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The Dall-Miles Beaded Cable is intended to be used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. In addition, these cables may be used for supplementary fixation when used with bone plates and screws and for the stabilization of bone graft material.

The Dall-Miles Stainless Steel Beaded Cable is a modification of the existing stainless steel cable. A bead is formed on one end of the cable by melting it with an electron beam. This modification allows the cable to be used with a one-sided Tensioner in those applications where a conventional two-sided Tensioner will not fit.

This 510(k) summary (K961569) for the Dall-Miles Stainless Steel Beaded Cable focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria for device performance. It's a pre-market notification for a medical device that usually doesn't involve clinical performance studies in the same way as a new drug or a novel, high-risk device might.

Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics. The "acceptance criteria" here is implicitly "demonstration of substantial equivalence" to the listed predicate devices in terms of intended use, materials, design, operational principles, indications, and contraindications.
• Reported Device Performance: No specific performance metrics (e.g., tensile strength, fatigue life) are reported in this summary. The summary states that the Beaded Cable is a "modification of the existing stainless steel cable" and that "This modification allows the cable to be used with a one-sided Tensioner in those applications where a conventional two-sided Tensioner will not fit." This is a functional description, not a performance metric against a specific acceptance criterion.

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

• Not applicable. This document does not describe a clinical performance study with a test set.

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)

• Not applicable. This document does not describe a clinical performance study.

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

• Not applicable. This document does not describe a clinical performance study.

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 mechanical implant, not an AI or imaging diagnostic tool.

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

• Not applicable. This device is a mechanical implant.

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

• Not applicable. This document does not describe a clinical performance study. The "truth" for substantial equivalence is based on regulatory comparison to predicate devices.

8. The sample size for the training set

• Not applicable. This document does not describe a clinical performance study or an AI development process.

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

• Not applicable. This document does not describe a clinical performance study or an AI development process.

Summary based on the provided text for a 510(k) submission:

• Acceptance Criteria: The implicit acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to identified predicate devices. This is achieved by comparing the new device's intended use, materials, design, operational principles, indications, and contraindications to the predicates.
• Reported Device Performance: The document highlights a design modification (bead formed on one end) that allows use with a "one-sided Tensioner" in specific applications where a two-sided tensioner would not fit. This is a functional description enabled by the modification, rather than a quantifiable performance metric (e.g., specific tensile strength, fatigue life, or clinical outcome data) against a defined acceptance criterion. The summary asserts that the substantial equivalence is based on these characteristics, implying that similar performance to the predicates is expected, but no new performance data is reported in this summary.

Key takeaway for 510(k)s:
510(k) submissions typically do not contain the detailed clinical study information requested above unless the device is of a novel type or has significant technological changes that warrant new clinical data. For modifications of existing devices demonstrating substantial equivalence, the focus is on comparative analysis with predicate devices, and performance data might be limited to bench testing (which isn't detailed here) or relying on the established performance of the predicates.

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