(57 days)
The Intellijoint HIP Generation 2C System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors.
The Intellijoint HIP Generation 2C System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective. The system aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning.
Example orthopedic surgical procedures include, but are not limited to:
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Total Hip Arthroplasty
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Minimally Invasive Hip Arthroplasty
The Intellijoint HIP® Generation 2C System is an imageless optical navigation system intended for use in orthopedic surgery. The device provides intra-operative assessment of patient leg length, offset, anterior-posterior change, hip center of rotation change, and acetabular cup angle during Total Hip Arthroplasty procedures. The system is composed of an infrared Camera, Tracker, computer workstation, software, and bone fixation instruments/hardware.
This submission describes updates implemented to provide terminally sterile bone screws to the user, which were previously only supplied non-sterile. The intended use and fundamental scientific technology is unchanged, and remains substantially equivalent to the predicate device.
The provided text describes a 510(k) submission for the Intellijoint HIP Generation 2C System, which is an update to a previously cleared computer-assisted orthopedic surgery system. The submission focuses on changes to the sterilization and packaging processes for bone screws, rather than a clinical performance study of the device's accuracy in intra-operative measurements.
Therefore, the acceptance criteria and study detailed below relate to manufacturing, sterilization, and packaging aspects of the bone screws included with the system, not the accuracy or clinical effectiveness of the Intellijoint HIP system itself. The document states "The intended use and fundamental scientific technology is unchanged, and remains substantially equivalent to the predicate device." and "This modification does not alter the device's fundamental scientific technology in comparison to the predicate devices (K151364 and K162364) and therefore has the same technological characteristics."
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| Manufacturing Cleaning Process | All gravimetric residue acceptance criteria specified for the cleaning process. | All gravimetric residue acceptance criteria were met. |
| Biocompatibility Analysis | Cytotoxicity levels meet specified acceptance criteria. | All acceptance criteria met with no deviations. |
| Packaging Integrity Testing | Packaging system design and integrity requirements are met, including visual integrity, seal integrity, and strength testing under physical and climatic stress. | All packaging system design and integrity requirements were met. |
| Sterilization Validation Testing | All sterility requirements for gamma irradiation sterilization dose for terminal sterilization are met. | All sterility requirements were met. |
| Sterile Barrier System Integrity Tests | No anomalies in visual inspection of seals and pouches; seal width measurements, bubble leak test, and seal strength meet acceptance criteria. | All acceptance criteria were met with no deviations. |
| Shelf-life/Aging Tests | No degradation to the sterile barrier system over a five-year period for both real-time (QSEAL® Tyvek pouch) and accelerated aging (clear barrier film and Tyvek® 1073B). | No degradation to sterile barrier system over a five-year period. |
| Pyrogenicity Testing | Bacterial endotoxin levels are quantified and meet specified endotoxin limits. | Bacterial endotoxin limits were met. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for each test mentioned (e.g., number of screws tested for cleaning, biocompatibility, sterilization, or packaging). The tests listed are primarily laboratory-based or engineering tests on components/packaging rather than clinical studies with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply in the context of these specific manufacturing and sterilization validation tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable to the types of tests described, as the ground truth is established through standardized laboratory testing procedures and specifications (e.g., gravimetric analysis for residue, cytotoxicity assays, bacterial endotoxin limits, physical testing for packaging integrity) rather than expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical or image-based studies where human interpretation or consensus is required. These methods are not relevant to the engineering and analytical tests described for manufacturing, sterilization, and packaging validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The submission explicitly states it does not alter the device's fundamental scientific technology and the purpose is for updates to sterilization and packaging processes. Therefore, a clinical MRMC comparative effectiveness study, particularly one measuring human reader improvement with or without AI, was not conducted nor is it applicable to this type of regulatory submission. The device is an "imageless optical navigation system" and the current submission is about manufacturing/sterilization, not a new AI component requiring human reader evaluations.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. The tests described are related to the manufacturing, sterility, and packaging of physical components (bone screws) of the system, not a standalone algorithm's performance in a clinical or diagnostic context.
7. The Type of Ground Truth Used
For the tests described:
- Manufacturing Cleaning Process: Measured gravimetric residue, compared against pre-defined acceptance criteria.
- Biocompatibility Analysis: Cytotoxicity levels determined via standardized assays, compared against safety limits.
- Packaging Integrity Testing: Physical measurements (e.g., seal width, strength), visual inspections, and performance under stress, compared against engineering specifications.
- Sterilization Validation Testing: Sterility assurance levels (SAL) confirmed through gamma irradiation studies, adhering to regulatory standards for medical device sterility.
- Sterile Barrier System Integrity Tests: Physical characteristics (seal width, strength), leak tests, visual inspection, compared against design specifications.
- Shelf-life/Aging Tests: Observation of material degradation and integrity over time (real-time and accelerated), compared against expected performance.
- Pyrogenicity Testing: Bacterial endotoxin levels quantified using LAL testing, compared against established endotoxin limits.
In essence, the ground truth for these tests is based on established scientific and engineering standards, validated laboratory methods, and regulatory limits applicable to medical device manufacturing and sterilization.
8. The Sample Size for the Training Set
This concept is not applicable here. The document describes validation tests for manufacturing and sterilization processes, not the development or training of an algorithm or AI model.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no training set for an AI/algorithm described in this submission.
§ 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).