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The SIGNEX plates and screws are indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Hand System is indicated for fixation of hand (metacarpals, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Wrist System is indicated for fixation of wrist (distal radius, ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Forearm System is indicated for fixation of forearm (radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Elbow System is indicated for fixation of elbow (distal humerus, olecranon, proximal radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Humerus System is indicated for fixation of humerus fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Foot System is indicated for fixation of foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Fibula System is indicated for fixation of fibula fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Tibia System is indicated for fixation of tibia fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Femur System is indicated for fixation of femur fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Clavicle System is indicated for fixation of clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The SIGNEX Universal Plates are indicated for fixation of arm (humerus, radius, ulna), leg (femur, tibia, fibula), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

This product is intended for closure /or bone fixation of fractures, fusion, osteotomies, non-union, malunion and reconstruction of hand, wrist, forearm, elbow, humerus, foot, fibula, tibia, femur and clavicle.

This is comprised of plates and screws. The plates are made of Pure Titanium (ASTM F67) or Ti-6Al-4V ELI Titanium alloy (ASTM F136), and screws are made of Ti-6Al-4V ELI Titanium alloy (ASTM F136).

The plates and screws are single-use only, non-sterile products. So, those must be sterile before use.

This FDA 510(k) clearance letter and summary for the SIGNEX device (K243469) primarily relies on bench testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the typical criteria for evaluating AI/ML-based medical devices, such as performance on a clinical test set, MRMC studies, or multi-reader studies, are not applicable or not reported in this document.

The document focuses on comparing the physical and mechanical properties of the SIGNEX plates and screws to legally marketed predicate devices.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to demonstrating performance comparable to the predicate devices through material and mechanical testing standards. The reported "performance" is that the device met these standards and was found to be substantially equivalent.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of bench tests (biocompatibility and mechanical testing) comparing the SIGNEX device to its primary and additional predicate devices.

Detailed Information:

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

   • See the table above. The acceptance criteria for these bench tests would be the specific quantitative thresholds defined by the ASTM/ISO standards and/or the comparative performance to the predicate devices. The document states "The acceptance criteria for the mechanical testing were all met." and "SIGNEX's materials conform to ASTM F67 or ASTM F136 respectively for chemical composition."

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

   • Test Set (Bench Testing): The document does not specify the exact number of samples (e.g., number of plates and screws) used for each bench test. These are typically performed on a statistically relevant sample size of components according to the respective ASTM/ISO standards.
   • Data Provenance: The tests were conducted to verify compliance with international standards (ISO, ASTM) and substantial equivalence to US-legally marketed predicate devices. The manufacturer is OSTEONIC Co., Ltd. from Korea, South. The document doesn't specify if the testing itself was performed in Korea, the US, or elsewhere, but it's common for medical device manufacturers to use accredited labs globally. The nature of the device (implants) means this testing would be "prospective" in terms of newly manufactured devices. It is not "retrospective" as that term usually applies to analysis of existing clinical data.

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 mechanical/biocompatibility test, not a clinical study requiring expert interpretation of images or patient outcomes. The "ground truth" is established by the specifications of the materials (ASTM) and the physical/mechanical properties measured against the standards (ISO/ASTM).

4. Adjudication method for the test set:

   • Not Applicable. As this is not a study involving human reader interpretations, there is no adjudication process. Test results are quantitative measurements against predefined 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:

   • No. An MRMC comparative effectiveness study was not done. This device is a bone fixation plate and screw system, not an AI-powered diagnostic or assistive tool for human readers. "No clinical data were necessary for the demonstration of substantial equivalence."

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

   • No. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

   • The "ground truth" for this device's performance demonstration is based on established engineering standards for materials (ASTM) and mechanical performance (ASTM) and biocompatibility (ISO), as well as comparison to the physical and mechanical properties of legally marketed predicate devices. No clinical or pathology-based "ground truth" was used.

8. The sample size for the training set:

   • Not Applicable. This device is hardware (plates and screws), not a software/AI algorithm that requires a "training set."

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

   • Not Applicable. As no training set was used.

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The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure:
shoulder, foot/ankle, knee, hand/wrist and elbow.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

The provided text is an FDA 510(k) clearance letter for a medical device called "Fix2Lock" (a bone anchor). This type of document primarily focuses on establishing substantial equivalence to a predicate device based on non-clinical performance data (bench tests). It does not contain information about clinical studies involving human patients, human readers (e.g., radiologists interpreting images), or AI algorithms for diagnostic purposes.

Therefore, I cannot provide details on:

• Acceptance criteria related to AI performance (e.g., sensitivity, specificity).
• Sample sizes for test sets or data provenance for AI.
• Number of experts or their qualifications for establishing ground truth for AI.
• Adjudication methods for AI test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone AI performance.
• Training set details for AI.

The document discusses bench testing to demonstrate the device's mechanical and material properties, and sterility, compared to existing standards and a predicate device.

Here's the information that can be extracted relevant to the performance and acceptance criteria for this specific type of medical device, which is a bone anchor, not an AI diagnostic tool:

Acceptance Criteria and Study for the Fix2Lock Device

The acceptance criteria and supporting studies for the Fix2Lock device are based on non-clinical (bench) testing, primarily to demonstrate that the device meets established material and mechanical performance standards and is substantially equivalent to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the exact sample sizes (number of units) used for each bench test. However, it indicates that "Bench tests were conducted to verify that the subject device met all design specifications."
• Data Provenance: Not applicable in the human patient context. The data is from laboratory bench testing of the physical medical device. The sponsor is OSTEONIC Co., Ltd. from Korea, South. The testing would have been conducted by or for the manufacturer.

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 this type of device is established through compliance with recognized consensus standards (e.g., ASTM, ISO) and comparison of physical/mechanical properties to a predicate device via laboratory testing, not through expert human interpretation of data like in an AI study.

4. Adjudication method for the test set:

• Not applicable. Bench tests have objective, measurable endpoints based on engineering and material science principles, not subjective interpretation 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:

• No. This is a physical medical device (bone anchor), not an AI diagnostic software.

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

• No. This applies to AI algorithms, not physical implanted devices.

7. The type of ground truth used:

• The "ground truth" for this device is compliance with established engineering, material, and sterilization standards (ASTM and ISO standards) and demonstration of equivalent performance characteristics (material, mechanical, sterilization properties) compared to a legally marketed predicate device through objective bench testing.

8. The sample size for the training set:

• Not applicable. There is no AI training set for this physical device.

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

• Not applicable. There is no AI training set.

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Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders, knees, foot/ankle, hand/wrist and elbow.

This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.

The provided text describes a 510(k) premarket notification for a medical device called "Fix2Lock (PEEK Self Punching)". This submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

The information provided does not pertain to an AI/ML device or its performance criteria, as indicated by the nature of the acceptance criteria and the listed tests. The device is a physical orthopedic implant. Therefore, I cannot extract information related to AI/ML specific criteria such as sensitivity/specificity, AUC, reader studies, ground truth establishment for AI, or training/test set sample sizes for an AI model.

The "acceptance criteria" discussed in the document are primarily related to physical and material properties, sterilization, packaging, and shelf life of the bone fixation fastener. The "study" proving these criteria refers to bench tests conducted to verify the device meets all design specifications and is substantially equivalent to the predicate device.

Here's a summary of the information that can be extracted based on the provided text, using the closest applicable interpretations:

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

Since this is not an AI/ML device, the "acceptance criteria" are compliance with relevant standards for medical devices and meeting design specifications. The "reported device performance" is a statement of compliance with these standards and equivalency to the predicate.

• ASTM F2848: 2021 (Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants) | The subject device utilizes PEEK material, and bench tests demonstrated compliance with these standards. |
  | Mechanical Performance | - ASTM F543: 2017 (Metallic medical bone screws) | Bench tests demonstrated compliance with this standard. |
  | Sterilization | - ISO 11135:2014 (Ethylene oxide sterilization methods)
• ISO 11138-1:2017, ISO 11138-2:2017 (Biological indicators for sterilization)
• ISO 11140-1:2014 (Chemical indicators) | Bench tests demonstrated compliance with these standards, ensuring the device is sterile via EtO sterilization. |
  | Microbiological | - ISO 11737-1:2018 [AMD1:2021] (Determination of microorganism population)
• ISO 11737-2:2019 (Tests of sterility) | Bench tests demonstrated compliance with these standards. |
  | Packaging & Shelf Life | - ISO 11607-1:2019, ISO 11607-2:2019 (Packaging for terminally sterilized medical devices)
• ASTM F1980:2016 (Accelerated Aging of Sterile Barrier Systems)
• ASTM F88/F88M-21 (Seal strength)
• ASTM F1929:2015 (Detecting Seal Leaks) | Bench tests demonstrated compliance with these standards, confirming packaging integrity and a 3-year shelf life. |
  | Bacterial Endotoxin | - USP (Bacterial Endotoxin Test)
• USP (Medical Devices-Bacterial Endotoxin and Pyrogen Tests)
• ISO 11737-3:2023 (Bacterial endotoxin testing) | Bench tests demonstrated compliance with these standards. |
  | Substantial Equivalence | Device must be substantially equivalent to the predicate device in terms of intended use, technological characteristics, and safety and effectiveness. | The subject device (Fix2Lock PEEK Self Punching) is determined to be Substantially Equivalent (SE) to the predicate device (K231322) in respect of safety and effectiveness. |

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

The document mentions "bench tests" were conducted. It does not specify sample sizes for these tests, nor does it provide details on data provenance beyond the product's manufacturer (Osteonic Co., Ltd., South Korea) and the standards used. These are typical engineering tests, not clinical studies.

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 involving expert "ground truth" for diagnostic or analytical tasks. The "ground truth" here is compliance with engineering and material standards, typically verified by laboratory testing and technical experts/engineers according to standard protocols.

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

Not applicable. This concept applies to expert review processes, typically in clinical studies or AI ground truth establishment. The "adjudication" for this device would be the interpretation of bench test results against established standard 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

Not applicable. This is not an AI-assisted device.

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 (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is established by compliance with internationally recognized engineering and medical device standards (e.g., ISO, ASTM, USP) for materials, mechanical performance, sterilization, packaging, and biological safety.

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. This is not an AI/ML device.

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The SIGNEX plates and screws are indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, tarsals, metatarsals, phalanges), and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Hand System is indicated for fixation of hand (metacarpals, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Wrist System is indicated for fixation of wrist (distal radius, ulna) fractures, fusions, osteotomies, nonunions, malunions and reconstructions.

The SIGNEX Forearm System is indicated for fixation of forearm (radius and ulna) fractures, fusions, osteotomies, nonunions, malunions and reconstructions.

The SIGNEX Elbow System is indicated for fixation of elbow (distal humerus, olecranon, proximal radius and ulna) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Humerus System is indicated for fixation of humerus fractures, fusions, osteotomies, malumions and reconstructions.

The SIGNEX Foot System is indicated for fixation of foot (tarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The SIGNEX Fibula System is indicated for fixation of fibula fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Tibia System is indicated for fixation of tibia fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Femur System is indicated for fixation of femur fractures, fusions, osteotomies, malunions and reconstructions.

The SIGNEX Clavicle System is indicated for fixation of clavicle fractures, fusions, osteotomies, non-unions and reconstructions.

The SIGNEX plates and screws are intended for closure /or bone fixation of fractures, fusion, osteotomies, non-union, malunion and reconstruction of hand, wrist, forearm, elbow, humerus, foot, fibia, tibia, femur and clavicle.

This is comprised of plates and screws. The plates are made of Pure Titanium (ASTM F67), Ti-6Al-4V ELI Titanium alloy (ASTM F136), and Screws are made of Ti-6A1-4V ELI Titanium alloy (ASTM F136). The plates and screws are single-use only, non-sterile products. so, those must be sterile before use.

The provided text describes the 510(k) summary for the SIGNEX device, which comprises plates and screws for bone fixation. It details the substantial equivalence comparison to predicate and reference devices, along with performance data. However, it does not describe an AI/ML-based device. The information provided is purely for a mechanical medical device (bone fixation plates and screws). Therefore, I cannot extract information related to AI/ML acceptance criteria or a study proving an AI/ML device meets those criteria from this document.

The document discusses:

• Biocompatibility testing: Cytotoxicity, Sensitization, Irritation/Intracutaneous reactivity, Systemic toxicity, Genotoxicity, Pyrogen testing, Implantation testing, all conforming to ISO 10993 series.
• Mechanical testing: Torsion test (ASTM F543), Axial pullout strength test (ASTM F543), Driving torque test (ASTM F543), 4-Point bending test (ASTM F382).
• Clinical Studies: Explicitly states "No clinical data were necessary for the demonstration of substantial equivalence."

Since the request pertains to "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically for an AI/ML device, and the provided text describes a mechanical bone fixation device, I am unable to fulfill the request as an AI/ML component is not present in the given information.

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Suture wing is intended for fixation of soft tissue to bone, using suture, in orthopedic surgery.

This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The anchor and sutures is made of non-absorbable and consists of Driver Shaft for anchor insertion. This product is sterilized product and single use only.

Sterile bone anchor-all suture is supplied EO gas sterile state and it was packed in tyvek and PE film.

The provided text is a 510(k) premarket notification for a medical device called "Suture Wing." This document focuses on demonstrating substantial equivalence to a previously cleared device, not on proving that the device meets specific acceptance criteria based on a study involving AI or human readers.

Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving the device meets those criteria (especially in the context of AI performance, human reader studies, and ground truth establishment) is NOT present in the provided document.

The document details non-clinical bench tests to verify design specifications and compliance with various standards related to materials, mechanical performance, sterilization, shelf-life, packaging, bacterial endotoxin, and pyrogenicity. It explicitly states: "Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

It describes the comparison to a predicate device and a reference device, indicating similarities and minor differences in material (needle presence, which is addressed by the reference device) and product size, with the safety of these differences evaluated through bench testing.

In summary, this document is a regulatory submission for a physical medical device (Suture Wing) establishing substantial equivalence based on bench testing and comparison to predicates, not a study evaluating AI or human reader performance.

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Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders, knees, foot/ankle, hand/wrist and elbow.

This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.

The provided text is a 510(k) premarket notification for a medical device called "Fix2Lock (PEEK Self Punching)". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing the detailed acceptance criteria and study results for a new, AI-powered device's performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, and training set specifics cannot be extracted from this document. This type of information is typically found in study reports or technical documentation submitted for devices that involve AI/ML components requiring performance validation against defined metrics.

The document primarily discusses:

• Device Identification: Fix2Lock (PEEK Self Punching), a Class II device for orthopedic surgery.
• Intended Use: Fixation of soft tissue to bone using suture (shoulders, knees, foot/ankle, hand/wrist, elbow).
• Substantial Equivalence (SE) Claim: The subject device (K231322) is substantially equivalent to a predicate device (K202763), and a reference device (K081511).
• Non-Clinical Tests: Bench tests were conducted to verify design specifications and SE to the predicate device, citing compliance with various ASTM and ISO standards for material, mechanical performance, sterilization, shelf life, packaging, and bacterial endotoxin (e.g., ASTM F2026, F543, ISO 11135, 11607, USP ).
• Comparison Table: Details similarities and differences in product code, regulatory class, intended use, operating principles, material, structure, product size, sterilization, single use/reuse, packaging, and shelf life between the subject, predicate, and reference devices.

In essence, this document is a regulatory submission for a traditional medical device demonstrating equivalence, not a performance study for an AI/ML diagnostic or assistive device that would have the requested acceptance criteria and study design details.

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The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery. This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

The provided text describes a 510(k) premarket notification for a medical device called Fix2Lock. It details the device's indications for use, comparison to predicate devices, and non-clinical test conclusions. However, it does not contain information about acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types used in a study to prove acceptance criteria for a software device.

This document is for a physical medical device (bioabsorbable bone anchor) and the "studies" mentioned are bench tests verifying compliance with material, mechanical performance, sterilization, shelf-life, packaging, and bacterial endotoxin standards. These are typical engineering and safety tests for a physical implant, not studies involving AI or software performance against clinical ground truth.

Therefore, I cannot fulfill your request for information related to AI/software acceptance criteria and studies, as the provided document does not contain this type of information.

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Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.95mm in lengths of 3.0 to 6.0mm. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.

Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient.

The Neuro Plating System has two types of sterilization method; Neuro Plating System is non-sterile state packed in PE bag which must be sterilized before use and Neuro Plating System - Sterile Kit is provide sterile state with gamma sterilization packed in Tyvek and PET. Both are single use only.

The provided text is a 510(k) Pre-Market Notification for the Neuro Plating System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, much of the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not directly available or applicable in the context of this 510(k) summary. This document primarily relies on non-clinical (mechanical and sterilization) testing to show equivalence.

However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serves as the "proof" for substantial equivalence in this regulatory context.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there isn't a table of specific clinical "acceptance criteria" with numerical targets and reported clinical device performance. Instead, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" refers to the non-clinical tests conducted on the subject device to show it is equivalent.

• Comparable bending strength
• Comparable torsion strength
• Comparable axial pullout strength | Non-clinical tests performed:
• 4 Point Bending Test
• Torsion Test & Axial Pullout Strength Test
  Rationale for equivalence: "The subject device's titanium grade is the same as the predicate device's, but the subject device is thicker than the predicate device. Therefore, the performance testing of the subject device is expected to be substantially equivalent to the predicate device." (This implies the subject device met or exceeded the predicate's performance in these tests, although specific numerical results are not provided in this summary.) |
  | Sterilization Efficacy:
• Achieves sterility for pre-sterilized kits
• Compatibility with steam sterilization for non-sterile components | Non-clinical tests performed:
• Packaging Process Validation Test (only Neuro Plating System - Sterile Kit)
• Gamma Sterilization Validation (only Neuro Plating System - Sterile Kit)
  Rationale for equivalence: "Validation of sterilization parameters... of the subject device are supported by sterilization validation... as provided in the primary predicate K190811." |
  | Biocompatibility:
• Biocompatible materials and design, similar to predicate | Rationale for equivalence: "...biocompatibility of the subject device are supported by... biocompatibility testing as provided in the primary predicate K190811." |
  | Shelf Life:
• Maintained functionality and sterility over intended shelf life (for pre-sterilized kits) | Non-clinical tests performed:
• Shelf life (only Neuro Plating System - Sterile Kit) |

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

• Sample Size for Test Set: Not specified in the provided summary. For mechanical tests, this would typically involve a specific number of samples for each test (e.g., n=5 or n=10 per test), but the exact numbers are not present.
• Data Provenance: Not specified, but implied to be from laboratory testing conducted on device samples. Country of origin for testing is not stated. The data is "non-clinical" (bench testing), not patient data, so "retrospective or prospective" is not applicable.

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

This information is not applicable as the submission relies on non-clinical, laboratory bench testing (mechanical and sterilization) rather than clinical data requiring expert review or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the submission relies on non-clinical, laboratory bench testing. Adjudication methods are typically relevant for clinical studies where subjective assessments or multiple interpretations of patient data might occur.

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 evaluating the performance of diagnostic imaging aids or AI assistance where human readers interpret cases. The Neuro Plating System is a surgical implant, not a diagnostic tool.

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

• No, a standalone (algorithm only) performance study was not done. This concept applies to AI/software as a medical device. The Neuro Plating System is a physical implant.

7. The Type of Ground Truth Used

• Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical tests, the "ground truth" would be the engineering specifications and established acceptable performance limits (often derived from the predicate device or relevant ASTM standards). For example, a "ground truth" for the 4-point bending test would be a minimum bending force or deformation standard that the device must meet, typically aligned with or surpassing the predicate's performance.

8. The Sample Size for the Training Set

• Not applicable. The Neuro Plating System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this device.

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The ORTHO MI SYSTEM is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.

The ORTHO MI SYSTEM is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.

The screw diameters and lengths vary as shown below. It is made of a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13).

These size combinations are the same across all model types (Double Head, Wing, Slot) with exception case.

The provided document is an FDA 510(k) Premarket Notification for the "ORTHO MI SYSTEM," an endosseous dental implant (orthodontic anchor screw). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies like those required for PMA (Premarket Approval).

Therefore, the document explicitly states: "No clinical data were necessary for the demonstration of substantial equivalence." This means there was no study performed to prove the device meets acceptance criteria in the way a clinical study for an AI/CADe device would.

Instead, acceptance criteria are met through bench testing demonstrating compliance with relevant performance and safety standards, and ensuring the device's technical characteristics and indications for use are substantially equivalent to marketed predicate devices.

Here's a breakdown of the missing and implied information based on the provided text:

Acceptance Criteria and Device Performance

Since no clinical study was conducted, there are no "acceptance criteria" in the sense of clinical performance metrics (like sensitivity, specificity, or reader improvement). The acceptance criteria are tied to bench test performance against established standards and the demonstration of substantial equivalence to predicate devices.

Study Information (as requested, but largely N/A for this 510(k) submission)

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

   • Test Set Sample Size: Not applicable. No clinical test set was used. The "test set" for this submission would refer to the physical devices subjected to bench testing according to the specified standards. The number of devices tested is not detailed, but it would have been sufficient to meet the requirements of the standards cited.
   • Data Provenance: Not applicable. No biological or clinical data was collected from patients or subjects. The data derived from physical testing of the device hardware.

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

   • Number of Experts/Qualifications: Not applicable. There was no ground truth determination by experts in a clinical context. Bench testing relies on objective measurements against engineering and materials standards.

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

   • Adjudication Method: Not applicable. No human interpretation requiring adjudication was involved.

4. 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:

   • MRMC Study: No. This device is an orthodontic anchor screw, a physical implant, not an AI/CADe system. Therefore, no MRMC study was performed.

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

   • Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

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

   • Type of Ground Truth: Not applicable in a clinical sense. The "ground truth" for this device's performance is adherence to established engineering, materials, sterilization, and biocompatibility standards, and demonstrating physical properties consistent with predicates.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

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

   • Ground Truth for Training Set: Not applicable.

In summary, the provided document details a 510(k) submission for a physical medical device (orthodontic anchor screw). These submissions do not typically involve clinical trials or studies like those conducted for AI/CADe devices, and therefore, most of the questions regarding clinical performance metrics, expert adjudication, or AI model training are not applicable. The "proof" of meeting acceptance criteria lies in comprehensive non-clinical (bench) testing demonstrating compliance with relevant consensus standards and establishing substantial equivalence to previously cleared predicate devices.

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Sterile bioabsorbable bone screw (Biocomposite ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery(Cruciate ligament reconstruction procedures).

The Sterile bioabsorbable bone screw (Biocomposite ACL screw) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

The implanted screw is made of poly(L-lactide-co-glycolide), PLGA and tri-calciumphosphate(S-TCP). Poly(L-lactide-co-glycolide), PLGA is gradually decomposed in vivo by hydrolysis and eventually excreted in carbon dioxide and water. Tri-calciumphosphate(ß-TCP) is gradually degraded in vivo by hydrolysis and eventually re-used as a calcium source.

Sterile bioabsorbable bone screw (Biocomposite ACL screw) is supplied EO gas sterile state and it is packed in Aluminum Pouch.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than clinical performance studies. Therefore, the typical information sought for AI/CADe devices (like ground truth establishment, reader studies, effect size with AI assistance, training set details, etc.) is not applicable here because this is a mechanical medical device, not an AI/CADe system.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are implied by adherence to referenced standards and successful completion of specific mechanical tests. The reported device performance is simply "PASS" for all tested criteria, indicating it met the established benchmarks.

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

The document states "All specimens selected (worst-case) to verify the performance of the test criteria established based on literatures and comparison with the predicate device." However, specific numerical sample sizes for each test are not provided. The provenance of the test samples (e.g., country of origin, retrospective/prospective) is also not specified, though it is implied these are manufactured device samples undergoing bench 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 as the document describes bench testing for a mechanical device. The "ground truth" here is determined by objective mechanical measurements against established ASTM and ISO standards, not expert interpretation of medical images or conditions.

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

This information is not applicable as the document describes bench testing for a mechanical device. There is no human adjudication process involved in these mechanical performance 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

This information is not applicable as this is a mechanical bioabsorbable bone screw, not an AI/CADe system. Therefore, no MRMC study or AI assistance is relevant.

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

This information is not applicable as this is a mechanical bioabsorbable bone screw, not an AI/CADe system.

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

The "ground truth" for the device's performance is established by objective mechanical measurements against recognized international standards (ASTM and ISO) for medical device performance (e.g., axial pullout strength, torsional yield strength, driving torque, degradation testing, fatigue).

8. The sample size for the training set

This information is not applicable as this is a mechanical device undergoing bench testing, not an AI/CADe system requiring a training set.

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

This information is not applicable as this is a mechanical device undergoing bench testing, not an AI/CADe system.

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