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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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