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HardyDisk™ Antimicrobial Seasitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test proccdure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial vathogens. Standardized methods for agar diffusion testing have been described for Euterobacteriaccas, Staphylococcus spp., Pseudomonas spn., Acinetobacter spp., Listerta monocytogenes, Enterococcus spp., other streptococci and, hy modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.

Hardy Disk™ Erythromycin is indicated for in vitro activity against Staphylococcus spp., and Streptococcus spp. including S. pneumoniae.

HardyDisk™ Erythromycin 15mcg is an antimicrobial sensitivity disk.

The provided text is a 510(k) premarket notification letter from the FDA to Hardy Diagnostics for their HardyDisk™ Erythromycin 15mcg. While it confirms the device's substantial equivalence to a predicate device and its regulatory classification, it does not contain the detailed study information or acceptance criteria requested.

Therefore, I cannot provide a response filling out the requested table and study details. The document is primarily a regulatory approval letter and an "Indications for Use Statement."

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To create lesions during neurosurgical lesion procedures.

The RFG-3CF, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available Radionics RFG-3C, Fischer Neuro 50, and Leksell LNG 30-T generators. Like these devices, the RFG-3CF is a radiofrequency lesion generator used to coagulate or lesion nervous tissue. In addition, the stimulator feature of the RFG-3CF has the same intended use and technological characteristics as the that of the predicate devices mentioned as well as the Grass Stimulator with Constant Current Unit. The stimulator feature is used to stimulate nerve cells to aid in the placement of electrodes. The stimulator is the major feature modification of the RFG-3CF from the RFG-3C. In the RFG-3CF, the user may choose from constant voltage or constant current stimulation. The user may also select the stimulator parameters such as pulse amplitude, duration and frequency.

Here's an analysis of the provided text in relation to your request for acceptance criteria and device study information:

Based on the provided text, it appears this is a 510(k) premarket notification for a Class II medical device, the Radionics RFG-3CF Radiofrequency Lesion Generator. The document is a summary of safety and effectiveness, not a detailed clinical study report with acceptance criteria and specific performance metrics in the way you've outlined.

Therefore, I cannot populate most of your requested fields directly from this text. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices and describing safety features and modifications, rather than presenting a performance study with defined acceptance criteria and statistical results.

Here's how the provided text relates to each of your requested points:

1. A table of acceptance criteria and the reported device performance

Cannot be created from the provided text. The document describes the device's function and modifications but does not list specific, quantifiable acceptance criteria (e.g., accuracy, sensitivity, specificity, or specific lesion size tolerances) or a table of device performance against such criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available in the provided text. There is no mention of a "test set" in the context of a clinical or ex-vivo performance study. The document refers to "system and unit testing results," but these are likely referring to engineering and functional tests, not a study involving a particular sample size of cases or patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not available in the provided text. This is not a clinical study assessing diagnostic or therapeutic outcomes that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not available in the provided text. As there's no described clinical test set, there's no adjudication method.

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 and not available in the provided text. This device is a radiofrequency lesion generator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this device.

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

Not applicable. This is a hardware device for creating lesions, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of a clinical performance study. The "ground truth" for this device would relate to its ability to accurately and reliably generate radiofrequency lesions according to its specifications (e.g., temperature control, power output, lesion size/shape in a phantom), which would be assessed through engineering and bench testing, not clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the way you're asking.

8. The sample size for the training set

Not applicable. There is no mention of an algorithm or AI requiring a "training set."

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

Not applicable. There is no mention of an algorithm or AI.

In summary:

The provided document (K965182, Radionics RFG-3CF) is a 510(k) summary demonstrating substantial equivalence to predicate devices and detailing engineering modifications and safety features. It does not present the type of clinical performance study data, acceptance criteria, or ground truth establishment that would be required for an AI or diagnostic device approval. For a device like this, the "study" demonstrating its safety and effectiveness primarily involves:

• Bench testing: Verifying that the device consistently meets its technical specifications (e.g., RF power output, temperature control, stimulation parameters).
• Safety testing: Ensuring electrical safety, EMC/EMI compatibility, and proper functioning of safety features (e.g., self-tests, watchdog timer).
• Comparison to predicate devices: Demonstrating that the technical and performance characteristics are substantially equivalent to devices already on the market for the same intended use.

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