(106 days)
The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market two (2) new accessory devices into the Gamma4 System: Plus Targeting Arm and Plus Nail Holding Screw.
The Gamma4 System was previously cleared under K213328, is a hip fracture nailing system and includes sterile implants (Trochanteric and Long Nails in various diameters and sizes, Lag Screws, and End Caps) as well as non-sterile instruments (targeting devices). The nails, lag screws and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.
The Gamma4 System has two (2) types of targeting devices: (1) Proximal Targeting Arm (consisting of Targeting Sleeve and Nail Holding Screw) previously cleared in K213328 and (2) the subject devices, Plus Targeting Arm (consisting of the Plus Nail holding Screw and Targeting Sleeve, previously cleared in K213328). The previously cleared Proximal Targeting Arm has less of an extension out from the axis of the nail, whereas the subject device is more rounded and extends out further to ensure sufficient tissue clearance. Both targeting devices are manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.
This is a 510(k) premarket notification for an orthopaedic device (intramedullary fixation rod system), specifically for an update to accessory devices (Plus Targeting Arm and Plus Nail Holding Screw) for an already cleared system. Therefore, the information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic performance or AI accuracy.
As such, many of the requested categories for AI/diagnostic device studies do not apply directly to this submission.
Here's an analysis based on the provided text:
The device in question is not an AI/Software as a Medical Device (SaMD) or a diagnostic device. It is an intramedullary fixation rod system with new accessory devices. Therefore, metrics like sensitivity, specificity, NPV, PPV, number of experts, ground truth, MRMC studies, or standalone algorithm performance are not applicable to this type of submission.
However, I can extract information related to the acceptance criteria and the (non-clinical) study performed for this specific device type:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Applicable to medical devices like this) | Reported Device Performance (as demonstrated in testing) |
|---|---|
| Substantial Equivalence: The new accessory devices (Plus Targeting Arm and Plus Nail Holding Screw) must not raise different questions of safety and effectiveness compared to the predicate device. | The submission argues that the Gamma4 System (with the new accessories) is "substantially equivalent to the previously cleared Gamma4 System (K213328) primary predicate and the Gamma3 System (K213328) additional predicate device." |
| Functional Equivalence: The new accessories should perform their intended function effectively and safely. | The new accessories are designed to increase tissue clearance. Testing was conducted to ensure "Targeting accuracy." |
| No Alteration to Intended Use/Indications: The introduction of the new accessories should not change the existing intended use or indications for use of the Gamma4 System. | The submission explicitly states: "The introduction of the Plus Targeting Arm and Plus Nail Holding Screw does not alter the intended use of the subject system previously cleared in K213328" and "The introduction of the Plus Targeting Arm and Plus Nail Holding Screw does not alter the indication for use of the subject system previously cleared in K213328." |
| Material Equivalence: Materials used for the new accessories should be safe and equivalent to those in predicate devices or well-established medical device materials. | The document states: "Both targeting devices are manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced." The nails, lag screws and end caps are "made of titanium alloy (Ti6Al4V ELI) as per ASTM F136." These are standard materials for such devices. |
| Performance Testing: Non-clinical testing to demonstrate performance, safety, and functionality. | "Targeting accuracy testing" was performed. |
Details on the "Study" (Non-Clinical Testing)
The submission refers to "Non-Clinical Testing" rather than a clinical study or a study related to AI performance.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the "Targeting accuracy testing." This sort of non-clinical testing for mechanical devices typically involves a defined number of test samples per configuration, but the specific number isn't in this summary.
- Data Provenance: Not applicable in the sense of patient data. It would be lab-generated data from mechanical testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of mechanical device testing refers to the actual performance or known standard measured against. This would be established by engineering specifications and metrology, not expert consensus in the medical sense.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 are for reconciling expert opinions, which isn't relevant for mechanical performance testing of an intramedullary rod system. Results are typically quantitative measurements compared to predefined engineering tolerances.
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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, an MRMC comparative effectiveness study was explicitly not done. The device is a physical orthopedic implant system, not a diagnostic imaging or AI-assisted product.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an algorithm or AI product.
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The type of ground truth used:
- For the "Targeting accuracy testing," the ground truth would be based on engineering specifications and metrological measurements, comparing the actual targeting performance against the design intent and acceptable tolerances.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
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How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
§ 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.