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Ideal® locking plate system is indicated for buttressing mutifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.

Ideal® locking plate system contains locking plates with various specifications, cortical and locking screws with various specifications, and various specific instruments. The bone plates are used for fixation of bones. The screws are used for fix the plates on the bones and the instruments are used for completing the surgery.

The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The cortical and locking screws are made of Ti6A14V ELI that meets to ASTM F136. The materials of titanium and Ti6A14V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

The provided document is a 510(k) premarket notification for a medical device called the "Ideal® Locking Plate System." It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical (bench) testing.

However, the document does not contain information about a study that would involve acceptance criteria related to device performance in a clinical setting, such as a study with human readers, AI assistance, or the establishment of ground truth by medical experts.

Therefore, many of the requested items cannot be extracted from this document as they are not applicable to the type of submission described. This is a submission for a metallic bone fixation appliance, and the evidence provided focuses on mechanical and material properties through bench testing, not clinical performance metrics typically associated with AI-driven or diagnostic devices.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

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

• Sample Size: Not specified in the document for any of the bench tests.
• Data Provenance: The tests were conducted to demonstrate compliance with ASTM standards, which are international standards. The device manufacturer is Jiangsu Ideal Medical Science & Technology Co., Ltd. in China. The specific location where the bench tests were performed is not mentioned within the text, but it can be inferred that they were part of the submission process from a Chinese manufacturer. The tests are non-clinical, so "retrospective or prospective" does not apply in the clinical sense.

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 submission relies on engineering bench tests, not clinical evaluation requiring expert ground truth for interpretation of images or other clinical data.

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

• Not applicable. Adjudication methods are relevant for clinical studies, especially those involving human interpretation of data. This submission is based on physical and mechanical testing against recognized standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a metallic bone fixation system, not a diagnostic or AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or discussed.

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

• Not applicable. This device does not involve algorithms or AI. It is a physical implant.

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

• Ground Truth: The "ground truth" for the bench tests would be the specifications and performance requirements defined by the ASTM standards (ASTM F 382-99 and ASTM F 543-07). The device's performance is compared directly against these established engineering criteria, not against biological or clinical "ground truth" like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This submission evaluates a physical medical device, not an AI model requiring a training set.

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

• Not applicable. As above, no training set or AI model is involved.

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Ideal® pedicle screw spinal system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The spinal system consists of pedicle screws, fixed screws, bars and crosslink rod etc. It is made of titanium alloy (Ti6Al4V ELI), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

This document is a 510(k) premarket notification for a medical device called the "Ideal® Pedicle Screw Spinal System." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt (acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, etc.) is not applicable or present in this document.

Here's why and what information is available:

• No acceptance criteria or device performance report: This document focuses on demonstrating that the new device (Ideal® Pedicle Screw Spinal System) is "substantially equivalent" to an existing, legally marketed device (Kangli® pedicle screw spinal system). This is typically achieved through design comparisons, material specifications, and bench testing rather than clinical studies with explicit acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader improvement.
• No clinical study: The document explicitly states: "Bench tests were conducted to verify that proposed device meet all design specifications as was Substantially Equivalent (SE) to the predicate device." This means the evaluation was limited to non-clinical, laboratory-based tests.
• No test set, training set, or ground truth information: These concepts relate to clinical studies involving AI/ML algorithms or human interpretation of data, which are not part of this 510(k) submission.

Information that is available from the document:

• Device Name: Ideal® Pedicle Screw Spinal System
• Predicate Device: K140053 Kangli® pedicle screw spinal system
• Non-Clinical Testing Standards:
  • ASTM F1717-14, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including:
    • Static compression bending test
    • Dynamic compression bending test
    • Static torsion test
• Materials: Titanium alloy (Ti6Al4V ELI) meeting ASTM F136.
• Sterilization: Non-sterile, required to be sterilized by autoclave to a SAL of 10^-6, validated per ISO 17665-1.
• Intended Use/Indications: Posterior, non-cervical, pedicle fixation for severe spondylolisthesis (grade 3 or 4) of L5-S1; trauma; spinal stenosis; curvatures (scoliosis, kyphosis, lordosis); tumor; pseudoarthrosis; and failed previous fusion. Used in skeletally mature patients as an adjunct to fusion with bone graft at levels T8-S1.

In summary, this 510(k) premarket notification describes a device that showed substantial equivalence to a predicate device through bench testing, not through a clinical study with performance acceptance criteria, test/training sets, or expert ground truth adjudication.

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The Ideal™ Intramedullary Nail System is intended to provide temporary fracture fixation and stabilization of the tibia. (Simple, compound first- and second-degree tibial shaft fractures, pseudarthrosis and delayed union).

The Ideal™ Intramedullary Nail System is intended to provide temporary fracture and stabilization of the tibia. (Simple, compound first- and second-degree tibial shaft fractures, pseudarthrosis and delayed union). It consists of intramedullary nail. locking screw and end cap. The Intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. The locking screw passes through the holes at the proximal and distal sections of intramedullary nail for preventing rotation and axial compression. The end cap which screws into the threaded end of the intramedullary nail provides intraoperative lengths adjustment and prevents tissues growth into nail threads. All implants of intramedullary nail system are manufactured from Ti-6A1-4V allov that meets the requirements of ASTM F-136. The materials are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

The provided text describes a 510(k) summary for the Ideal™ Intramedullary Nail System, a medical device intended for temporary fracture fixation and stabilization of the tibia. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size (number of nails or screws) used for each of the non-clinical tests.
• Data Provenance: The tests were conducted by the manufacturer, Jiangsu Ideal Medical Science & Technology Co., Ltd., which is based in China. The data would therefore be considered prospective non-clinical test 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 non-clinical bench testing study, not a clinical study involving human or animal subjects that would require expert-established ground truth for a test set. The "ground truth" here is adherence to specified ASTM standards.

4. Adjudication method for the test set:

• Not Applicable. As a non-clinical bench testing study, there is no need for an adjudication method as would be used in a clinical trial to resolve discrepancies in expert interpretation. The performance is objectively measured against predefined engineering 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. This document pertains to a physical medical implant (an intramedullary nail system), not an AI-powered diagnostic or interpretive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

• No. This is not an AI algorithm. The tests performed are standalone in the sense that they assess the physical properties of the device itself (mechanical strength, resistance to forces) without human-in-the-loop interaction in the testing process. However, this question typically refers to the performance of an AI algorithm operating independently, which is not applicable here.

7. The type of ground truth used:

• The ground truth for this device's performance is based on established engineering standards and specifications, specifically ASTM (American Society for Testing and Materials) standards. The device's performance is compared against the requirements outlined in ASTM F1264-03 (Reapproved 2007) for intramedullary fixation devices and ASTM F 543-07 for metallic medical bone screws.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. As this device does not utilize a training set, the establishment of ground truth for such a set is not relevant.

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