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Passing Needle with PANACRYL, ETHIBOND, or ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.

Mitek Passing Needle with ETHIBOND Loop is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.

Mitek Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture is a suture and needle assembly to be used in vivo for suture passage through soft tissue during the surgical procedure. It is packaged with two colored clips and is designed to be used with the Mitek Suture Passer. The Passing Needle with PANACRYL, ETHIBOND or ORTHOCORD suture may also be used with other Mitek anchor products.

Mitek Passing Needle with ETHIBOND Loop is a utility suture and needle assembly that is used in vivo for suture passage of operative suture through soft tissue during the surgical procedure. It is packaged with a colored clip and is designed to be used with the Mitek Suture Passer.

The provided text is a 510(k) summary for a medical device (Passing Needle with various sutures) that seeks to demonstrate substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing.

Instead, the document primarily focuses on:

• Device Classification and Description: Details about the sutures used and the intended use of the passing needle assemblies.
• Substantial Equivalence: Listing predicate devices (previously cleared sutures) to which the current device is deemed substantially equivalent.
• Indications for Use: What orthopaedic procedures the device is intended for.
• Safety Reference: Stating that safety data for the sutures can be referenced in the clearance documents of the predicate devices.

Therefore, I cannot provide the requested information, which typically pertains to performance studies with specific metrics, acceptance criteria, sample sizes, and ground truth establishment. This type of information is usually found in detailed performance study reports, not in a 510(k) summary that relies on substantial equivalence.

To answer your request, if this were a document that did contain such a study (e.g., a clinical trial report or a comprehensive bench testing report), the table and other details would look something like this (hypothetical example, as the provided text doesn't support it):

(Hypothetical Example Based on a Fictional Performance Study)

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

2. Sample sized used for the test set and the data provenance

• Tensile Strength (Suture A): Test Set N=50 sutures. Data provenance: Manufactured samples, tested in an independent lab in the USA (prospective bench testing).
• Knot Security (Suture B): Test Set N=60 sutures (10 knots per condition). Data provenance: Manufactured samples, tested in a material science lab in Germany (prospective bench testing).
• Needle Bend/Breakage (Needle Type 1): Test Set N=100 needles. Data provenance: Manufactured samples, tested in a biomechanics lab in the USA using a custom-built cyclic loading apparatus (prospective bench testing).
• Passage Force (Needle Type 2): Test Set N=40 needles, 10 passes each in 5 different types of ex-vivo animal tissue samples. Data provenance: Manufactured samples, tested in a university biomechanics department in Canada using porcine and bovine tissue (prospective ex-vivo testing).
• Biocompatibility: Test materials (extracts, direct contact with cell cultures) from N=3 production lots. Data provenance: Independent contract lab, USA (prospective in-vitro/in-vivo animal testing).

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

• For bench and ex-vivo tests, "ground truth" is typically defined by the physical measurement or observation itself, not expert consensus. Calibrated instruments and standardized protocols establish the truth.
• However, if there was a subjective component (e.g., visual assessment of tissue damage from needle pass), it might involve:
  • Needle Passage Tissue Trauma Assessment: 3 board-certified orthopedic surgeons (average 15 years experience) evaluated tissue samples for trauma severity using a blinded scoring system.

4. Adjudication method for the test set

• For objective bench data (tensile strength, breakage force, passage force): No adjudication as measurements are quantitative and performed by calibrated equipment according to standard protocols. Any outliers would be investigated for experimental error or manufacturing defects.
• For subjective assessments (e.g., tissue trauma): If used, a 3-way consensus method or 2+1 adjudication (if 2 experts agreed, that was the ground truth; if not, a third expert resolved the discrepancy) would be applied.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, MRMC studies are typically for diagnostic imaging devices where human readers interpret images with and without AI assistance. This device is a surgical tool (needle and suture assembly), so such a study would not be applicable.

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

• Not applicable as this is a physical surgical device, not a software algorithm.

7. The type of ground truth used

• Objective Measurement: Quantitative physical properties (tensile strength, force measurement, cycle counts) determined by calibrated test equipment.
• Visual Inspection/Physical Observation: For breakage events or gross damage, directly observed under magnification.
• Standardized Laboratory Assays: For biocompatibility (e.g., cell viability assays, irritation tests).

8. The sample size for the training set

• Not applicable in this context. Training sets are relevant for AI/ML algorithms. For physical devices, design parameters are developed through engineering and material science principles, often with iterative prototyping and testing, but not a "training set" in the AI sense.

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

• Not applicable.

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