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The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
• Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).

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

• This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.

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

• No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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The "new" SPIN® SNAP-OFF SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of small bone fragments. Weil osteotomy Mono-cortical fixation Osteotomies and fractures fixation in the foot and hand

The SPIN ® SNAP-OFF SCREW is self drilling and self tapping snap-off screw One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is important enough to cause dissociation between the screw and the snap-off. In comes in lengths from 11 to 14 mm. The length varies whereas the head diameter is constant ( 2 mm) and the distal thread length is 7 mm to 10 mm.

K011946 refers to the SPIN® SNAP-OFF SCREW. The provided text, however, does not contain a study that proves the device meets specific acceptance criteria in the typical format of a clinical or performance study.

The document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence to existing predicate devices. It focuses on demonstrating that the "new" SPIN® SNAP-OFF SCREW is as safe and effective as previously cleared devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated in the format of acceptance criteria and performance metrics. The document instead highlights "technical equivalence" and "same torque."

2. Sample Size for the Test Set and Data Provenance

No specific test set or associated sample size is mentioned for a formal study. The evaluation likely relied on pre-existing data or comparison of design specifications and material properties to predicate devices.

• Sample Size (Test Set): Not applicable, as a formal test set for a comparative effectiveness study is not described.
• Data Provenance: Not applicable in the context of a clinical study. The comparison is based on the design, materials, and intended use relative to predicate devices. The sponsor is NewDeal SA in France.

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

Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set. The substantial equivalence determination is made by the FDA based on the provided technical comparative analysis.

4. Adjudication Method for the Test Set

Not applicable, as no external adjudication of a test set is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No MRMC comparative effectiveness study is described. The submission is a 510(k) for substantial equivalence, which primarily relies on comparing the new device's characteristics to cleared predicate devices.

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

This is not applicable as the device is a mechanical bone fixation screw, not an algorithm or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The new device is deemed "substantially equivalent" if it shares the same intended use, technological characteristics, and performs as safely and effectively as the predicate without raising new questions of safety or effectiveness. This is based on a technical comparative analysis, rather than a direct clinical "ground truth" derived from patient outcomes or pathology for the "new" device in a de novo study.

8. Sample Size for the Training Set

Not applicable. The device is 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

Not applicable.

Summary of the Study (as described in the 510(k) document):

The "study" presented is a technical comparison and declaration of substantial equivalence to previously cleared predicate devices.

• Objective: To demonstrate that the "new" SPIN® SNAP-OFF SCREW is substantially equivalent to the currently approved SPIN® SNAP-OFF screw (K991477) and other predicate devices like the Depuy Twist-off Screw (K962233), the Howmedica Luhr Screw system (K950595), Synthes Cortex Screws (K952272 and K002271), and the Osteomed M3 Screw (K924018, K924138).
• Methodology: The sponsor asserts that the "new" device has the "same intended use" and that the "design of the active part (screw itself) has not changed." Key comparability points include:
  • Intended Use: Identical to the currently cleared SPIN® SNAP-OFF screw and similar to other predicates (fixation of bone fractures or reconstruction, particularly small bone fragments, Weil osteotomy, mono-cortical fixation in foot and hand).
  • Technological Characteristics:
    • The torque of the "new" SPIN® SNAP-OFF SCREW is the "same" as the "old" (currently cleared) SPIN® SNAP-OFF screw.
    • All comparable devices are made from Titanium alloys (except Luhr and 2.4mm Synthes which are Cobalt-Chrome and SS respectively), a material commonly used in orthopedics.
    • Similar dimensions (e.g., 2.0mm diameter for most, with a range for others).
    • Most have a low profile head, are self-drilling, and self-tapping.
• Conclusion: Based on this comparative analysis, the FDA found the device "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to the market.

This 510(k) submission does not present a de novo clinical trial with specific acceptance criteria and direct patient outcome data for the new device. Instead, it leverages the established safety and efficacy of previously cleared devices.

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The SPIN® SNAP-OFF Screw is intended to be implanted for fixation of bone fractures or for bone reconstructions. The SPIN® SNAP-OFF Screw is indicated for fixing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only. Examples include: -Weil osteotomy - Unicortical small bone fixation. The SPIN® SNAP-OFF SCREW® is indicated for fixing the elective osteotomies in the metatarsal and phalanges of the foot only. Examples include: Weil osteotomy Lesser metatarsal osteotomies

The SPIN® SNAP-OFF Screw is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14 mm.

The provided text is a 510(k) premarket notification for a medical device called the "SPIN® SNAP-OFF SCREW®". It describes the device, its intended use, and a comparison to predicate devices, along with some information about a summary study. However, the document does not contain detailed information about acceptance criteria, comprehensive device performance data, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established, as typically required for AI/ML device descriptions.

The study described is a basic assessment of the screw's physical properties against a standard, not a clinical performance study using patient data. Therefore, many of the requested points cannot be answered from the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: This is an engineering/mechanical acceptance criterion for the device's physical properties, not a clinical performance metric and corresponding acceptance criteria as would be expected for an AI/ML device.

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

• Sample Size: Not specified. The document only mentions "Rupture torque of the. SPIN® SNAP-OFF SCREW was compared with requirement of the French Standard NF-F 90414". It doesn't detail how many screws were tested.
• Data Provenance: Not applicable in the context of patient data. The study relates to the physical characteristics of the screw itself.

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

• Not applicable. This was a mechanical test against a standard, not a clinical evaluation requiring expert ground truth on patient data.

4. Adjudication method for the test set:

• Not applicable. No adjudication process for clinical ground truth 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:

• No. This is a medical device, not an AI/ML imaging or diagnostic product. No MRMC study or AI assistance is mentioned.

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:

• For the "Summary of Studies": The "ground truth" was the French Standard NF-F 90414 for resistance to torsion. This is a regulatory/engineering standard, not clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

• Not applicable. This is a physical medical device. The concept of a "training set" for an algorithm does not apply.

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

• Not applicable.

In summary: The provided document is a 510(k) submission for a bone fixation screw, focusing on its substantial equivalence to predicate devices and adherence to an engineering standard. It does not provide the type of performance and study details commonly associated with the evaluation of AI/ML-driven medical devices, which the questions in the prompt are tailored for.

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