(296 days)
For Lateral Patient Registration:
The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes.
The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a lateral decubitus position.
The Navbit® Sprint System for lateral patient registration is indicated for use:
- . in Hip Arthroplasty surgical procedures;
- with acetabular cups that are uncemented and allow for post-impaction correction; .
- when post-impaction confirmatory measurement checks can be obtained.
For Supine Patient Registration:
The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes.
The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position.
The Navbit® Sprint System for supine patient registration is indicated for use:
- in Hip Arthroplasty surgical procedures; .
- with acetabular cups that are uncemented and allow for post-impaction correction; .
- . when post-impaction confirmatory measurement checks can be obtained.
The Navbit® Sprint System is a computer assisted surgical navigation system for use in hip arthroplasty procedures. The Navbit® Sprint System utilizes a palm-sized computer module containing sensors including rate gyroscopes and accelerometers to generate real time angular measurements (inclination and anteversion angles) used to guide acetabular cup implantation during orthopedic procedures.
During hip arthroplasty procedures, the Navbit® Sprint System assists the surgeon in registering the pelvic coordinate system and determining the inclination angle and the anteversion angle of the introducer/impactor relative to the registered pelvic coordinate system.
The device requires registration to be performed in one of two acceptable patient positions - supine and lateral, and alignment guidelines are provided for each. Any surgical approach that allows this registration to be performed is appropriate for use with the Navbit® Sprint.
The Navbit® Sprint System is provided terminally sterilized, single-use disposable.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text.
It's important to note that the provided text is a 510(k) summary, which is a high-level overview. It does not contain detailed results, specific performance metrics for acceptance criteria, or most of the information requested regarding study design (sample size, expert qualifications, etc.). The document states that "All tests confirmed the product met the predetermined acceptance criteria," but it does not list what those criteria are or the exact performance achieved against them.
Therefore, I will extract what is available and highlight where information is missing.
Acceptance Criteria and Device Performance (Partial)
The document primarily relies on non-clinical testing, particularly "System accuracy testing: bench testing with mechanical fixtures to verify angular measurement accuracy using ASTM F2554-18" and "Simulated use (cadaver) testing…to validate that the system meets the requirements for user needs in a simulated use environment provides validation evidence that the product met the predetermined clinical pass/fail criteria."
While specific numerical acceptance criteria and reported device performance are not explicitly detailed in a table, the document states:
"All tests confirmed the product met the predetermined acceptance criteria."
"Performance testing addressed the functionality and surgical procedure workflows/steps as defined in the Navbit® Sprint user manual and demonstrates that the Navbit® Sprint System is as safe, as effective, and performs as well as the predicate device [OrthAlign Plus® System (K172462)]."
Based on the mention of ASTM F2554-18, the acceptance criteria would likely be related to accuracy for positional measurements. Without the actual criteria and results, a complete table cannot be generated.
Inferred Acceptance Criteria (Based on ASTM F2554-18):
| Acceptance Criteria Category | Inferred Specifics (if known, based on ASTM F2554-18) | Reported Device Performance (as stated in document, actual values not provided) |
|---|---|---|
| System Accuracy (Angular Measurement) | Likely thresholds for angular deviation (e.g., within X degrees for inclination and anteversion). | "All tests confirmed the product met the predetermined acceptance criteria." and "demonstrates that the Navbit® Sprint System is as safe, as effective, and performs as well as the predicate device." |
| Functionality | Device performs as described in the user manual for hip arthroplasty procedures. | "Performance testing addressed the functionality and surgical procedure workflows/steps as defined in the Navbit® Sprint user manual." |
| Simulated Use (Clinical Pass/Fail Criteria) | User needs met in a simulated surgical environment (e.g., successful registration, accurate guidance). | "product met the predetermined clinical pass/fail criteria." |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size:
- Bench Testing (ASTM F2554-18): Not specified. Likely involved a series of repeatable measurements on mechanical fixtures.
- Simulated Use (Cadaver) Testing: Not specified. The number of cadavers used is not mentioned.
- Data Provenance: The studies appear to be prospective bench and cadaver tests conducted by Navbit Pty Ltd or its partners. The country of origin of the data is not specified, but the company is based in Australia.
- Test Set Sample Size:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Bench Testing: Ground truth for angular accuracy in bench testing is typically established by the precision of the mechanical fixtures and reference measurements (e.g., using a goniometer or inclinometer, or highly accurate instrumentation).
- Simulated Use (Cadaver) Testing: The document mentions "an advising surgeon," implying at least one surgeon. Their specific qualifications (e.g., years of experience, subspecialty) are not specified. The nature of how "ground truth" was established in the cadaveric setting is also not detailed (e.g., post-implantation CT scan, radiographic measurement, etc.).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. Given the nature of bench testing (quantitative measurements against a standard) and cadaver testing with an "advising surgeon," a formal multi-reader adjudication process (like 2+1 or 3+1) is unlikely to have been performed in the context of this device's validation.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study was not performed, nor was it required for this 510(k) submission. The device is a navigation system, not an AI for image interpretation that typically necessitates MRMC studies. The human "readers" would be surgeons, and the device assists them, rather than an AI interpreting images for human readers.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this was not an AI-assisted diagnostic/interpretive device in the traditional sense, and no such comparative study was conducted or reported.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, partially. The "System accuracy testing: bench testing with mechanical fixtures to verify angular measurement accuracy using ASTM F2554-18" can be considered a standalone performance assessment of the device's measurement capabilities. This evaluates the algorithm's output against a known physical ground truth. The "human-in-the-loop" (i.e., the surgeon) is involved in using the device in the simulated use, but the fundamental accuracy measurements of the system itself are determined in a standalone fashion on the bench.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing: Engineering/mechanical ground truth based on precise fixtures and instrumentation (e.g., known angles).
- Simulated Use (Cadaver) Testing: "Predetermined clinical pass/fail criteria" validated by an "advising surgeon." The specific method for establishing objective ground truth (e.g., post-operative imaging, physical measurement) in the cadavers is not detailed.
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The sample size for the training set:
- Not applicable/Not specified. This device is a computer-assisted surgical navigation system, using sensors (gyroscopes, accelerometers) to generate real-time angular measurements. The summary does not imply that it uses machine learning/AI models that require a "training set" in the conventional sense of image classification or predictive analytics. Its "algorithm" is likely deterministic (physics-based calculations from sensor data) rather than data-driven in the ML/AI context.
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How the ground truth for the training set was established:
- Not applicable/Not specified. No training set for an AI/ML model is mentioned.
§ 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).