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The General System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordoss), (3) spinal tumor, (4) failed previous fusion, (6) spinal stenosus. It is not intended for pedicle screw fixation above T8. This device may be used with autograft and/or allograft.

The General Spinal System consists of Fixed-Angle Reduction Screws. Rods, Cross Link and set screws. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, 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 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices

The provided document is a 510(k) summary for the "General Spinal System," a pedicle screw spinal system. It describes the device, its intended use, and states that non-clinical tests were conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, reported device performance metrics, detailed study designs (such as sample sizes, ground truth establishment, or expert qualifications), or the results of comparative effectiveness studies (MRMC) or standalone algorithm performance studies that would be necessary to answer the questions thoroughly.

Therefore, I can only provide information based on what is available in the document.

Detailed Breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., specific load endurance values, displacement limits) that a device must meet, nor does it report specific numerical performance results for the device against such criteria.

Instead, the document states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standard: ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items: Static compression bending test; Dynamic compression bending test; Static torsion test."

This implies that the acceptance criteria are adherence to the ASTM F1717-04 standard's methodologies and achieving comparable performance to the predicate device(s) within the scope of these tests. Without specific data, a table cannot be constructed with numerical values.

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

The document describes non-clinical mechanical tests. It does not involve human data or test sets in the context of clinical trials. Therefore, "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable in the context of this device's testing as described. The testing was likely conducted in a laboratory setting.

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

This question is not applicable as the document describes non-clinical mechanical testing, not a study involving ground truth established by experts (e.g., radiologists, pathologists). The "ground truth" for mechanical testing is typically defined by the test standard (e.g., ASTM F1717-04) and the physical properties observed.

4. Adjudication method for the test set

This question is not applicable for the same reason as points 2 and 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert consensus scenarios, not for mechanical bench testing.

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

This question is not applicable. The device is a "General Spinal System" (a pedicle screw spinal system), which is a physical implant, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance are irrelevant to this device.

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

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

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

For the non-clinical tests described, the "ground truth" refers to the established performance characteristics and requirements outlined in the ASTM F1717-04 standard for spinal implant constructs, as well as the observed mechanical properties (e.g., strength, stiffness, fatigue life) of the tested device and its predicate(s). It is purely objective mechanical measurement, not a subjective "truth" established by experts or clinical outcomes.

8. The sample size for the training set

This question is not applicable. The document describes the testing of a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This question is not applicable for the same reason as point 8.

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The Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius and tibia.

The proposed product, Locking Compression Bone Plates and Screws System, contains (1) locking compression plates (LCPs) with various specifications, (2) locking screws with various specifications and (3) various specific instruments. The locking compression plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used for completing the surgery.

The provided text is a 510(k) Summary for a medical device (Locking Compression Bone Plates and Screws System). This type of submission focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of characteristics. It does not contain information about clinical studies with human participants, expert review, or AI algorithms.

Therefore, most of the requested information (regarding acceptance criteria for a study, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for clinical data) is not present in the provided document. The device in question is a physical orthopedic implant, not an AI/software device.

However, I can extract information related to the acceptance criteria for the non-clinical tests and the device performance as reported in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are that the device 'complies' or 'meets' the requirements of the specified ASTM standards (ASTM F382-99 for metallic bone plates and ASTM F543-07 for metallic medical bone screws). The "reported device performance" indicates that the tests were conducted according to these standards and the device met all design specifications to demonstrate substantial equivalence to the predicate. The summary states: "The test results demonstrated that the proposed device complies with the following standards." and "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

Regarding the other requested information:

• 2. Sample sizes used for the test set and the data provenance: Not applicable. This document describes non-clinical, in-vitro mechanical testing of orthopedic implants, not a study involving human data or a "test set" in the context of an AI algorithm.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for mechanical testing is established by the defined parameters and methods within the ASTM standards.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical mechanical testing.
• 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 physical bone plate and screw system, not an AI diagnostic or assistance tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's evaluation is adherence to established mechanical testing standards (ASTM F382-99 and ASTM F543-07) for metallic bone plates and screws.
• 8. The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device mechanical testing.
• 9. How the ground truth for the training set was established: Not applicable.

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