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Bioptimal Bipolar Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.

Bioptimal's Bipolar Pacing Catheter is made of radiopaque polyurethane catheter tubing at a usable length of 110 cm that allows the use of fluoroscopy for guiding the catheter during insertion or to verify its position when necessary. The catheter has radiopaque bands marked every 10 cm along their length to assist the physician in determining the depth of catheter insertion.

The Bipolar Pacing Catheter has an electrode lumen, which provides electrical conductor isolation from electrodes to the connector pins. It has two metal electrodes attached to the distal end of the catheter and the distal electrode forms its distal tip. The proximal electrode is 10 mm apart from the distal electrode.

Bipolar Pacing Catheters are available in two generic models: balloon-guided floatation (with balloon) and semi-floated (without balloon), with or without contamination shield. All models have the same basic design, construction and material. The balloon-guided models(BP2502-10 and BP2502CS-10) includes a latex balloon mounted between the distal and proximal electrodes and associated balloon lumen and tubing extension for inflating and deflating the balloon. The balloon is used for the advancement of the catheter tip by means of balloon flotation in the blood flow. The models with a contamination shield (BP2502CS-10 and BPX2502CS-10) have an expandable shield up to 110cm that provides a sterile environment for the enclosed catheter, and hence prevents the contamination of a catheter as it is inserted into and withdrawn from a body cavity or lumen.

Balloon guided models are supplied with a 1.0cc syringe for balloon inflation.

Bipolar Pacing Catheters are supplied sterile (through ethylene oxide sterilization), non-pyrogenic and are for single use only.

The catheter primary packaging: the catheter is packed in a blue thermoformed polystyrene tray and is covered with a clear APET cover held in place by snap buttons. White label printed with the product name, model ID, manufacturer and authorized representative's information, lot number, expiry date, UDI, symbols and other product information is pasted on the clear APET tray cover. The catheter tray is placed inside a sealed Tyvek bag which forms a single sterile barrier primary packaging.

The catheter is supplied sterile in a box of 5 units of single sterile barrier primary packaging with IFU.

The provided FDA 510(k) clearance letter and summary for the Bioptimal Bipolar Pacing Catheter focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving novel performance. Therefore, typical acceptance criteria and a study design to meet them (as would be seen for a new AI/software device often requiring standalone performance and MRMC studies) are not present in this document.

However, based on the information provided, we can extract the performance goals and reported performance as though they were acceptance criteria, particularly for the clinical data analysis.

Here's an analysis based on the provided text, categorized by your requested information:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sized used for the test set and the data provenance:
* Test Set Size (Clinical Data Analysis): 85 patients
* Data Provenance: Retrospective, Fsingle-center, single-arm, consecutive cases without omission at a hospital in China. Data collected between March 2022 and December 2024.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This information is not provided in the document. The retrospective clinical data analysis implies that patient outcomes and event rates were recorded, likely by the treating physicians or hospital staff, but there's no mention of a separate panel of experts specifically establishing a "ground truth" for the device's performance post-hoc.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* This information is not provided. Given it's a retrospective analysis of clinical outcomes, a formal adjudication process as seen in prospective studies or AI algorithm evaluations is unlikely to have been explicitly detailed for this type of submission.

4. 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, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic or assistive devices. The Bioptimal Bipolar Pacing Catheter is a physical implantable device, not an AI software.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No, a standalone algorithm performance study was not conducted. This device is a physical medical device, not a software algorithm operating in isolation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* For the clinical data analysis, the "ground truth" was based on clinical outcomes data (pacing success, complication events, maintenance of pacing rate) as observed and recorded in a real-world clinical setting.
* For the biocompatibility tests, the ground truth was adherence to established test standards and criteria (e.g., ISO 10993-1:2018).
* For the bench and performance testing, the ground truth was meeting defined specifications and requirements.

7. The sample size for the training set:
* Not applicable / Not provided. This device is a physical medical device, not an AI model that requires a "training set" in the computational sense. The "training" here refers to the engineering, design, and manufacturing processes.

8. How the ground truth for the training set was established:
* Not applicable / Not provided. As above, it's not an AI model with a training set. The "ground truth" for its development would be based on engineering principles, material science, and regulatory standards to ensure functionality and safety. The predicate device also serves as a benchmark for established safety and effectiveness.

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