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In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat- Cut QUANTUM® talar implants.

PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the positioning of the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones.

TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.

The previously cleared single use QUANTUM® Patient Specific Instrumentation (PSI) system subject of this submission consists of:
• QUANTUM® patient specific instrumentation (PSI) and reusable instruments:

• QUANTUM® patient specific tibial and talar guides;
• QUANTUM® reusable instruments;
• QUANTUM® patient specific tibial and talar bone models
  • ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software (specific modification implemented in this submission).

The QUANTUM® PSI Guides are patient-specific devices adapted to the patient bones anatomy and the preoperative surgical plan validated by the surgeon. QUANTUM® PSI guides and bone models are designed using the dedicated ORTHO-PLANIFY TAR planning software.

The QUANTUM® system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The ORTHO-PLANIFY TAR planning software involved in this submission was previously cleared under K221432.

The scope of this submission is an addition of a manufacturer for the ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software related to the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) previously cleared in K211883.

This FDA document, K231699, describes the QUANTUM® Patient Specific Instrumentation (PSI) System. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

The document primarily focuses on:

• The FDA's determination of substantial equivalence for the device.
• The indications for use of the device and its associated planning software.
• A 510(k) summary, which outlines contacts, device description, predicates, and a high-level statement about performance data.

Key points from the document regarding performance:

• Performance Data: "Non-clinical performance data were included in the 510(k) submission. Functional cadaver testing and software validations (previously provided under K221432) were conducted to demonstrate that the QUANTUM® PSI system is substantial equivalence to the predicate device."

Based on the provided text, I can answer some of your questions, but not all, as the detailed study information is not present.

Here's an analysis of what can be inferred and what is missing:

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

• Cannot be provided. The document states that "non-clinical performance data were included in the 510(k) submission," and mentions "functional cadaver testing and software validations." However, the actual acceptance criteria (e.g., specific thresholds for accuracy, precision) and the reported performance values from these tests are not detailed in this publicly available summary.

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

• Partially available. The document mentions "functional cadaver testing." This implies the test set involved cadavers. The sample size (number of cadavers or cases) is not specified. The provenance (e.g., country of origin, retrospective/prospective) of the cadaver data or the software validation data is not provided.

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)

• Cannot be determined. The document does not mention the use of experts to establish ground truth for a test set, nor their number or qualifications. The "pre-operative planning validated by the surgeon" for the PSI guides suggests surgeon involvement in the clinical application, but not necessarily in an independent ground truth assessment for a test study.

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

• Cannot be determined. The document does not describe any adjudication methods used for a test set.

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/Cannot be determined. The device is a "Patient Specific Instrumentation (PSI) System" and "TAR Planning Software" which assists in orthopedic surgery. It doesn't appear to be an AI-driven diagnostic or interpretative tool that would typically involve "human readers" in a traditional MRMC study comparing AI assistance. The software "allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively." This is an assistive tool for surgical planning, not an AI for image interpretation. Therefore, a conventional MRMC study comparing human readers with/without AI assistance using diagnostic images is unlikely to have been performed or would be relevant in the typical sense.

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

• Implied, but details are missing. The "software validations" mentioned likely included testing of the software's algorithms in a standalone capacity (e.g., accuracy of measurements, positioning calculations) without direct human interaction as part of the performance evaluation. However, the exact nature of these standalone tests and their results are not provided. The device is explicitly designed for a "surgeon... to use advanced display and positioning tools," indicating a human-in-the-loop system for its intended use.

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

• Implied to be anatomical/measurement-based. For surgical planning software and patient-specific instrumentation, ground truth would typically relate to anatomical accuracy (e.g., how closely the PSI guide matches the actual anatomy, or how accurately the software calculates bone cuts/implant positions relative to predefined anatomical landmarks). Given "functional cadaver testing," direct anatomical measurements on cadavers would form the basis of ground truth. Exact details are not specified.

8. The sample size for the training set

• Not applicable/Not provided. This document describes a medical device submission, not specifically a machine learning model's training set. While the software algorithms might have been developed using data, this document does not specify a "training set" in the context of an AI model.

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

• Not applicable/Not provided. As with point 8, this information is not relevant to the content of this FDA document.

In summary, while the document confirms that performance data (functional cadaver testing and software validations) were submitted, it does not provide the specific details regarding acceptance criteria, reported performance values, sample sizes for test sets, expert involvement, or ground truth methodologies in a detailed manner.

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In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat-Cut QUANTUM® talar implants.

PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones.

TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.

The previously cleared single use QUANTUM® Patient Specific Instrumentation (PSI) system subject of this submission consists of:
• QUANTUM® patient specific instrumentation (PSI) and reusable instruments:

• QUANTUM® patient specific tibial and talar guides;
• QUANTUM® reusable instruments;
• QUANTUM® patient specific tibial and talar bone models (not medical devices);
  • ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software.

The QUANTUM® PSI system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

QUANTUM® PSI guides are single use instruments designed using the dedicated ORTHO-PLANIFY TAR planning software, in correlation with a pre-operative surgical plan validated by the surgeon. They fit the anatomy of the specific patient's distal tibia and proximal talus.

The scope of this submission is an addition of a manufacturer, slight update to dimensions and raw material for the cut guides related to the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) previously cleared in K211883.

This document describes the In2Bones QUANTUM® Patient Specific Instrumentation (PSI) System, which is an orthopaedic instrument system used to assist in the positioning of instrumentation for Total Ankle Replacement (TAR) implantation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document typically focuses on demonstrating "substantial equivalence" to a previously cleared predicate device, rather than presenting a comprehensive clinical study with detailed performance metrics and acceptance criteria as one might find for a novel device or AI algorithm. Therefore, many of the requested data points (like specific performance metrics, sample sizes for test sets, expert qualifications for ground truth, and details about training sets) are not detailed in this type of submission. The focus here is on non-clinical performance and equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical performance study and a comparison against a predicate device for the purpose of demonstrating substantial equivalence.

• The 510(k) summary states: "Non-clinical performance data were included in the 510(k) submission. Validations equipment, biocompatibility (ISO 10993) and sterilization (ISO 17665) were conducted to demonstrate that the QUANTUM PSI system is substantial equivalence to the predicate device."
• The conclusion explicitly states: "Based on the comparison of indications for use and technological characteristics and the results of the testing performed, the QUANTUM® PSI System is substantially equivalent to the predicate device identified in the 510(k) submission."

This implies a series of engineering tests, material characterization, and process validations (biocompatibility and sterilization) were performed to ensure the device's safety and performance characteristics are consistent with its predicate and regulatory standards. However, specific performance metrics (e.g., accuracy of bone cuts, alignment deviation) are not provided in this summary.

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

• Sample Size: The document does not specify a sample size for a "test set" in the context of clinical performance or a specific AI/software validation. The studies mentioned are primarily non-clinical engineering tests (biocompatibility, sterilization, equipment validation).
• Data Provenance: Not applicable in the context of clinical data for performance evaluation in this 510(k) summary. The "data" refers to engineering test results.

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

• This information is not provided in the document. For a 510(k) of this nature, especially one focused on demonstrating equivalence and non-clinical performance, expert-established ground truth for a test set (as would be typical for an AI diagnostic device) is not usually a central component. The ground truth for the non-clinical tests would be defined by the specifications and standards (e.g., ISO for biocompatibility/sterilization).

4. Adjudication Method for the Test Set

• This information is not provided as it is not relevant to the type of non-clinical testing described.

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. The device (QUANTUM® PSI System and TAR Planning Software) is a surgical planning and instrumentation system, not an AI diagnostic tool primarily aimed at improving human reader interpretation of medical images. While the software utilizes "advanced display and positioning tools," its primary role is to create a pre-operative plan for physical guides used in surgery. The clinical efficacy is linked to the overall TAR procedure and the use of the PSI guides, rather than human "reading" performance improvement with AI assistance.

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

• Yes, a form of "standalone" evaluation of the planning software's capability is implied by "validations equipment" and the general assessment of the software's functional specifications. The TAR Planning Software, in a sense, operates "stand-alone" to generate the surgical plan based on imaging data before a surgeon validates it and the PSI guides are manufactured. The accuracy of this plan and the resultant PSI guides would have been verified through engineering tests and comparison to specifications, which is a form of standalone performance evaluation for the software component's capabilities. However, specific metrics for such a standalone performance are not enumerated in this summary.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical tests (biocompatibility, sterilization, equipment validation), the ground truth is based on established regulatory standards and engineering specifications (e.g., ISO standards, internal performance requirements for mechanical properties and fit).
• For the TAR Planning Software, the "ground truth" for its output (the surgical plan and resultant PSI guide design) would be its ability to accurately reflect the desired surgical alignment and fit the patient's anatomy based on the input imaging data and surgeon validation. This is assessed indirectly through the overall substantial equivalence claim and the intended function of guiding the procedure.

8. The Sample Size for the Training Set

• This information is not applicable/not provided for this device. The TAR Planning Software described is not a machine learning or AI algorithm that typically relies on a "training set" in the conventional sense of deep learning or supervised learning. It uses "advanced display and positioning tools" to facilitate surgical planning, which suggests it might be based on CAD/CAM principles and anatomical modeling rather than a data-driven learning model requiring a training set.

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

• Not applicable, as there is no indication of a "training set" in the context of machine learning for this device.

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In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat-Cut QUANTUM® talar implants. PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the positioning of the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones.

TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.

The QUANTUM® Patient Specific Instrumentation (PSI) system subject of this submission consists of:
• QUANTUM® patient specific instrumentation (PSI) and reusable instruments:

• QUANTUM® patient specific tibial and talar guides;
• QUANTUM® reusable instruments;
• QUANTUM® patient specific tibial and talar bone models;
  • ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software.

The QUANTUM® PSI system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
QUANTUM® PSI guides are single use instruments designed using the dedicated ORTHO-PLANIFY TAR planning software, in correlation with a pre-operative surgical plan validated by the surgeon. They fit the anatomy of the specific patient's distal tibia and proximal talus.

The provided document is limited to a 510(k) summary for the QUANTUM® Patient Specific Instrumentation (PSI) System, which includes the ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software. The document mentions that "software verification and validation, repeatability testing and cadaveric validations" were included in the non-clinical performance data. However, it does not provide specific details on the acceptance criteria, reported device performance metrics, study design, sample sizes, ground truth establishment, or expert involvement in a way that would allow for a comprehensive answer to all parts of your request.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Tests results demonstrate that QUANTUM PSI system and its associated ORTHO-PLANIFY TAR planning software are safe and effective for their intended use." However, specific acceptance criteria and quantitative performance metrics (e.g., accuracy, precision) from the software validation, repeatability testing, or cadaveric validations are not detailed in this 510(k) summary.

2. Sample size used for the test set and the data provenance
This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.

4. Adjudication method for the test set
This information is not provided in the document.

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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The software is described as a "preoperative surgical planning software" and PSI guides, suggesting it assists surgeons, but a formal comparative effectiveness study with human readers is not detailed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states "software verification and validation" was performed. This implies some level of standalone algorithm testing. However, specific details of this standalone performance, including metrics or methodology, are not provided. The device is intended to be used by a surgeon, indicating a human-in-the-loop setup for its clinical application.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document mentions "cadaveric validations." For these, the ground truth would likely be measurements taken directly from the cadaveric specimens after the application of the PSI guides and potentially after bone cuts, using highly precise measurement tools to compare against the planned surgical outcome. However, the specific methodology for establishing this ground truth is not detailed. For software verification, ground truth might involve simulated data with known correct outputs or comparison against established gold-standard algorithms/methods.

8. The sample size for the training set
This information is not provided in the document. The document refers to the system as "software" and "planning software," but does not explicitly state that it employs machine learning or requires a 'training set' in the traditional sense of AI/ML development. If it uses rule-based algorithms or traditional image processing, a "training set" might not be applicable in the same way.

9. How the ground truth for the training set was established
This information is not provided in the document, as the existence or nature of a training set is not detailed.

In summary, while the K211883 summary states that non-clinical performance data (including software verification and validation, repeatability testing, and cadaveric validations) were used to demonstrate safety and effectiveness, it lacks the specific details required to answer most of your questions regarding acceptance criteria, study design parameters, and ground truth establishment. This level of detail is typically found in the full submission, not in the publicly available 510(k) summary.

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The Quantum® total ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Note: In the United States, the ankle prosthesis is intended for cement use only.

The QUANTUM® Total Ankle Prosthesis is a fixed-bearing total ankle replacement device. The prosthesis is composed of a tibial implant, a tibial inlay, and a talar implant. Both the tibial implant and talar implant are secured to patient anatomy via bone cement; the intermediate inlay is rigidly fixed to the tibial implant intra-operatively. When all three components are implanted, the intermediate inlay acts as a bearing along the talar implant, enabling movements at the replaced joint. Components are available in a variety of sizes and design configurations to accommodate the various anatomical needs of a patient's ankle joint, and intended for both primary and revision applications. QUANTUM® Total Ankle Prosthesis is accompanied by a complete instrumentation set including trial and drill/cutting guide to assist surgeons in implantation of the device.

The In2Bones QUANTUM® Total Ankle Prosthesis underwent performance testing to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

• Range of Motion: Allowable physiological range of motion without impingement or abnormal articulation.
• Contact Pressure and Constraint: Acceptable contact stress distributions on articulating surfaces and adequate constraint against abnormal translations/rotations.
• Component Fatigue: Resistance to fracture or failure under cyclic loading representative of physiological conditions for a specified number of cycles.
• Insert Locking Mechanism: Secure engagement and retention of the insert within the tibial component under relevant forces. | The results indicate that the QUANTUM® total ankle prosthesis met the acceptance criteria for:
• Range of Motion study
• Contact pressure and constraint evaluation
• Component Fatigue analysis
• Insert Locking mechanism |
  | Wear Evaluation (ISO 22622) | The specific quantitative acceptance criteria for wear are not detailed in the provided text, but generally, for total ankle prostheses tested to ISO 22622, criteria would involve demonstrating that the wear rate of the articulating components (specifically the polyethylene insert) is within acceptable limits to ensure long-term device function and minimize wear debris generation. | The results indicate that the QUANTUM® total ankle prosthesis met the acceptance criteria for wear evaluation. |
  | Pyrogen Testing (ANSI/AAMI ST72:2011) | The device must meet the pyrogen limit specification according to ANSI/AAMI ST72:2011. This typically involves demonstrating that the endotoxin level is below a specified threshold. | The device meets pyrogen limit specification as determined by the Limulus Amebocyte Lysate (LAL) test. |

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

The provided text does not specify the sample sizes used for the mechanical bench testing, wear evaluation, or pyrogen testing. It also does not mention the data provenance (e.g., country of origin, retrospective/prospective) for these tests, as these are in vitro and in silico studies, not human subject data.

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

Not applicable. The performance data for this medical device (a total ankle prosthesis) is based on mechanical bench testing, finite element analysis, and laboratory pyrogen testing, not on human expert interpretation of images or clinical data. Therefore, there is no "ground truth" established by experts in the context of a test set, nor are there experts "qualifications" relevant to this type of testing.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the testing performed is mechanical and laboratory-based, not involving human interpretation or adjudication processes typical of clinical studies or image-based AI evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. The provided information pertains to the mechanical and biological safety performance of the device itself, not to a diagnostic or interpretive AI system that would assist human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is not an AI algorithm but a physical medical device. The "performance" described is the standalone performance of the implant under various simulated physiological conditions.

7. The Type of Ground Truth Used:

The "ground truth" for the performance testing is based on:

• Engineering principles and material science standards: For mechanical bench testing (ASTM F2665), wear evaluation (ISO 22622), and finite element analysis, the "ground truth" is adherence to established industry-recognized performance metrics and models that predict in-vivo behavior.
• Biological safety standards: For pyrogen testing (ANSI/AAMI ST72:2011), the "ground truth" is the absence of pyrogens above a defined safe limit.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI system that requires a "training set."

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

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

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The TRIWAY® TTC Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:

• Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
• Rheumatoid arthritis with severe deformity
• Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
• Revision of failed total ankle arthroplasty with subtalar intrusion
• Talar deficiency conditions, including avascular necrosis (requiring a tibiocalcaneal arthrodesis)
• Neuroarthropathy or neuromuscular deformity or other neuromuscular disease with severe deformity of the ankle, including Charcot foot
• Severe pilon fractures with trauma to the subtalar joint
• Malunited tibial pilon fractures
  The addition of an IBS™ 6.5mm compression screw through the subtalar joint and through the nail is required.

The TRIWAY® Tibiotalocalcaneal (TTC) Arthrodesis System is composed of an angulated nail available in several sizes and different screws for bony fixation. Rigid fixation is achieved by screws.
An instrument set is available for the bone preparation, screw sizing and insertion of the TRIWAY® TTC Arthrodesis System. A specific targeting device is available for the positioning and the insertion of the different cotter screws and the I.B.S® 6.5mm compression screw, which is inserted in an oblique way to provide additional compression throughout the nail, between the calcaneus and the talus.
Sizes:
The TRIWAY® Arthrodesis Nail is available in several sizes, with left and right versions (diameter 10, 11, 12mm, lengths from 160mm to 250mm).
Cotter screws are available in 5.0mm diameter, with length ranging from 25 to 110mm by 5mm increment.
Material: The TRIWAY® TTC Arthrodesis System implants (nail and screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and ASTM F136.
Single use: The TRIWAY® TTC Arthrodesis System is designed for single use only.
Sterilization: The TRIWAY® TTC Arthrodesis System is supplied sterile, using gamma irradiation.

The provided text is a 510(k) premarket notification for a medical device (TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System) and discusses its substantial equivalence to predicate devices, focusing on mechanical performance and material properties. It does not describe an AI medical device or a study involving human readers or expert ground truth for image interpretation. Therefore, I cannot extract the information required by your requests, as those particulars relate to the evaluation of AI-powered diagnostic or assistive devices.

The document discusses:

• Device description: An intramedullary fixation rod system for tibiotalocalcaneal arthrodesis.
• Material: Ti6Al4V, as per ISO 5832-1 and ASTM F136.
• Sterilization: Gamma irradiation, supplied sterile.
• Performance testing: "Performance testing of the TRIWAY® TTC Arthrodesis System was assessed through mechanical bench testing performed by an independent test laboratory. Testing performed included static and dynamic bending tests on TRIWAY® TTC Arthrodesis System. The results indicate that the TRIWAY® TTC Arthrodesis System met the acceptance criteria."
• Pyrogen testing: Limulus Amebocyte Lysate (LAL) test in accordance with ANSI/AAMI ST72:2011.

It does not contain information about:

• Acceptance criteria for an AI device.
• Device performance metrics like accuracy, sensitivity, or specificity for an AI.
• Sample sizes for test or training sets for an AI.
• Data provenance (country, retrospective/prospective) for an AI.
• Number of experts or their qualifications for establishing ground truth for AI.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth (e.g., pathology, outcomes data) for an AI training set.

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The DIP implants are indicated for distal interphalangeal joint fusion of the long fingers. Treatment may include complementary immobilization of the finger (e.g. splint) if considered preferable by the surgeon.

The Distal InterPhalangeal (DIP) Arthrodesis System, is composed of intramedullary implant, designed to act as a bone fastener for distal interphalangeal arthrodesis of the long fingers. The implant is composed of 2 parts implanted in the proximal and distal phalanx and locked together in a rigid arthrodesis system.
Sizes: The DIP Arthrodesis System is composed of implants available in different lengths and angles. The proximal implant is available in two sizes. The distal implant is available in 2 sizes combined with two angles of plantar flexion: 0 degree or 15 degrees to accommodate the size variation of the phalanges across the patient population and interphalangeal angles.
Material: The DIP Arthrodesis System is manufactured from PEEK-OPTIMA® (PolyEtherEtherKetone) polymer from Invibio® as per ASTM F2026, a radiolucent material.
Single use: The DIP Arthrodesis System is designed for single use only.
Sterilization: The DIP Arthrodesis System is supplied sterile, using gamma irradiation.

This is a 510(k) premarket notification for a medical device called the "DIP Arthrodesis System". It's a bone fixation fastener used for distal interphalangeal joint fusion of the long fingers.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify exact sample sizes for the mechanical bench testing. It only states that the testing was performed on the "DIP Arthrodesis System compared to predicate device." This implies a comparative study, but the number of devices tested for each condition (test device vs. predicate) is not detailed.

The data provenance is not explicitly mentioned (e.g., country of origin). However, given that it's a bench test for device performance, the "data provenance" would refer to the testing facility and the conditions under which the tests were run. The summary states it was performed by an "independent test laboratory."

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

This information is not applicable for this type of device and study. The "ground truth" for mechanical bench testing is established by engineering standards and specifications (e.g., ASTM standards for material properties, specified load limits, fatigue cycles). It does not involve human expert interpretation of clinical data in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human readers to resolve discrepancies in expert interpretations. Mechanical bench testing relies on objective measurements and established engineering protocols.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to evaluate the performance of diagnostic devices, often involving human readers interpreting medical images with and without AI assistance. This device is a bone fixation fastener, and its evaluation is based on mechanical performance and biocompatibility, not diagnostic accuracy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in a sense, a standalone evaluaton was done. The mechanical bench testing and pyrogen testing are evaluations of the device itself (standalone performance) against predefined engineering and safety standards, without human intervention in the device's function during the test. There is no "algorithm" in the context of this mechanical device.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation consists of:

• Engineering Standards and Specifications: For mechanical bench testing, the ground truth is established by accepted engineering principles for bone fixation devices, performance characteristics of the PEEK-OPTIMA® material (ASTM F2026), and comparison against the performance of legally marketed predicate devices. The acceptance criteria would be derived from these standards and the performance of the predicates.
• Regulatory Standards: For pyrogen testing, the ground truth is defined by regulatory standards such as ANSI/AAMI ST72:2011, which specifies acceptable limits for bacterial endotoxins.

8. The Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to develop and train machine learning algorithms. This device is a physical, mechanical implant and does not involve AI or machine learning algorithms. Therefore, there is no training set.

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

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

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The In2Bones Ankle Fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
The addition of a compression screw through the tibiotalar joint (example IBS™ 6.5mm screw) is required.

The Ankle Fusion Plating System is composed of an anatomically contoured plate, with a distal part adapted to the talar neck, and a proximal part adapted to the distal tibial epiphysis and diaphysis. Rigid fixation is achieved by screws.
The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V. A dedicated instrument set is available for the bone preparation, screw sizing and insertion of the Ankle Arthrodesis Plating System. A specific targeting device is available for the insertion of the additional I.B.S® 6.5mm screw.
Sizes: The Ankle Fusion Plate is available in one size, with left and right versions. Fixation screws are available in 3.5 or 4.5mm diameter, with length ranging from 10 to 100mm.
Material: The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and ASTM F136.
Single use: The Ankle Fusion Plating System is designed for single use only.
Sterilization: The Ankle Fusion Plating System is supplied sterile, using gamma irradiation.
Place of use: The Ankle Fusion Plating System is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.

I am sorry, but the provided text does not contain the detailed information needed to answer your request regarding acceptance criteria and a study proving device performance on an AI/ML device.

The document is a 510(k) premarket notification letter from the FDA for an "Ankle Fusion Plating System," which is a metallic bone fixation appliance, not an AI/ML device.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size and data provenance for an AI/ML test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for an AI/ML test set.
5. Multi-reader multi-case comparative effectiveness study results for AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth for an AI/ML device.
8. Sample size for an AI/ML training set.
9. How ground truth for an AI/ML training set was established.

The "Summary Performance Data" section in the document broadly states: "Performance testing of the Ankle Fusion Plating System was assessed through mechanical bench testing performed by an independent test laboratory, animal and clinical testing being considered not applicable. Testing performed included static and dynamic compression tests on Ankle Fusion Plating System. The results indicate that the Ankle Fusion Plating System met the acceptance criteria." This refers to mechanical testing of a physical implant, not an AI/ML system.

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The PIT Stop implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

• Flat foot treatment in children and adolescents
• Congenital flat foot
• Non successful long term orthopaedic treatment (shoes, insoles ... )
• Tarsal coalitions
• Painfully flat foot
• Supple deformity in posterior tibial tendon dysfunction
• Paralytic flat foot
• Subtalar instability

The PIT'Stop® implant is a cannulated implant composed of two symmetrical and flattened sides, and small blades. The PIT'Stop® implant is designed to adequately maintain the filling of the sinus tarsi, and is made of PEEK, a material recognized for its mechanical and radiolucent properties. The PIT'Stop® implant is introduced into the axis of sinus tarsi, and its fixation is performed by anti-return flanges. The PIT'Stop implant should be removed: at the end of the growth when used in pediatric patients or by 12 months when used in adult patients or if pain occurs earlier Sizes: The PIT'Stop® implant is designed in 7 sizes, from 10mm to 17mm. Material: The PIT'Stop® implant is made of PEEK according to standard ASTM F2026 and include markers made of tantalum according to ASTM F560. Single use: The PIT'Stop® implant is designed for single use only. Sterilization: The PIT'Stop® implant is supplied sterile, using gamma irradiation.

The provided text describes a medical device, the PIT'Stop® implant, and its substantial equivalence to predicate devices, but it does not contain information about studies proving the device meets acceptance criteria for an AI/ML powered device. The document is a 510(k) premarket notification for a traditional medical implant.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies for an AI/ML device based on the given input. The categories you've asked for (such as test set sample size, ground truth establishment, MRMC studies, standalone performance, training set size) are relevant for AI/ML device evaluations, but they are not applicable to the information provided in this 510(k) submission for the PIT'Stop® implant.

The "Summary Performance Data" section does mention performance testing:

"Performance testing of the PIT'Stop® implant was assessed through mechanical bench testing performed by an independent test laboratory, animal and clinical testing being considered not applicable. Testing performed included static and dynamic compression tests on PIT'Stop® implant. The results of the testing performed by the independent test laboratory indicate that the PIT'Stop® implant met the acceptance criteria."

This refers to mechanical engineering tests for an implant, not AI/ML performance evaluation.

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The I.B.S.TM compression and neutralization osteosynthesis screws are intended for:

• The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs
• Osteosynthesis requiring a mono or bicortical compression
  The size of the chosen screw should be adapted to the specific indications.

The modified I.B.STM osteosynthesis screws are a range extension of the existing screw line cleared in K131920 I.B.STM osteosynthesis screw.
The modification made on the I.B.S.TM osteosynthesis screw are:
I.B.S.TM Osteosynthesis Compression Screw, diameter 6.5mm:

• Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references;
• Modification of the distal thread to a long distal thread for screws, with total length comprised between 60mm and 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Neutralization Screw, diameter 6.5mm:
• Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Compression and Neutralization screw, diameter 2.5mm:
• Range extension of the total screw length, with addition of length 30mm, and creation of dedicated references.

The provided document is a 510(k) premarket notification for a medical device, specifically osteosynthesis screws. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving new efficacy or safety through clinical trials or comprehensive performance studies against acceptance criteria in the way AI/ML devices typically would.

Therefore, the requested information categories (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are largely not applicable in the context of this device type and the regulatory submission provided.

However, I can extract information related to the device's technical validation, which serves a similar purpose to "meeting acceptance criteria" in this context:

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

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

• This is not a study involving patient data or test sets in the typical sense of AI/ML device evaluation. The "test set" here refers to the physical devices undergoing mechanical testing and material analysis.
• The document states, "No new bench testing was deemed required to assess the torsional properties, driving torque and axial pullout of the modified I.B.S.™ osteosynthesis screws." This implies that existing data or established properties from the predicate device (K131920) were leveraged, and the analysis focused on the impact of the modifications on these properties rather than re-testing a specific number of new screws for all properties.
• The pyrogen test refers to "batch testing"; however, the specific sample size for LAL testing is not provided.
• Data provenance regarding a specific country of origin or retrospective/prospective nature isn't applicable as it's primarily an engineering and material equivalence assessment against standards.

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. The "ground truth" for this type of device is established by engineering standards (e.g., ASTM F543, ISO 5832-3, ASTM F136, ANSI/AAMI ST72:2011) and material science principles, not by human experts interpreting clinical data.

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

• Not applicable. This is not a study requiring human adjudication for data interpretation. Adherence to standards is the primary method of verification.

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 (screw), not an AI/ML diagnostic or assistive device that would involve human readers.

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

• Not applicable. This is a physical medical device.

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

• The "ground truth" for this device's performance and safety is rooted in engineering standards, material specifications, and regulatory requirements (e.g., ISO, ASTM, ANSI/AAMI) that define the expected mechanical properties, material composition, and biocompatibility (e.g., pyrogenicity) for bone fixation screws. The demonstration of substantial equivalence relies on conforming to these established objective benchmarks.

8. The sample size for the training set

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

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

• Not applicable. This is not an AI/ML device that requires ground truth for a training set.

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The I.B.S.TM 2.0 Osteosynthesis screws are intended for:

• The fixation of arthrodeses, osteotomies or fractures of the upper and lower limbs
• Osteosynthesis requiring mono or bicortical compression
  The size of the chosen screw should be adapted to the specific indications.

The I.B.S.TM 2.0 Osteosynthesis screw is a line extension of the existing compression screw line cleared in K131920 I.B.S.TM Osteosynthesis screw.
The I.B.S.TM 2.0 Osteosynthesis screws are cannulated screws available in a compression design. The cannulation of the screws provides a helpful feature during surgery, as a wire is used to guide insertion of the screw. The compression design has a non-threaded shaft, allowing optimal compression between the two bone fragments, which may enhance bone osteosynthesis.
The I.B.S.TM 2.0 Osteosynthesis screws are self-drilling and self-tapping screws, which enables introduction of the screw without any preparation of the hole (using a drill and /or a tap) in most cases.
Sizes: The I.B.S.TM 2.0 Osteosynthesis screws are available in 2.0mm diameter, in length ranging from 10mm to 30mm.
Material: The I.B.S.TM 2.0 Osteosynthesis screws are manufactured from titanium alloy Ti6Al4V as per ISO 5832-3 and ASTM F136. They do not have any coatings.
Single use: The I.B.S.TM 2.0 Osteosynthesis screws are designed for single use only.
Sterilization: The I.B.S.TM 2.0 Osteosynthesis screws are supplied sterile, using gamma irradiation.
Place of use: The I.B.S.TM 2.0 Osteosynthesis screws are indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.

This document describes the I.B.S.™ 2.0 Osteosynthesis screw, a bone fixation fastener. The acceptance criteria and supporting studies are based on mechanical performance tests, demonstrating substantial equivalence to predicate devices rather than direct clinical outcomes or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the mechanical performance test set (e.g., number of screws tested for each mechanical property). The data provenance is from mechanical bench testing conducted by a test laboratory. The country of origin for the data is not specified, but the sponsor is In2Bones SAS, located in France. The study is a retrospective comparison against known predicate device performance and standards.

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

Not applicable. This device is a mechanical bone fixation screw, and its performance is evaluated against engineering standards and comparison with predicate devices, not through expert-labeled data for an AI algorithm.

4. Adjudication Method for the Test Set

Not applicable. Performance is determined by mechanical testing results against predetermined criteria in ASTM F543-13 and comparison to predicate devices, not by expert adjudication of clinical outcomes or image interpretations.

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 for bone fixation, not an AI software/algorithm requiring an MRMC comparative effectiveness study.

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

Not applicable. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering standards (ASTM F543-13) and direct mechanical comparison to legally marketed predicate devices. The objective is to demonstrate substantial equivalence in terms of mechanical properties.

8. The Sample Size for the Training Set

Not applicable. No training set is mentioned as this is a physical medical device, not an AI model.

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

Not applicable. No training set is mentioned.

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