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NET BRAND Osteosynthesis Nailing System are provided non-sterile.

Tibial Nails are indicated for stabilization of fractures of proximal and distal tibial shaft, open and closed tibial shaft fractures, certain pre and postisthmic fractures, non-unions and malunions.

Femoral Nails are indicated for stabilization of femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.

The Elastic Nails are indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or the flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients, the flexibility of the elastic intramedullary nailing allows it to be inserted at a point which avoids disruption of the bone growth plate.

All Implants are for single use only.

NET BRAND Osteosynthesis Nailing System consists of various shape and sizes of Nails and Screws, Locking Bolts.

The NET BRAND Osteosynthesis Nailing System are fabricated from Stainless Steel And Titanium.

The system contains several models based on the size of the device and application site such as fixation/reconstruction of Tibia and Femoral bones appropriate for the device. The Nail implants are available in many diameters and lengths.

These all are mainly divided into

• Tibia Nail
• Femoral Nail
• Elastic Nail
• Corresponding Screws and Locking Bolts for Fixations of These Nails.

These implants are supplied non-sterile, the products have to be sterilized prior to use.

The provided text is a 510(k) Premarket Notification for the "NET BRAND Osteosynthesis Nailing System." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on material, performance standards, and dimensional verification, rather than presenting a standalone study with detailed acceptance criteria and performance data for the device itself.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not extensively provided or applicable in the context of this 510(k) submission.

However, I can extract the information that is present concerning performance standards and the comparison with predicate devices.

1. A table of acceptance criteria and the reported device performance

The document states that the performance standards used in both the Subject Device (NET Brand) and the predicate device are "Equivalent." This implies that the NET BRAND Osteosynthesis Nailing System is expected to meet the performance criteria defined by these standards, which were also met by the predicate devices.

Here's a table summarizing the performance standards the device was tested against:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the "side-by-side testing" that was performed. It only mentions that these tests were conducted. The data provenance is not specified beyond the fact that the tests were conducted as part of this 510(k) submission by Narang Medical LTD. in India.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the submission relies on adherence to engineering performance standards rather than human-interpreted ground truth from medical imaging or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the evaluation method is based on mechanical performance testing against established standards, not human expert adjudication.

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

This is not applicable; the device is an osteosynthesis nailing system (physical implant), not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable; the device is a physical medical implant.

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

The "ground truth" in this context refers to the defined performance requirements as outlined in the ASTM material and performance standards (ASTM F 136, ASTM F 139, ASTM F 1264, ASTM F 384, ASTM F 543). The device's performance was compared "side-by-side" with predicate devices against these technical specifications to demonstrate equivalence.

8. The sample size for the training set

This is not applicable as the device is a physical implant and does not involve AI/machine learning requiring a training set.

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

This is not applicable.

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