(149 days)
The Quadsense is indicated for use in primary Total Knee Arthroplasty (TKA), where the patella is resurfaced.
For use as a comparative tool to measure patellofemoral joint force. Quadsense sensor is sterile, for single patient use.
The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement.
The QUADSENSE system has been designed to allow surgeons to compare forces in the patellofemoral joint during total knee surgery.
The QUADSENSE system includes a sensor that attaches to the patella, adjustment shims that attach to the sensor, a control puck, and a touchscreen Panel PC with QUADSENSE software. The patella sensor can take readings of Medial, Lateral, Superior, and Inferior loads during range of motion trials. The sensor records data that is displayed on the Panel PC in real time. The Panel PC remains outside of the sterile field, and the software workflow can be controlled by the surgeon using the control puck, within the sterile field. The Panel PC collects and temporarily stores sensor reading data so the surgeon can view the sensor readings of force through the patellofemoral joint during different stages of the surgical procedure.
The sensor has been designed to attach to the patella at the start of the surgical procedure, following a conservative resection of the patella. This allows the surgeon to take a sensor reading of the patient's force through the patellofemoral joint during range of motion trials, prior to the resurfacing of the femur and the tibia. The surgeon can then take a reading of the force through the patellofemoral joint with the trial femoral and tibial components in situ. This allows the surgeon to assess how the new position of the femoral and tibial components has impacted the patient's force through the patellofemoral joint by comparing the reference reading taken prior to resurfacing to the reading(s) taken following trial implant insertion.
The sensor is supplied with several shims with different thicknesses and angles. By changing the thickness, rotation angulation parameters of the shim attached to the surgical procedure the surgeon can assess how change in patella thickness or angulation will impact the force through the patellofemoral joint.
The provided text describes the regulatory clearance for the QUADSENSE device and includes some performance data, but it does not contain the specific information requested in your prompt regarding detailed acceptance criteria, the study proving the device meets those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, or training set details.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (VERASENSE for Zimmer Biomet Persona) for FDA clearance (K241298). It mentions several types of testing performed to ensure safety and performance, but these are general categories rather than specific performance studies with detailed outcomes against acceptance criteria.
Here's an breakdown of the information that is available and what is missing based on your request:
Information available in the document:
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1. A table of acceptance criteria and the reported device performance: A direct table is not provided. However, some performance aspects are mentioned:
- Applied Force of Load Sensing - Load Range and Accuracy:
- Predicate (VERASENSE): 5-40 lbf ≤ 3.5 lbf; 41-70 lbf for reference only
- Subject Device (QUADSENSE): Sensor is calibrated at 70 Newtons (15.7 lbf) with 10% error
- Maximum Safe Load:
- Predicate (VERASENSE): 70 lbf
- Subject Device (QUADSENSE): 16.8kg (37.0 lbf)
- Biocompatibility: Meets requirements of ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Material mediated pyrogenicity).
- Electrical Safety: Complies with IEC 60601-1.
- Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2.
- Software Verification and Validation: Conducted, documentation provided as per FDA guidance.
- Cybersecurity: Threat modeling, risk management, and mitigation measures performed.
- Applied Force of Load Sensing - Load Range and Accuracy:
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states, "The QUADSENSE software application does not directly drive a decision regarding treatment or therapy." It's a "comparative tool to measure patellofemoral joint force." This implies a standalone measurement capability to provide data to the surgeon, so in that sense, its basic functionality is standalone.
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7. The type of ground truth used: Not explicitly stated for performance validation beyond compliance with standards (e.g., electrical safety, biocompatibility). For force measurement, the "ground truth" would implicitly be the calibrated reference loads used during testing.
Information NOT available in the document:
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No details on sample sizes for any performance testing, nor on data provenance (country, retrospective/prospective).
- 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 or not specified, as the device doesn't make a diagnosis but rather measures force. The "experts" would be the engineers validating the force measurement.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the nature of the device (a measurement tool, not a diagnostic imaging AI).
- 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. This device is a surgical tool that measures force, not an AI for interpreting medical images by human readers.
- 8. The sample size for the training set: The document does not describe any machine learning/AI training sets for the device.
- 9. How the ground truth for the training set was established: Not applicable, as no training set is described.
In summary, the document demonstrates that QUADSENSE has undergone various engineering and safety tests to meet medical device standards and establish substantial equivalence. However, it does not detail a clinical performance study with defined acceptance criteria for diagnostic accuracy, nor does it describe an AI component with associated training or test data specifics as often found for AI/ML-based diagnostic devices.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).