(278 days)
The QuickLock Orthopaedic Targeting System is indicated for use whenever distal interlocking screws are placed in intramedullary nails. The system includes nail-specific, reusable accessory adapter components that enable mechanical attachment of the QuickLock Probe to the nail system proximal instrumentation and alignment of the QuickLock Guide during calibration.
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Here's an analysis of the provided text, focusing on acceptance criteria and study details for the QuickLock Orthopaedic Targeting System:
Acceptance Criteria and Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative, pass/fail manner. Instead, it presents a comparative effectiveness study against predicate devices, highlighting improvements in various aspects. The "acceptance criteria" can be inferred from the areas where the QuickLock system demonstrates superior or equivalent performance to the predicate devices.
Table 1: Inferred Acceptance Criteria and Reported Device Performance
| Inferred Acceptance Criteria | Reported Device Performance (QuickLock System) | Predicate Device Performance |
|---|---|---|
| Improved Efficiency / Reduced Procedure Time | Averaged 8.1 minutes (range 5.2 - 14.0 minutes) for distal targeting over 22 procedures (13 femoral, 9 tibial). Specifically, the average time using the final probe configuration was 6.6 minutes. | Averaged 16.1 minutes (range 10.4 - 30.0 minutes) for distal targeting over 17 procedures (10 femoral, 7 tibial) using Richards or Synthes radiolucent drills. |
| Reduced Skill and Experience Required for Users | Users have continuous visual control, making the task easier. Less training, skill, and experience are required. Surgeons learn the technique after a few minutes of training and proficiency is retained without frequent performance. (Qualitative improvement) | Requires considerable skill and experience due to reliance on short x-ray exposures and intermittent visual control. Surgeons who infrequently perform the procedure become markedly less effective. (Qualitative assessment) |
| Improved Accuracy of Visual Cues and Drilling Accuracy | The probe and guide are mechanically aligned with target holes during calibration, electronically offsetting errors. Drilling accuracy is enhanced by high visual sensitivity of dot and cross-hair sight adjustments and continuous display of visual sighting information. Ensures correct hole size and shape for maximum screw holding strength and endurance. Reduces the occurrence of drill strikes. (Qualitative improvement with direct impact on outcome) | Adjustment of C-arm position relies on visual perception of distal holes as true circles, limited by subjective judgment. Operator skill strongly affects drilling accuracy between visual snapshots. Holes started out of alignment must be elongated, reducing holding strength and endurance. Drills often strike edges, causing nicks that can lead to premature nail breakage. (Qualitative assessment with direct impact on outcome) |
| Enhanced Operator Comfort | No need to stay out of an x-ray beam, allowing surgeons to stand, hold the guide, and drill in a comfortable position. (Qualitative improvement) | Surgeons work in awkward positions, reaching from the side to avoid the x-ray beam, due to the need to minimize x-ray exposure. (Qualitative assessment) |
| Minimization of Radiation Exposure to Surgeons and Patients | The low-energy, 25 KHz sinusoidal, nonionizing electromagnetic field generated by the probe coils is a nonsignificant radiation hazard and produces negligible temperature rise of the probe surface. (Qualitative assessment based on expert opinion) | Ionizing electromagnetic x-rays are generated by the C-arm image intensifier, posing a prominent risk. (Qualitative assessment) |
| Compliance with Safety Standards (Electrical, Biocompatibility) | The display, probe, and guide are to be certified to UL Standard 544, 2d Edition. Risk of shock is eliminated by low voltage levels, isolation, insulation, and grounding. Components are made of surgical stainless steel, nickel-titanium alloy (Nitnol SE 508), USP Class VI biocompatible polysulfone, and USP Class III biocompatible polyphenylsulfone. (Certification planned, material biocompatibility stated) | Predicate devices are described as using surgical stainless steel, radiolucent plastic, etc. The document implies predicate devices also meet general safety standards, but no specific comparative detail is provided; rather, the QuickLock system is presented as meeting safety norms appropriate to its design. |
Study Details
The provided text describes a clinical trial that primarily focused on time required for distal targeting and provided qualitative assessments for other performance aspects.
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Sample size used for the test set and the data provenance:
- Sample Size:
- Predicate devices: 17 procedures (10 femoral, 7 tibial)
- QuickLock system: 22 procedures (13 femoral, 9 tibial)
- Data Provenance: Clinical trials performed at the University of Arizona Health Sciences Center, Tucson, Arizona, USA, from September 1995 to the present (at the time of the document). These trials were conducted under IRB classification as a nonsignificant risk device.
- Sample Size:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts used to establish a quantitative ground truth for the performance metrics (e.g., accuracy of drilling in mm).
- The primary investigator for the clinical trials was John T. Ruth, M.D., Assistant Professor, Section of Orthopedic Surgery at the University of Arizona Health Sciences Center. He, as the operating surgeon and researcher, would be responsible for the data collection and judgment of "ground truth" performance during the actual procedures, particularly for the time measurement and qualitative observations.
- For the radiation hazard assessment, the opinion was from Howard Bassen, Head, Electro-Physics Branch, FDA Office of Science and Technology.
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Adjudication method for the test set:
- The document does not specify a formal adjudication method (e.g., 2+1 consensus) for establishing ground truth regarding the procedure time or qualitative aspects. The data appears to have been collected directly from the clinical procedures and reported by the investigators. For time measurements, the "ground truth" is a direct measurement. For qualitative aspects like skill required or operator comfort, it's based on observations and experience of the operating surgeon (Dr. Ruth) and perhaps the surgical team.
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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:
- No, a MRMC comparative effectiveness study was not done in the context of "human readers" or "AI assistance." This device is a surgical targeting system, not an imaging diagnostic AI system. The comparison is between two surgical methods/devices – one "freehand" (predicate) and one "assisted" (QuickLock system) – in terms of surgical outcomes like time, accuracy, and comfort.
- The "effect size" for time reduction is substantial:
- QuickLock (final configuration): 6.6 minutes
- Predicate devices: 16.1 minutes
- This represents a reduction of approximately 59% in targeting time ( (16.1 - 6.6) / 16.1 * 100 ).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The QuickLock system is a human-in-the-loop surgical guidance device. It assists the surgeon; it does not operate autonomously.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Time Data: Direct quantitative measurement during live surgical procedures.
- Accuracy/Quality/Nicking: Surgeon's direct observation and assessment of the quality of drilled holes, alignment, and occurrence of nicks during the procedure. This is a form of expert observation/assessment derived from surgical outcomes.
- Skill/Comfort/Radiation: Expert qualitative assessment based on the surgeon's experience and comparison between the two methods.
- Electrical Safety & Biocompatibility: Compliance with established safety standards (UL Standard 544) and use of biocompatible materials (based on material specifications and external certifications/approvals like FDA for stents).
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The sample size for the training set:
- The document does not explicitly describe a "training set" in the context of machine learning. The QuickLock system is a mechanical/electronic guidance system, not an AI/ML algorithm that requires a separate training set for its development. The "training" for the device itself would have been its engineering design and manufacturing. The clinical trials served as validation/testing.
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How the ground truth for the training set was established:
- Since there's no "training set" in the AI/ML sense, this question is not applicable.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.