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510(k) Data Aggregation
(164 days)
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is a 6.3 Fr (2.08 mm) diameter, single-lumen, metal alloy hypotube shaft, a proximal polymer outer jacket and a balloon expandable scoring element at the distal tip. Designed to work with a standard PTA balloon catheter. The XO Score catheter essentially adds the lesion scoring / cutting capability to a standard PTA balloon catheter with the scoring element at its distal end. It is available in various catheter lengths (65cm, 125cm), and longitudinal scoring element lengths (5cm, and 7cm).
The provided text describes the "XO Score Percutaneous Transluminal Angioplasty Scoring Catheter" and its substantial equivalence to predicate devices, without directly presenting acceptance criteria in a table format with reported performance. However, it does state that "All necessary verification steps met pre-determined acceptance criteria to support substantial equivalence." and "All data met pre-determined acceptance criteria." It also mentions "The XO Score catheter met all acceptance criteria to support substantial equivalence."
Based on the information provided, here's an attempt to infer and structure the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of quantitative acceptance criteria alongside specific reported performance values for each criterion. Instead, it generally states that the device met "pre-determined acceptance criteria" and demonstrated "substantially equivalent" performance to the predicate devices.
However, based on the "Functional Testing" and "Comparative Analysis" sections, we can infer areas where performance was assessed and accepted:
| Acceptance Criteria Category | Reported Device Performance (Implicitly Met) |
|---|---|
| Design Verification | Met or exceeded Transit Scientific's in-house requirements and ISO 10555-1 requirements. |
| Packaging Integrity | Validated in conjunction with sterilization studies. |
| Biocompatibility | Verified according to ISO 10993-1 and FDA guidance for external communicating device with limited exposure (<24hrs) to circulating blood. Specific tests (Cytotoxicity, Irritation/Intracutaneous Toxicity, Sensitization, Systemic Injection, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity) were conducted and presumably met their respective acceptance limits. |
| Functionality (Animal Study) | At least equivalent to the predicate catheter in functionality, safety, and performance (Ovine model). |
| Safety (Animal Study) | At least equivalent to the predicate catheter in functionality, safety, and performance (Ovine model). |
| Performance (Animal Study) | At least equivalent to the predicate catheter in functionality, safety, and performance (Ovine model). |
| Intended Use | Same or similar to predicate devices. |
| Indications for Use | Same or similar to predicate devices. |
| Fundamental Scientific Technology | Same or similar to predicate devices. |
| Material Properties | Same or similar to predicate devices. |
| Operating Principle | Same or similar to predicate devices. |
| Performance Specifications | Same or similar to predicate devices. |
| Patient-User Interface | Same or similar to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "An animal study (Ovine model)" was conducted. However, the specific number of animals or anatomical sites used in this Ovine model is not provided.
- Data Provenance: The animal study data would be considered prospective data, specifically for a pre-clinical assessment in an animal model. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The animal study would likely involve veterinary scientists or surgeons, but the specific number and qualifications of experts for establishing "ground truth" (e.g., assessing lesion scoring effectiveness or adverse events) are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
An MRMC study is not mentioned or implied. The device is a physical catheter, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable to the provided context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
For the animal study:
- The "ground truth" would be established through direct observation and assessment of the anatomical effects of the catheter on the Ovine model, likely involving histological examination, imaging, and macroscopic evaluation to determine functionality, safety (e.g., lack of perforation, dissection), and performance (e.g., successful scoring of lesions). This falls under a combination of pathology and outcomes data (clinical outcomes in the animal model).
For other verification tests (biocompatibility, design verification):
- Ground truth would be established by conformance to established international standards (ISO 10993-1, ISO 10555-1) and Transit Scientific's in-house requirements.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as in point 8.
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