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Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of small, narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.

The Symmetry Balloon Dilatation Catheter is an over-the-wire catheter offered in a three lumen catheter shaft design. One lumen, marked "distal", is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. The Symmetry device is designed to be placed over guidewires which have outer diameters of 0.018" or smaller. The lumen marked "balloon" is comprised of two smaller, separate lumens which both communicate with the balloon at one end and terminate in a single balloon hub and lead tube at the proximal end of the device. The Symmetry device is offered in both standard and stiff shaft versions.

The provided document does not contain information regarding detailed acceptance criteria or the specific studies conducted to demonstrate the device meets those criteria. The submission, K060959, is a 510(k) summary for the "Symmetry Balloon Dilatation Catheter."

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Symmetry Balloon Dilatation Catheter K953602, cleared October 18, 1995). The basis for this equivalence is explicitly stated as:

• Identical device materials and design characteristics.
• The only change being initiated is to add a single warning to the Directions for Use.

Therefore, there is no mention of performance metrics, sample sizes, expert ground truth, or statistical studies typically associated with proving a device meets specific acceptance criteria in the manner requested. The substantial equivalence pathway relies on the prior clearance of the predicate device.

To directly answer your specific questions based only on the provided text:

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

   • Acceptance Criteria: Not explicitly stated as performance metrics. The underlying acceptance criterion for this 510(k) is "substantial equivalence" to the predicate device. This implies that the device must be safe and effective for its intended use, as demonstrated by the predicate.
   • Reported Device Performance: Not provided. The submission states "identical device materials and design characteristics," implying performance is expected to be the same as the predicate.

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 as no specific test set or performance data is presented for this 510(k) submission.

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 as no specific test set or human evaluation is presented.

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

   • Not applicable.

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/software device.

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

   • Not applicable; this is not an AI/software device.

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

   • Not applicable. The ground for clearance is based on the substantial equivalence to a legally marketed predicate device, rather than new "ground truth" establishment for this specific submission.

8. The sample size for the training set:

   • Not applicable as no training set for an algorithm is mentioned.

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

   • Not applicable.

In summary: K060959 is a 510(k) submission that relies on the "substantial equivalence" pathway for regulatory clearance. It asserts that the proposed device is substantially equivalent to a predicate device due to identical materials, design, and indications for use, with only a minor labeling change. Therefore, it does not detail new performance studies, acceptance criteria, or ground truth establishment as would be required for a novel device or a device demonstrating new performance claims.

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