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The D-KuttingTm LL Peripheral Scoring Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.

The Peripheral Scoring Balloon Dilatation Catheter is an over the wire (OTW) catheter. It features a non-compliant balloon with 3 scoring elements mounted longitudinally on its outer surface. The scoring element is attached on the surface of balloon by adhesive. The scoring elements were tightly circled by a nitinol wire and the cross section of the scoring element is a triangular. The length of the scoring element is according to effective length of balloon. The catheter has two radiopaque marker bands, which fluoroscopically indicates the expanded part of the balloon and aid in the placement of the balloon and scoring element and to facilitate proper placement. The two radiopaque marker bands are located on the inner-lumen which is underneath the balloon. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the inflation site. A lubricious coating is applied at from the distal tip to shaft tubing to enhance insertion and withdrawal performance. The inner lumen in the shaft tubing and ends in a Y-connector manifold hub with 2 Luer lock fittings. The straight manifold port is used to pass the catheter over the suitable guidewire. The second side port communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The diameter and length of the balloon and the diameter of the compatible guide wire are printed on the hub. The balloon is folded an inserted in a PTFE casing to protect the balloon and scoring element. The Peripheral Scoring Balloon Dilatation Catheter is offered in balloon diameters ranging from 2.5mm-7.0mm and lengths are from 20mm to 150mm. The catheter length is 90cm, 135cm and 150cm and is compatible with 0.014″ or 0.018″ guide wires accordingly.

This 510(k) clearance letter pertains to a medical device, the D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter, rather than an AI/ML-driven device. As such, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable or cannot be extracted from this document.

However, I can provide the acceptance criteria and a summary of the study results for the non-clinical tests performed to demonstrate the device's substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

The document states that "The subject device, the Peripheral Scoring Balloon Dilatation Catheter, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance and test protocols." However, the specific quantitative acceptance criteria for each test are not explicitly detailed in this summary. The reported performance is generally stated as having met these unquantified criteria.

Study that Proves the Device Meets Acceptance Criteria

The study performed to prove the device meets acceptance criteria consists of a comprehensive set of non-clinical tests, including bench testing, biocompatibility testing, animal testing, sterilization validation, and packaging/shelf-life testing. The document states that these tests were performed "in accordance with the FDA Guidance Document titled Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters (April 14, 2023)".

1. A table of acceptance criteria and the reported device performance:
See table above. The document generally states that the device "met all predetermined acceptance criteria" for each category of tests but does not provide the quantitative criteria themselves.

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

• Test Set Sample Size: The document does not specify the sample sizes used for the individual bench tests, biocompatibility tests, or animal tests.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the submitter is "DK Medical Technology Co., Ltd." located in "Suzhou Industrial Park, Jiangsu, China", it is highly probable that the testing, or at least the data generation, occurred in China. The animal study is prospective by nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device (catheter) clearance, not an AI/ML device, so "ground truth" established by experts in the context of image interpretation or diagnosis is not relevant here. The "ground truth" for these tests would be objective measurements and observations determined by validated methods and trained technical personnel.

4. Adjudication method for the test set:
Not applicable. See point 3.

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 medical device (catheter) clearance, not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (catheter) clearance, not an AI/ML device.

7. The type of ground truth used:
For the non-clinical tests:

• Bench Testing: Objective measurements (e.g., dimensions, forces, times), visual inspections, and functional performance outputs, compared against engineering specifications and regulatory standards.
• Biocompatibility Testing: Laboratory results from in-vitro and in-vivo tests based on standardized toxicology and biological evaluation protocols (e.g., ISO 10993 series), indicating the biological safety of materials.
• Animal Testing: Clinical observations, procedural success rates, and potentially histological findings from acute and chronic animal models, compared against a control device.

8. The sample size for the training set:
Not applicable. This is a medical device (catheter) clearance, not an AI/ML device. There is no AI model "training set" mentioned or implied.

9. How the ground truth for the training set was established:
Not applicable. See point 8.

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The D Kutting™ PTA Scoring Balloon Dilatation catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

The D·Kutting™ PTA Scoring Balloon Dilatation Catheter is an Over-The-Wire (OTW) balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.018" or 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with Luer lock fillings. 3 scoring wires between the two marker bands are radially distributed every 120° and mounted on the surface of the balloon. A PVP coating is applied to the tip to enhance insertion and withdrawal performance. The D. Kutting™ PTA Scoring Balloon Dilatation Catheter will be available with balloon diameters 4.0 mm to 8.0 mm, balloon lengths 20 mm to 80 mm and with catheter lengths of 50 cm, 90 cm, and 130 cm. The diameter and length of the balloon and the diameter of the compatible guide wire are printed on the hub.

The provided document is a 510(k) summary for the D.Kutting™ PTA Scoring Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device through various performance, biocompatibility, sterility, and animal studies. However, the document does not describe a study involving an AI/Machine Learning (ML) component, nor does it provide acceptance criteria and performance data in the context of AI/ML.

Therefore, I cannot extract the information requested for an AI/ML device from this document. The document primarily concerns the safety and effectiveness of a physical medical device (a balloon dilatation catheter) and its equivalence to a similar, previously cleared device.

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The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.

The D·Kaptain™ PTA High Pressure Balloon Dilatation Catheter is an over-the-wire balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fillings. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. A PVP coating is applied to the tip to enhance insertion and withdrawal performance. The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 150 mm and with shaft lengths of 50 cm, 75 cm, and 130 cm.

This is a medical device submission, specifically for a balloon dilatation catheter, not an AI/ML powered device. As such, the typical acceptance criteria and study designs for AI/ML devices (e.g., test set sample size, data provenance, expert adjudication, MRMC studies, standalone performance) are not applicable here.

The document describes the performance criteria for the physical medical device and the studies conducted to demonstrate that the device meets those criteria, ensuring its substantial equivalence to a legally marketed predicate device.

Here's the information extracted based on your request, adapted for a medical device:

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

The document lists various in-vitro performance tests that were conducted and states that "The test results met all acceptance criteria" and "ensure the design and construction are suitable for its intended use." Specific numerical acceptance criteria are not detailed in this summary, but the successful outcome is reported. Some of these performance characteristics are implied comparisons to the predicate device, where "SE" (Substantial Equivalence) indicates the performance is considered comparable.

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

The document primarily discusses in-vitro testing for the device. It does not mention a "test set" in the context of clinical data for AI/ML. The performance data is derived from laboratory tests on the physical device prototypes. No mention of country of origin or retrospective/prospective nature is given for these laboratory tests.

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

This concept is not applicable to the evaluation of a physical medical device like a balloon catheter. "Ground truth" established by experts is relevant for diagnostic AI/ML models.

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

This concept is not applicable to the evaluation of 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

No such study was conducted or mentioned, as this is not an AI-assisted device.

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

This refers to AI/ML algorithm performance. The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter is a physical medical device, not an algorithm.

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

For the physical performance tests, the "ground truth" would be established engineering specifications, industry standards (like ISO 10993-1), and FDA guidance for Class II Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submission. Device performance against these established criteria forms the basis of proving suitability.

8. The sample size for the training set

This is not applicable to a physical medical device.

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

This is not applicable to a physical medical device.

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