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The LARS® AC Band 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 LARS® AC Band device is intended for single use only.

The LARS® AC Band device is a knitted surgical scaffold manufactured from poly(ethylene terephthalate) (PET) which is non-biodegradable. The LARS® AC Band device is available in 1 size which is 6mm wide by 400mm in length with a loop at one end and is secured by sutures. The use of high strength #2, non-resorbable single use sterile sutures is recommended. The construct permits the mesh to be cut into any desired size without unraveling. The device is supplied sterile, for singlepatient use.

Here's an analysis of the provided text regarding the LARS® AC Band Device's acceptance criteria and studies:

Based on the provided FDA 510(k) summary, the device is a medical implant, and the documentation primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics against specific acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested points related to AI/algorithm performance, such as sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone algorithm performance, are not applicable to this submission as it's for a physical medical device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the submission):

Regarding the specific questions:

1. A table of acceptance criteria and the reported device performance: See table above. The acceptance criteria are largely inferred from the substantial equivalence claim and the types of non-clinical and clinical reviews performed. The "reported performance" is that these tests/analyses were conducted, implying acceptable results for the claim of substantial equivalence. Specific quantitative acceptance criteria or performance metrics are not provided in this 510(k) summary for a physical device.

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

   • Test set sample size: Not applicable in the context of an AI/algorithm test set. For the non-clinical mechanical tests (tensile, tear, burst), standard engineering sample sizes would have been used, but these are not specified. For the clinical data review, the "sample size" would refer to the number of patients/cases in the published literature reviewed, which is not provided.
   • Data provenance: Not specified for the clinical data review. It's likely a review of existing global literature, but no details are given.

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 this is a physical medical device submission, not an AI/algorithm where expert ground truth is typically established for image/data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical medical device.

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 a physical medical device, not an AI-assisted diagnostic tool.

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 (expert consensus, pathology, outcomes data, etc): For the non-clinical testing, the "ground truth" would be the measured physical properties according to established engineering standards. For the clinical review, the "ground truth" would be the reported clinical outcomes in the published literature and test reports.

8. The sample size for the training set: Not applicable; this device does not involve a "training set" in the machine learning sense.

9. How the ground truth for the training set was established: Not applicable; there is no training set for this physical device.

Summary of the Study for Substantial Equivalence:

The study conducted was primarily a non-clinical testing program combined with a review and analysis of published clinical data and test reports.

• Non-Clinical Testing: Included mechanical tests (tensile strength, tear strength, burst strength) and biocompatibility testing of the LARS® AC Band device itself. The summary implies these tests demonstrated the device's physical properties are suitable and comparable to the predicate/reference devices.
• Clinical Testing/Review: This was not a de novo clinical trial for the LARS® AC Band device. Instead, it involved a "review and analysis of published clinical data and test reports" related to the LARS® AC Band device or similar devices, focusing on aspects like wear, bone fracture, particulates, and inflammatory/biologic response at the surgical site. This review was presumably used to support the safety and effectiveness profile based on existing literature for the claimed indications.

The overall approach was to demonstrate substantial equivalence to existing legally marketed devices (LOCKDOWN™ Acromioclavicular (AC) device (K091207) as predicate, and Surgicraft Surgical Mesh System (K072370) as a reference for material). Substantial equivalence means the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.

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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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OrthADAPT® PR is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias. suture-line reinforcement and other reconstructive procedures.

The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

OrthADAPT® PR is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors. used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

OrthADAPT® PR is comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, which is derived from the same equine pericardial tissue used in the fabrication of its predicate device, the OrthADAPT® Bioimplant, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.

The provided text describes the OrthADAPT® PR Bioimplant, a surgical mesh device, and its substantial equivalence to predicate devices, rather than a study with acceptance criteria in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity). This documentation is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving device efficacy through a comparative performance study with predefined acceptance criteria for AI or diagnostic performance.

Therefore, many of the requested fields cannot be filled as they pertain to a different type of study (e.g., an AI/diagnostic performance study).

Here's the information available from the text, framed within the requested table and addressing the other points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The "study that proves the device meets the acceptance criteria" in this context refers to the collective body of biocompatibility testing, biomechanical bench testing, and an animal implant study, all performed to demonstrate substantial equivalence to predicate devices.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "biocompatibility testing," "biomechanical bench testing," and "an animal implant study." The sample size for each of these tests is not quantified in the provided text.
• Data Provenance: Not explicitly stated. The document indicates the testing was conducted to support a submission to the FDA (U.S.). It does not specify the country of origin for the animal study or other testing data, nor whether the studies were retrospective or prospective.

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

• Not applicable. This device is a surgical mesh, not an AI or diagnostic device that relies on expert interpretation of results for "ground truth" establishment in a diagnostic accuracy study. The "ground truth" here is established through objective physical and biological tests (e.g., tensile strength for biomechanical performance, histological assessment in animal studies for tissue response).

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

• Not applicable. This is not a study requiring adjudication of expert opinions for a diagnostic outcome.

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 a diagnostic device or an AI-assisted interpretation tool. It is a surgical implant.

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 (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the performance evaluation of the OrthADAPT® PR Bioimplant is based on:
  • Biocompatibility Standards: Meeting established biological safety standards for medical devices.
  • Biomechanical Measurements: Objective quantitative measurements of mechanical properties (e.g., tensile strength, tear resistance) against performance requirements deemed suitable for its intended use and comparable to predicate devices.
  • In Vivo Animal Study Observations: Histological and functional assessments of tissue response, integration, and functionality in an animal model, conforming to expectations for surgical mesh.
  • Sterility and Endotoxin Testing: Objective laboratory tests (USP sterility testing, LAL endotoxin limit).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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