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Device Name: Auxein Nailing System are categorized to the following system:

1. Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Gamma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System

INDICATION FOR USE:

1. AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and distal tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.

2. AUXEIN Brand of Expert Femoral Nailing System -is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.

3. AUXEIN Brand of Gamma Nailing System -The Gamma Nail with Anti -Rotation Screw is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.

4. AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.

5. The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures.

6. AUXEIN Brand of Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

7. AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.

An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body.

The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136).

Auxein Brand of Expert Tibia Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 8mm to 12mm; the length varies from 255mm. The screw implants are in corresponding diameter of 4.4mm & 4.8mm diameters with lengths varying as per the requirements and minimum length: 24mm to maximum length 90mm.

Auxein Brand of Expert Femoral Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking screw & Anti-rotation screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.The diameter of the nails varies from 9mm to 13mm; the length varies from 320mm to 440mm.The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 25mm to maximum length 130mm.

Auxein Brand of Ga-mma Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, Inner screw, locking bolts, Anti-rotation screw & Cephalic screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9mm to 13mm; the length varies from 180mm. The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm.

Auxein Brand of Humeral Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking bolt, compression screw, and proximal screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 6mm to 9mm; the length varies from 180mm to 320mm. The screw implants are in corresponding diameter of 3.5mm & 4.5mm diameters with lengths varying as per the requirements and minimum length: 20mm to maximum length 70mm.

Auxein Brand of AJAX Advance Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking bolts, Cephalic screw, Ajax Blade, and inner screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9mm to 12mm: the length varies from 170mm to 420mm.The screw implants are in corresponding diameter of 4.9mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm.

Auxein Brand of Elastic Nailing system consists of various shapes and sizes of sterile nails featuring end caps of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 1.5mm to 4.0mm; the total length of 440mm. The end caps are in corresponding diameter ranges from 1.5mm to 4.0mm diameters with length of 14mm & 25mm.

Auxein Brand of Retrograde Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9.5 to 12mm; the length varies from 180mm to 360mm. The screw implants are in corresponding diameter of 5.0mm diameters with lengths varying as per the requirements and minimum length: 32mm to maximum length 80mm.

Auxein Nailing System covered same products as of covered in K192003. In this addition Auxein Nailing System is offering sterile version of the nailing devices.

The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136).

However, we are adding a new device i.e. Ajax Blade in this submission. The associated Instruments with the newly added device are tabulated below.

1. Inner Screwdriver, Hex 4.0mm
2. Inner Screw Holder, Hex 4.0mm
3. Container for AJAX Cephalic Screw Instrument Set

These implants will be supplied in Sterile State (Gamma Irradiation) Only.

The provided text is a 510(k) summary for the Auxein Nailing System, which is a medical device. This type of document is for premarket notification of a device to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It focuses on comparing the new device to existing ones based on design, materials, and intended use, and generally does not contain information about clinical studies with human participants, AI algorithms, or detailed performance metrics like sensitivity/specificity derived from such studies.

Therefore, many of the requested items, which are typical for studies involving AI algorithms or comparative effectiveness of diagnostic devices, are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not specify quantitative acceptance criteria for device performance beyond compliance with material and performance standards. The "performance" is demonstrated through adherence to these standards and comparison to a predicate device.

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

This information is not applicable and not provided. The testing described is non-clinical (material and mechanical), not involving human patient data.

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 information is not applicable and not provided. "Ground truth" in the context of clinical expert consensus is not relevant to the non-clinical testing performed here.

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

This information is not applicable and not provided.

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 an AI device. No MRMC study was performed or is relevant to this submission.

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

This is not an AI device. No standalone algorithm performance was assessed.

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

The "ground truth" for the non-clinical testing is compliance with established engineering and material standards (e.g., ASTM F136 for material composition, ASTM F543 for mechanical properties).

8. The sample size for the training set

This information is not applicable and not provided. There is no AI training set for this device.

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

This information is not applicable and not provided. There is no AI training set for this device.

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The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:
Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm):
The 515 - 1200 nm intense pulsed light wavelengths are indicated for:
The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars and striae;
The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent , hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Nd:YAG Laser Wavelength (1064 nm):
The 1064 nm wavelength produced by the Nd: YAG laser is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including:
Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Real Time Chiller:
The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
Reduce discomfort during and/or associated with light or laser treatment;
Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are comprised of the following main components:
A light/laser system console (including software and control electronics);
A control and display panel;
One or two attached handpiece(s);
A skin cooling device integrated into the handpiece (on some handpieces);
A trigger button integrated into the handpiece;
A remote interlock connector (disables light/laser when treatment room door is opened).

The provided text describes a 510(k) submission for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems, including the Real Time Chiller. This is a medical device submission, and the information presented here is typical of such submissions, which focus on demonstrating substantial equivalence to previously cleared devices (predicates) rather than establishing new performance criteria through de novo studies.

Therefore, the requested information regarding detailed acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven device's performance metrics (like sensitivity, specificity, F1-score, or human reader improvement, standalone performance) is not directly present in this document. This submission is for a physical laser/light system, and its "performance" is primarily assessed against safety and effectiveness relative to its predicate devices through clinical data (for safety/effectiveness) and engineering specifications (for things like cooling).

However, I can extract the information related to safety and effectiveness demonstration for this type of device, which serves a similar purpose to "acceptance criteria met by study results" in the context of its regulatory clearance.

Here's a breakdown of what can be extracted and inferred from the text, formatted to match your request where possible, and noting where the information is not applicable or not provided for this type of device:

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

For a laser/light system, "acceptance criteria" and "reported device performance" are typically related to clinical safety and effectiveness and adherence to specifications.

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 states: "Clinical data was provided to demonstrate that the Lumenis Family of IPL/Nd: YAG laser systems (1064 nm) are safe and effective..." However, it does not specify the sample size for this clinical data. It also does not specify the data provenance (country of origin, retrospective or prospective nature).

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 information is not provided in the document. For a physical device, "ground truth" establishment in the context of diagnostic algorithms is not typically a direct component of the regulatory submission in the way you've phrased it. Clinical studies would involve physician assessments of treatment outcomes, but the number and specific qualifications of assessors for "ground truth" are not detailed.

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

This information is not provided in the document.

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 to this device. The Lumenis system is a laser/light treatment device, not an AI-driven diagnostic or assistive imaging tool that involves "human readers" and "AI assistance."

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

This is not applicable to this device. It is a physical treatment device, not an algorithm.

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

For the clinical data provided, the "ground truth" would be clinical outcomes data related to the indications for use (e.g., observed hair reduction, clearance of vascular or pigmented lesions, safety endpoints like adverse events or reduced thermal injury due to cooling). However, the specific methodology of how this outcomes data was collected and validated is not detailed.

8. The sample size for the training set

This is not applicable as this is not an AI/algorithm-driven device requiring a training set in that sense. Clinical data provided would be for demonstration of safety and effectiveness, similar to a "test set" for performance evaluation, but not for "training" an algorithm.

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

This is not applicable for the reasons stated in point 8.

Summary for this specific device (Lumenis IPL/Nd:YAG Laser System):

This 510(k) submission focuses on demonstrating substantial equivalence to existing predicate devices based on shared indications for use, design, and functional features. Additionally, clinical data was provided to support the safety and effectiveness of the IPL/Nd:YAG laser systems for their stated specific applications, and performance data was included for the integrated cooling head to show it meets specifications. The document does not provide the granular details often found in submissions for AI/ML-driven diagnostic devices regarding sample sizes, ground truth establishment, or reader studies.

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