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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 LOQTEQ® VA Elbow Plates 2.7/3.5 includes the LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 and LOQTEO® VA Olecranon Plate 2.7/3.5.

LOQTEQ® VA Distal Medial Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Dorsolateral Humerus Plate 2.7/3.5, LOQTEQ® VA Distal Lateral Humerus Plate 2.7/3.5 are indicated for:

• Intra-articular fractures of the distal humerus
  · Supracondylar fractures of the distal humerus
  · Osteotomies, and non-unions of the distal humerus

LOQTEQ® VA Olecranon Plate 2.7/3.5 is indicated for:

· Fixation of fractures, osteotomies and non-unions of the olecranon, particularly in osteopenic bone

The components of the LOOTEO VA Elbow Plates 2.7/3.5 are trauma implants, bone plates and screws, which are implanted into the human body to achieve an internal fixation of bone fragments, typically after fractures or other bone injuries (e.g., joint reconstruction). LOQTEQ plates function according to the fixateur interne principle, i.e., they incorporate an angular stable plate-screw connection as a result of screwing threaded screw heads into threaded plate holes. Conventional bone screws can be used in all plate holes and allow for off-axis angulation up to 15° inside threaded plate holes. After fracture healing, the implants (plates and screws) are to be removed.

The shape of the bone plates is adapted to the anatomy of and the biomechanical stress on the distal humerus and the olecranon (ulna), respectively.

The LOQTEQ VA Elbow Plates 2.7/3.5 consists of the LOQTEQ VA Distal Dorsolateral Humerus Plate, LOQTEQ VA Distal Lateral Humerus Plate, LOQTEQ VA Distal Medial Humerus Plate and the LOQTEQ VA Olecranon Plate 2.7/3.5.

This appears to be a 510(k) summary for a medical device (LOQTEQ® VA Elbow Plates 2.7/3.5) and not a study describing a new AI/ML-based medical device. Therefore, the information typically found in an AI/ML device submission regarding acceptance criteria, study design for AI performance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this document.

The document discusses the following:

• Device Description: LOQTEQ® VA Elbow Plates 2.7/3.5 are trauma implants (bone plates and screws) for internal fixation of bone fragments after fractures or injuries, particularly in the distal humerus and olecranon. They function on the "fixateur interne principle" with an angular stable plate-screw connection.
• Predicates: The device demonstrates substantial equivalence to previously cleared predicate devices (K132787, K140607, K161696, and K120717).
• Performance Data: Non-clinical testing data was submitted, referencing or relying on the predicate devices. This included biocompatibility testing and validation of the recommended end-user moist heat sterilization cycle (according to ANSI AAMI ISO 17665-1). Mechanical testing against predicate device K120717 was completed.
• Clinical Data: "Clinical data were not submitted in this premarket notification."

Given the content, I cannot provide details on the acceptance criteria and study proving an AI/ML device's performance because this document pertains to a traditional medical device (bone plates) that did not include AI/ML components or require clinical performance data for its 510(k) clearance due to its substantial equivalence to predicate devices based on non-clinical testing.

The "acceptance criteria" for a traditional device like this primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device through engineering analysis, mechanical testing (as mentioned), material characterization, and biocompatibility, rather than clinical performance metrics in a study.

Therefore, many of the requested points related to AI/ML device studies (such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI training set details) are not applicable to this document.

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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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For fractures and osteotomies of the calcaneus, including, but not limited to
-extra-articular, intra-articular
-joint depression
-tongue type
-severely comminuted fractures

The LOQTEQ® VA Calcaneus Plate 3.5 is an anatomical, polyaxial angular stable, asymmetrical titanium plate (L/R version) for the treatment of calcaneus fractures. The shape of the plate is adapted to the lateral, anatomical shape of the calcaneus.

The polyaxial, angle-stable plate-screw-connection (VA technology) allows up to 15° angulating of the screws. Thus, the screws can be placed under the posterior articular facet into the sustentaculum tali, ensuring a stable supply of the fracture.

The provided text describes a medical device, the LOQTEQ® VA Calcaneus Plate 3.5, and its substantial equivalence to predicate devices, focusing on mechanical safety testing. However, it does not contain information relevant to the acceptance criteria and study proving device meets the criteria for an AI/ML powered medical device as requested in the prompt.

Specifically, the document discusses:

• Device Name: LOQTEQ® VA Calcaneus Plate 3.5
• Intended Use/Indications for Use: Temporary fixation, correction or stabilization of the calcaneus for fractures and osteotomies (extra-articular, intra-articular, joint depression, tongue type, severely comminuted fractures).
• Predicate Devices: Synthes Locking Calcaneal Plate (K991407 - Primary) and aap Bone Plate and Screw Implants (K072411).
• Testing Performed: Customized static and dynamic 3-point-bending tests of bone plates according to ASTM F2193 and ASTM F382, and mechanical testing for screws according to ASTM F543.
• Conclusion: The device functioned as intended, had similar results to predicate devices, and was found to be substantially equivalent.

The document does NOT contain any of the following information:

• A table of acceptance criteria and reported device performance (for an AI/ML device)
• Sample size used for the test set or data provenance
• Number of experts used to establish ground truth or their qualifications
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• If a standalone (algorithm only) performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How the ground truth for the training set was established

Therefore, I cannot fulfill your request using the provided text. The document describes a traditional medical device (bone plate and screws) and its mechanical testing, not an AI/ML medical device.

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The system LOQTEQ® VA Foot Plates 2.5 is intended for use in stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of bones of the feet. Implants are intended for single use on adult human bone.

LOQTEQ® VA Plantar Fusion Plate 2.5, TMT 1:

• plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure)

LOQTEQ® VA L-Fusion Plate 2.5:

• LisFranc Arthrodesis and/or Stabilization
• 2nd Tarsometatarsal (TMT) Fusions

LOQTEQ® VA Straight Fusion Plate 2.5:

• LisFranc Arthrodesis and/or Stabilization
• 3rd Tarsometatarsal (TMT) Fusions

LOQTEQ® VA Osteotomy Plate 2.5:
First metatarsal osteotomies for hallux valgus correction including:

• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Proximal Chevron osteotomy

LOQTEQ® VA MTP Fusion Plate 2.5:
Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• Primary MTP Fusion due to hallux rigidus and/or hallux valgus

LOQTEQ® VA MTP Revision Plate 2.5:
Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• Revision MTP Fusion
• Revision of failed first MTP Arthroplasty implant

LOQTEQ® VA Metatarsal Straight Plate 2.5/LOQTEQ® VA Metatarsal L-Plate 2.5/LOQTEQ® VA Metatarsal T-Plate 2.5

• Metatarsal or metacarpal fractures and osteotomies
• Phalanges fractures and osteotomies

LOQTEQ® VA X-Plate 2.5:

• fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including the foot

LOQTEQ® VA Hook Plate 2.5:

• internal bone fixation for bone fractures of the 5th metatarsal of the foot

LOQTEQ® VA Plantar Fusion Plate 3.5, TMT 1:

• plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure)

The LOQTEQ® VA Foot Plates 2.5 includes invasive products for the implantation on bones of the foot. The implants consist of a titanium-aluminum-vanadium alloy (TiAl6V4) and have different kind of holes that can be used for fixation with polyaxial angular stable locking screws or standard cortical screws. The DC-hole can be used for dynamic compression with a lag screw. As the case may be, the plates can be placed with a K-wire to fix the plate temporarily before the screws are tightened.

The provided text describes a 510(k) premarket notification for the LOQTEQ® VA Foot Plates 2.5. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria against specific metrics. Therefore, the concept of "acceptance criteria" as applied to novel performance outcomes is not directly applicable in the same way as it would be for, say, an AI-powered diagnostic device.

Instead, the "acceptance criteria" here implicitly refer to the demonstration that the subject device performs comparably to its predicate devices in terms of mechanical safety and functionality. The study that proves the device meets these comparative acceptance criteria is primarily bench testing.

Here's the breakdown of the information requested, adapted to the context of a 510(k) submission for a metallic bone fixation appliance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated regarding the number of plates or screws tested. The text refers to "tests" and "test results" but does not provide specific quantities for the bench testing.
• Data Provenance: The testing was conducted by an "independent, certified and accredited test laboratory (MDD 93/42/EEC, ISO 17025): Questmed GmbH." This suggests the testing was performed in a controlled, prospective manner by a third-party laboratory. The location of Questmed GmbH is not provided in the document, but it is typically a European certification body.

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

This information is not applicable to this type of device submission. Bench testing for mechanical properties does not involve human experts establishing a "ground truth" in the same way an AI diagnostic device would require radiological expert consensus. The "ground truth" here is the physical measurement of mechanical properties against established standards and predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical bench testing does not involve adjudication of results by multiple experts. The results are quantitative measurements against predefined protocols (e.g., ASTM F 382-14 for plates, ASTM F543-13 for screws).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices to compare human performance with and without AI. The LOQTEQ® VA Foot Plates 2.5 are physical metallic bone fixation appliances, not an AI or diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance evaluation in the context of AI algorithms was not done. This device is a physical implant. The "standalone" performance here refers to the device's mechanical properties tested independently.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its 510(k) submission, is established through:

• Mechanical Performance Standards: Adherence to recognized industry standards such as ASTM F 382-14 for plates and ASTM F543-13 for screws.
• Predicate Device Performance: Direct comparison of the subject device's mechanical test results against "well clinically proven and equivalent benchmark products" (predicate devices). The performance of these predicate devices acts as the "ground truth" for what constitutes acceptable mechanical properties.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no "training set."

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

This information is not applicable as there is no training set for this physical device.

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Intra-articular fractures, supracondylar fractures, osteotomies and non-unions of the distal humerus

The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is part of the LOQTEQ® Elbow System (K132787 and K140607), to be implanted by a surgeon in order to achieve a repositioning of fragments and an internal fixation of the bone after fractures, osteotomies or non-unions. By using locking screws the plate-screw system guarantees an additional mechanical fixation and enables the application for osteopenic bones. aap already offers a system of two plates for treatment of distal Humerus fractures: these are the anatomical shaped Plates LOQTEQ® Distal Dorsolateral Humerus Plate and LOQTEQ® Distal Medial Humerus Plate. Typically these devices are used together for one fracture and are placed under 90° orientation. The devices are already registered under the premarket notification K132787. Depending on the surgeons education some doctors prefer to use a different placement of the two plates. Therefore aap wants to add a further plate for the use in the identical intended use: this is the LOQTEQ® Distal Lateral Humerus Plate which is also used together with the LOQTEQ® Distal Medial Humerus Plate (see surgical approach above). In some rare indications this new device might be used as a standalone The anatomically performed plates are available as right and left version and in different lengths and with several shaft holes. The tapered end of the plate enables tissue-conserving, submuscular insertion. The tip of the shaft is tapered to allow a minimally invasive surgical technique. The bottom of shaft area is structured and tunnelled by cross grooves to minimize bone contact. All shaft holes, with the exception of the elongated hole are compatible with unidirectional locking screws as well as cortical screws. The use of locking screws is state of the art and is particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate. The round locking holes are suitable for locking screws as well as cortical screws. The locking screws allow evening catching very small fragments. The design of the so-called glide holes allows angle stable fixation and proximal compression of bone fragments at the same time if LOQTEQ® Cortical Screws are used. The use of standard cortical bone screws leads to a non-angle stable fixation. A compression of the bone fragments can be realised, if the screws are positioned eccentric inside the glide hole. If the screws are placed directly in the locking part of the gliding hole, no compression occurs. The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 consists of: LOQTEQ® Distal Lateral Humerus Plate, right/left, 2/3/5/7/11 holes LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 2.5, small head, T8, self-tapping Cortical Screw 3.5, self-tapping Set of Instruments aap LOQTEQ® Distal Lateral Humerus Plate

This is a 510(k) Premarket Notification for a medical device, specifically bone fixation plates, and does not involve AI or machine learning. Therefore, the requested information about acceptance criteria, study details for AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not applicable to this document.

The document discusses the substantial equivalence of the "aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5" to a legally marketed predicate device (Synthes (USA): 3.5 MM LCP Distal Humerus System). The acceptance criteria and "study" are engineering analyses focusing on mechanical performance.

Here's the relevant information extracted from the provided text regarding the device's acceptance criteria and the "study" proving it:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This is an engineering analysis/mechanical testing, not a clinical study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established through standardized engineering protocols and measurements, not expert consensus.

4. Adjudication method for the test set: Not applicable.

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 device is a bone plate, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the mechanical performance data, the ground truth is based on physical scientific measurements and established engineering standards for bending strength, bending stiffness, bending structural stiffness, and fatigue strength.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of the "study" (Performance Data):
"An engineering analysis was used to show substantial equivalence of the subject device to the predicate device in terms mechanical performance, including bending strength, bending stiffness, bending structural stiffness, and fatigue strength. The LOQTEQ®Distal Humerus Plate has passed all defined criteria, has performed as well or better than the predicate device and therefore considered substantially equivalent to the cleared predicate device."

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LOQTEQ® VA Distal Medial Tibia Plate 3.5:
Fixation of complex intra- and extra-articular fractures of the distal tibia; osteotomies of the distal tibia

LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5:
Fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone

LOQTEQ® VA Distal Fibula Plate 2.7/3.5:
Fractures, osteotomies, and non-unions of the distal fibula, especially in osteopenic bone

The aap LOQTEQ® VA Distal Tibia Plate System consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures, osteotomies or non-unions.
The system includes anatomically preformed and angle-stable small fragment plates, which are available as right and left versions as well as in different lengths. The geometrical shape of those plates is based on the anatomy and biomechanical stress of the distal tibia/distal fibula. A flat plate design, smooth transition of cross sections, chamfers and roundings preserve soft tissue irritation. The tapered tip of those shafts enable a minimal invasive surgery. For a minimization of the contact between bone (tibia) and plate, all holes of the shaft zone are tunneled and the bottom of the plates is structured.
All plate holes, with exception of the oblong hole, are compatible with unidirectional locking screws as well as cortical screws. The use of locking screws is state of the art and particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate. The use as a conventional bone plate and screw osteosynthesis is also possible with standard cortical screws.
The System incorporates:
• LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5, right/left
• LOQTEQ® VA Distal Medial Tibia Plate 3.5, right/left
• LOQTEQ® VA Distal Fibula Plate 2.7/3.5, right/left
• LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping
• Cortical Screw 2.5, small head, T8, self-tapping
• LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping
• Cortical Screw 3.5, T15, self-tapping
• LOQTEQ® Cortical Screw 3.5, T15, self-tapping
• LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping

The provided text is a 510(k) summary for the LOQTEQ® VA Distal Tibia Plate System, indicating that no acceptance criteria in the traditional sense of AI/algorithm performance are relevant here. This document is for a medical device (bone plates and screws) that is a physical implant, not an AI or software device.

Therefore, many of the requested categories in the prompt (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of device and submission.

However, I can extract and structure the information related to the device's performance and safety as described in the 510(k) summary.

Acceptance Criteria and Device Performance for LOQTEQ® VA Distal Tibia Plate System

The submission asserts "substantial equivalence" to predicate devices, meaning the new device is as safe and effective as legally marketed devices. The "acceptance criteria" here relate to meeting or exceeding the mechanical performance and biocompatibility standards demonstrated by the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. For physical medical devices, "test sets" typically refer to samples of the device undergoing mechanical and biocompatibility testing, not patient data sets. The documents refer to mechanical testing samples (e.g., plates and screws). The exact number of samples tested for each mechanical test is not specified in this summary but would be detailed in the full test reports.
• Data Provenance: Not applicable in the context of patient data. The tests are non-clinical, conducted in a laboratory setting.

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

• Not applicable. "Ground truth" in this context would refer to objective measurements from validated mechanical tests and material characterization, not expert clinical interpretations.

4. Adjudication Method for the Test Set

• Not applicable. This concept applies primarily to studies involving human interpretation or clinical outcomes, not to mechanical performance testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human readers interpret cases. This device is a physical implant. The submission states, "Clinical data and conclusions were not needed for this device."

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

• Not applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• Mechanical Testing Results and Biocompatibility Assessment: The ground truth is established through objective, standardized mechanical tests (e.g., ASTM F 382-14) and material biocompatibility assessments, which measure physical properties and interactions to ensure safety and performance.

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" as it is not an AI or machine learning device.

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

• Not applicable. This device does not have a "training set."

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Fractures, osteotomies and non-unions of the distal fibula, particularly in osteopenic bone.

The aap Plate and Screw System LOQTEQ Distal Fibula Plates consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve a repositioning of fragments and an internal fixation of the bone after fractures, osteotomies or non-unions. By using locking screws the plate screw system guarantees an additional mechanical fixation and enables the application for osteopenic bones. The Distal Fibula Plate System 3.5 is part of the LOQTEQ anatomic plate system. The anatomically preformed plates are available as right and left versions and in different lengths. The tapered end of the plate enables tissue-conserving, submuscular insertion. The 1.8 mm thin anatomic LOQTEQ Distal Fibula Plate 3.5 prevents skin and soft tissue irritation. All plate holes, with the exception of the oblong hole, are compatible with unidirectional locking screws as well as cortical screws (gold). The use of locking screws is state of the art and is particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate. The partially threaded Cancellous Screw dia 4.0 engages the remote bone fragment and slides through the bone fragment near the screw head. Thus, partially threaded screws enable interfragmentary compression. Washers in conjunction with aap screws are used to fixate small bone fragments. The aap Plate and Screw System LOQTEQ Distal Fibula Plates 3.5 incorporates: LOQTEQ Distal Fibula Plate 3.5, right and left. LOQTEQ Cortical Screw 3.5, small head, T15, self-tapping. Cortical Screw 3.5, T15, self-tapping. Cancellous Screw 4.0, small head, T15. Washer, I-Ø4.4, A-Ø8.0. Set of Instruments LOQTEQ Distal Fibula Plates 3.5. Material: All implants are made of Ti6Al4V (according ISO 5832-3 or ASTM F136). The surface of the plates is generated by an automatic slide finishing, the so-called "KeramoFinish". Those surfaces correspond to polished surfaces. The surface of the LOQTEQ Cortical Screws are slightly polished and anodised. The surface of the Cortical Screws are fine blasted and anodised as well.

The provided text is a 510(k) Premarket Notification for a medical device, specifically the LOQTEQ® Distal Fibula Plate 3.5, Cancellous Screw 4.0, and Washer. This document primarily focuses on demonstrating the substantial equivalence of this new device to previously marketed predicate devices, rather than on proving the device meets specific performance criteria through a clinical study for a new, novel technology (like an AI algorithm).

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for an AI/ML medical device submission, are not applicable to this document.

Here's why and what information is available in the provided text:

• Type of Device: The device is a bone fixation appliance (metallic plate, screws, washer) used for internal fixation of the distal fibula. This is a traditional mechanical implant, not an AI/software as a medical device (SaMD).
• Regulatory Pathway: The submission is a 510(k) Premarket Notification, which aims to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove efficacy/safety through a de novo clinical trial that would require the kind of detailed study breakdown requested.
• "Study" described: The document mentions "Non-clinical tests" including:
  • "Mechanical Safety of aap Implantate AG – LOQTEQ" Distal Fibula Plate, Static and Dynamic 4-point-bending test of bone plates according to ASTM F 382-99 (Reapproved 2008)."
  • "Mechanical properties of metallic bone screws in accordance with ASTM F543-13e1"
  • "Biocompatibility of Implants and Instruments of aap LOQTEQ Distal Fibula Plates and Screw"
• "Acceptance Criteria" described: For these mechanical tests, the acceptance criteria are implicitly that the device performs "as good as or better than the predicate devices" and "fulfil the relevant demands of ASTM F543-13" and ASTM F382-99.
• Performance: The document states, "Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The screws fulfil the relevant demands of ASTM F543-13. The implants have successfully passed the tests and have hereby been proven to be mechanically as good as or better than the predicate devices."
• Clinical Data: The document explicitly states: "Clinical Data were not needed for these devices to show substantial equivalence." This is a key indicator that the detailed clinical study information requested is not part of this submission.

In summary, none of the specific bullet points regarding acceptance criteria and study design for an AI/ML device (e.g., sample size for test set, data provenance, expert numbers/qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) can be extracted from this document because it is for a mechanical orthopedic implant, not an AI/ML diagnostic or therapeutic device. The "study" here refers to mechanical bench testing, not clinical performance or AI algorithm validation.

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The aap LOQTEQ® VA Volar Distal Radius Plate 2.5, LO- QTEQ® VA Distal Radius Straight Plate 2.5, LOQTEQ® VA Distal Radius L-Plate 2.5 are intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius . The aap LOQTEQ® VA Distal Ulna Plate 2.5, LOQTEQ® VA Distal Ulna Hook Plate 2.5 are intended for fractures and osteotomies of the distal ulna .

The aap LOQTEQ® VA Radius Set 2.5 consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures, osteotomies. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).

This document is a 510(k) premarket notification for a medical device: "aap LOQTEQ® VA Radius Set 2.5," which includes plates and screws for fixing fractures and osteotomies of the distal radius and ulna. The FDA determined the device to be substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

• Static and dynamic system tests
• Screws meet relevant demands of ASTM F543-13 | Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained.
  The screws fulfill the relevant demands of ASTM F543-13. |
  | Safety and Effectiveness:
• Meets requirements of pre-defined acceptance criteria
• Meets intended uses | The subject device is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses. |

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data for algorithmic performance. The studies mentioned are non-clinical (mechanical tests) and thus do not involve patient data or data provenance (country of origin, retrospective/prospective). The studies involve device components and system performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The studies are non-clinical mechanical tests, not dependent on expert interpretation of clinical data.

4. Adjudication method for the test set

Not applicable. The studies are non-clinical mechanical tests.

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 notification for a hardware device (bone plates and screws), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device does not involve an algorithm.

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

For the non-clinical mechanical tests, the "ground truth" would be established by:

• Engineering specifications and design requirements.
• Industry standards (e.g., ASTM F543-13 for screws).
• Comparative performance data against predicate devices.

8. The sample size for the training set

Not applicable. The studies are non-clinical mechanical tests and do not involve a training set as understood in AI/machine learning contexts.

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

Not applicable. There is no training set mentioned in the context of this device and its studies.

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