Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that this document does not contain the level of detail typically found in a clinical study report regarding device performance beyond a basic declaration of substantial equivalence.

The provided text is a 510(k) Premarket Notification for a saline solution, not a complex AI/ML-driven medical device. Therefore, many of the requested categories (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable or not present in this type of submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance and Remarks
Intended Use	Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated. Performance is deemed substantially equivalent to the predicate device for this intended use.
Environments of Use	Hospital, sub-acute care or home. Performance is deemed substantially equivalent to the predicate device in these environments.
Patient Population	Any patient population. Performance is deemed substantially equivalent to the predicate device for this patient population.
Contraindications	None. No contraindications were identified, consistent with the predicate device.
Prescription Status	Prescription Use. This matches the requirement and is considered acceptable.
Design (Composition)	USP sodium chloride solutions of 3.5%, 6% and 7% concentrations, packaged sterile in 4 ml vials. The design is described and considered substantially equivalent to the predicate.
Performance (General)	"None applicable" beyond adherence to USP monograph. The core acceptance criterion is "substantial equivalence" to the predicate device (DEY Laboratories – K972778) with "no significant differences that affect the safety or effectiveness." The performance is implicitly accepted as equivalent to a legally marketed device for the stated indications.

Study Information (Based on Available Text)

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. This is a 510(k) submission for a saline solution, which typically relies on chemical and manufacturing standards, and substantial equivalence to a predicate, rather than large-scale clinical trials with test sets in the context of an AI/ML device.
- Data Provenance: Not applicable in the context of clinical trial data. The data provenance primarily relates to the formulation and manufacturing process ensuring compliance with USP standards, and the comparison to an existing legally marketed device.
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 context of clinical outcomes or expert consensus for interpretation tasks is not relevant for this type of device. The "ground truth" here is adherence to chemical specifications and the established safety and effectiveness of the predicate device.
Adjudication method for the test set:
- Not applicable. No clinical test set requiring adjudication in the context of diagnostic or interpretive accuracy is mentioned.
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 not an AI/ML-driven diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a saline solution, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on established chemical standards (USP monograph) for sodium chloride solutions and the demonstrated safety and effectiveness of a legally marketed predicate device (DEY K972778) as determined by the FDA's substantial equivalence review process. Real-world clinical outcomes or pathology data were not used to establish a performance "ground truth" in the way they would be for a diagnostic tool.
The sample size for the training set:
- Not applicable. There is no concept of a "training set" for a saline solution in the context of AI/ML.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 26-Apr-07

PARI Innovative Manufacturers, Inc.2943 Oak Lake Blvd.Midlothian, VA 23112	APR 26 2007
Tel - (804) 253-7274Fax - (804) 639-7244
Official Contact:	Mike Judge - RA
Proprietary or Trade Name:	Hyper Sal
Common/Usual Name:	Saline solution
Classification Name:	CAF – Nebulizer (Direct Patient Interface)
Device:	Inhaled saline solutions – 3.5%, 6% and 7%
Predicate Devices:	DEY Laboratories – K972778
Device Description:

The proposed inhaled saline solutions are in 3.5%, 6% and 7% concentrations. They are packaged sterile in 4 ml vials for use as indicated.

Indications for Use:
Indicated Use --	Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated..
Patient Population --	Any patient population
Environment of Use --	Hospital, sub-acute care or home
Contraindications --	None

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Premarket Notification 510(k) K070498

. .

Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 26-Apr-07

Attributes
Intended use	Used in conjunction with a nebulizer for induction ofsputum production where specimen collection isindicated.
Environments of use	Hospital, sub-acute care or home
Patient Population	Any
Contraindications	None
Prescription	Yes
Design	USP sodium chloride solutions of 3.5%, 6% and 7%
Performance	None applicableUSP monograph

Differences between Other Legally Marketed Predicate Devices

The proposed inhale saline solutions are viewed as substantially equivalent to the following predicate device – DEY K972778.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pari Innovative Manufacturers, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court #102 Bonita Springs, Florida 34134

APR 2 6 2007

Re: K070498

Trade/Device Name: Inhaled Saline Solutions 3.5%, 6%, and 7% Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 14, 2007 Received: February 20, 2007

Dear Mr. Dryden:

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. Dryden -

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 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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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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Premarket Notification 510(k) Section 4 - Indications for Use Statement

Indications for Use Statement 4

Page 1 of 1

510(k) Number:	K070498 (To be assigned)
Device Name:	Inhaled saline solutions 3.5%, 6%, and 7%
Indications for Use:	Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated.

Prescription Use XX (Part 21 CFR 801 Subpart D) or Over-the-counter use __ (21 CFR 807 Subpart C)

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

and the comments of the country of

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chlotte

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Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).