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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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Headless bone screw system for the fixation of osseous fragments or fractures including:

HBS - MINI: Scaphoid fractures, Lunate fractures, Capitate, Trapezial fractures, Metacarpal and metatarsal fractures, Phalangeal fractures, Radial head fractures, Ulnar styloid fractures, Osteo-chrondral, Small joint fusions

HBS - STANDARD: Scaphoid fractures, Carpal fractures & non-unions, Capitellum fractures, Metacarpal fractures, Phalangeal fractures, Distal radial fractures, Radial head fractures, Ulnar styloid fractures, Small joint fusions, Humeral head fractures, Glenoid fractures, Intercarpal fusions, Interphalangeal fractures, Metatarsal osteotomies, Tarsal fusions, Malleolar fractures, Patellar fractures, Osteo-chrondral fractures, Odontoid fractures, Mandibular fractures

Not Found

This document is a 510(k) clearance letter from the FDA for the HBS Headless Bone Screw. It does not contain any information about acceptance criteria or a study proving device performance in relation to such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended indications for use.

Therefore, I cannot provide the requested information.

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Headless bone screw system for the fixation of osseous fragments or fractures including:

HBS - MINI: Scaphoid fractures, Lunate fractures, Capitate, Trapezial fractures, Metacarpal and metatarsal fractures, Phalangeal fractures, Radial head fractures, Ulnar styloid fractures, Osteo-chrondral, Small joint fusions

HBS - STANDARD: Scaphoid fractures, Carpal fractures & non-unions, Capitellum fractures, Metacarpal fractures, Phalangeal fractures, Distal radial fractures, Radial head fractures, Ulnar styloid fractures, Small joint fusions, Humeral head fractures, Glenoid fractures, Intercarpal fusions, Interphalangeal fractures, Metatarsal osteotomies, Tarsal fusions, Malleolar fractures, Patellar fractures, Osteo-chrondral fractures, Odontoid fractures, Mandibular fractures

The HBS™ (Headless Bone Screw) and the mini HBS™ are supplied as two series of cannulated bone screws varying in length and diameter. Both systems are intended for small bone applications and are thus considered a single system. Indeed, both systems are intended for use primarily in the hands and feet. The systems may be used for selected fractures elsewhere in the body so long as medically indicated and bone mass compatible.

Available screws and instrumentation are available as two individually boxed sets offered in the following sizes:

MINI HBS™: 1.5mm shaft diameter, 3.2mm proximal thread diameter, 2.5mm distal thread diameter. 10mm through 30mm length in one millimeter increments.

STANDARD HBS™: 3.0mm shaft diameter, 4.7mm proximal thread diameter, 4.0mm distal thread diameter. 10mm through 30mm length in one millimeter increments.

The screws are made from titanium alloy.

The provided document is a 510(k) Premarket Notification Summary for the HBS™ Headless Bone Screw. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not available in these documents.

Here's a breakdown of the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify formal acceptance criteria for device performance in the context of a clinical study, as it's a 510(k) for substantial equivalence. The "performance" discussed is primarily in terms of biomechanical properties and material specifications, which are compared to predicate devices for equivalence.

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

This document does not describe a clinical "test set" for performance evaluation in the way one would for an AI/diagnostic device. The biomechanical testing mentioned is likely laboratory-based. No patient-specific data or data provenance (country of origin, retrospective/prospective) is provided.

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

Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in that sense. The "ground truth" for biomechanical performance would be the experimental measurements themselves.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is 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

Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned.

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

Not applicable. This is a surgical implant, not an algorithm.

7. The Type of Ground Truth Used

For the biomechanical testing, the "ground truth" is the empirically measured force values (e.g., 200N, 165N) obtained from testing the screws. For material and manufacturing, the ground truth is compliance with relevant ISO standards.

8. The Sample Size for the Training Set

Not applicable. No training set for an algorithm is mentioned in this document.

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

Not applicable. No training set is mentioned.

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