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The OrthoPediatrics Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.

The OrthoPediatrics Blade Plate System will combine implants and instruments in one convenient system. This system will offer the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety.

This 510(k) premarket notification describes the OrthoPediatrics Blade Plate System. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

• Plate thickness(s) and width(s) are substantially equivalent to predicates.
• Range of plate angles are substantially equivalent to predicates.
• Range of screw sizes and threads are substantially equivalent to predicates.
• The fundamental scientific principles and technological characteristics, including the intended use, material, sizes, and general design are the same as, or similar to the predicate devices. The technological characteristics of the subject device and the predicates are substantially equivalent to the predicates. |
  | Indications for Use Equivalence: Same or similar intended use as predicates. | Met: Indications for Use is substantially equivalent to predicates. The OrthoPediatrics Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies. Consistent with the predicate devices. |
  | Mechanical Strength & Resistance to Bending Moments: Equivalent or better mechanical properties compared to predicates. | Met: Engineering calculations with worst-case loading calculations of subject device and corresponding predicate device, confirmed that subject device has equivalent or better strength and resistance to bending moments. (This is a claim based on calculations, not a direct performance measurement against a benchmark from a study.) |
  | Safety and Effectiveness: No new questions of safety or effectiveness are raised. | Met (by inference): A review of the MAUDE complaint database of similar predicate devices supports the safety and effectiveness of the device. The FDA's substantial equivalence determination implies they found no new questions of safety or effectiveness. The fundamental scientific principles and technological characteristics, including the intended use, material, sizes, and general design are the same as, or similar to the predicate devices, leading to the conclusion that "safety and efficacy is expected to be equivalent." |

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: Not applicable. This submission relies on bench testing (engineering calculations) and comparison to predicates, not a clinical test set with human subjects or medical image data.
• Data Provenance: The "data" primarily comes from:
  • Specifications and material properties of the subject device.
  • Specifications and material properties of predicate devices.
  • Engineering calculations for mechanical properties.
  • MAUDE (Manufacturer and User Facility Device Experience) database – this is a post-market surveillance database for adverse events for marketed devices (predicates in this case), not a data set for a prospective study. Its provenance is from various healthcare facilities in the US reporting issues.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable. There was no "test set" requiring ground truth established by experts in the context of clinical or diagnostic performance. This is a submission for a mechanical device, primarily demonstrating equivalence in design and materials.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert adjudication was used.

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 medical device (bone plate system), not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable in the conventional sense of clinical ground truth. The "ground truth" for this submission is implicitly based on:
  • Engineering Principles: Equations and models used for the strength calculations.
  • Material Standards: ASTM-F138 for 316L stainless steel.
  • FDA's Premarket Notification (510(k)) Process: The determination of "substantial equivalence" to legally marketed predicate devices, meaning the previous predicate devices serve as an established baseline for safety and effectiveness.

8. The sample size for the training set

• Not applicable. There is no machine learning or AI component requiring a training set.

9. How the ground truth for the training set was established

• Not applicable. No training set.

Summary of the Study (Performance Analysis):

The "Performance Analysis" section clearly states: "Subject device has similar configuration, sizes and design as the predicate device(s). Engineering calculations with worst case loading calculations of subject device and corresponding predicate device, confirmed that subject device has equivalent or better strength and resistance to bending moments. A review of the MAUDE complaint data base of similar predicate devices support the safety and effectiveness of the device."

Essentially, the "study" demonstrating the device meets (implicit) acceptance criteria for safety and effectiveness is a bench-top engineering analysis (computational modeling/calculations) and a comparison to the established safety record (MAUDE data) of substantially equivalent predicate devices, rather than a clinical trial or diagnostic performance study. The core method is demonstrating substantial equivalence to legally marketed devices.

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