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The ECLIPSE™ Filter System - Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulants are contraindicated. .
• Failure of anticoagulant therapy for thromboembolic disease. .
• Emergency treatment following massive pulmonary embolism where anticipated . benefits of conventional therapy are reduced.
• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed . or is contraindicated.
  ECLIPSE™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.

The ECLIPSE™ Filter consists of twelve electropolished shape-memory nitinol wires emanating from a central electropolished nitinol filter hook. These 12 wires form two levels of embolic filtration: the legs provide the lower level of filtration and the arms provide the upper level of filtration. The ECLIPSE™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.
The ECLIPSE™ Filter System - Femoral Delivery Kit consists of a 7 French inner diameter (I.D.) introducer catheter and dilator set and a storage tube preloaded with the ECLIPSE™ Filter and pusher system. The dilator is fitted with 2 radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The storage tube and pusher system attach to the introducer and allow for delivery and deployment of the ECLIPSE™ Filter.
The ECLIPSE™ Filter System – Jugular/Subclavian Delivery Kit consists of a 10 French I.D. introducer catheter and dilator set and a delivery device preloaded with the ECLIPSE™ Filter. The dilator is fitted with 2 radiopaque marker bands spaced 28 mm apart for caval sizing. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and has a delivery mechanism to deploy the ECLIPSE™ Filter.

The provided text describes the ECLIPSE™ Filter System, an intravascular filter, and its FDA 510(k) submission (K101431). However, it does not contain information related to acceptance criteria or a study proving device performance using clinical data, AI, or human-in-the-loop performance.

The submission focuses on demonstrating substantial equivalence to a predicate device (K093659) based on modifications primarily related to labeling and minor physical changes (addition of a kangaroo pouch). The performance testing described is limited to in vitro testing for packaging, sterilization, and latex, which are not directly about the clinical efficacy or diagnostic performance of the filter itself.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered:

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

• NotFound: The document does not provide specific acceptance criteria or clinical performance metrics related to the filter's efficacy (e.g., emboli capture rate, complication rates). It only mentions that in vitro tests (packaging, sterilization, latex) demonstrated comparability to the predicate device.

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

• NotFound: No clinical test set or data provenance is mentioned. The testing was in vitro.

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)

• NotFound: As no clinical test set is described, there's no mention of experts establishing ground truth.

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

• NotFound: Not applicable as there's no clinical test set.

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: No MRMC study was done, and the device is a physical filter, not an AI-assisted diagnostic tool for human readers.

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

• No: This is a physical medical device, not an algorithm.

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

• Not Applicable: For the in vitro tests mentioned (packaging, sterilization, latex), "ground truth" would relate to meeting pre-defined physical or chemical specifications, not clinical outcomes or expert consensus on a diagnosis.

8. The sample size for the training set

• NotFound: No training set is mentioned as this is a physical device, not an AI model.

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

• Not Applicable: No training set is mentioned.

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SmartPin® is indicated for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization.

SmartPin® is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical Dearing 'oches, 'osteochonies and cancellous/non-load bearing fragments.

SmartPin® is not intended for use in and is contraindicated for: 1) Fractures and Sthart mis is not intended for assess cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) treatment of which patient co operation callier see effect of SmartPin® upon the healing of growth plate has not been tested clinically.

The device description of SmartPin® is as follows:

• Composed of poly-96L/4D-lactide copolymer -
• Tapered, smooth pins -
• Lengths 10 70mm -
• Diameters 1.1, 1.5, 2.0, 3.2 and 4.5 mm -

The dimensions and shape are completely identical with Linvatec Biomaterials The unnersholis and brin) (K010983), SmartPin® PDX (the previous PLGA Pin) (K003659) and Biofix SR-PGA Pin (K890902).

This document is a 510(k) premarket notification for a medical device called SmartPin®, submitted by Linvatec Biomaterials Ltd. in 2004. The purpose of a 510(k) is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and thus does not require a PMA (Premarket Approval). This type of submission does not typically involve the presentation of clinical study data with acceptance criteria for device performance as would be required for a novel device or one requiring a PMA.

The information provided describes the device, its intended use, and its similarities to previously cleared predicate devices. The FDA's letter (K041288) confirms that the device is substantially equivalent to the predicate devices and can be marketed.

Therefore, many of the requested categories related to clinical study data, acceptance criteria, and performance metrics are not applicable in this 510(k) context.

Below is an attempt to address your request based on the provided document, indicating where information is not applicable:

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

• Acceptance Criteria: For a 510(k) submission based on substantial equivalence, the primary "acceptance criterion" is demonstrating that the new device has the same or similar intended use, operating principle, basic design, manufacturing process, packaging, and sterilization as the predicate devices, and does not raise new questions of safety or effectiveness.
• Reported Device Performance: The document does not report specific quantitative performance metrics against pre-defined acceptance criteria, as this is a substantial equivalence claim rather than a de novo or PMA submission. The performance is implicitly considered equivalent to the 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)

• Not applicable. This 510(k) submission relies on demonstrating substantial equivalence to predicate devices, not on new clinical study data with a specific test set. The document leverages information about previously cleared devices.

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. No new clinical study data with ground truth establishment is described in this 510(k) submission.

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

• Not applicable. No new clinical study data with adjudication is described in this 510(k) submission.

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 device for bone fixation, not an AI/imaging diagnostic device. No MRMC study was conducted or is relevant to this 510(k).

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

• Not applicable. This is a physical medical device (bone fixation pin), not an algorithm or software.

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

• Not applicable. No new clinical study data requiring ground truth is described in this 510(k) submission. The "ground truth" for this submission is the regulatory precedent set by the predicate devices.

8. The sample size for the training set

• Not applicable. No training set for an algorithm or new clinical data is described.

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

• Not applicable. No training set or ground truth establishment relevant to an algorithmic or novel device performance study is described here.

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