Search Results

The device consists of a manual syringe and display to be used during Angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

The Osprey Medical Contrast Monitoring System (CMS) allows for monitoring and display of manually injected contrast volumes. Volumes are displayed and compared to physician entered contrast usage thresholds during angiographic procedures.

The use of the system is intended to provide the user an easier way to measure cumulated volumes and support physician-determined minimization of contrast volumes. The additional benefit of the system is to allow for a visual and audible indication of when the cumulated volume injected into the patient is approaching a physician determined contrast volume threshold. This allows for attentive physician decision-making of total contrast volumes use during a patient case while allowing the physician's primary focus to remain on the image and the therapeutic need of imaging.

The provided document does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is primarily a 510(k) summary and an FDA clearance letter for a "Contrast Monitoring System."

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly presented in a table format with specific acceptance criteria and corresponding performance metrics for the device's main function (contrast monitoring accuracy). The provided text mentions "bench testing...demonstrates that the Contrast Monitoring System meets product specification, meets performance requirements and demonstrates substantial equivalence." It lists categories of tests performed (e.g., "accuracy testing of cumulative and individual injection volume measurement along with display verification"), but it does not provide the specific acceptance criteria for these tests (e.g., "accuracy must be within +/- X% of actual volume") nor the numerical results for the device's performance against those criteria.

2. Sample size used for the test set and the data provenance: Not specified for the core performance tests (e.g., accuracy of volume measurement). For "Simulated Use (Animal and Bench)," it states "Animal testing was conducted with swine model," but no sample size for the animals is given. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For the "Simulated Use (Animal and Bench)" which included animal testing, it mentions "conducted with swine model by three physicians." Their specific qualifications (e.g., years of experience, specialization) are not provided. For other performance tests like "accuracy testing of cumulative and individual injection volume measurement," the method for establishing ground truth and any expert involvement is not described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified based on the type of non-clinical testing described. The tests are primarily technical performance evaluations rather than image interpretation or diagnostic studies requiring adjudication.

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 MRMC study was mentioned. The device is a 'Contrast Monitoring System' for manual injection with a display, not an AI-powered diagnostic imaging tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device involves a human operator (physician) manually injecting contrast while the device monitors and displays volumes. Therefore, a purely standalone algorithm evaluation without human interaction would not be directly relevant to its intended use and is not described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "accuracy testing of cumulative and individual injection volume measurement," the ground truth likely refers to precisely measured actual volumes of contrast injected, compared against the device's displayed measurements. However, the specific method for establishing this "ground truth" (e.g., by gravimetric analysis, calibrated syringes) is not detailed.

8. The sample size for the training set: Not applicable and not mentioned. The device is a monitoring system and does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for an AI/ML model.

In summary, the provided document focuses on regulatory clearance by demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It lists categories of tests performed and states that "all testing passed," but it lacks the detailed quantitative acceptance criteria and specific performance outcomes you've requested for each criterion.

Ask a specific question about this device

The NAMIC RCS is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media and saline solutions during an angiographic procedure.

Piston Syringe

This application is for a medical device (NAMIC RCS, a piston syringe) and not an AI/ML device. Therefore, the requested information regarding acceptance criteria for AI/ML performance, study design with human readers, ground truth establishment, and training/test set details is not applicable. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data and material comparisons.

Here's an analysis based on the provided document, addressing the relevant sections:

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

The document does not explicitly state quantitative acceptance criteria in a tabled format for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through adherence to recognized standards and non-clinical testing.

Reported Device Performance (as described by the sponsor):
"The NAMIC RCS is substantially equivalent to the predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included the performance evaluation conducted in accordance with the following FDA guidance documents, international standards, and testing which included:

• FDA's "Guidance on the Content of Premarket Notification 510(k) Submissions for Piston Syringes dated April 1993"
• ISO 7886-1:1997 "Sterile Hypodermic Syringes for Single Use -- Part 1: Syringes for Manual Use"
• ISO 594-2:1998 "Conical Fittings 6% (Luer) Taper for Syringes, Needles, Certain Other Medical Equipment - Part 2: Lock Fittings"

The conclusion states: "The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent."

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 is a non-clinical device submission. Testing would likely involve bench testing of physical samples, not clinical data sets.

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. Ground truth for AI/ML algorithms is not relevant for this device. The evaluation is based on engineering and material standards.

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

Not applicable. This is not an AI/ML device, so no adjudication of expert opinions on a test set is relevant.

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 not an AI/ML device, and no MRMC studies are relevant.

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

Not applicable. This is a physical medical device (syringe), not an algorithm.

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

Not applicable. The "ground truth" for this device would be established by compliance with engineering standards and specifications, and potentially functional testing against established benchmarks for syringes (e.g., force to depress plunger, leak integrity, Luer taper dimensions).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, no training set for an AI/ML algorithm is involved.

Ask a specific question about this device

VITOSS® Scaffold Synthetic Cancellous Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. VITOSS Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. VITOSS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

VITOSS Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

The VITOSS-Filled Cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This Cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Scaffold® and deliver the material to the orthopaedic surgical site.

The Vitoss-Filled Cartridge is a device that combines two Orthovita products, Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337) and the Imbibe II Syringe (K030208) into a kit configuration. The convenience kit provides the Imbibe II Syringe loaded (filled) with Vitoss Scaffold and an empty 30cc secondary syringe (Merit Piston Syringe. K875196). An adapter valve, which can be connected to the vacuum line in the surgical suite, is also provided. The surgeon can use either the secondary syringe or the vacuum line adapter to aspirate blood or marrow into the Vitoss-Filled Cartridge.

The provided text describes a 510(k) submission for the Orthovita Vitoss-Filled Cartridge, which is a combination of two existing products: Vitoss Scaffold bone void filler and the Imbibe II Syringe.

However, the document does not contain any information about a study proving the device meets specific acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on the combination of existing cleared components without changes to their individual designs. Therefore, a table of acceptance criteria and reported device performance cannot be generated from this text, nor can other study-specific details.

The 510(k) summary explicitly states: "No changes have been made to the Vitoss Scaffold or the Imbibe II Syringe." This indicates that the regulatory approval is based on the established safety and efficacy of the individual components and their combination into a convenience kit, rather than on new performance studies for the combined product.

Ask a specific question about this device