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The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

• Open and Closed Fractures .
• . 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
• Pseudoarthrosis or non-union of long bones .
• Limb lengthening by epiphyseal or metaphyseal distraction .
• Correction of bony or soft tissue deformity t
• Correction of segmental bony or soft tissue defects .
• Joint arthrodesis .
• Management of comminuted intra-articular fractures of the distal radius .

The Stryker Hoffmann LRF System is indicated in adults for:

• . Osteotomy
• · Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures .
• Fusions and replantations of the foot .
• Charcot foot reconstruction .
• Lisfranc dislocations .

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market additional components as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System, previously cleared in KI 13327. The Hoffmann LRF System is an external fixation device that consists of carbon and aluminum full/open rings and ring segments, aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. The additional components will consist of the following: carbon foot ring, foot arch, hinge coupling and compatibility with the previously cleared Hoffmann 3 couplings. This external fixation system may also be used with the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins. Hoffmann II External Fixation 90° Post. Carbon Connecting Rod and Miami Post.

The provided text describes a 510(k) submission for a medical device (external fixation device) and explicitly states that clinical testing was not required. This means there is no study conducted to prove device performance against acceptance criteria in a clinical setting with human subjects.

The submission focuses on non-clinical laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices. Therefore, the following information, which pertains to clinical studies, cannot be provided based on the given text:

• A table of acceptance criteria and the reported device performance (in a clinical context).
• Sample size used for the test set and data provenance (for clinical data).
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used (for clinical data).
• Sample size for the training set (for clinical data).
• How ground truth for the training set was established (for clinical data).

However, the provided text does detail the non-clinical testing performed. Here's a summary of that information:

Acceptance Criteria and Device Performance (Non-Clinical Testing)

Study Details (Non-Clinical Testing):

1. Sample size used for the test set and data provenance: Not explicitly stated beyond "additional components and component compatibility." The provenance is internal laboratory testing by Stryker Trauma AG.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was engineering performance testing.
3. Adjudication method: Not applicable. This was engineering performance testing.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: No, this was not a clinical study.
5. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a mechanical device, not an algorithm.
6. Type of ground truth used: Based on the compliance with ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device," the ground truth is defined by the standardized test methods and their performance requirements.
7. Sample size for the training set: Not applicable. This was engineering performance testing.
8. How the ground truth for the training set was established: Not applicable. This was engineering performance testing.

Conclusion stated by the submitter: "Clinical testing was not required for this submission. The Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to the predicate devices identified in this premarket notification."

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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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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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