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The BioPro HBS screw is designed for hand, foot and small bone fragment repairs or fusions. Uses include osteotomy fixation, joint arthrodesis or post traumatic fragment repair. The BioPro HBS screw is made of titanium in compliance with ASTM F136-02a. The screw is similar to other screws available on the market. The HBS screw is cannulated and comes in two diameters, 2.5mm and 3.0mm. Each screw is available in several lengths ranging from 6mm up to 40mm in length. The screws have a Torx driving head. The new versions of the screw will be provided sterile.

The provided text describes a 510(k) submission for a medical device (HBS Headless Bone Screw) and primarily focuses on proving substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics in the way that would typically be described for a diagnostic or AI-driven medical device.

The "performance testing" mentioned refers to engineering rationale regarding the screw's material and design, particularly torsional strength, in relation to ASTM F-543 ("Standard Specification and Test Methods for Metallic Medical Bone Screw"). The primary "studies" described relate to sterilization validation.

Therefore, many of the requested elements for describing acceptance criteria and a study cannot be directly extracted from the provided document.

However, I can extract and interpret the information that is present regarding the device's characteristics and the rationale for its approval.

Here's a breakdown based on the categories you provided, indicating where information is present versus not present:

Acceptance Criteria and Device Performance Study (Based on Submitted Information)

The document's primary "study" is a demonstration of substantial equivalence, with particular focus on the unchanged design (except for length), material, and sterilization process. It does not present specific quantitative performance metrics or acceptance criteria for clinical efficacy or diagnostic accuracy, as it is a bone screw and its performance is more related to mechanical properties and sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of a clinical performance study as defined for AI or diagnostic devices. Performance is largely based on engineering testing and sterilization validation. Specific sample sizes for engineering tests (e.g., how many screws tested for torsional strength, or how many sterilization cycles validated) are not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data for software. The "data" pertains to engineering specifications, material compliance, and sterilization validation results, which would be generated internally from laboratory testing.

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

• Not applicable. "Ground truth" in this context would relate to objective measurements of mechanical properties or sterility, not expert interpretation of clinical data.

4. Adjudication Method for the Test Set

• Not applicable.

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

• No. This is a medical device (bone screw), not a diagnostic tool or AI software. Therefore, an MRMC study is not relevant.

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

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

7. The Type of Ground Truth Used

• Engineering Specifications: Compliance with ASTM F136-02a for material and, by engineering rationale, maintenance of torsional strength based on unchanged diameter.
• Sterilization Validation Standards: Compliance with ANSI/AAMI/ISO 10933-7 and ANSI/AAMI ST 27-1988 for sterility assurance and residuals.
• Predicate Device Equivalence: The ultimate "ground truth" for the 510(k) submission is demonstrating substantial equivalence to the legally marketed predicate device (K020791 for the original design, and K991197 for additional lengths) in terms of safety and effectiveness, given the minor modifications (sterilization and increased length).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device requiring a training set.

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

• Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the 510(k) summary is not a single, comprehensive clinical trial for performance metrics typical of AI or diagnostic devices. Instead, it comprises several components:

• Engineering Rationale: An engineering rationale was provided to demonstrate that because the screw diameters remain unchanged, there is no change to the torsional strength from the predicate device, which is made of the same ASTM-compliant titanium (F136-02a). This addresses the mechanical performance aspect.
• Sterilization Validation Study: A complete summary of studies related to sterilization (Attachment "B" of the submission) was included. This validation was performed using the Ethylene Oxide (EtO) method with an AAMI Overkill Method to achieve a Sterility Assurance Level (SAL) of 10^-6. EtO and ECH residuals were tested to meet ANSI/AAMI/ISO 10933-7 standards.
• Packaging Validation: Packaging (double blister system with Tyvek® Lids) was certified and tested according to current medical packaging requirements.
• Risk Analysis: A complete risk analysis for sterilization and packaging (Attachment "A" of the submission) was provided.
• Device Comparison: A tabular comparison highlighting the similarities in material and design, and the modifications (sterilization, length increase) relative to predicate devices (Vilex 510k 991197, Osteomed K010783, and the original HBS 510k 020791).

The conclusion of the submission states that "Based on these studies we believe the subject device is safe and effective" and that the device is "substantially equivalent to the predicate devices" due to the unchanged design (except for length), material, and new sterilization. The FDA's 510(k) clearance (K101030) confirmed this substantial equivalence.

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The use of the ROI Fusion Rods and Plates are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).

The ROI Rods and Plates are utilized similar to screws in treating fractures, non-unions and fusions. The rods come in a variety of diameters and lengths. The plates are available in various widths, lengths and thicknesses. Both the rods and plates have fins to aid in resisting rotation or movement. The rods and plates are made from titanium alloy ((T1-6A1-4V ELI, ASTM F136 or Ti 3Al2.5V, ASTM B348 Grade 9) or CP titanium. The bodies are plasma spray coated with commercially pure titanium

This 510(k) submission (K051309) for the ROI Fusion Rods & Plates does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices.

Instead, this submission follows the traditional pathway for a medical device by demonstrating substantial equivalence to legally marketed predicate devices. The "study" here refers to nonclinical tests performed to show that the new device is functionally, materially, and in terms of indications similar to existing devices.

Therefore, the requested information elements related to AI/ML device performance (like sample size, experts, adjudication, MRMC studies, standalone performance, and training set details) are not applicable to this document.

Here's an attempt to answer the questions based on the provided text, while highlighting the non-applicability of certain AI/ML-centric questions:

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 information is not applicable as the submission relies on demonstrating substantial equivalence through nonclinical testing (material, functional, and indications comparison), not through clinical trial data or performance testing on a specific "test set" in the context of AI/ML.

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)

This information is not applicable. The "ground truth" for this type of device is established through engineering and material standards, and comparison to existing, legally marketed devices. It does not involve expert image interpretation or diagnostic ground truth.

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

This information is not applicable. Adjudication methods are relevant for clinical studies, especially those involving expert review of diagnostic or prognostic outcomes, which is not the case here.

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. MRMC studies are specific to evaluating AI-assisted diagnostic or interpretative devices, which the ROI Fusion Rods & Plates are not.

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

This information is not applicable. This device is a bone fixation implant, not an algorithm.

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

The "ground truth" in this context is based on established engineering principles, material standards (e.g., ASTM F136, ASTM B348 Grade 9), and the proven safety and effectiveness of the legally marketed predicate devices. The substantial equivalence argument relies on showing that the new device conforms to these established standards and practices.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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