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The LOQTEQ® Proximal Humerus Plate 3.5 System is intended for fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.

The subject device includes a total of nine (9) bones plates for internal fixation of bone fragments. i.e., for treatment of bone fracture and other bone injuries. All LOOTEO® Proximal Humerus Plate 3.5 are available non-sterile.

The subject device is provided in anatomic designs in overall lengths of 85 mm, 92 mm, 105 mm, 118 mm. 143 mm. 169 mm. 195 mm. 221 mm. and 247 mm. The plates are provided with 3, 4, 5, 6. 8, 10, 12, 14, and 16 holes, respectively, in plate. The lengths of 92 mm, 118 mm, 143 mm, 169 mm, and 195 mm are identical to the plates previously cleared in K121495. Subject device lengths of 85 mm, 221 mm, and 247 mm are identical to the plates previously cleared in K121495 except for the length and number of holes.

The subject device plates include screw holes designed to accommodate appropriately sized locking and non-locking cortical and periprosthetic bone screws, previously cleared in K121495, and K-wires cleared in K131459, presented marked as part of the LOQTEQ® Proximal Humerus Plate 3.5 System. The compatible screws are 3.5 mm in diameter. The subject device plates are also compatible with the 1.6 mm diameter app K-Wires.

The provided text, K211582, describes a 510(k) premarket notification for a medical device: the LOQTEQ® Proximal Humerus Plate 3.5 System. It explicitly states that no clinical data were submitted for this premarket notification (see sections titled "PERFORMANCE DATA" and the summary at the end of section {7}). Instead, substantial equivalence was demonstrated based on non-clinical testing.

Therefore, many of the requested items related to clinical study design, such as acceptance criteria, sample size for test sets, expert ground truth establishment, MRMC studies, and training set details, are not applicable to this submission.

However, I can extract information related to the performance data that was provided and how the device met the requirements for substantial equivalence.

Here's a breakdown of the information based on your request, as much as can be gleaned from the provided text:

Acceptance Criteria and Device Performance (Non-Clinical)

The acceptance criteria for this device are not framed in terms of clinical performance metrics (e.g., sensitivity, specificity) as it's not an AI/diagnostic device or a device requiring clinical trial for performance. Instead, the acceptance criteria are based on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing, ensuring the new device does not raise new questions of safety or effectiveness.

The "performance" of the device is assessed by its equivalence in key technological characteristics and biomechanical performance to its predicates.

Table of Acceptance Criteria (Implied for Substantial Equivalence) and Reported Device "Performance":

Study Details (as inferable for a non-clinical 510(k))

2. Sample sizes used for the test set and the data provenance:

   • Test Set (Non-Clinical): Not directly defined in terms of a "test set" for a clinical study. The "test" here refers to the comparisons against predicate devices. The "sample" is the set of subject device configurations (9 plate lengths) and their features.
   • Data Provenance: The data referenced (biocompatibility, sterilization validation, biomechanical cross-sectional analysis) is from non-clinical testing and previous 510(k) submissions (K121495, K131459, K121494) for the manufacturer's own predicate devices. The country of origin for this testing is not specified, but the manufacturer is aap Implantate AG in Berlin, Germany. The data is retrospective in the sense that it relies heavily on previously established equivalence for predicate devices.

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 non-clinical substantial equivalence submission. There is no "ground truth" to be established by experts in the context of clinical performance or diagnosis. The "truth" is established by adherence to standards and comparison to cleared predicates.

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

   • Not Applicable. No expert adjudication was relevant for this type of submission.

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:

   • No. This is a bone fixation device, not an AI/diagnostic device.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

   • Not Applicable in the clinical sense. The "ground truth" for substantial equivalence is derived from:
     • Compliance with recognized standards (e.g., ANSI AAMI ISO 17665-1 for sterilization, ASTM F136 for material).
     • Previously cleared predicate devices whose safety and effectiveness are already established by the FDA.
     • Engineering analysis (cross-sectional analysis for biomechanical performance).

8. The sample size for the training set:

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

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

   • Not Applicable.

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