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510(k) Data Aggregation
(184 days)
The Locking Pediatric Osteotomy Plate (LolliPOP) System
The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension of proximal femoral osteotomies (PFO) and fractures in the pediatric (ages 2 to 21 years old) population. Indications for use include the following:
*Inter and subtrochanteric valgus osteotomies
*Inter and subtrochanteric varus osteotomies
*Inter and subtrochanteric derotation osteotomies
*Inter and subtrochanteric flexion and extension osteotomies,
*Inter and subtrochanteric fractures.
The Locking Pediatric Osteotomy Plate (LolliPOP) system is a modular hip blade-plate system intended for stable fixation of valgus, varus, derotation, flexion and extension, of proximal femoral osteotomies (PFO) and fractures in the pediatic population. PFOs are widely performed reconstructive surgeries in children with hip deformities, such as Coxa Valga, Coxa Vara and other congenital deformities. The implants are made of medical grade 316L Stainless Steel (ASTM F138) and are offered in four sizes: infant, child, adolescent and adolescent HD. The system is comprised of a set of plates, connectors, locking cortical screws, polyaxial compressions screws, and all the instrumentation required for implantation and retrieval of the device.
The provided document is a 510(k) summary for the "The Locking Pediatric Osteotomy Plate (LolliPOP) System" and does not describe a study involving an AI/CADe device or an imaging device. Instead, it describes a mechanical bone fixation appliance. Therefore, many of the requested fields (such as "effect size of how much human readers improve with AI vs without AI assistance", "standalone performance", "training set", "ground truth for the training set", etc.) are not applicable.
Here's an analysis based on the information provided in the document for the medical device in question, which is a physical orthopedic implant system:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent design, intended use, and function to predicate devices | Stated to be substantially equivalent in design, intended use, and function to the predicate devices. |
| Equivalent technological characteristics | Technological characteristics are the same or similar to predicate devices. Uses screws as the primary fixation method, similar to predicate systems. Modularity is equivalent to the Modular Blade Plate system (K080109). |
| Resistance/Mechanical Properties (bench testing) | Verification calculations completed. Mechanical properties of all blade, plate, and screw components analyzed in comparison to predicate systems. Bench testing in static and fatigue confirmed validity of calculations. |
| Single cycle and fatigue compression bend testing on the construct | Completed, but specific numerical results for acceptance are not provided. The conclusion states that results demonstrate equivalent performance to predicate devices. |
| Screw performance (torsional strength, axial pullout, driving torque) | Completed, but specific numerical results for acceptance are not provided. The conclusion states that results demonstrate equivalent performance to predicate devices. |
| Bending strength of the plate | Completed, but specific numerical results for acceptance are not provided. The conclusion states that results demonstrate equivalent performance to predicate devices. |
| Safety and effectiveness for intended use | A systematic search of scientific literature (Clinical Evidence Review report) was carried out to identify and analyze published peer-reviewed scientific literature regarding intended uses and predicate systems, to establish safety and effectiveness, addressing clinical hazards from device Risk Analysis. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This device is an orthopedic implant system, not a data-driven AI/CADe device. Therefore, the concept of a "test set" in the context of data points is not directly applicable.
- Mechanical Testing: Bench testing was performed on the device and a predicate device (Synthes CAPOS System). The exact sample size (number of devices or constructs tested) for these mechanical tests is not specified in the summary document. The "data provenance" would be laboratory testing.
- Clinical Evidence Review: A systematic search of scientific literature was conducted. This would involve reviewing existing published studies; no new clinical data was generated for this submission. The provenance would be the published scientific literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for a mechanical device. "Ground truth" in this context would be established by engineering standards and mechanical test results, and by established clinical knowledge from the scientific literature review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a mechanical device.
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 is a mechanical orthopedic implant, not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical orthopedic implant, not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be the engineering specifications, performance standards, and the measured mechanical properties of the predicate device. For the clinical evidence review, the "ground truth" was derived from published peer-reviewed scientific literature related to the intended uses and the predicate devices.
8. The sample size for the training set
Not applicable. This is a mechanical orthopedic implant, not an AI/CADe device that uses a training set.
9. How the ground truth for the training set was established
Not applicable.
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