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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Fitting of lower limb prosthesis .
Highly mobile individuals and/or individuals who need stance stability .

C-LEG (3C100) is a microprocessor-controlled knee joint system with hydraulic stance and swing phase control. The C-LEG immediately adapts to different walking speeds and provides knee stability.
The C-LEG (3C100) is recommended for lower limb amputees weighing up to 110 kg (220 pounds) who have a moderate (level 2 or 3) functional level. It is a monocentric knee joint composed of:

• Carbon Fiber Frame ●
• Hydraulics with Servo Motor ●
• Electronics .
• Distal Tube Clamp ●
• . Upper Joint
• Shin Tube Adapter
  Components of the C-LEG (3C100) are the following:
• Electronic Knee Joint 3C87 ●
• 2R90 Tube Adapter or .
• Tube Adapter with Torsion Adapter 2R91 .
• Rotation Adapter 4R57 .
  Accessories are the following:
  • 757L17 Charging Device
• Power Unit ● 757L16
• Prosthetic Foot 1D10, 1D25, 1A30 .
• Foam Cover ● 3826
• . 4X70 Slider Software
• Extension Cable . 4X72
• 4X71 PC Interface .
• 4R302 Transportation Case ●

The provided text does not contain detailed information about specific acceptance criteria or a study that proves the device meets those criteria in the format requested.

The document is a 510(k) summary for the Otto Bock C-LEG (3C100), which declares its substantial equivalence to a legally marketed predicate device (Otto Bock's 3C1). In the context of 510(k) submissions, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device, rather than meeting specific performance thresholds through a new, independent clinical study as might be required for a PMA or de novo submission.

Here's a breakdown of why many of your requested items cannot be fulfilled based on the provided text:

• No detailed performance study with acceptance criteria: The document focuses on demonstrating substantial equivalence, not on presenting a standalone performance study with specific metrics and acceptance thresholds.
• No information on sample sizes, ground truth, experts, or adjudication methods for a performance study: Since a detailed performance study proving specific acceptance criteria isn't described, these details are absent.
• No MRMC study information: This type of study would be part of a comprehensive performance evaluation, which is not detailed here.

However, I can extract information related to the device and its intended use, which indirectly relates to its "acceptance" for market clearance:

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

Based on the 510(k) summary, the primary "acceptance criterion" for market clearance is substantial equivalence to a predicate device.

The study that proves the device meets the acceptance criteria:

The document states: "The C-LEG (3C100) is substantially equivalent to Otto Bock's 3C1, a Class I Exempt Device according to 21 CFR Part 890.3420. Differences that exist between these devices, relating to technical specifications, physical appearance and design, do not affect the relative safety and effectiveness of the C-LEG (3C100)."

This suggests that the "study" was primarily a comparative analysis demonstrating that the C-LEG (3C100) is sufficiently similar to the predicate device, and any differences do not raise new questions of safety or effectiveness. This is typical for a 510(k) submission. No specific patient study with acceptance criteria, sample sizes, or ground truth establishment is described in this summary.

Details that cannot be extracted from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable/not provided for a comparative equivalence submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
4. Adjudication method: Not applicable/not provided.
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. The device is a prosthetic knee joint, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a prosthetic knee joint, not an algorithm.
7. The type of ground truth used: Not applicable/not provided.
8. The sample size for the training set: Not applicable (not an AI/ML device, and no training set for a performance study is mentioned).
9. How the ground truth for the training set was established: Not applicable.

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