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The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in:

1. Post-Traumatic joint contracture which has resulted in loss of range of motion ( not applicable for Smith & Nephew Rail System)
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
3. Open and closed fracture fixation
4. Pseudoarthrosis of long bones
5. Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X Fixator)
6. Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
7. Correction of segmental bony or soft tissue defects
8. Joint arthrodesis (not applicable for Smith & Nephew Rail System)
9. Infected fractures or nonunions
10. Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius (not applicable for Smith & Nephew Rail System)
11. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints. As well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (not applicable for Smith & Nephew Rail System)

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. External Fixation Instrumentation. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew External Fixation Systems and their cleared Indications for Use. Smith & Nephew External Fixation Instruments can be organized into instrument families which are categorized as follows: Tightening/Insertion, Alignment, Guides, and Drills.

The provided text is a 510(k) Premarket Notification for the "Smith & Nephew, Inc. External Fixation Instrumentation." This submission is for surgical instruments, not a device that generates performance metrics in the way an AI diagnostic or therapeutic device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment is not applicable to this type of regulatory submission.

This 510(k) submission establishes substantial equivalence to legally marketed predicate devices based on similarities in:

• Raw materials
• Manufacturing processes
• Sterilization procedures
• Nature of body contact
• Design and function

The FDA's review for this type of device focuses on ensuring these accessory instruments are safe and effective for their intended use alongside the cleared Smith & Nephew External Fixation Systems, and that they are substantially equivalent to existing predicate instruments. It does not involve a performance study with quantitative acceptance criteria as would be expected for a diagnostic or AI-driven device.

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The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for:

• Temporary stabilization of open or closed acute fractures with soft tissue injuries; .
• . Definitive stabilization of open or closed fractures where open or alternative closed treatment is undesirable or otherwise contraindicated;
• Stabilization of fractures in the context of polytrauma; .
• Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries; .
• Arthrodesis and osteotomies with associated soft tissue problems; .
• Stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for . infection or other failure;
• Neutralization of fractures stabilized with limited internal fixation; .
• . Stabilization of non-unions; and
• . Intraoperative temporary stabilization tool to assist with indirect reduction.

The XtraFix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.

The provided document describes the XtraFix External Fixation System, a medical device for stabilizing bone fractures. It does not contain information about a study with acceptance criteria and device performance in the context of an AI/algorithm-driven device. The document is a 510(k) summary, which is typically a premarket notification for a medical device demonstrating substantial equivalence to a legally marketed predicate device.

Specifically, the document states:

• "The principles of operation of the XtraFix External Fixation System are the same as for the predicates."
• "The XtraFix External Fixation System was characterized and evaluated according to the requirements outlined in FDA Guidance document, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." Testing confirmed the device can be used in an MR environment under predetermined conditions. Therefore, the term "MR Conditional" can be used to describe the system in accordance with the guidance document."
• "All evaluations determined that the XtraFix External Fixation System is substantially equivalent to the predicate devices."

This indicates that the "study" conducted was primarily focused on demonstrating MR compatibility and confirming the device's technological characteristics are similar to existing predicate devices, rather than a performance study with acceptance criteria for an AI-powered diagnostic or therapeutic tool.

Therefore, I cannot populate the requested table and information points as they pertain to AI/algorithm performance and ground truth, as that information is not present in the provided text. The device is a physical external fixation system, not a software-based AI device.

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Jet-X External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; correction of bony or soft tissue deformities; correction of segmental bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions; mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius.

Subject of this Traditional 510(k) premarket notification is the Reprocessed Jet-X Clamps. The subject reprocessed Jet-X clamps are specially designed components used in the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. The devices have been manufactured from stainless steel, aluminum and titanium alloys and have been designed to allow for the appropriate amount of rigidity and stability. Components of this premarket notification include:

• Freedom Clamp, Bar to Pin Clamps .
• Freedom Clamp, Bar to Bar Clamps .
• Freedom Clamp, Bar to Ring Clamps ●
• Mini Freedom Clamp, Bar to Pin Clamps .
• Ouick Clamp, Bar to Pin Clamps .
• Mini Quick Clamp, Bar to Pin Clamps .
• Pin Clamps, 4 and 6 holes .
• Freedom Post .
• Freedom Ankle Clamp .
• Mini Double Pin Clamp with Ball Joint .
  These devices are used with existing components such as pins, wires, bars and other external fixation devices cleared in previous premarket notifications.

The provided text describes a 510(k) premarket notification for reprocessed medical devices (Jet-X Bar System Clamps and Posts) and focuses on demonstrating substantial equivalence to predicate devices, rather than a study proving new device performance against acceptance criteria. Therefore, most of the requested information regarding clinical studies, ground truth, expert adjudication, and sample sizes is not directly applicable to this type of submission.

However, I can extract the information that is present and indicate where the requested information is not available in the provided document.

Acceptance Criteria and Device Performance (Not Applicable - Reprocessing Equivalence)

The submission is for reprocessed devices, and the "acceptance criteria" here are centered around demonstrating that the reprocessed devices maintain the safety and effectiveness of the original, legally marketed devices. The "performance" is assessed by showing that reprocessing does not degrade the material properties or functionality.

• Construct fatigue testing (bar clamp)
• Construct fatigue testing (bar to pin clamps)
• Fatigue testing (bar to pin clamps) |
  | Sterilization Efficacy: Reprocessing effectively sterilizes the devices. | Validation of steam sterilization process of Jet-X Bar System devices performed. |
  | Cleaning Efficacy: Reprocessing effectively cleans the devices. | Validation of cleaning process of Jet-X Bar System devices performed. |
  | No change in intended use, performance specifications, or method of operation after reprocessing. | The reprocessed devices are stated to have no changes in intended use, performance specifications or method of operation compared to predicates. They utilize similar designs, the same materials, and technological characteristics. The intended use statement from the predicate applies to the reprocessed devices. |
  | Material Equivalence post-reprocessing: Materials remain suitable for their intended use. | Reprocessed devices utilize the "same materials" as the predicate devices. |

Study Details (Not Applicable - Reprocessing Equivalence)

The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This means there was no de novo clinical study or performance study in the way one might typically describe for a new device's acceptance criteria. The "study" here refers to the mechanical and sterilization/cleaning validation tests.

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

   • Not Applicable / Not Provided for clinical data. The document refers to "mechanical testing" and "validation of steam sterilization process" and "validation of cleaning process." The specific sample sizes for these engineering tests are not provided in the summary.
   • Data Provenance: Not specified, but generally, such testing is conducted in-house by the manufacturer or by a contracted lab. This is a technical validation, not clinical data from patients.

2. 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, in the context of clinical or diagnostic performance, is not established for this type of submission. The "ground truth" for mechanical testing is based on engineering standards and measurements.

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

   • Not Applicable. This concept applies to clinical judgment/interpretation, not to mechanical or sterilization testing.

4. 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 a diagnostic device involving human readers or AI.

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

   • Not Applicable. This is not an algorithmic or AI-driven device.

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

   • Not Applicable (in the clinical sense). For the mechanical and sterilization/cleaning validations, the "ground truth" would be established by industry standards, engineering specifications, and validated analytical methods. For instance, for sterilization, it would be the absence of viable microorganisms after the process, confirmed by standardized microbiological testing. For mechanical tests, it would be meeting predefined force/fatigue limits.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set.

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