The SI Handheld Gamma Finder is indicated to detect and quantify the gamma photons in the body intra-operatively or extra-operatively, when gamma emitting radiopharmaceuticals are administered into the human body.

Device Description

The gamma-detector, energy discriminator, amplifier, controls and energy supply have been assembled into a single hand-held unit SI-Handheld Gamma Finder® (HGF), which is shielded by a biocompatible polymer. The probe's shape is conical; its shaft tapers off towards a tip that holds the collimator, the crystal and the PINdiode while a head of larger diameter houses the display, menu buttons, and other components. The device is held in one hand by the middle of the shaft. Outer diameters and weight are designed so as to allow single-handed use over periods of time longer than those of routine sentinel biopsies. The polymer casing of SI HGF is water resistant and thus allows extended cleansing with commercial surface disinfectants. The probe tip may even be immersed in disinfectants for several hours. This fulfills standard requirements of hospital hygiene. Disinfection of the probe is comparable to other, larger probes that are being used like Gamma Finder in conjunction with disposable sterile plastic covers. The HGF can be switched on or off by any key. Results are numerically shown in the liquid crystal display in counts per second (CPS), and updated every second. The HGF has only four keys. The currently measured value can be retained in the display for 5 seconds by pressing Key A. The HGF is packaged and transported in a small suitcase. The HGF can only be operated by a Sonnenschein Lithium Battery (SL2770/T), with a maximum charging current of 15 mA. It is not user replaceable. The display of the HGF will display an battery symbol, warning the user the battery life is approximately 20 hours from exhaustion. If the battery is exhausted, the display will show "LobAt". The only accessory is a Sterile Sleeve (No. SI-FOL-101) that accompanies each device, along with the User Manual.

AI/ML Overview

Here's an analysis of the provided text regarding the "SI-Handheld Gamma Finder (HGF)" acceptance criteria and study, structured to answer your specific questions:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results for novel acceptance criteria. As such, some of your requested information (e.g., specific acceptance criteria for performance metrics, detailed sample sizes for training sets, MRMC study details) is not explicitly present in the document. Where information is not available, it will be noted.

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria for a novel device, as it is a 510(k) submission seeking substantial equivalence to a predicate device (Neoprobe Model 1500). The "study" mentioned refers to verification testing to ensure the HGF performs comparably and meets safety standards, rather than proving performance against specific acceptance metrics in a clinical trial.

Acceptance Criteria Category	Reported Device Performance (HGF)
Energetic Range Detection	140 keV to 360 keV (e.g., Tc-99M and I-131)
Operational Control	Single-handed use, four-key operation, display of counts per second (CPS), acoustic signal ON/OFF, LED ON/OFF, menu mode (dynamics, volume).
Battery Life Warning	Battery symbol displayed; "LobAt" when exhausted. Warns approximately 20 hours from exhaustion.
Disinfection	Water-resistant polymer casing; allows extended cleansing with commercial surface disinfectants. Probe tip can be immersed for several hours.
Dimensions/Weight	Designed for single-handed use over prolonged periods (compared to routine sentinel biopsies). Specific dimensions/weight not given, but implied to be comparable to predicate for this use case.
Accessories	Compatible with Sterile Sleeve (No. SI-FOL-101).
Safety Standards	Tested to appropriate electrical standards, biocompatibility, and sterilization standards.

Study Details

The document refers to "verification testing conducted by a university as to both system and technical evaluations" rather than a single, comprehensive "study" with a defined clinical endpoint.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The verification testing seems to be internal technical and system evaluations, not a clinical trial with patient-specific "data provenance."
- Data Provenance: The verification testing was conducted by "a university." The country of origin is not explicitly stated for the testing, but the company is based in Berlin, Germany. The nature of the testing (technical/system evaluation) suggests it involved devices and possibly radioactive sources, not patient data in the sense of retrospective or prospective clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the verification testing described is technical/system evaluation, not a clinical study requiring expert ground truth for diagnostic accuracy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The reported testing is technical verification, not a clinical study requiring adjudication of expert interpretations.
If a multi-reader multicase (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:
- No MRMC comparative effectiveness study was done. This device is a gamma detection probe, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the device itself is a standalone measurement instrument. Its performance is evaluated on its ability to detect and quantify gamma radiation, independently of human interpretation of a complex algorithm's output. The "verification testing" would assess this standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical verification testing, the "ground truth" would likely be established through calibrated radioactive sources of known energy and activity, and adherence to relevant electrical, biocompatibility, and sterilization standards. It is not expert consensus, pathology, or outcomes data related to patient diagnosis.
The sample size for the training set:
- Not applicable. This device is a hardware instrument with firmware, not a machine learning model that requires a "training set" in the conventional AI sense.
How the ground truth for the training set was established:
- Not applicable for the same reasons as above.

Summary

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K013751

Image /page/0/Picture/1 description: The image shows the logo for Silicon Instruments GmbH. The logo features the letters 'SI' in a stylized design, followed by the words 'SILICON INSTRUMENTS' in all caps. Below the logo is the text 'GmbH', which is a German abbreviation for a limited liability company.

Silicon Instruments GmbH Berlin FORESTATION OF SEDERED BEAU ATTERSTAGE OF CHORICAL e M a il : s i @ s i l i c o n - i n s t r u m e n t s . d e
Internet: http//www.silicon-instruments.de

Unternehmen der Silicon Sensor Gruppe

Silicon Instruments GmbH Berlin ▪ Ostendstraße 1 ▬ D-12459 Berlin

510(k) SUMMARY of SAFETY and EFFECTIVENESS

FEB 0 6 2002

A. General Information
1.	Submitter's Name:	Silicon Instruments, GmbH
	2. Address:	Ostendstrasse 1Berlin, D-12459Germany
3.	Telephone:	49-3-06-39-92-360
4.	Contact Person:	Dr. Thomas Goebel
5.	Date Prepared:	October 29, 2001
6.	Registration Number:	FDA Form 2891 Submitted

B. Device

1.	Name:	SI-Handheld Gamma Finder (HGF)®
2.	Trade Name:	Handheld Gamma Finder
3.	Common Name:	Nuclear Uptake Probe
4.	Classification Name:	Probe, Uptake, Nuclear
5.	Product Code:	IZD
6.	Class:	I
7.	Regulation Number:	892.1320

Silicon Instruments GmbH Ostendstraße 1 = D-12459 Berlin Tel. +49 (0)30/53 01 58 70
Fax +49 (0)30/53 01 58 72

Amtsgericht AG Berlin-Charlottenburg
HRB 68092

Geschäftsführer: Dr. Bernd Kriegel

Dauterha Rank Rorlin

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C. Identification of Legally Marketed Devices

1. Name:	Neoprobe Model 1500
2. K Number:	K971167
3. Date Cleared:	June 26, 1997

D. Description of the Device

The HGF can be switched on or off by any key. Results are numerically shown in the liquid crystal display in counts per second (CPS), and updated every second. The HGF has only four keys:

E. Latest Valve Measured
Acoustic Signal ON/OFF in menu mode(+) F.
LED ON/OFF in menu mode(-) G.
Menu Mode ON/OFF H.
- Sub-menu dynamics lx
- Sub-menu volume (Six levels) 2x
- 3x Menu Mode off

The currently measured value can be retained in the display for 5 seconds by pressing Key A.

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The HGF is packaged and transported in a small suitcase, see Appendix A for a photograph.

The HGF can only be operated by a Sonnenschein Lithium Battery (SL2770/T), with a maximum charging current of 15 mA. It is not user replaceable. The display of the HGF will display an battery symbol, warning the user the battery life is approximately 20 hours from exhaustion. If the battery is exhausted, the display will show "LobAt".

Battery Information is located in Appendix B.

The only accessory is a Sterile Sleeve (No. SI-FOL-101) that accompanies each device, along with the User Manual.

E. Intended Use Statement

The HGF is a measuring instrument for preoperative and intraoperative detection of radioactive substances in the energy range between 140 keV and 360 keV (e.g. TC-99M and I-131).

It is contraindicated in dosimetric applications, detection of radiation other than gamma and detection of radiopharmaceuticals with radiation energies outside the range of 140keV - 360 keV.

F. Technological Characteristics Summary

The HGF is substantially equivalent to the Neoprobe Model 1500, cleared on June 26, 1997 as K971167.

Each nuclear uptake probe and accessories is compact, operates on an internal battery; is software or micro-controller controlled, and intended to detect and quantify gamma radiation. Both the Neoprobe Model 1500 and HGF are indicated for external and intraoperative detection of radioactivity.

The HGF was tested to the appropriate electrical standards, biocompatibility, and sterilization standards. In addition, verification testing was conducted by a university as to both system and technical evaluations.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2002

Dr. Thomas Goebel Head of Senior Technology Silicon Instruments GmbH OstendstraBe 1 D-12459, Berlin GERMANY

Re: K013751

Trade/Device Name: SI-Handheld Gamma Finder® Regulation Number: 21 CFR 892.1320 Regulation Name: Nuclear uptake probe Regulatory Class: I Product Code: 90 IZD Dated: October 29, 2001 Received: November 13, 2001

Dear Dr. Goebel:

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 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.

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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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510(k) Number: K013751

SI – Handheld Gamma Finder Device Name:

Indications for Use:

The SI Handheld Gamma Finder is indicated to detect and quantify the gamma t photons in the body intra-operatively or extra-operatively, when gamma emitting radiopharmaceuticals are administered into the human body.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OVER-THE-COUNTER USE _________________________________________________________________________________________________________________________________________________________ (optional Form 1-2-96)

David G. Lynam

and Rs 510(k) Number

Regulation Number and Section

§ 892.1320 Nuclear uptake probe.

(a)
Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.