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The HC Spinal System is intended for posterior noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients for the following indications: severe spondylolisthesis (i.e., Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The HC Spinal System offers a comprehensive solution for immobilizing and stabilizing spinal deformities in patients as an adjunct to fusion. The HC Spinal System consists of monoaxial and polyaxial pedicle screws, set screw and rods. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile and will be used for either posterior or anterolateral non cervical fixation.

The provided text is a 510(k) summary for the HC Spinal System, a medical device. It does not describe a study involving an AI algorithm or human-in-the-loop performance. Instead, it details the non-clinical testing performed on a physical spinal implant system to demonstrate its substantial equivalence to a predicate device.

Therefore, most of the requested information regarding AI performance, sample sizes for test/training sets in an AI context, expert ground truth, adjudication methods, and MRMC studies is not applicable to this document.

Here's the relevant information that can be extracted:

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

The document states that a series of non-clinical tests were performed. The "reported device performance" is a general statement that the device met the requirements. Specific numerical acceptance criteria and performance values are not provided in this summary.

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

• Sample sizes for test set: Not specified in the document. The tests performed are engineering/materials tests on physical devices, not clinical studies with human participants.
• Data provenance: Taiwan (R.O.C.) (where the submitter is located), for the device manufacturing/testing.

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 this type of device (spinal implant) is established through engineering and material testing standards (e.g., ASTM F1717). No human expert consensus for a "test set" in the context of interpretation of medical data is described.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of 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 document does not describe an AI device or an MRMC study.

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

Not applicable. This document does not describe an AI algorithm.

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

The "ground truth" or standard for evaluation is based on pre-defined acceptance criteria derived from established engineering and material testing standards, such as ASTM F1717 for mechanical performance, and general biological safety standards for cytotoxicity, irritation, etc. These are objective measures rather than expert consensus on medical image interpretation or pathology.

8. The sample size for the training set

Not applicable. There is no AI algorithm, so no training set.

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

Not applicable. There is no AI algorithm, so no training set or associated ground truth establishment.

Summary of the study that proves the device meets the acceptance criteria:

The study described is a series of non-clinical tests performed on the HC Spinal System. These tests are outlined in Section 8 ("Non-clinical Testing") and include:

• Shelf Life Test
• In vitro Cytotoxicity Test
• Intracutaneous Irritation Study
• Skin Sensitization Study
• Pyrogen Test
• Acute Intravenous Systemic Toxicity Study
• Acute Intraperitoneal Systemic Toxicity Study
• Salmonella Reverse Mutation Test
• In Vitro Mammalian Chromosomal Aberration Test
• Rodent Micronucleus Test
• Bone Implantation Study
• Subchronic Intravenous Systemic Toxicity Study
• Static and Dynamic axial Compress Bending Testing
• Static Torsional Test

The document states that "All the test results demonstrate that HC Spinal system meets the requirements of its pre-defined acceptance criteria and intended uses." Specifically, for performance, it notes compliance with ASTM F1717. The purpose of these tests was to demonstrate the safety and performance of the device and to establish substantial equivalence to the predicate device (Xia® 4.5 Spinal System) under 510(k) regulations. No clinical test data was used to support this decision.

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The HC-Bios Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.

The HC-Bios Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

Here's an analysis of the provided 510(k) summary for the HC-Bios Dental Implant System, focusing on acceptance criteria and the study proving adherence:

The provided document describes a traditional 510(k) submission for a dental implant system. As such, the "study" proving the device meets acceptance criteria is primarily non-clinical testing demonstrating substantial equivalence to a predicate device. This is typical for Class II devices like dental implants. There is no mention of clinical studies involving human patients, AI components, or complex ground truth establishment for diagnostic performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For medical devices seeking 510(k) clearance, the primary "acceptance criterion" is generally demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented here is to support that claim of equivalence, often by showing the proposed device meets relevant performance standards and has similar characteristics to the predicate.

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

• Test Set Sample Size: Not explicitly stated as a number of devices or cases. The "test set" refers to the samples of the HC-Bios Dental Implant System that underwent non-clinical (in vitro and in vivo preclinical) testing. These are typically representative samples of the manufactured device. The common practice for such testing involves a sufficient number of samples to achieve statistical significance or meet the requirements of the specific test standard (e.g., a certain number of fatigue test samples).
• Data Provenance: The tests were "in vitro and in vivo preclinical" and "bench testing." This refers to laboratory and possibly animal testing. The location of the testing laboratories is not specified, but the manufacturer is based in Taiwan. The data is entirely retrospective relative to the 510(k) submission, meaning the tests were completed before the submission. There is no indication of human patient data provenance.

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

This information is not applicable in the context of this 510(k) submission.

• No Human Experts for Ground Truth: Since this is non-clinical testing of a physical medical device (dental implant), there is no 'ground truth' established by a panel of human experts in the way one would for an AI diagnostic algorithm. The "truth" or "correctness" of the device's performance is determined by its adherence to established engineering, material, and biocompatibility standards (e.g., ISO, ASTM).
• Qualifications: The tests would have been performed by engineers, materials scientists, and toxicologists familiar with the respective ISO/ASTM standards and Good Laboratory Practices (GLP), but they are not acting as "experts establishing ground truth" in a diagnostic sense.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical device testing described in this 510(k). Adjudication methods like 2+1 or 3+1 refer to processes for resolving disagreements among multiple human readers when establishing ground truth, typically in imaging or clinical diagnostic studies. For physical device testing, the results are objectively measured against predefined standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

This information is not applicable.

• No AI Component: The HC-Bios Dental Implant System is a physical dental implant. There is no mention of any AI component, software, or diagnostic capabilities that would involve human readers or AI assistance.
• No MRMC Study: Consequently, an MRMC comparative effectiveness study, which is typically performed for AI-powered diagnostic devices, was not performed.

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

This information is not applicable. As stated above, there is no AI algorithm or software product in this submission. This is a physical medical device.

7. The Type of Ground Truth Used

For this device and submission type, the "ground truth" is defined by:

• Established Industry Standards: ISO 10993 (biocompatibility), ISO 14801 (mechanical testing for dental implants), ASTM F 543, ASTM F 1980, and ISO 11137-1 (sterilization).
• Predicate Device Performance: The performance characteristics and safety profile of the legally marketed Dentium Co., Ltd Implantium (K041368). The "ground truth" for substantial equivalence is that the proposed device performs comparably to this predicate given its intended use.
• Material Properties: The established safety and performance characteristics of Grade 4 titanium and AISI 316L Stainless Steel in medical applications.

8. The Sample Size for the Training Set

This information is not applicable. There is no machine learning or AI component to this device, and therefore no "training set." The device is a physical implant, not a data-driven model.

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

This information is not applicable for the same reasons as point 8.

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