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The General Spinal System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The spinal system consists of screws, rods, crosslink plates, set screws and hooks.

It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility.

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development. validation, and routine control of a sterilization process for medical devices

The provided text describes a 510(k) submission for a spinal system and focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It does not contain information about the use of AI, human readers, or clinical study data for device performance as would be relevant for acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, the following information regarding acceptance criteria and a study proving device performance as typically applied to AI devices (especially those involving diagnostic accuracy) cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: Not available. The document refers to "design specifications" being met, but these are not defined in terms of specific performance metrics suitable for a table.
2. Sample size used for the test set and the data provenance: Not applicable, as no test set beyond bench testing materials is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert evaluation for ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as clinical ground truth establishment is not mentioned for this type of device. The studies are bench tests.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable.

However, based on the provided text, here's what can be extracted regarding the device's "acceptance criteria" (in the context of a 510(k) submission for a physical implant) and the study that proves it meets them:

Acceptance Criteria and Device Performance for the General Spinal System (K122994)

Study Details:

• Type of Study: Non-clinical bench tests.
• Sample Size for Test Set: Not explicitly stated, typical for bench testing where a representative number of samples are tested according to defined standards.
• Data Provenance: Not applicable, as these are laboratory bench tests, not clinical data.
• Ground Truth Establishment: For bench tests, the "ground truth" is defined by the specified performance limits and methodologies outlined in the ASTM and ISO standards used. The device's physical properties and performance are verified against these objective criteria.
• Training Set: Not applicable as this is not an AI device.
• Adjudication Method: Not applicable for bench testing against established engineering standards.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: The non-clinical bench tests evaluate the device's standalone physical performance parameters. The "algorithm only" concept does not apply here.

The core of the submission relies on demonstrating that the proposed device, the General Spinal System, performs similarly to a legally marketed predicate device (CD HORIZON® Spinal System, K042790) by meeting the same widely accepted industry standards for spinal implants.

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• · Simple, compound first- and second-degree tibial shaft fractures
• · Pseudarthrosis and delayed union

The Intramedullary Nail System is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. It consists of Intramedullary nail, Locking screw and End cap.
The Intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. The Locking screw passes through the holes at the proximal distal sections of intramedullary nail for preventing rotation and axial compression. The End cap which screws into the threaded end of the intramedullary nail provides intraoperative lengths adjustment and prevents tissues growth into nail threads.
All implants of Intramedullary Nail System are manufactured from Ti-6AI-4V alloy that meets the requirements of ASTM F-136. The materials are wildly used in the industry with well known biocompatibility. No new materials are used in the development of this implant.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Intramedullary Nail System:

This device (Intramedullary Nail System) is a medical device for fracture fixation, and as such, its acceptance criteria and supporting studies are centered on its mechanical performance and biocompatibility rather than diagnostic accuracy or human interpretation. Therefore, many of the requested categories related to AI performance, expert consensus, and ground truth in a diagnostic context are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (e.g., number of nails, screws) used for the bench tests. The tests were conducted to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. The provenance is not explicitly stated beyond the manufacturing location of the device being China. The tests are de novo mechanical bench tests, not data derived from patients (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device for fracture fixation and stabilization, not a diagnostic device requiring expert interpretation for ground truth establishment. The ground truth for mechanical performance is established by standardized testing protocols (ASTM standards) and engineering principles.

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

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the case for these mechanical bench tests.

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 device is an intramedullary nail system, a physical implant for fracture fixation. It is not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant.

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

Not applicable. This refers to an AI algorithm's performance, which is not relevant for this physical medical device. The "standalone" performance here relates to the device's mechanical performance in bench tests, independent of human interaction during its function as an implant.

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

The ground truth for the performance of this device is based on established engineering standards and material specifications from ASTM (American Society for Testing and Materials). Specifically:

• ASTM F1264-03 (Reapproved 2007): Standard Specification and Test Methods for Intramedullary Fixation Devices (for static bending, static torsion, and dynamic bending).
• ASTM F 543-07: Standard Specification and Test Methods for Metallic Medical Bone Screws (for pull-out strength).
• ASTM F-136: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (for material biocompatibility).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. The device design is informed by engineering principles and existing predicate devices, not machine learning training from a dataset.

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

Not applicable, as there is no training set for this type of device submission.

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Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.

In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants.

Indications for the ReVision Nail include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.

Knee Fusion Nails are intended for intramedullary knee arthrodesis.

Ender Nails are indicated as follows: fracture of the neck, trochanteric, and subtrochanteric region of the femur; distal femoral fractures with a distal fragment 10 cm or longer; tibial shaft fractures; and proximal humeral fractures.

The Intramedullary Nail System includes femoral, tibial, ulnaradial, humeral, ankle fusion, knee fusion nails and accessories. Components are manufactured from stainless steel and UHMWPE.

This 510(k) summary for the Smith & Nephew Intramedullary Nail System describes a medical device (an intramedullary nail system), not a diagnostic AI device. Therefore, the requested information regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not present in the provided text.

The 510(k) process for a device like an intramedullary nail focuses on demonstrating substantial equivalence to a predicate device. This typically involves comparing:

• Intended Use: The proposed device serves the same purpose as the predicate.
• Technological Characteristics: The proposed device has similar design, materials, and other characteristics to the predicate.
• Performance Data: If there are technological differences, performance data (often mechanical testing for implants) is provided to demonstrate that the new device is as safe and effective as the predicate.

In this specific 510(k) summary, the manufacturer states:

"The Intramedullary Nail System is similar to the devices listed below... All of the devices listed above are similar in design to the Intramedullary Nail System. The new devices have the same technological characteristics as the predicate device."

This statement implies that the primary "study" proving the device meets acceptance criteria is the demonstration of substantial equivalence based on similar technological characteristics and intended use to existing, legally marketed predicate devices. The acceptance criteria, in this context, are implicitly met if substantial equivalence is successfully established, meaning the device is considered as safe and effective as its predicates.

Without further information (which is not included in this 510(k) summary), it's impossible to describe acceptance criteria or study details in the way requested for an AI/diagnostic device.

Therefore, I cannot populate the table or answer the specific questions about AI/diagnostic device evaluation. The provided text is for a hardware implant device, not a software AI solution.

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The intended use of the Intramedullary Nail System is as follows:

Femoral and Tibial Nails

The Intramedullary Nail System femoral and tibial nails are indicated for use in fixation of femoral fractures including subtrochanteric, intertrochanteric, comminuted or segmental fractures, as well as fractures with bone loss, proximal and distal fractures, and nonunions.

Humeral Nail

The humeral Nail is indicated for comminuted fractures, segmental fractures. fractures with bone loss proximal and distal fractures, as well as nonunions, delayed unions, pathological fractures, floating elbow, nerve lesion, and multiple trauma injuries

The Intramedullary Nail System is a series of cannulated intramedullary rods and interlocking screws for use in fixation of long bone fractures. Included in the system are femoral, tibial and humeral nails in varying diameters and lengths. The design of the nail includes four longitudinal flutes along the length of the nail. The larger sized nails have a sawcut over the majority of the length of the nail to aid in insertion. The distal tip of the nail is conical in shape and tapered. All nails include proximal and distal holes for the insertion of interlocking screws. The nails can be used in either the locked or unlocked mode and can be inserted with or without prior reaming of the medullary canal. The nails and screws are manufactured from stainless steel. The nails are inserted using a closed technique.

This document is a 510(k) summary for a medical device (Intramedullary Nail System), not a study evaluating AI or computational device performance. It describes the device, its intended use, and performance data related to its mechanical properties (bending and torsional strength), comparing it to predicate devices.

Therefore, most of the requested information regarding acceptance criteria, study design for AI/computational devices, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, is not applicable to this document.

However, I can extract the relevant performance data related to the device's mechanical properties, which serves a similar function to "acceptance criteria" in terms of confirming the device's physical capabilities.

Here's the information that can be extracted from the provided text:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document refers to mechanical testing of physical implants, not data derived from human subjects or clinical imaging.

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)
Not applicable. Ground truth for mechanical testing is based on objective physical measurements and engineering specifications, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device performance is based on objective mechanical engineering measurements according to a specified standard (ASTM Standard F 383).

8. The sample size for the training set
Not applicable. There is no "training set" for mechanical device testing.

9. How the ground truth for the training set was established
Not applicable.

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