(85 days)
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.
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.
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable for the same reasons as above.
§ 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.