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The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to 6 years, after conservative treatment did not result in a flat foot correction,

• Age

The MC-Subtalar™ II screws are partly threaded, cannulated and self-tapping screws. They are designed to be implanted into the calcaneus bone of the foot for subtalar extra-articular arthroeresis. A hexagonal shaped shaft end allows easy adjustment while operation. The screws are made of X2CrNiMo 18-15-3 stainless steel and are also available made of Ti6Al4V titanium alloy. The MC-Subtalar™ II is offered in sizes of 25 mm, 30 mm and 35 mm and with different head diameter of 6 mm, 8 mm and 10 mm to meet the specific anatomical requirements for various age groups.

The provided text is a 510(k) premarket notification for a medical device called MC-Subtalar™ II. This document describes the device, its indications for use, and its equivalence to legally marketed predicate devices. However, it explicitly states: "Clinical Data were not needed for these devices to show substantial equivalence."

Therefore, based on the provided text, a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or analytical performance study with specific acceptance criteria related to accuracy, sensitivity, or specificity, and human reader performance against an AI, was not performed or required for this 510(k) submission.

The "acceptance criteria" and "device performance" described are mechanical and biomechanical in nature, rather than diagnostic or clinical effectiveness outcomes that would involve complex statistical analyses of sensitivity, specificity, or reader studies.

Here's a breakdown of what is available in the document regarding the device's assessment:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, it describes mechanical and biomechanical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated in terms of patient data. The "test set" refers to the physical devices subjected to mechanical and biomechanical testing. The number of devices tested is not specified, but such tests typically involve a statistically relevant number of samples to ensure robust results.
• Data Provenance: The tests were conducted by Merete Medical GmbH, a German company (Alt-Lankwitz 102, 12247 Berlin, Germany). The origin of the data (i.e., the conditions under which the mechanical tests were performed) would be laboratory-based and controlled, rather than patient data from a specific country or collected retrospectively/prospectively.

3. 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)

This question is not applicable. The "ground truth" here is based on engineering standards (ASTM F543-13) and mechanical testing results, not expert interpretation of medical images or clinical outcomes. The evaluation relies on standardized physical tests and measurements.

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

This is not applicable. Adjudication methods are typically used in clinical studies or expert consensus for ground truth establishment. For mechanical testing, the results are objectively measured against pre-defined engineering specifications.

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, an MRMC comparative effectiveness study was not done. This device is a surgical implant (Subtalar Arthroereisis Implant), not an AI-driven diagnostic or image analysis tool. There is no "human reader" component in its assessment for this 510(k) submission.

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

No, a standalone algorithm performance study was not done. This is not an algorithm or software device.

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

The "ground truth" for the device's performance is based on:

• Adherence to engineering standards (ASTM F543-13).
• Mechanical and biomechanical test results demonstrating the physical properties (e.g., strength, durability) of the implant.

8. The sample size for the training set

This is not applicable as there is no "training set" for an algorithm. The device is a physical implant.

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

This is not applicable as there is no "training set" for an algorithm.

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Indications for use include fixation of fractures. For specific screw indications please see below.

MetaFixTM LS Locking Screws

• · For adult and pediatric patients
• · In combination with Merete Locking Plates
• · Fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals
• · Hallux Valgus osteotomy correction, middle hand and middle foot bones and particular in osteopenic bone

Merete® Cannulated PCS

• · For adult and pediatric patients
• · Fixation of fresh fractures
• · Revision procedures
• · Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes

Merete® CS Cortical Screws

• · For adult and pediatric patients
• · Fixation of fresh fractures
• · Revision procedures
• · Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes

Merete® Cannulated HCS

• · Fixation of fractures and reconstruction of various bones
• · Osteotomies in the foot (as Hallux Valgus) or hand
• · Athrodesis in hand, foot or ankle surgery
• · Fixation of bone fragments in long bones or small bone fractures

DuoThread™ Scarf Screws

• · Small bone fracture fixation
• · Fixation and stabilization of bones of the feet
• · Osteotomies (Scarf-Osteotomy, Chevron-Austin Osteotomy, Closing Wedge Osteotomy)
• · Fusion (MPG-Athrodesis)
• · Fixation of almost all common osteotomies of the first metatarsal

TwistCut™ Snap-Off Screws

• · Fixation of fractures and reconstruction of bones
• · Fixation of small bone fragments
• · Mono cortical fixation
• · Osteotomies (Weil-Osteotomy)
• · Fracture fixation in the foot and hand

MetaFix™ LS Locking Screws: The screws are fully threaded and self-tapping with a threaded head to lock into Merete Locking plates. Locking screws/plates incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm (Ø3.0 mm), 12 mm to 48 mm (Ø3.5 mm) and 10 mm to 48 mm (Ø3.8 mm).

Merete® Cannulated PCS: The Merete® Cannulated PCS screw is a partly threaded, self-tapping, self-drilling and cannulated compression screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 12 mm to 48 mm (Ø3.0 mm). The wrench type of the screw is a torx socket.

Merete® CS Cortical Screws: The Merete® CS Cortical Screw is fully or partly threaded and self-tapping. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm (Ø3.0 mm or Ø3.5 mm). The wrench type of the screw is a torx socket.

Merete® Cannulated HCS: The Merete® Cannulated HCS screw is a partly threaded, self-tapping, self-drilling and cannulated headless compression screw. The screw is featured with a sinkable threaded head. The thread pitch of the shaft and the head are different to achieve a better compression. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm to 40 mm (Ø3.0 mm to 60 mm (Ø4.3 mm). The wrench type of the screw is a torx socket.

DuoThread™ Scarf Screws: The DuoThread™ Scarf screw is a partly or fully threaded, cannulated compression screw. The compression is obtained through a different thread pitch at the head of the screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm to 34 mm (Ø3.0 mm). The wrench type of the screw is a torx socket.

TwistCut™ Snap-Off Screws: The TwistCut™ Snap-Off screw is self-tapping and self-drilling. The screw has a shank to chuck it into a K-Wire pistol, which is cut off when the screw head hits the cortex. The screws are made of titanium (ASTM-F136) and are available in the lengths from 11 mm to 14 mm (Ø2.0 mm).

This document is a 510(k) Premarket Notification from the FDA regarding Merete Medical Incorporated's bone fixation fasteners. It does not provide information about a study proving the device meets specific acceptance criteria in the context of an AI/ML device, as it describes physical medical devices (screws) rather than a software or AI-driven system.

Therefore, most of the requested information (acceptance criteria, device performance, sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable to this document.

However, I can extract the following relevant information based on the document's content:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to physical device testing (mechanical, sterilization, packaging) not a software test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would refer to material and mechanical engineering standards, not expert clinical interpretation.

4. Adjudication method for the test set: Not applicable. Testing was based on engineering standards (ASTM F543).

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 document is about physical bone fixation screws, not an AI system.

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

7. The type of ground truth used: For mechanical performance, the ground truth is established by engineering standards, specifically ASTM F543. For sterilization and packaging, the ground truth is established by validated protocols and current standards.

8. The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device testing in this context.

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

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The PediatrOS™ RigidTack™/ FlexTack™ bone staples are indicated for pediatric patients (children/ adolescents) with angular deformities or leg length discrepancies. Therefore PediatrOS™ RigidTack™ / FlexTack™ is intended to redirect the angle of growth of long bones and to correct leg length discrepancies by inhibition of longitudinal growth of the physis (growth plate) in growing children and adolescents.

Specific pediatric conditions/diseases for which the devices will be indicated include:

• Valgus, varus, or flexion, extension, deformities of the knee (femur and/or tibia) ●
• Valqus or varus deformities of the elbow (humerus) ●
• Leg length discrepancies ●

PediatrOS™ RigidTack™

The PediatrOS™ RigidTack™ bone staples are used to correct leg length discrepancies through (dual) epiphysiodesis of long bones. The PediatrOS™ RigidTack™ has a trapezoidal shape which allows the staples to fit well to the epiphyseal bone. The staples are made from titanium alloy TiAl6V4 ELI and are available in several sizes, so they can be used for children of various age groups (before reaching skeletal maturity). The jagged surfaces of the staples' legs help secure it into the bone to prevent loosening. The staples have cannulated legs to facilitate placement through K-wires. In order to achieve a stiff mechanical behavior, the staples are equipped with a support strut. Female threads, built in the cannulated legs, help to remove the staples with threaded K-wires and the appropriate explantation instruments.

PediatrOS™ FlexTack™

The PediatrOS™ FlexTack™ bone staples are used to correct axial deformities through hemiepiphysiodesis of long bones. The PediatrOS™ FlexTack™ has a trapezoidal shape which allows the staples to fit well to the epiphyseal bone. The staples are made from titanium alloy TiAl6V4 ELl and are available in several sizes, so they can be used for children of various age groups (before reaching skeletal maturity). The jagged surface of the staples' legs help secure it into the bone to prevent loosening. The staples have cannulated legs to facilitate placement through K-wires as well as a flexible middle part which can be bent in vivo by the strength of bone growth permitting successive growth delay. Female threads, built in the cannulated legs, help to remove the staples with threaded K-wires and the appropriate explantation instruments.

The provided document is a 510(k) premarket notification for a medical device (bone staples) and focuses on demonstrating substantial equivalence to existing predicate devices based on mechanical properties and indications for use. It is not a study that evaluates the performance of an AI/ML-driven medical device in terms of diagnostic accuracy or clinical outcomes.

Therefore, many of the requested items related to AI/ML device performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document. This document details the mechanical testing performed to demonstrate equivalence, not clinical performance metrics.

Here's an attempt to address the relevant points based on the provided text, while clearly stating what information is not available:

Acceptance Criteria and Device Performance Study (for Non-AI Device)

This submission describes the PediatrOS™ RigidTack™/FlexTack™ bone staples, which are mechanical medical devices. The "study" referenced in the document is a series of mechanical analyses and functional worst-case tests, not a clinical trial or an AI/ML performance study. The acceptance criteria are related to the mechanical properties of the staples compared to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Ability to withstand forces encountered during bone growth without failure. | - "The mechanical strength is as high or higher than the strength of the predicate device."
• "All products have successfully passed the tests."
• "The PediatrOS™ RigidTack™ / FlexTack™ bone staples have hereby been proven to be mechanically as good as or better than the compared predicate devices." |
  | Stiffness | - Stiffness comparable to both predicate devices. | - "The stiffness is comparable to both predicate devices, too." |
  | Mechanical Behavior | - For FlexTack™: Demonstrate flexible bending zone deforms under small loads and allows larger opening angles than physiologically possible, as intended for successive growth delay.
• For RigidTack™: Demonstrate stiff mechanical behavior. | - "The mechanical behavior comparison illustrated that the flexible bending zone in FlexTack™ deforms under small loads as intended and allows larger opening angles than physiological possible."
• "In order to achieve a stiff mechanical behavior, the staples are equipped with a support strut." (RigidTack™ description)
• "All products have successfully passed the tests." |
  | Fixation into Bone | - Secure fixation into the bone to prevent loosening. | - "A secure fixation into the bone was proven."
• "The jagged surfaces of the staples' legs help secure it into the bone to prevent loosening." (Device description)
• "All products have successfully passed the tests." |
  | Compliance with Standards| - If applicable, tests performed according to valid standards (e.g., ASTM-F564-10(2015)). | - "If applicable the tests were performed according to valid standards as ASTM-F564-10(2015)." |
  | Material Composition | - Made from biocompatible and appropriate materials (Titanium alloy TiAl6V4 ELI). | - "The staples are made from titanium alloy TiAl6V4 ELI." (Device description) |
  | Sterility/Biocompatibility| (Implicit in any medical device submission, though not detailed as a performance test here beyond the material choice. Typically covered by other sections of a 510(k) not provided in these snippets.) | (Not explicitly detailed as a performance test in the provided text, but assumed to be addressed as part of general FDA requirements for the material and manufacturing process.) |

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

• Sample Size: The document does not specify a "sample size" in terms of number of patients or cases. The tests described are mechanical tests performed on the devices themselves. The number of individual staples or test configurations tested is not provided.
• Data Provenance: Not applicable in the context of clinical data. The tests are laboratory mechanical tests, likely performed at Merete Medical GmbH or a contracted testing facility.

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

• Not Applicable. This is a mechanical device submission. There is no "ground truth" established by human experts in the context of diagnostic accuracy or clinical outcomes for these mechanical tests. The "ground truth" for these tests are the physical laws and engineering specifications used to define satisfactory mechanical performance.

4. Adjudication Method for the Test Set

• Not Applicable. There is no adjudication method in the sense of expert consensus for resolving discrepancies, as these are mechanical tests with objective measurements.

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

• No. This is not an AI/ML diagnostic device, and thus no MRMC study, which assesses human reader performance with and without AI assistance, was performed.

6. If a Standalone Performance study was done

• Yes (for mechanical function). The document describes standalone mechanical testing of the PediatrOS™ RigidTack™/FlexTack™ staples to evaluate their strength, stiffness, mechanical behavior, and fixation into bone. This is a "standalone" evaluation of the device's physical properties.

7. The Type of Ground Truth Used

• For the mechanical tests, the "ground truth" is defined by:
  • Engineering specifications and design requirements: How the device should perform structurally.
  • Performance of predicate devices: The established mechanical properties of the legally marketed predicate devices serve as benchmarks for equivalence.
  • Relevant ASTM standards: Such as ASTM-F564-10(2015), which provide methodologies and acceptance criteria for bone staples.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device; therefore, there is no "training set" in the context of machine learning.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

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The device is intended to be used in the management of segmental diaphyseal bone loss of the femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.

The OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System is a series of modular intramedullary rod segments that may be used as either proximal or distal segments. The segments are designed to be attached together to form a complete intramedullary rod using semicircular hollow attachment shells that are clamped together with multiple screws to create a complete intramedullary rod. The complete unit is designed to accept interlocking bone screws for additional rotational stability. The implants from this submission are an extension of the OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System (K051965/K113303). The components from this submission can be used in combination with the rod segments from the OsteoBridge™ IDSF diameter 10 to 16 mm (K051965) as well as with the dia. 5 mm interlocking screws. In addition sterile intramedullary rod segments are available in diameters of 18 mm and 20 mm in lengths of 90 mm and 110 mm. The hollow central attachment shell for use in the femur has a diameter of 34 mm and is available in four lengths 40 mm, 50 mm, 60 mm and 70 mm with reducing bushings to allow the use of different diameter rods proximally and distally to better fit the medullary canal. If the defect size is larger than 70 mm, two attachment shells can be connected by a spacer connector. All components of the OsteoBridge™ IDSF system are manufactured from Ti-6Al-4V titanium alloy conforming to ASTM F 136-13.

This section describes the acceptance criteria and study proving the device meets said criteria for the OsteoBridge™ IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System.

The provided document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with explicit acceptance criteria for performance against a specific clinical outcome. Therefore, the "acceptance criteria" here refer to the mechanical performance standards necessary to be "as safe and effective as" the predicate device, as determined by recognized standards.

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 explicitly stated as a "sample size" in the context of clinical trials. The testing refers to mechanical and functional testing of device components. This typically involves a certain number of manufactured units or material samples to ensure consistency and meet statistical requirements for mechanical testing. However, the exact number is not provided in this summary.
• Data Provenance: The "Non-Clinical Performance Data" was generated by Merete Medical, the manufacturer. The location of the testing facilities is not specified, but the applicant (Merete Medical GmbH) is based in Berlin, Germany. The data is retrospective in the sense that the testing was performed to support the 510(k) submission.

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

This section is not applicable as the "test set" in this context refers to physical device components undergoing mechanical testing, not human-interpreted data requiring expert consensus or ground truth from medical professionals. The "ground truth" here is metallurgical and mechanical performance meeting a defined ASTM standard.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as above. Mechanical tests are typically evaluated against predefined pass/fail criteria from a standard, not through adjudication.

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 submission is for a medical device (intramedullary rod system) and concerns mechanical performance, not an AI or imaging diagnostic algorithm that would typically involve MRMC studies.

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

No, a standalone algorithm performance study was not done. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data is adherence to the ASTM F-1264-03 standard for intramedullary fixation rods. This standard specifies test methods and performance requirements for the mechanical properties of such devices. The ground truth refers to whether the device's mechanical properties (e.g., strength, fatigue resistance) meet the requirements set forth in this recognized standard.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of mechanical device testing or a 510(k) submission for a physical implant. Training sets are relevant for machine learning algorithms.

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

This section is not applicable for the same reasons as above.

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The IntraBlock™ BioBall™ Hip System (IBS) is intended for use in total hip arthroplasty.

The IBS is indicated for:

• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis,
• Avascular necrosis of the femoral head, -
• = Correction of functional deformity,
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques,
• -Revision procedures where other treatment or devices have failed.

The IBS is indicated for cementless use only.

The IntraBlock™ BioBall™ Hip System (IBS) is composed of femoral stems, heads, taper adapter sleeves and acetabulum cups. The System is designed for uncemented use for either primary or revision hip arthroplasty.

The Ceramic Head is made of Biolox® delta (Alumina Matrix Composite ISO 6474-2) and available in diameters 28, 32 and 36 mm.

The cementless MultiCup Locking PressFit is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a titanium plasma spray (TPS) coating on the outer surface. It is used with a UHMWPE Inlay sized for Ø28, 32 and 36 mm heads. 5 holes with threaded plugs give the option for an additional fixation with locking screws. The MultiCup is available in 9 different sizes ranged from 46 mm, 48 mm up to 62 mm outer diameter.

The provided document is a 510(k) premarket notification decision letter and summary for a medical device: the IntraBlock™ BioBall™ Hip System (IBS). It focuses on establishing substantial equivalence to previously marketed devices based on non-clinical performance data (mechanical testing and analysis).

Therefore, this document does not contain information about acceptance criteria for a study proving device performance on human subjects, nor does it describe such a study. It describes a regulatory submission for a medical device (a hip replacement system) primarily based on non-clinical (laboratory) testing for mechanical properties and material characteristics to demonstrate substantial equivalence to predicate devices.

Specifically, the document states:

• Non-Clinical Performance Data: "Non-clinical testing and analysis were provided to support substantial equivalence. Mechanical testing included testing of the modular connection, wear testing and mechanical testing of the coating as well as coating characterization. Range of Motion analysis also was performed. The modular connection analysis included fretting and corrosion as well as static compression testing (burst testing and post-fatigue burst testing) consistent with the "Guidance document for the preparation of premarket notifications for ceramic ball hip systems". Furthermore the connections between the stem, the adapter and the head, as well as the liner locking mechanism were tested in pull-off, rotation testing and cup/liner disassembly testing."

This clearly indicates a focus on laboratory or bench testing rather than clinical studies involving human subjects or expert assessment of clinical data.

Therefore, I cannot provide the requested information regarding acceptance criteria for a device performance study involving human subjects or expert ground truth, as that information is not present in the provided text.

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The Merete Locking Bone Plate System can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.

Not Found

I apologize, but the provided text from the FDA 510(k) letter for the "Merete Locking Bone Plate System III" does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document is a standard FDA clearance letter for a Class II medical device, indicating that the device has been found substantially equivalent to a predicate device. It outlines regulatory requirements and proper labeling but does not delve into the technical details of performance testing or clinical studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided.

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The Merete BLP™ Small Fragment Locking Bone Plate System is used for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non-unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

Not Found

This document is an FDA 510(k) clearance letter for the Merete BLP™ Small Fragment Locking Bone Plate System. It explicitly states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, the letter does not describe any acceptance criteria or a study proving the device meets those criteria, as these are typically part of a device's submission which is not provided here. The 510(k) process for this type of device does not usually require clinical trials with human subjects or detailed performance studies against specific acceptance criteria in the same way a new, high-risk device might.

The letter focuses on regulatory clearance based on substantial equivalence to existing devices.

Based on the provided text, none of the requested information regarding acceptance criteria or a study that proves the device meets them can be extracted.

The document only serves as regulatory clearance and states the intended use and indications for the device.

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The IntraBlock™ BioBall™ Hip System (IBS) is intended for use in total hip arthroplasty.

The IBS is indicated for:

• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis,
• -Avascular necrosis of the femoral head,
• Correction of functional deformity. ー
• -Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques,
• Revision procedures where other treatment or devices have failed. -

AND/OR

The IBS is indicated for cementless use only.

The IntraBlock™ BioBall™ Hip System (IBS) is composed of femoral stems, heads. taper adapter sleeves and acetabulum cups. The System is designed for uncemented use for either primary or revision hip arthroplasty.

The IBS stem is straight, collarless, and flat with a tapered design. The stem is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a proximal titanium plasma spray (TPS) coating. The stems are proportionally sized and shaped in sizes 6.25 mm to 15.00 mm to match the geometry of the femur. A lateralized version of the device is available. Both versions have a neck shaft angle of 135° and a 12/14 morse taper trunion. The Ceramic Head is made of Biolox® delta (Alumina Matrix Composite ISO 6474-2) and available in diameter 28 mm.

The taper adapter sleeves are made from titanium alloy (Ti-6AI-4V ELI) with a 12/14 morse taper trunion in the four neck lengths S, M, L and XL.

The cementless MultiCup Locking PressFit is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a titanium plasma spray (TPS) coating on the outer surface. It is used with a UHMWPE inlay sized for Ø28 mm heads. 5 holes with threaded plugs give the option for an additional fixation with locking screws. The MultiCup is available in 9 different sizes ranged from 48mm up to 62mm outer diameter.

This document describes the 510(k) summary for the IntraBlock™ BioBall™ Hip System (IBS), a total hip replacement device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state specific acceptance criteria with numerical targets for device performance that would traditionally be found in a clinical study result table (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it describes a series of non-clinical tests conducted to demonstrate the device's mechanical integrity and material properties, aligning with established FDA guidance documents for orthopedic implants.

• Static compression testing performed, consistent with "Guidance document for the preparation of premarket notifications for ceramic ball hip systems."
• Connections between the stem, the adapter, and the head, as well as the liner locking mechanism, were tested.
• Range of Motion analysis was performed. |
  | Coating Characterization | - TPS coating underwent characterization per FDA's "Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopaedic Implants to support reconsideration of Post Market Surveillance Requirements." |
  | Modular Connection Analysis | - Fretting and corrosion analysis performed. |

It's important to note that the document states these tests were performed and were consistent with guidance documents, which implies they met the inherent "acceptance criteria" defined within those guidances for demonstrating safety and efficacy for substantial equivalence, rather than detailing the specific numerical outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: The document refers to "non-clinical testing and analysis" which typically involves physical samples or prototypes of the device, rather than patient data. No specific sample sizes (e.g., number of stems, cups, or heads tested) are explicitly mentioned for each mechanical test.
• Data Provenance: The tests are non-clinical (laboratory-based). There is no patient data, so "country of origin" or "retrospective/prospective" are not applicable in the human data sense. The manufacturer is Merete Medical GmbH, based in Berlin, Germany.

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 submission for a mechanical implant based on non-clinical testing, not a diagnostic or prognostic device requiring expert-established ground truth from medical images or patient data. The "ground truth" here is the adherence to mechanical and material standards established by recognized guidance documents.

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

Not applicable. As noted above, this involves non-clinical mechanical testing against predefined standards, not a review of clinical cases by experts.

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 total hip replacement system, an implantable medical device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm or AI system.

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

The "ground truth" for this submission are the established mechanical and material standards and performance requirements outlined in referenced FDA guidance documents (e.g., "Guidance for Industry and FDA staff Non-Clinical Information for femoral Stem Prostheses", "Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopaedic Implants", "Guidance document for the preparation of premarket notifications for ceramic ball hip systems"). The device's performance in battery of non-clinical tests is compared against these engineering standards.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI/ML algorithm for this type of device. The design and manufacturing processes are developed based on engineering principles and existing knowledge of materials science and biomechanics, not machine learning training.

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

Not applicable, as there is no training set for this device.

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Merete® CS, Cortical Screws 3.0 and 3.5mm can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, wrists, ankles, fingers and toes.

Not Found

The provided document is an FDA 510(k) clearance letter for a medical device (Merete® CS, Cortical Screw 3.0 and 3.5mm) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as described in the prompt.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and performance. However, it does not include a detailed report of a study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot answer the questions based on the provided input.

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The Merete Locking Bone Plate System III can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.

The Merete Locking Bone Plate System III consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures for the fixation with Merete 3.0 and 3.5 mm locking screws and 3.0 mm cannulated compression screws. Before placing the screws, plates can be fixed temporarily with K-Wires. Plates, screws and K-Wires of the Merete Locking Bone Plate System III are made of Ti-6Al-4V ELI Alloy for Surgical Implant Applications (ASTM F136, ISO 5832-3). K-Wires are additionally made of CrNiMo Stainless Steel for Surgical Implants (ASTM F138, ISO 5832-1).

The information provided describes the Merete Locking Bone Plate System III, a medical device for bone fixation. The document focuses on the regulatory submission to the FDA (510(k)) and the mechanical testing conducted to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information based on the provided text, primarily drawing from the "Mechanical testing" section:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in a table format. However, it does mention the types of mechanical tests performed and the general outcome.

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

The provided text does not specify the sample size used for the mechanical tests.
The data provenance is from nonclinical mechanical testing conducted by Merete Medical GmbH. This is an in-vitro (laboratory) study, not human or animal data.

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

This question is not applicable to the provided information. The "ground truth" for this device's performance is established through objective mechanical testing against international standards (ASTM and ISO), not through expert consensus or interpretation of images.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments. Mechanical tests follow predefined protocols and objective measurements.

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

This question is not applicable. The device is a bone plate system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

This question is not applicable. The device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Merete Locking Bone Plate System III is established through objective mechanical measurements against established international standards (ASTM F382-2003, ISO 9585, ASTM F543, ISO 6475). The successful completion of these tests under "worst-case scenarios" serves as the ground truth for its mechanical integrity and functional performance.

8. The Sample Size for the Training Set

This question is not applicable. Mechanical testing of a physical device does not involve "training sets" in the context of machine learning or AI.

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

This question is not applicable. As stated above, there is no "training set" in the context of this device's testing.

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