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The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is a combination of two FDAcleared Surgicraft Products, the Surgicraft LOCKDOWN Mesh (K072370) and the Surgicraft LOCKDOWN Screw (K080447). The new product for this indication is designated as the LOCKDOWN™ Acromioclavicular (AC) device and will have a new indication to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

It is not intended that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device be used as the sole means of reconstructing a chronic acromioclavicular joint dislocation.

The Surgicraft LOCKDOWN Mesh device is a woven mesh 11mm wide by 4 to 20 cm in length with loops at both ends. The Surgical Mesh is made from braided Polyethyleneterephthalate (Polyester) fibers (PET).

The Surgicraft LOCKDOWN Screw is manufactured from stainless steel and titanium alloy. The self-tapping 3.5 mm screws are available in lengths from 14- 40 mm in 1 mm increments. The washers have a hole with an inner diameter of 4.2 mm and an outer diameter ranging from 7 to 9 mm in 1 mm increments.

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is provided sterile.

The provided document is a 510(k) summary for the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device. It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed. However, it explicitly states that no clinical testing was performed. Therefore, several sections of your request related to acceptance criteria proved by clinical studies, sample sizes for test sets, expert involvement, and ground truth for clinical outcomes cannot be addressed.

Here's a breakdown of the available information based on your request:

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

No explicit quantitative acceptance criteria or detailed reported device performance metrics were provided in the document in a way that would allow for a direct comparison table. The document states that "side-by-side testing was performed with the named predicate device in appropriate cadaver models and indicated that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is substantially equivalent to predicate device." This implies performance comparable to the predicate, but specific quantitative metrics comparing acceptance criteria to performance are not available.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "appropriate cadaver models" were used for side-by-side testing. The number of cadaver models is not specified.
• Data Provenance: The cadaveric testing would be considered prospective in the context of the study design; however, details on the origin of the cadaver models (e.g., country) are not provided.

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 clinical testing with human subjects or expert assessment of clinical outcomes was performed. The testing involved mechanical and cadaveric models.

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

Not applicable, as no clinical testing with human subjects or expert assessment of clinical outcomes was performed.

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 surgical implant, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This is a medical device, not a software algorithm. The "standalone" performance would refer to the mechanical and biocompatibility testing of the device itself.

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

For the non-clinical testing:

• Biocompatibility testing (per ISO 10993): Ground truth would be established by the ISO 10993 standards for material safety.
• Screw pull-out testing, mesh burst strength, and suture attachment strength: Ground truth would be established by engineering specifications and benchmarks to ensure the device's mechanical integrity meets required safety and performance thresholds, likely compared against the predicate device's known performance.
• Cadaveric model testing: Ground truth for substantial equivalence would be based on direct mechanical comparison of the device's performance (e.g., stability, fixation strength) against the predicate device in a simulated anatomical environment.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model that requires a training set.

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

Not applicable, as no training set was used.

Summary of Device Acceptance Criteria and Study:

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device gained regulatory clearance (K091207) based on demonstrating substantial equivalence to a predicate device, the Arthrex TightRope® Acromioclavicular device (K052776).

Acceptance Criteria (Implied by Substantial Equivalence):

The device must demonstrate similar:

• Indications for use.
• Function.
• Materials (braided Polyethyleneterephthalate (Polyester) fibers (PET), stainless steel, and titanium).
• Mechanical performance (screw pull-out strength, mesh burst strength, suture attachment strength).
• Biocompatibility.
• Performance in a cadaveric model, matching the predicate device's performance.

Study Proving Acceptance Criteria:

The study was a non-clinical comparative study against the predicate device.

• Mechanical Testing:

  • Tests Performed: Biocompatibility testing (per ISO 10993), screw pull-out testing, mesh burst strength, and suture attachment strength.
  • Methodology: These tests would involve standard engineering and biocompatibility protocols to assess the physical properties and material safety of the device and its components.
  • Ground Truth: Established by adherence to ISO 10993 standards and engineering specifications for material strength and performance, likely benchmarked against the known performance of the predicate device.
  • Sample Size: Not explicitly stated for each mechanical test, but typically these involve a statistically relevant number of samples for each component.

• Cadaveric Model Testing:

  • Methodology: "Side-by-side testing was performed against the predicate device in an appropriate cadaveric model." This would involve implanting both the Surgicraft device and the predicate device in cadaveric shoulder models and subjecting them to mechanical stress to compare their fixation capabilities and stability.
  • Ground Truth for Comparison: The performance of the predicate device within the cadaveric model. The Surgicraft device was deemed equivalent if its performance matched that of the predicate.
  • Sample Size: Not explicitly stated, but implies multiple applications and comparisons within these models.
  • Data Provenance: Cadaver models, assumed to be prospective in nature.

Conclusion: The device met its acceptance criteria by demonstrating substantial equivalence to the predicate device through a series of non-clinical mechanical and cadaveric model tests. No clinical studies were deemed necessary for this 510(k) clearance.

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