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The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. DynaBunion™ 4D Minimal-incision Bystem and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™HiMAX™ Implant System cleared in K142727, K181410 and K193452.

The subject devices branded as DynaBunion and DynaMet are additional plate confiqurations and screws being added to the predicate system, MotoBAND CP Implant System.

DynaBunion™ 4D Minimal-incision Bunion System:
The subject DynaBunion™ 4D Minimal-incision Bunion System includes the addition of the DynaBunion plates and screws to the MotoBAND CP Implant System. The Anti-Drift Bolt (ADB) is a modification of the MotoBAND CP Implant System screws for optional use with the subject DynaBunion plate to anchor the first metatarsal back to the base of the second metatarsal. DynaBunion instruments are used with the MotoBAND CP Implant System for the Lapidus procedure. The cut block and all associated instruments are Class I exempt instruments and may be used with previous versions of the MotoBAND CP Lapidus plates.

DynaMet™ Lesser TMT Fusion System:
The subject DynaMet™ Lesser TMT Fusion System includes the addition of the DvnaMet staple compression plates (SCP) to the MotoBAND CP Implant System. The subject plates have 8 configurations with templates and are compatible with 15mm or 18mm HiMAX C staples. The subject plates are compatible with the same MotoBAND CP screws cleared in K193452. The DynaMET plates are a variation of plate designs for a specific application.

The provided document is a 510(k) summary for the MotoBAND™ CP Implant System, which includes the DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System. This submission focuses on demonstrating substantial equivalence to predicate devices for these metallic bone fixation appliances.

It's important to note that this document does not describe a study involving device performance evaluated against acceptance criteria using patient data, AI, or human readers. Instead, it describes an engineering analysis to demonstrate substantial equivalence based on mechanical properties and design.

Therefore, I cannot provide information for many of the requested categories (e.g., sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) as they are not relevant to the type of submission described.

Here's an analysis based on the information provided, focusing on what is present:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No clinical or patient data test set was used. The evaluation was based on engineering analysis and comparison to predicate devices, focusing on mechanical properties and design.

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)

Not applicable. No ground truth based on expert review of clinical data was established. The "ground truth" here is the established mechanical performance of the predicate device.

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

Not applicable. No adjudication of clinical data was performed.

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 not an AI-enabled device, and no MRMC study was conducted.

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

Not applicable. This is a medical implant, not an algorithm, and no standalone algorithm performance was assessed.

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

The "ground truth" in this context refers to the established mechanical and material properties and performance of the legally marketed predicate devices. The subject device demonstrates substantial equivalence by showing that its engineering characteristics (strength, materials, design, intended use) are equivalent to or exceed those of the predicate devices.

8. The sample size for the training set

Not applicable. No training set was used. This is an engineering comparison, not a machine learning model.

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

Not applicable. No training set was used. The "ground truth" for comparison (predicate device performance) was established through prior regulatory clearances and mechanical testing of those predicate devices.

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FootHold™ System is intended to be used for suture or tissue fixation in the foot, ankle, hand, and wrist. Specific indications are listed below:

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, and MCP Joints for All Digits, Digital Tendon Transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction

The FootHold™System is a device which is preloaded with suture and is designed to attach soft tissues to bone. The device is deployed through a bicortical drill hole and secured on the far cortex.

The provided document is a 510(k) premarket notification for a medical device called the FootHold™ System, which is a metallic bone fixation fastener. The information contained within this document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical and materials testing, rather than clinical study results with human participants or a machine learning component.

Therefore, the requested information regarding acceptance criteria, study design for machine learning models, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for AI devices is not applicable to this submission.

The "study" described in the document is a series of mechanical and materials tests to demonstrate the safety and effectiveness of the device.

Here's a summary of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

   Test Type	Acceptance Criteria	Reported Device Performance
   Abrasion Strength	Suture does not present a new worst-case for abrasion strength.	Mechanical testing demonstrated the suture does not present a new worst-case for abrasion strength.
   Pull-out Strength	Performance substantially equivalent or improved compared to predicate device.	Bench testing showed a statistically significant improvement of pull-out strength for the subject device as compared to the listed predicate.
   Sterilization	Sterility Assurance Level (SAL) of $10^{-6}$ (in conformance with ANSI/AAMI/ISO 11135-1).	SAL of $10^{-6}$ established. Residuals of ethylene oxide and ethylene chlorohydrin are below thresholds specified in ANSI/AAMI/ISO 10993-7.
   Packaging Shelf Life	Meets acceptance criteria for labeling of 5-year shelf-life (ISO 11607-2).	Packaging met all acceptance criteria for labeling a 5-year shelf life.
   Bacterial Endotoxin	Meets established limits.	Bacterial endotoxin testing meets the established limits.
   Biocompatibility	Meets ISO 10993-1.	Based on comparative analysis, the subject FootHold™System meets ISO 10993-1 for biocompatibility. The results demonstrate the performance is substantially equivalent to the predicate device.

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

   • Not applicable. This is a medical device application based on bench testing of physical properties, not a software device relying on clinical data.

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):

   • Not applicable. Ground truth for mechanical testing is established by recognized standards and objective measurements (e.g., force, weight, material composition).

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

   • Not applicable. Testing is against predefined mechanical and material standards.

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 not an AI device.

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

   • Not applicable. This is not an AI device.

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

   • The "ground truth" for this device's performance is established by engineering and biological standards (e.g., ASTM, ISO standards for material properties, sterility, and biocompatibility) and direct physical measurements of mechanical properties (pull-out strength, abrasion strength).

8. The sample size for the training set:

   • Not applicable. This is not a machine learning device; there is no "training set" in the context of AI.

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

   • Not applicable. No training set for an AI model.

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The CrossRoads Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The CrossRoads Tray System are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap. Sterilization for the worst-case CrossRoads Tray System included surgical instruments such as drills, inserters, reamers, fixation pin, benders, and ratcheting handles. The CrossRoads Tray System were validated for a maximum load of 8.5 lbs (tray + instruments).

Method: Steam Sterilization (Moist Heat Sterilization) Cycle Prevacuum
Temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Drying time: 20 minutes

The tray is 20.60" length x 9.80" width x 2.00" depth.

The subject CrossRoads Tray System is a reusable sterilization tray or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. All components are perforated for steam penetration. The tray can hold implants and instruments such as inserters, K-wire guides, fixation pins, reamers and ratcheting handles.

The tray is 20.60" length x 9.80" width x 2.00" depth.

The CrossRoads Tray System tray is manufactured from aluminum conforming to ASTM B029, silicone, 304 stainless steel conforming to ASTM A240 and ASTM A313, 18-8 stainless steel, 17-4 stainless steel 304 stainless steel, and 316 stainless steel.

This document pertains to the CrossRoads Tray System, a reusable sterilization tray for medical devices. The primary study presented verifies the sterilization efficacy and cleanability of the tray and its contents, along with its biocompatibility.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sterilization Efficacy: The test involved Geobacillus stearothermophilus biological indicators (8 BI carriers and 2 SporView self-contained BIs) placed in areas deemed most difficult for sterilant penetration, within the CrossRoads Tray System containing a maximum load. The specific DynaBunion Non-Sterile Set, 15NS-4800, was used as the representative load. The test was performed over three pre-vacuum autoclave cycles. This appears to be a prospective test conducted specifically for this device submission. The country of origin of the data is not specified but is presumably where the manufacturing and testing occur, likely the USA given the FDA submission.
• Reprocessing (Cleanability):
  • Instruments: Three cleaning cycles were performed on 5 instruments.
  • Tray: Three cleaning cycles were performed on the tray.
  • This is a prospective test. The country of origin of the data is not specified but is presumably where the manufacturing and testing occur, likely the USA.
• Biocompatibility: The test involved the ratchet handle component of the tray system. The specific number of samples tested is not explicitly stated, but "any of the sample extracts at 24 and 48hrs contact" implies multiple extracts were tested. This is a prospective test. The country of origin of the data is not specified but is presumably where the manufacturing and testing occur, likely the USA.

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

This type of study does not involve expert readers establishing ground truth in the way a medical image interpretation study would. Ground truth in these types of performance tests (sterilization, cleaning, biocompatibility) is established through standardized laboratory methods and analytical measures (e.g., assessing microbial growth, measuring residual protein/hemoglobin levels, observing cytotoxic reactions) performed by qualified laboratory personnel following established protocols (e.g., ANSI/AAMI/ISO 14937:2013, AAMI TIR12-2010, AAMI TIR30-2011, ANSI/AAMI/ISO 10993-5:2009). The "experts" are the scientists and technicians conducting these validated tests. Their qualifications are inherent in the adherence to these recognized standards.

4. Adjudication method for the test set:

Not applicable for these types of laboratory performance tests. The results are based on objective measurements against predefined acceptance criteria, not subjective human assessments requiring adjudication.

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 not an AI-assisted device or a diagnostic device involving human readers or case interpretation.

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

Not applicable. This is a physical medical device (sterilization tray), not an algorithm or AI system. The tests evaluate the physical performance of the tray itself.

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

The ground truth for these tests is based on objective laboratory measurements and adherence to established scientific and regulatory standards:

• Sterilization Efficacy: Ground truth is the observable absence of microbial growth in biological indicators after sterilization, confirming a 6-log reduction in the indicator organism as required for a Sterility Assurance Level (SAL) of 10-6.
• Reprocessing (Cleanability): Ground truth is the quantitative measurement of residual protein and hemoglobin levels on the instruments and tray, falling below the specified AAMI TIR-30 guideline acceptance criteria.
• Biocompatibility: Ground truth is the absence of a cytotoxic reaction (Grade 0 score) in in-vitro tests, indicating the material does not harm cells.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model. Therefore, 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 MIS Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

The CrossRoads MIS Bunion System contains a buttressing implant which can be surgically implanted using a minimally invasive surgical technique to correct hallux valgus. The MIS Bunion implant is to be made of implant grade titanium (Ti-6Al-4V ELI) per ASTM F136 with features allowing it to accept a CrossRoads MotoBAND CP screw (previously cleared in K152306), the subject Ø3.0mm MIS Bunion locking screw, or the optional subject Ø2.7mm non-locking screw in the implant. Instrumentation required for performing this surgery include a k-wire, for use with an osteotomy guide, osteotome guide and osteotome, a suture passing loop, drill bit and handle. Additional general surgical instrumentation utilized include reamers, drill guide/depth gauge. The MIS Bunion implant is tapered on the proximal end so that it can be easily inserted into the intramedullary canal of the metatarsal and the distal head of the implant will seat directly against the osteotomy surface. The MIS bunion implant wedges firmly within the intramedullary canal and acts as a buttress to hold the metatarsal head in place. To accommodate a range of anatomical sizes and severities of corrections, the implant will be offered in an array of configurations; wherein each incremental size will increase in thickness on the distal end, resulting in different buttressing offsets. The tapered proximal end of the implant will also have interrupted surfaces to gain traction within the cancellous bone, thus resisting pullout. Finally, the MIS bunion implant will accept Ø3.0mm or Ø3.5mm CrossRoads MotoBAND CP screws (K152306) or the subject MIS Bunion Ø 3.0mm polyaxial locking screws in the most distal hole, in addition to the optional subject Ø2.7mm non-locking screw accepted only in the angular cross hole for additional fixation of the implant to the metatarsal shaft.

This Special 510(k) submission seeks to modify the design of the previously cleared plate to add an additional angular distal screw hole to accept optional placement of the subject Ø2.7mm non-locking screw for additional plate stability. Additionally, this submission seeks to expand the size range of the plates to include a shorter length plate to better accommodate patient anatomy.

The provided text is a 510(k) summary for the CrossRoads Extremity Systems, LLC MIS Bunion Plating System. This document describes a medical device and its equivalence to a previously cleared device, not an AI or software device that would require specific performance criteria based on an algorithm's accuracy, sensitivity, or specificity.

Therefore, the information required to answer your prompt, which is tailored for performance claims of AI/ML or diagnostic devices (e.g., acceptance criteria for accuracy, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, training set details), is not present in this document.

This 510(k) filing primarily focuses on:

• Device Description: The physical characteristics and materials of the MIS Bunion Plating System.
• Indications for Use: What the device is intended to treat (fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus).
• Substantial Equivalence: How the modified device is similar to a previously cleared predicate device (K181872). The changes are design modifications to the plate (additional screw hole, shorter length plate) and new screw sizes.
• Performance Testing: This refers to mechanical analysis and screw pull-through construct testing to demonstrate that the design changes do not worsen the device's structural performance compared to the predicate device. It explicitly states, "Thus, it was determined that no additional mechanical testing is required."

In summary, this document does not contain the type of data or study design that your questions refer to for evaluating an algorithm's performance on a test set using ground truth established by experts.

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The MIS Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

The CrossRoads MIS Bunion System contains a buttressing implant which can be surgically implanted using a minimally invasive surgical technique to correct hallux valgus. The MIS Bunion implant is to be made of implant grade titanium (Ti-6A1-4V ELI) per ASTM F136 with features allowing it to accept a CrossRoads MotoBAND CP screw (previously cleared in K 152306 ) in the distal end of the implant. Instrumentation required for performing this surgery include a k-wire, for use with an osteotomy guide, and osteotome. Additional general surgical instrumentation utilized include reamers, drill guide, and depth guage. The MIS Bunion implant is tapered on the proximal end so that it can be easily inserted into the intramedullary canal of the metatarsal and the distal head of the implant will seat directly against the osteotomy surface. The effect of the MIS Bunion implant being wedged firmly within the intramedullary canal is that it acts as a buttress to hold the metatarsal head in place. To accommodate a range of anatomical sizes and severities of corrections. the implant will be offered in an array of configurations; wherein each incremental size will increase in thickness on the distal end, resulting in different buttressing offsets. The tapered proximal end of the implant will also have interrupted surfaces to gain traction within the cancellous bone, thus resisting pullout. Finally, the MIS bunion implant will accept Ø3.0mm or Ø3.5mm CrossRoads MotoBAND CP screws (K152306) to secure the metatarsal head firmly in place, allowing fusion to occur.

The provided text does not describe an AI/ML device or a study involving such a device. Instead, it describes a medical device called the "MIS Bunion System" which is a metallic bone fixation appliance. The document is an FDA 510(k) premarket notification, which focuses on device design, materials, and substantial equivalence to predicate devices, rather than algorithmic performance.

Therefore, many of the requested categories related to AI/ML device acceptance criteria and study design (like ground truth, expert adjudication, MRMC studies, training set, effect size of AI assistance) are not applicable to this document.

However, I can extract the relevant "acceptance criteria" (performance testing) and the study that proves the device meets them, based on the information provided for this specific type of medical device:

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

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

• Mechanical Testing: The document does not specify a numerical "sample size" for the theoretical analysis or pull-out testing beyond implying that worst-case cross-sections were analyzed and pull-out tests were conducted. It doesn't mention data provenance in terms of country of origin or retrospective/prospective; these tests are typically internal laboratory tests.
• Pyrogen Testing: The document does not specify the number of samples or batches tested for pyrogenicity. Data provenance is not mentioned.

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 as the studies are mechanical and biocompatibility tests, not studies requiring expert interpretation or ground truth establishment in the clinical sense.

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

• Not applicable for mechanical and biocompatibility testing. The "adjudication" is based on meeting defined engineering and safety limits.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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

• For mechanical testing, the "ground truth" is defined by established engineering principles, material properties (e.g., ASTM F136 for Ti-6A1-4V ELI), and performance metrics (e.g., pull-out force), often in comparison to a predicate device.
• For pyrogen testing, the "ground truth" is the established endotoxin limit (20 Endotoxin Units (EU)/Device).

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. There is no concept of a "training set" for this type of mechanical device.

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

• Not applicable as this is not an AI/ML device.

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The MotoCLIP™/HiMAX™ Step Staple Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

The MotoCLIP™/HiMAX™ Step Staple Implant System gives the surgeon a means of bone fixation in the management of bone fractures and reconstruction surgery. The MotoCLIP™/HiMAX™ Step Staple Implant System includes implants and the related instruments needed for implantation. The implants are made of nitinol. Prior to implantation, the legs of the implant are held substantially parallel to facilitate insertion into the prepared bone. Once implanted and released from the insertion device, the implant will move towards each other in a converging fashion. This movement creates compression across the adjoining bone members.

This document describes a 510(k) premarket notification for a medical device, the MotoCLIP™/HiMAX™ Step Staple Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical or standalone performance study in the way one would for an AI/ML device.

Therefore, many of the requested sections (acceptance criteria table, sample size for test/training sets, experts, adjudication, MRMC, standalone performance, ground truth establishment) are not applicable in the context of this 510(k) submission, as it relies on different types of evidence.

However, I can extract information related to the device performance testing and the standard for acceptance in this regulatory pathway.

Here's a breakdown based on the provided document:

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

For a 510(k) submission, the "acceptance criteria" for demonstrating substantial equivalence primarily revolve around meeting or exceeding the performance of the predicate device(s) in relevant testing. The reported "performance" is a demonstration of this equivalence.

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

• Sample Size: Not applicable in the context of a clinical test set. The performance testing was based on finite element analysis (FEA), which is a computational simulation method, not a physical test on a "sample size" of devices in the traditional sense or a patient data set. The FEA was performed "utilizing the worst-case sizes" of the device.
• Data Provenance: Not applicable. FEA is a computational modeling technique, not derived from patient data.

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):

• Not Applicable. This is not an AI/ML device requiring human expert annotation for ground truth. The "ground truth" here is established by engineering principles and the performance of the predicate device as a benchmark.

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

• Not Applicable. There was no human "adjudication" of a test set as this is not a study involving human interpretation of data (e.g., images).

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 study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool.

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

• Yes, in spirit. The "standalone performance" of this device was assessed through Finite Element Analysis (FEA) to predict its mechanical properties (bending strength, stiffness, pullout strength) without human intervention in the device's function or the analysis itself (though humans design the FEA). This is the "algorithm only" equivalent for a mechanical device.

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

• For this mechanical device, the ground truth for substantial equivalence is primarily the established mechanical performance and safety profile of the predicate device(s). The FEA results are compared to these established benchmarks to demonstrate that the subject device performs equivalently.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of a 510(k) submission for a mechanical device like this. This is not an AI/ML product that learns from data.

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

• Not Applicable. As there is no training set.

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The MotoCLIP™HiMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

MotoCLIP™/HiMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation in the management of bone fractures and reconstruction surgery. The MotoCLIP™/HiMAXIM Implant System is a line extension of the previously cleared CrossCLIP™ System K142727. After clearance, CrossRoads re-branded the CrossCLIP™ System to the MotoCLIPTMTM Implant System.

The MotoCLIP™/HiMAX™ Implant System gives the surgeon a means for fixation of fractures, fusions, and osteotomies of the foot, ankle, and hand. The MotoCLIP™/HiMAX™ Implant System includes implants and the related instrumentation needed for implantation. The implants are made from implant grade Nitinol per ASTM F2063.

The only modifications being made in this submission are changes in the geometry of the implants and associated instruments.

This document describes the MotoCLIP™/HiMAX™ Implant System, which is a staple system for bone fixation in hand and foot osteotomy and joint arthrodesis. The submission is a line extension of the previously cleared CrossCLIP™ System (K142727).

Here's a breakdown of the acceptance criteria and study information provided in the document:

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

The document does not explicitly state "acceptance criteria" in a tabulated format with numerical targets. Instead, the performance evaluations are centered around demonstrating substantial equivalence to a predicate device (CrossCLIP™ Implants, K142727). The core acceptance is that the device does not introduce a new worst case and meets or exceeds the strength of the worst-case implant in the previously cleared system.

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

• Sample Size for Test Set: Not specified for the theoretical analysis (FEA) or pull-out testing. The description only refers to "worst case" analysis and "the subject device."
• Data Provenance: Not specified. It's an engineering analysis and bench testing, likely conducted internally by the manufacturer or a contracted lab. There's no mention of patient data (retrospective or prospective) for this type of device.

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

Not applicable. This submission concerns a mechanical device (bone fixation staple). The "ground truth" for its performance is established through biomechanical testing and engineering analysis, not expert clinical interpretation of images or patient outcomes.

4. Adjudication method for the test set

Not applicable, as this is a mechanical performance study, not a clinical study involving human judgment or interpretation.

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 (implantable staple), not an AI/imaging diagnostic device.

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

Not applicable. This describes a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence and acceptable performance for this device is based on bench testing and theoretical engineering analysis (FEA), specifically:

• Predicted compression force
• Maximum strain
• Pull-out strength

These are compared against the known performance characteristics of the predicate device.

8. The sample size for the training set

Not applicable. This is not a study involving machine learning or statistical modeling that would require a "training set." The data comes from engineering simulations and physical bench tests.

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

Not applicable, for the same reasons as #8.

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The MotoBAND™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. When used for these indications, the MotoBAND™ Implant System with the exception of the MTP plates and 2-hole plate may be used with the MotoCLIPTM Implant System.

The MotoBAND™ CP Implant System is comprised of implant plates and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries include valgus options of 0°, 5° and 10°, dorsiflexion options of 0°, 2.5°, 5°, 7.5° and 10° and options to use either a 15mm or 18mm nitinol clip. MotoBAND™ CP Implant System is compatible with MotoCLIP™ Staple.

The provided FDA K173710 document for the MotoBAND™ CP Implant System does not contain the information requested regarding acceptance criteria and study details for a medical device that relies on AI or software for its performance evaluation (e.g., image analysis, diagnostic support devices).

The MotoBAND™ CP Implant System is a physical medical device (metallic bone fixation fastener, plate system) used for orthopedic fixation. Its substantial equivalence determination is based on:

• Theoretical analysis: Predicting torsional, pullout, and plate bending strengths.
• Comparison to predicate devices: Showing that the subject device's predicted performance is substantially equivalent to previously cleared devices (K152306, K160300).
• Materials: Stating the material used (titanium alloy).
• Indications for Use: Matching the scope of the predicate devices.

Therefore, the document does not include:

1. A table of acceptance criteria and reported device performance related to AI/software metrics (e.g., sensitivity, specificity, accuracy).
2. Sample sizes for test sets (as there's no diagnostic test set).
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication methods.
5. MRMC studies or effect sizes for human readers.
6. Standalone algorithm performance.
7. Types of ground truth (as it relates to diagnostic accuracy).
8. Training set sample sizes or ground truth establishment for training data.

The performance testing mentioned in the document refers to mechanical integrity and strength tests for the physical implant, not data-driven performance of a diagnostic or AI-enabled device.

In summary, this document is irrelevant to the prompt's request for information about a study that proves a device meets acceptance criteria related to AI or data-driven performance.

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The STROPP(TM) System is intended for use with a suture in metatarsal ligament and tendon repairs.

The STROPP™ System is sterile packaged kit to include implants and instruments for plantar plate repair. Implants are 3.0 mm or 3.5 mm diameters and range in length from 6 mm to 12 mm. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, an inserter, Kwires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system.

The provided text describes a 510(k) premarket notification for a medical device called the STROPP™ (Single Tunnel Repair of Plantar Plate) System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than a device's standalone performance compared to a set of acceptance criteria.

Therefore, the input text does not contain the information requested in sections 1-9 regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement in the context of a new device's performance validation against a defined set of criteria.

The information provided is specific to the regulatory process for demonstrating substantial equivalence for a Class II medical device, which typically involves comparing the new device's characteristics (design, materials, intended use, performance testing) to those of legally marketed predicate devices.

Here's what can be extracted, interpreted based on the context of a 510(k):

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

• The document does not explicitly state acceptance criteria for a new device's performance in a standalone study. Instead, it refers to demonstrating "statistical equivalence to current plantar plate repair options" for construct pull-through testing. This means the performance of the STROPP™ system was compared against existing methodologies or devices, rather than a predefined absolute threshold.
• Reported Device Performance:
  • "The construct pull through testing demonstrated statistical equivalence to current plantar plate repair options and that the STRoPP™ System introduces no additional failure modes."
  • "The cadaveric testing resulted in no damage to the bone, implant or suture."
  • "All testing met the specified acceptance criteria and raised no new issues of safety or effectiveness." (This "acceptance criteria" likely refers to the equivalence criteria mentioned above or other internal design specifications, not external performance benchmarks specified in the document.)

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

• Sample Size: Not specified. The text mentions "test samples that are representative of the finished device" for construct pull-through testing and "cadaveric simulated use testing" but does not give a number for either.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests appear to be laboratory-based ("simulated use model," "cadaveric simulated use testing").

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

• This information is not applicable and not mentioned. The studies focus on mechanical performance and simulated use, not diagnostic accuracy requiring expert interpretation.

4. Adjudication method for the test set

• This information is not applicable and not mentioned. The studies focus on mechanical performance.

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 information is not applicable and not mentioned. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

• This is a physical medical device, not an algorithm. Therefore, this question is not directly applicable. However, the performance testing described is analogous to a "standalone" mechanical performance evaluation of the device itself (construct pull-through, cadaveric testing).

7. The type of ground truth used

• For the construct pull-through test: It appears the "ground truth" was the mechanical strength or failure point, compared against existing "plantar plate repair options."
• For the cadaveric testing: The "ground truth" was the observation of "damage to the bone, implant or suture."

8. The sample size for the training set

• This device is not an AI/ML algorithm that requires a training set.

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

• This device is not an AI/ML algorithm.

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The MotoBAND™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. When used for these indications, the MotoBAND™ CP Implant System with the execption of the MTP plates and 2-hole plate may be used with the MotoCLIP™ Implant System

The MotoBANDTM CP Implant System is comprised of implant plates, bone screws and instruments, having various features and sizes to accommodate differing patient anatomy. MotoBANDTM CP Implant System is compatible with MotoCLIPTM Implant System. The MotoBANDTM implants are manufactured from titanium alloy (ASTM F136). Each hole in the plate accepts locking or non-locking screws. Certain plates have a slot that accepts the MotoCLIPTM nitinol staple. MotoBANDTM CP Implant System is compatible with the MotoCLIPTM Implant System The MotoCLIPTM implants are made of biocompatible nitinol and are designed to exhibit superelastic properties.

MotoBAND™ CP Implant System

This document describes the acceptance criteria and study proving the MotoBAND™ CP Implant System meets these criteria. The device is intended for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the biocompatibility and mechanical integrity of the device, particularly when the MotoBAND™ CP system is used in conjunction with the MotoCLIP™ nitinol compression staple. The acceptance criteria are implicitly tied to the absence of adverse galvanic corrosion and a maintained passive state of the nitinol component, along with mechanical stability under fatigue.

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

The document does not specify the exact sample size for the test set. The data provenance is described as performance testing conducted by the manufacturer, CrossRoads Extremity Systems, as part of their 510(k) submission. This is retrospective testing performed on manufactured devices. The country of origin of the data is implicitly the USA, given the FDA submission.

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

Not applicable. This study involves mechanical and electrochemical performance testing of a medical device's physical properties, not a diagnostic or AI-driven system requiring expert assessment of ground truth in medical images or conditions. The "ground truth" here is objective scientific measurement (e.g., breakdown potential, mechanical failure).

4. Adjudication method for the test set

Not applicable. As described in point 3, this is objective performance testing, not a study requiring adjudication of expert opinions.

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 performance study for a surgical implant system, not a diagnostic device or an AI assistant for human readers.

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

Not applicable. This device is a surgical implant, not an algorithm or AI system.

7. The type of ground truth used

The ground truth used for this performance testing is established through objective scientific measurements and analyses in a laboratory setting. This includes:

• Electrochemical measurements for cyclic polarization and galvanic corrosion susceptibility.
• Mechanical testing for fatigue and structural integrity.
• Material science principles (e.g., passive condition of nitinol, breakdown potential).

8. The sample size for the training set

Not applicable. This is a performance study for a physical device, not a machine learning model, and therefore does not have a "training set."

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

Not applicable. As described in point 8, there is no training set for this type of performance study.

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