The Nortech® Electro-Mechanical Lithotriptor (EML) was designed to be used with Nortechs'® Intracorporeal Electro-Mechanical Lithotriptor probes for the fragmentation of urinary calculi.

Device Description

The Intracorporeal Electro-Mechanical Lithotriptor (EML) generator incorporates front panel controls that include a lighted main "Power Switch." An "Energy Switch" and "Rate Switch".

AI/ML Overview

The provided text describes a 510(k) summary for the Nortech® Electro-Mechanical Lithotriptor (EML). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with acceptance criteria for a novel device performance claim. Therefore, the information requested in your prompt (acceptance criteria, specific study design, sample size, expert ground truth, MRMC study, standalone performance, training set details) is not extensively provided in these documents, as it's not typically required for a 510(k) submission that relies on bench testing for substantial equivalence.

However, based on the text, I can extract the following information relevant to device performance and the "study" that proves it meets criteria for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Strictly speaking, the document doesn't define "acceptance criteria" in the way one might for a clinical trial's primary endpoint (e.g., "sensitivity > 90%"). Instead, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to a predicate device. The performance is assessed through bench testing to show similar functionality and effectiveness in fragmenting calculi.

Aspect	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Nortech® EML)
Primary Goal	Demonstrate substantial equivalence to a legally marketed predicate device (EMS Swiss Lithoclast) for the fragmentation of urinary calculi.	"The Northgate EML unit and EMS Swiss Lithoclast were compared during bench testing. The two (2) systems were similar in the way the calculi was fragmented." "The performance data listed above, Comparison of Features, and detailed test data, indicate that the Northgate Technologies Inc. system is substantially equivalent to the EMS Swiss Lithoclast System."
Intended Use	Fragmentation of urinary calculi.	"The Nortech® Electro-Mechanical Lithotriptor (EML) was designed to be used with Nortechs'® Intracorporeal Electro-Mechanical Lithotriptor probes for the fragmentation of urinary calculi."
Method of Fragmentation	Similar mechanism to predicate device (mechanical impact on stone).	"Mechanical Impact" via a probe striking the stone.
Clinical Application	Requires use with a rigid or semi-rigid endoscope under direct vision for ureteral and bladder calculi (similar to predicate).	"Both units require using a rigid or semi-rigid endoscope under direct vision for ureteral and bladder calculi."
Materials	Non-toxic and previously used in other medical devices (similar to predicate if applicable for materials for 510k).	"All materials used to manufacture the Northgate Technologies Inc. EML generator, probe handle, and stainless steel probes (rods) are non-toxic and have been previously used to manufacture other medical devices."
Energy Settings	Provide controlled energy relevant to stone fragmentation (functional equivalence).	Low setting: ~40mJ; High setting: ~90mJ.
Rate Settings	Provide controlled pulse frequency relevant to stone fragmentation (functional equivalence).	Single pulse, 15 consecutive pulses (Low), 30 consecutive pulses (High).

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

Test Set Sample Size: The document does not specify a numerical sample size for "bench testing." It mentions a comparison of "the two (2) systems" (Nortech EML and EMS Swiss Lithoclast). This implies a qualitative and quantitative comparison of their performance on a set of calculi, but no specific count of stones or test runs is provided.
Data Provenance: The data is from bench testing conducted by the manufacturer, Northgate Technologies Inc. The country of origin for the data is not explicitly stated but would presumably be the United States, where Northgate is located (Elgin, IL). The data is prospective in the sense that it was generated specifically for this submission to compare the two devices.

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

The document does not indicate the involvement of experts to establish a "ground truth" for the bench tests in the sense of clinical interpretation. The "ground truth" for the bench testing would be the objective physical fragmentation of calculi, which can be measured and observed without expert clinical interpretation. The assessment of "similarity in the way the calculi was fragmented" would likely be based on objective observations and physical measurements rather than expert clinical consensus.

4. Adjudication method for the test set

Not applicable. There is no mention of a human-based adjudication process for the bench testing results described. The comparison was likely based on objective measurements and observations of stone fragmentation.

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 medical device (lithotriptor) for physical stone fragmentation, not an AI or imaging diagnostic device that involves "human readers" or "AI assistance."

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

Not applicable. This device is an electro-mechanical lithotriptor, not an algorithm. Its operation inherently involves a human operator (physician) positioning the probe and activating it. The "standalone performance" referred to in the document is the EML unit's ability to fragment stones in bench tests, independent of a live patient, but still operated by a human.

7. The type of ground truth used

The "ground truth" for the bench testing was the objective physical fragmentation of urinary calculi. This would involve direct observation, measurement of fragment size, and potentially energy required for fragmentation. There is no mention of pathology, expert consensus (in the clinical interpretation sense), or outcomes data for this specific bench study.

8. The sample size for the training set

Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

Not applicable. As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth establishment process.

Summary

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990341

EXHIBIT #9A

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

[as required by 807.92(a)]

Classification/Common/Usual Name: Lithotriptor, Electro-Hydraulic

Proprietary Name: Intracorporeal Electro-Mechanical Lithotriptor

Classification: Class III (876.4480)

Materials:

All materials used to manufacture the Northgate Technologies Inc. EML generator, probe handle, and stainless steel probes (rods) are non-toxic and have been previously used to manufacture other medical devices.

Description:

The Intracorporeal Electro-Mechanical Lithotriptor (EML) generator incorporates front panel controls that include a lighted main "Power Switch." An "Energy Switch" and "Rate Switch".

Energy Switch

This switch sets the relative energy delivered with each pulse. The selected switch setting will be illuminated.

Low The low setting transmits approximately 40mJ of energy to the probe.
High The High setting transmits approximately 90mJ of energy to the probe. ●

Rate Switch

This switch sets the rate or frequency of pulses delivered. The selected switch setting will be illuminated.

Single ● The Single setting delivers one pulse per footswitch activation.
Low The Low setting delivers fifteen consecutive pulses per footswitch activation.
High The High setting delivers thirty consecutive pulses per footswitch activation. ●

Probe selection is dependent on the application and physician preference.

Fragmentation occurs after the probe tip is placed in contact with the stone and the selected pulses are discharged.

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Substantial Equivalence:

Northgate's EML Generator and probes are substantially equivalent in design, materials, and intended use to other currently marketed devices such as Medispecs' Lithospec™, and the Lithoclast which is manufactured by Electro Medical Systems.

Intended Use:

The Nortech® Electro-Mechanical Lithotriptor (EML) was designed to be used with Nortechs'® Intracorporeal Etectro-Mechanical Lithotriptor probes for the fragmentation of urinary calculi.

Technological Comparison, Summary

	NorthgateElectro-Mechanical	EMSSwiss Lithoclast
Probe Fabrication	Stainless Steel	Stainless Steel
Energy Type	Electrical	Pneumatic
Energy Transfer	Mechanical Impact	Mechanical Impact
Theory Of Operation	A drive unit convertselectrical energy intomechanical force which isapplied to an impacthammer that strikes theend of the probe. Theprobe strikes the stone.	Compressed airgenerates ballistic energyto a projectile within thehand piece - Theprojectile hits the probe.The probe strikes thestone.

Performance Data. Summary

The Northgate EML unit and EMS Swiss Lithoclast were compared during bench testing. The two (2) systems were similar in the way the calculi was fragmented. Both units require using a ridgid or semi-ridged endoscope under direct vision for ureteral and bladder calculi.

Conclusion

Different in technology i.e., energy type and Theory of Operation, the Northgate Technologies Inc. Electro-Mechanical Lithotriptor and EMS Swiss Lithoclast have many similarities.

The performance data listed above, Comparison of Features, and detailed test data, indicate that the Northgate Technologies Inc. system is substantially equivalent to the EMS Swiss Lithoclast System.

Date of Summary- March 16, 1999 Contact- Casey Kurek, Regulatory Manager

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 1999

Mr. Casev Kurek Regulatory Manager Northgate Technologies, Inc. 600 Church Road Elgin, IL 60123

Dear Mr. Kurek:

Intracorporeal Electro-Mechanical Lithotriptor Dated: June 8, 1999 Received: June 9, 1999 Requlatory Class: III 21 CFR §876.4480/Procode: 78 FFK

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 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). 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.

Re: K990341

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 requirements, 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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 regulations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ 1_ of _________________________________________________________________________________________________________________________________________________________________

Confidential

510(k) Number (if known

ELECTRO-MECHANICAL LITHOTRIPTOR (EML)

K990341

Indications For Use:

Device Name:

The Nortech® Electro-Mechanical Lithotriptor (EML) was designed to be used with Nortechs' 9 Intracorporeal Electro-Mechanical Lithotriptor Probes for the fragmentation of urinary calculi.

Casey Kirk

C. Kurek, Regulatory Manger

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Rach Palles

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological 510(k) Number

(Optional Format 1-2-96)

Regulation Number and Section

§ 876.4480 Electrohydraulic lithotriptor.

(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”