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510(k) Data Aggregation
(138 days)
PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
The PiGalileo™ Total Hip Replacement (THR) System is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g. hip center, pelvic plane etc.).
Examples of some surgical procedures include but are not limited to: Primary total hip replacement Revision hip surgery Minimally invasive hip arthroplasty
The PiGalileo™ Total Hip Replacement (THR) software application when provided with the PiGalileo™ system cart results in the PiGalileo™ THR System, a softwarecontrolled electromechanical stereotaxic device for computer-aided navigation of PiGalileo™ surgical instruments with the purpose of assisting the surgeon in optimally positioning hip prostheses. Refer to Section 11.0 for an in depth description of the PiGalileo™ THR System.
The PiGalileo™ THR System is intended to be used in computer-assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively.
The PiGalileo™ THR System is based on common stereotaxic technology in which Infrared (IF) LED (light emitting diodes) or passive markers on the surgical instruments allow the instruments to be tracked in real time in the surgical field.
In the case of PiGalileo™ THR System, patient data that is required to navigate the surgical instruments is collected during the procedure. The system utilizes this data to establish a connection between passive locaters, i.e., Infrared (IF) light, and the system's IF camera as previously described tracks the surgical instruments in real time in the surgical field.
The precision of navigation-assisted surgery depends on accurate scanning of skeletal landmarks. Scanned morphological data represents the basis for calculating the position of the hip cup and hip stem. Scanned points must represent unique anatomic landmarks so that they can be located in a safe and reproducible manner throughout surgery. For cup navigation, the spinae, left/ right are scanned as well as the symphysis. Each point is scanned three times to enhance precision and used for inclination and anteversion alignment. For stem navigation, the sagital plane is determined from the tibialis anterior and the intersection point on the femur. The position and alignment of the proximal stem axis are determined with a probe which provides the basis of the varus/valgus alignment.
The surgeon maintains control of the operation and any decisions required with regard to the surgery at all times. Risk mitigations implemented under Design Controls ensure that sufficient fail safe mechanisms allow the surgeon to convert to non-navigated conventional surgical techniques at any time.
The navigation platform for the PiGalileo™ THR System is the same as the navigation platform cleared under PiGalileo™ TKR System, K061362, and includes the following elements:
(a) System Cart housing the following items; there are no changes to the system cart as compared to K061362.
1 System electronics such as CPU and connection box
Monitor
User Interface consisting of keyboard, touch pad and hard controls, e.g., "ON / OFF", footswitch
Infrared (IF) Camera and Camera Stand/Tripod
Optional printer
System cabling
(b) PiGalileo™ THR Software refers to the PiGalileo™ System Software and the THR software application:
PiGalileo™ System Software: this software is the same as that of the PiGalileo™ TKR System; there are no changes to either the system software or the calculations or the landmark technique as compared to K061362.
PiGalileo™ THR software application consists of two applets, PiGalileo™ Hip Cup and PiGalileo™ Hip Stem. Each applet consists of a collection of software modules that support the surgeon in hip cup and hip stem replacement. Each module is designed specifically for an implant in which the software calculates the values provided on screen differently for each implant, the specific implant geometry and the implant specific instruments.
(c) Surgical Instruments: include universal instruments such as hemispheres, and various locators; navigated instruments are equipped with markers that are tracked by the stereotaxic camera.
The POLARCUP® Dual Mobility System consists of two components: a thin press fit shell and a liner component.
The provided text describes the PiGalileo™ Total Hip Replacement (THR) System and its premarket notification (510(k)) to the FDA. However, the document does not contain specific acceptance criteria or a study detailing device performance against such criteria in terms of clinical accuracy or effectiveness.
Instead, the document focuses on:
- Device Description: What the PiGalileo™ THR System is and how it functions as a navigation system for hip replacement surgery.
- Intended Use/Indications for Use: The surgical procedures and assistance it provides.
- Predicate Device Comparison: How it compares to previously cleared navigation systems.
- Performance Standards (Regulatory Compliance): Conformance to various FDA-recognized standards for safety (electrical, mechanical, thermal), electromagnetic compatibility, software, sterilization, risk analysis, and biocompatibility of surgical tools.
- Design Control Performance Testing: A general statement about design verification and validation (bench testing) performed under FDA's Design Control Requirements.
Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria, specific performance measures, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies. The document does not provide this type of detailed performance study information.
Here's a summary of what can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of clinical accuracy (e.g., X mm accuracy for implant placement). The "acceptance criteria" here are largely met through adherence to recognized regulatory and design control standards.
- Reported Device Performance: No specific clinical or quantitative performance metrics (e.g., accuracy in degrees or millimeters, success rates, complication rates) are reported in this summary.
| Acceptance Criteria Category | Specific Criteria (as inferred/stated) | Reported Device Performance |
|---|---|---|
| Regulatory Compliance | FDA's "Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30" | "Design verification and design validation, e.g., bench testing, was performed according to FDA's Design Control Requirements." |
| Electrical, Thermal, Mechanical Safety | IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety | "PiGalileo™ Total Hip Replacement (THR) System does conform to the following FDA recognized standards." (Implied successful conformance) |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:01, IEC 61000-3-2:01, IEC 61000-3-3:94+A1:01 | "PiGalileo™ Total Hip Replacement (THR) System does conform to the following FDA recognized standards." (Implied successful conformance) |
| Software | IEC 60601-1-4:1996, FDA's "Reviewer Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (2005), FDA's "Guidance for Off-The-Shelf Software Use in Medical Devices" | "PiGalileo™ Total Hip Replacement (THR) System does conform to the following FDA recognized standards." (Implied successful conformance) |
| Sterilization (for reusable components) | AAMI TIR 12-1994, ISO 17664, AINSI/AAMI/ISO 11134, EN 556-1, AINSI/AAMI ST 67, LM P 2-11-04, LM SOP 2-11-04 | "Cleaning, disinfection and sterilization testing was performed according to the following test protocols." (Implied successful conformance) |
| Risk Analysis | ISO 14971:2000, Application of risk management to medical devices. | "PiGalileo™ Total Hip Replacement (THR) System does conform to the following FDA recognized standards." (Implied successful conformance) |
| Biocompatibility (surgical tools) | ASTM/ISO standards for surgically invasive devices for transient to short term use. | "Applies only to surgical tools, i.e., materials for system and THR software application do not come into contact with the patient." (Implied successful conformance) |
| Substantial Equivalence | To predicate devices (VectorVision Hip, Orthopilot® 2 THA V 2.0, Stryker Navigation System, PiGalileo™ TKR System) in indications for use/intended use and technical characteristics. | "The information and data provided in this 510(k) Premarket Notification establish that the PiGalileo™ Total Hip Replacement (THR) System is substantially equivalent to the afore-mentioned predicate devices." |
2. Sample size used for the test set and the data provenance: Not mentioned. The document refers to "bench testing" for design verification and validation, but no details on sample size, type of data, or provenance are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. Given the nature of the device (a surgical navigation system) and the timeframe (2007), the 'ground truth' for bench testing would likely involve highly precise measurements by engineers or technical experts rather than clinical experts establishing a ground truth in diagnostic interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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 mentioned. This document is for a surgical navigation system, not a diagnostic AI tool, so an MRMC study in the context of "human readers" is not applicable. The device assists surgeons, but the document doesn't quantify improvement in surgeon performance with the device versus without.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated regarding specific numerical performance of the algorithm. The system is designed with human-in-the-loop (the surgeon) and explicitly states, "The surgeon maintains control of the operation and any decisions required with regard to the surgery at all times." Standalone performance (algorithm only) would pertain to the accuracy of its tracking and calculation systems, which is generally covered under design verification/bench testing, but no specific metrics are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For a navigation system, ground truth during verification testing would likely involve highly accurate physical measurements of instrument position and spatial relationships in a controlled environment, possibly using precision measurement tools.
8. The sample size for the training set: Not mentioned. The system is a rule-based or model-based navigation system, not a machine learning/AI diagnostic system trained on large datasets in the modern sense. It relies on mathematical algorithms and optical tracking.
9. How the ground truth for the training set was established: Not applicable in the context of modern machine learning training sets. The "ground truth" for the device's development would be engineering specifications and anatomical models used to program its navigational calculations.
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