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The aap Cannulated Headless Bone Screws are indicated for use in non-spinal fragment fixation, osteotomy and arthrodesis of human bones appropriate for the size of the screw. The devices are intended for single use only. The aap Cannulated Headless Bone Screws are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.

K-Wires are indicated for use as guide wire for osteosynthesis implants and for application as implant according to the AO/ASIF principles of fracture management.

The K-Wires are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The subject device Cannulated Headless Bone Screws are cannulated at both the leading end (tip) and at the trailing end. The leading/trailing diameters are: 2.5/3.4 mm. 3.5/4.5 mm. 4.0/4.8 mm. 4.5/5.3 mm, 5.5/6.2 mm, 6.5/7.2 mm, and 7.5/7.9 mm., The leading thread have different pitches which facilitates closure of any fracture gap and generates compression across the bone fragments. The subject screws are provided in overall lengths ranging from 12 mm, and with threaded lengths (at the leading end or tip) ranging from 4 mm to 40 mm. The subject screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3.

The subject K-Wire is provided in one size with a diameter of 2.4 mm and a length of 250 mm. The subject K-Wire has a trocar point, is threaded, and is manufactured from stainless steel conforming to ASTM F138 and ISO 5832-1.

This document describes the aap Cannulated Headless Bone Screws, a medical device for bone fixation. Since this is a 510(k) summary, the core of the submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than establishing brand-new performance criteria for a novel device. Therefore, the "acceptance criteria" here are largely defined by demonstrating that the new device performs at least as well as and shares similar characteristics with the predicate devices.

Here's an analysis of the provided information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of explicit acceptance criteria with numerical targets as one might see for a novel device, the "acceptance criteria" here are met by demonstrating similarity and comparable performance to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of devices or clinical cases for this submission's testing. The non-clinical performance data mentions "mechanical testing of the subject device screws according to ASTM F543." ASTM F543 outlines test methods, but the specific number of screws tested is not provided in this summary.
• Data Provenance: The data is primarily non-clinical performance data which includes mechanical testing, sterilization validation, and references to previous submissions (K111316, K130590, K131459, K161616) for biocompatibility, packaging, and shelf-life. There is no clinical data included in this submission. The origin of the reference data for predicate devices is not specified, but previous 510(k) submissions would have their own established provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission relies on non-clinical performance testing and substantial equivalence to predicate devices, not on establishing ground truth via expert review of clinical cases.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. There's no test set requiring human adjudication for diagnostic or interpretive tasks. The evaluation is based on engineering specifications, material standards, and mechanical test results.

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 a medical device (bone screws and K-wires), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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 or software.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through:

• Engineering Specifications and Material Standards: Compliance with recognized standards like ASTM F136, ISO 5832-3, ASTM F138, ISO 5832-1, ASTM F543, ISO 17665-1, ISO 10993-1. These standards define the acceptable properties and performance for such devices.
• Bench Testing: Mechanical testing data according to ASTM F543.
• Referencing Predicate Devices: The established regulatory clearances and performance data of the cited predicate devices (K111316, K130590, K131459, K161616) serve as a de-facto "ground truth" for comparison under the substantial equivalence pathway.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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The Hammerdesis™ Interphalangeal Fusion System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

The Hammerdesis™ Interphalangeal Fusion system is composed of a counter rotation ring implant, recovery dowel and K-wire to be used in conjunction with a peg and hole fusion of the phalanges. The implant comes in two different sizes to accommodate differing anatomies. The counter rotation ring has axial spikes that prevent either side of the joint from rotating and allow fusion of the joint.

The provided text is a 510(k) summary for the Hammerdesis™ Interphalangeal Fusion System, a medical device. This document focuses on demonstrating the substantial equivalence of the device to existing predicate devices, primarily through mechanical performance testing.

It does not contain information about an AI/ML-driven device or diagnostic study. Therefore, I cannot provide a response addressing acceptance criteria and study details related to AI/ML device performance, such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document describes the device, its indications for use, technological characteristics, and performance data related to its mechanical properties. The performance data section states:

"The subject Hammerdesis™ Interphalangeal Fusion System was evaluated in static torsion test, static and dynamic cantilever bend testing, and axial pullout. The subject device demonstrated superior performance in comparison to that of the predicate (K131459); therefore, the subject device mechanical performance is considered substantially equivalent to the predicate (K131459)."

This indicates that the acceptance criteria for this device are based on its mechanical equivalence or superiority to the specified predicate device in these specific tests, rather than diagnostic accuracy metrics.

To answer your request, the provided document would need to be about a diagnostic AI/ML device, which it is not.

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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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Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions; and osteotomies of the femur

The subject device includes a total of 14 bones plates for internal fixation of the distal lateral femur. All LOQTEQ Distal Lateral Femur Plates 4.5 are available non-sterile.

The subject device is provided in anatomic designs in overall lengths of 153 mm, 207 mm, 243 mm, 279 mm, 314 mm, 350 mm, and 386 mm, for the left and right distal femur. The plates are provided with 4, 7, 9, 11, 13, 15, and 17 screw holes, respectively, in the shaft of the plate. Lengths of 153 mm, 207 mm, 279 mm, 279 mm, and 314 mm are identical to the plates previously cleared in K121494. Subject device plates in lengths of 350 mm and 386 mm are identical to the plates previously cleared in K121494, except for the length.

The subject device plates include screw holes designed to accommodate appropriately sized locking and non-locking cortical and periprosthetic bone screws, previously cleared in K121494 and K072411 and K-wires, previously cleared in K131459, presently marketed as part of the LOQTEQ Distal Lateral Femur Plate 4.5 System. The compatible screws are 4.5 mm in diameter. The subject device plates also are compatible with 2.0 mm diameter aap K-Wires.

The provided document is a 510(k) summary for the LOQTEQ® Distal Lateral Femur Plate 4.5 System, a Class II medical device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing. This document does NOT describe a study involving an AI/software device that requires intricate acceptance criteria related to accuracy, sensitivity, or specificity, nor does it detail a multi-reader multi-case (MRMC) study or complex ground truth establishment processes typical for such devices.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/software performance study for which your template is designed. The document explicitly states: "Clinical data were not submitted in this premarket notification." and "Any differences in the technological characteristics among the subject and predicate devices do not raise different questions of safety and effectiveness."

Instead, the "performance data" section refers to:

• Biocompatibility referenced from K121494 and K153034.
• Validation of the recommended end-user moist heat sterilization cycle.
• Mechanical testing referenced from K121494.

The "acceptance criteria" here would relate to these engineering and material standards, not to diagnostic or prognostic performance metrics of an AI.

To answer your prompt truthfully based on the provided text, I must state that the information you requested regarding acceptance criteria and studies proving the device meets them (in the context of AI/software performance) is not present in this 510(k) summary. The document is for a traditional medical device (a bone plate system) and details its substantial equivalence based on material, design, and manufacturing similarities to existing devices, supported by non-clinical engineering tests, not AI performance studies.

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Devices (K-Wires and Steinmann Pins) are intended to be used as:

• · Guide wires for osteosynthesis implants
• · Accessories for external fixation (Steinmann Pins)
• · Implants according to principles of fracture management

The SMV Scientific K-Wire and Pin consists of K-Wire and Pins in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided nonsterile. All devices are manufactured from medical grade Stainless Steel or Titanium alloys.

This document is a 510(k) clearance letter for the "SMV Scientific K-Wire and Pins." It does not contain information about a study with acceptance criteria and device performance in the context of an AI/ML device. The device described here is a physical medical device (K-wires and Steinmann pins), and its clearance is based on substantial equivalence to a predicate device, not on a performance study with acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states:

"Testing, therefore, was not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices."

This indicates that the clearance was based on engineering analysis and comparison to a predicate device, not on a performance study that would generate the kind of data requested (acceptance criteria, reported device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.).

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