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The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters.

The V-Guide is a sterile, single use, Neurological Stereotactic Instrument that provides the surgeon with a localized reference guide for performing Ventriculostomies. The device is compatible with 3.3mm ventricular catheters. The device consists of a Base Assembly, three Impression Pins (16 Gauge Stainless Steel needles with aluminum hubs) that act as legs for the Base, a Pierce Sagittal assembly and a Pierce Barrel.

The device allows the user to orient the sagittal plane to 0° and the lateral plane to 0°. This aligns the device to a perpendicular track to the entry point. A standard 3.3mm catheter is then passed through the guide into the brain at the predetermined distance as in a standard Ventriculostomy. If the flow of cerebrospinal fluid is noted and the surgeon is satisfied the position of the catheter, the V-guide can be removed from the catheter by removing the barrel. If the surgeon is not satisfied with the position of the catheter, the catheter is removed and this technique can be repeated with different angles to allow for an objective change in direction of the catheters angle to the cranium.

The provided document describes the 510(k) summary for the Arc Surgicals Manufacturing LLC's V-Guide for Ventriculostomies (K141559), a neurological stereotaxic instrument designed for frontal placement of an intraventricular catheter. The document seeks to establish substantial equivalence to a legally marketed predicate device, the Sparta Instrument Corporation's Ghajar Intraventricular Catheter Guide (K854475).

Here's an analysis of the acceptance criteria and the study that proves the device meets the criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "a bench model" for accuracy testing, but does not provide details on the number of trials, measurements, or the total sample size used in this testing.
• Data Provenance: The study was a non-clinical bench test. There is no information regarding country of origin, retrospective, or prospective nature, as it was not a clinical study on human subjects.

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

• Number of Experts: Not applicable. The "ground truth" for the accuracy test was established by the physical setup of the bench model with a target at a known depth (6 cm) and the objective measurement of the V-Guide's placement accuracy. This is a technical measurement, not an expert-driven assessment.
• Qualifications of Experts: Not applicable for establishing ground truth in this context.

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

• Adjudication Method: Not applicable. The testing described is a technical performance assessment against a defined physical target, not an assessment requiring adjudication of human interpretations or classifications.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical stereotaxic instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

• Standalone Performance: Not applicable in the context of an algorithm. This device is a physical instrument intended for use by a surgeon (human-in-the-loop) during a medical procedure. The "standalone" performance here refers to the instrument's accuracy as measured on a bench model, independent of a human surgeon's skill in operating it, other than to set it up for the test.

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

• Type of Ground Truth: The ground truth for the accuracy testing was physical measurement against a known target. Specifically, the accuracy was measured in relation to a target at a 6 cm depth within the "bench model." The predicate device's performance was also tested against this same physical ground truth for comparison.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This document describes the testing of a medical device's physical performance, not the training of an AI algorithm.

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

• Ground Truth for Training Set: Not applicable, as there is no AI algorithm being trained.

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The BIOTRAK™ Pin is intended for use in fixation and/or alignment of fragments and fractures of non-load bearing bones, osteotomies, arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities.

The ARC Surgical BIOTRAK TM Pin System is composed of pins injection molded from poly-L-lactic acid (PLLA) with diameter 1.5mm to 2.0mm and length 20mm to 40mm. External features on the pin provide increased resistance to loosening of bone fragments. The screws are provided sterile.

This document is a 510(k) summary for the ARC Surgical BIOTRAK™ Pin System. It describes a medical device, specifically a bioabsorbable bone fixation pin, and asserts its substantial equivalence to previously marketed devices. The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., performance metrics, sample sizes, ground truth establishment, or comparative effectiveness studies).

Instead, the document states:

"A discussion of clinical and non-clinical tests is not applicable."

And further:

"Based upon the similarities of the ARC Surgical BIOTRAK™ Pin System and the predicate devices studied, the safety and effectiveness of the BIOTRAK.™ Pin is substantially equivalent to the predicate devices referenced."

This indicates that the device's approval was based on demonstrating substantial equivalence to existing predicate devices, rather than on new performance studies with specific acceptance criteria. This is a common pathway for 510(k) clearances, where new clinical or non-clinical performance data is not always required if the device is sufficiently similar to legally marketed devices.

Therefore, I cannot provide the requested information. The document explicitly states that a discussion of clinical and non-clinical tests is not applicable for this submission.

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The Bone Reduction Screw is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.

The ARC Surgical Bone Reduction Screw is a headless, cannulated twopiece screw assembly. The two-piece design incorporates the use of a distal and proximal screw component. The implant is used to anatomically reduce two bone portions. The distal screw component engages the distal bone portion and the proximal screw component engages the proximal bone component.

The provided text makes no mention of an AI/ML device or its performance criteria. The submission is for a "Smooth or threaded metallic bone fixation fastener" named the "Arc Surgical Bone Reduction Screw System." The document primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device. The document explicitly states: "A discussion of clinical and non-clinical tests is not applicable." because the device is a simple mechanical device with well-established uses.

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The Biotrak™ resorbable compression screw is intended to provide fixation and/or reduction of small bone fractures, osteotomies, and arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities. Specifically, these indications include osteochondral defects (OCDs), patella rim fractures, metatarsal fusions and fractures, metatarsal osteotomies, hallux valgus corrections, humeral condyle fractures, metacarpal fusions and fractures, carpal fusions and fractures, radial head fractures, and distal radius fractures.

The ARC Surgical Biotrak™ Screw System is composed of screws injection molded from poly-L-lactic acid (PLLA) with diameter (4.3mm to 4.8mm) and length (16mm to 24mm). Headless screw compression is obtained from the variable pitch of the threads. The screws are provided sterile.

This document is a 510(k) summary for the ARC Surgical Biotrak™ Screw System. It describes a medical device, specifically a resorbable compression screw for bone fixation. The provided text is a regulatory submission to the FDA, asserting substantial equivalence to previously marketed devices.

Based on the provided text, there is no information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

Here's why and what information is available:

• Type of Submission: This is a 510(k) Pre-market Notification. For this type of submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove performance against specific acceptance criteria in the way a clinical study for a new technology might.
• Performance Data Mention: The document explicitly states: "Performance data is included in Section 10. A discussion of clinical and non-clinical tests is not applicable." This means the details of any performance data are in a separate, unprovided section of the 510(k) submission, and the current document does not include a discussion of studies with acceptance criteria, sample sizes, or expert ground truth.
• Focus on Substantial Equivalence: The document repeatedly emphasizes that the device's safety and effectiveness are based on "similarities" and "substantial equivalence" to predicate devices. This approach relies on the existing track record of the predicate devices rather than new performance studies with specific statistical targets.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: What the device is made of (PLLA, injection molded), its dimensions, and how it works (headless screw, variable pitch threads).
• Intended Use: Specific types of bone fractures and fusions in upper and lower extremities for which the screw is intended.
• Technological Characteristics: The materials and manufacturing process (PLLA pellets, ring-opening polymerization, stannous octoate catalyst).
• Predicate Devices: A list of existing devices to which the Biotrak™ system is compared for substantial equivalence.

Without "Section 10" or further documentation detailing specific performance tests and their results, none of the points (1-9) in your request can be answered.

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The ARC Surgical Resorbable Compression Screw System is a bioabsorbable PLLA screw intended to provide fixation and/or reduction of bone fragments and bones. Specifically, as listed below, the screw is intended to fix osteochondral fragments, osteotomies and fractures in the foot, and limited fractures in the wrist, elbow, and ankle.

• . Osteochondral fragments
  • Femoral condyle o
  • Talus 0
  • Navicular ্
• Hallux Valgus correction ●
• Tarsal fractures .
• Distal Radius fractures ●
• Radial Head fractures .

The ARC Surgical Resorbable Compression Screw System is composed of screws injection molded from poly-L-lactic acid (PLLA) with diameter (4.3mm to 4.8mm) and length (16mm to 24mm). Headless screw compression is obtained from the varying pitch of the threadless screw has a tapered square cannulation and the driver has a square-shaped geometry to drive the screw. The screws are provided sterile.

The provided document, K043176, is a 510(k) summary for the Arc Surgical Resorbable Compression Screw System. Based on the content, there are no acceptance criteria, performance data, or studies present in this document.

The document explicitly states:

"An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."

This indicates that the device was approved based on its substantial equivalence to predicate devices, and no new performance studies were required or presented for this 510(k) submission. Therefore, it's not possible to provide the requested information regarding acceptance criteria and study details from this document.

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