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The eG1 High Speed System is indicated for cutting and shaping bone including spine and cranium.

The eG1 Wireless Hand Control System is intended to be used as an optional accessory to the eG1 High Speed System (K133604) to provide an alternative method for controlling the eG1 Handpiece motor speed instead of using the existing wired foot control pedal.

The eG1 Wireless Hand Control System consists of two articles:

1. The Wireless Hand Control, EG1A (article # WIRELESS-HC) is a sterile, single-use device that snaps on the eG1 Handpiece.

2. The Receiver for Wireless Hand Control, EG1A (article # RECEIVER-HC) is a non-sterile reusable device that plugs into the eG1 Control Console.

The WIRELESS-HC sends information about the amount of pressure applied by the user on its button to the RECEIVER-HC wirelessly. The RECEIVER-HC uses this information to modulate the speed of the eG1 Handpiece motor.

This looks like an FDA 510(k) summary for a medical device called the "eG1 Wireless Hand Control System." The document aims to demonstrate that this new device is substantially equivalent to a previously cleared predicate device ("Foot control pedals used with eG1 High Speed System K133604").

However, the provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way you've outlined for diagnostic aids or AI products (e.g., sensitivity, specificity, clinical endpoints).

Instead, this document focuses on demonstrating substantial equivalence based on:

• Identical intended use and indications for use.
• Similar technological characteristics where applicable, and where there are differences (e.g., wireless technology, power source, sterilization), verifying that these differences do not raise new questions of safety or effectiveness through specific engineering and regulatory testing.

The "studies" and "acceptance criteria" discussed here are primarily engineering verification and validation tests and compliance with recognized standards.

Let's break down what is available in the provided text in relation to your request, and explicitly state what is not present:

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

• What's available: The document lists several tests performed to assess the device's safety, effectiveness, and compliance with standards. It generally states that "All acceptance criteria are met." However, it does not provide a specific table with quantitative acceptance criteria (e.g., a specific speed range, latency, signal reliability percentage) paired with reported performance metrics from a clinical study or a performance study with human subjects operating the device for diagnostic or therapeutic outcomes.
• Example of what is present as "performance" in this context:
  • Test Category: Design verification analysis
  • Purpose: Verify physical characteristics meet design inputs related to interfaces.
  • Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
  • Test Category: Design verification testing
  • Purpose: Verify functional aspects of the proposed device.
  • Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
  • Test Category: Software Validation
  • Purpose: Developed applying IEC 62304:2015.
  • Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
  • Test Category: Electrical Safety (IEC 60601-1:2012 / ANSI/AAMI ES60601-1:2012)
  • Purpose: Basic Safety and Essential Performance.
  • Reported Performance/Conclusion: Certified compliant.
  • Test Category: Electromagnetic Compatibility (IEC 60601-1-2:2014)
  • Purpose: Electromagnetic disturbances.
  • Reported Performance/Conclusion: Certified compliant.
  • Test Category: Radio Emissions (IEC 62311:2007)
  • Purpose: Human exposure restrictions for electromagnetic fields.
  • Reported Performance/Conclusion: Tested according to standard. (Implies compliance, though "compliant" isn't explicitly stated here).
  • Test Category: Sterilization Validation (ISO 11135:2014)
  • Purpose: Ethylene Oxide sterilization for WIRELESS-HC.
  • Reported Performance/Conclusion: Validated according to standard.

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

• Not applicable/Not provided in this document. This device is a surgical tool control, not a diagnostic device relying on patient data. The "test set" here refers to the physical devices and software being tested. There's no mention of patient data, retrospective/prospective studies, or country of origin for such data.

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 applicable/Not provided. This type of information is relevant for studies involving expert interpretation of medical images or other clinical data to establish a "ground truth." This document describes engineering and regulatory compliance testing for a physical device. Ground truth, in this context, would be defined by engineering standards and specifications.

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

• Not applicable/Not provided. Similar to point 3, this refers to methods for resolving discrepancies among expert interpretations, which is not relevant for the type of testing described here.

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/Not provided. This is explicitly for AI-enabled diagnostic aids. The eG1 Wireless Hand Control System is a physical surgical control device, not an AI system or diagnostic aid.

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

• Not applicable/Not provided. Again, this is for AI algorithms. The device performs its function as designed; there's no "algorithm only" performance separate from the device's operation.

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

• N/A in the context of your question. For this device, "ground truth" equates to adherence to engineering specifications, performance standards (e.g., motor speed control accuracy, signal latency, electromagnetic compatibility limits), and recognized regulatory standards (IEC, ISO, FCC). It's not a clinical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/machine learning device that requires a training set.

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

• Not applicable/Not provided. As above, no training set for this device.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a new surgical control device to an existing one by confirming adherence to engineering specifications, recognized safety and performance standards (like IEC and ISO), and regulatory compliance (FCC). It does not present clinical study data with acceptance criteria for diagnostic performance or AI model evaluation as implied by your detailed questions.

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