIM® Sterile single use Insulin Syringe	Feel-ject Insulin syringe
Model/type	Insulin syringe 0.5ml/ccInsulin syringe 1ml/cc	FIS-1001 1.0mlFIS-0502 0.5ml
Appearance	Image: Insulin syringe	Image: Insulin syringe
Productconfiguration	BarrelPlungerCapGasketNeedle	BarrelPlungerCapGasketNeedle
Material	Part	Material	Part	Material
	Barrel	Polypropylene	Barrel	Polypropylene
	Plunger	Polypropylene	Plunger	Polypropylene
	Cap	Polyethylene	Cap	Polyethylene
	Gasket	Rubber	Gasket	Rubber
	Needle	Stainless steel STS304	Needle	Stainless steel STS 304
Length of parts (mm) : 1.0mL
Total length ofassembly	118.2±2	116±2
Side length ofassembly(max)	19.2±1	19.2±1
Inner diameter ofbarrel	4.74±0.3	4.7±0.3
Out diameter ofbarrel	7.0±0.3	6.6±0.3
Scale of syringe	1mL	1mL
Gauge	28G, 29G, 30G, 31G	28G, 29, 30, 31G
Length of needle	8 mm, 12.7 mm	5 mm, 8 mm, 12.7 mm
Sterilization	EO Gas sterilization	EO Gas sterilization

7. Predicate device comparison table

Although the Indications for Use is not identical to that of the predicate device it does not change the intended use because both are single use insulin syringes intended for the injection of U-100 insulin.

8. Conclusion:

The materials, performance and features of both the subject device and the predicate device are considered to be substantially equivalent.

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).