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The intended use of this device is for the removal of 90° winged infusion sets, THE GRIPPER™, and VasTack™, having a 1-1/2" needle or shorter from implanted ports and the containment of the used needle until placed in a sharps container.

The MedCare Medical Group's HuberLoc is a device designed to assist in the removal and containment of Huber needles. The device consists of three plastic molded components; an inner slide and an outer housing, right and left halves. The HuberLoc is slid over the Huber needle, so the needle cannula is in the slot of the forks. Pressure is applied to the top of the HuberLoc to support the skin and the infusion port with your thumb. The first and middle finger of the same hand pull on the wings of the inner slide, in opposition to the thumb pressure. This action removes the Huber needle and draws it into the outer housing. The inner slide locks into place and contains the needle. The operation utilizes an easy one handed technique. This eliminates any rebound reflex. The HuberLoc is provided sterile, disposable, and for single patient use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HuberLocTM device:

Based on the provided K973497 510(k) summary, there is no explicit mention of acceptance criteria or a formal study with defined endpoints and statistical analysis to prove the device meets acceptance criteria. This submission focuses on demonstrating substantial equivalence to a predicate device, as was common for 510(k) submissions in 1998 for lower-risk devices.

Therefore, many of the requested sections below cannot be fully populated as they are not detailed in this type of regulatory submission.

Acceptance Criteria and Device Performance

There are no formal acceptance criteria or quantitative performance metrics explicitly stated in the 510(k) summary. The summary describes the device's function and claims without providing specific numerical targets for success.

Study Information (Based on available documentation)

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

• Sample Size: Not specified. The document does not describe a formal test set or corresponding sample size.
• Data Provenance: Not specified. There is no mention of a study, so no data provenance is available.

2. 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. There is no mention of a ground truth establishment process or experts in this 510(k) submission.

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

• Not applicable. No formal test set or adjudication method is described.

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

• Not applicable. This document describes a mechanical device, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

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

• Not applicable. This device is a mechanical tool for needle removal and containment, not an algorithm.

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

• Not applicable. No formal ground truth was established as part of this submission. The device's functionality is described, and its "performance" is implied through its design features.

7. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI/algorithm-based system requiring a training set.

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

• Not applicable. As above, no training set was used.

Summary of Device Claims and Basis for Clearance:

The HuberLocTM device received 510(k) clearance based on demonstrating substantial equivalence to a predicate device (Doyle Extractor, K955748). The key differences highlighted are that the HuberLocTM provides containment of the removed sharps, which the predicate device does not. The claims revolve around reducing needle sticks, enabling one-handed operation, and eliminating rebound reflex.

This type of 510(k) submission focuses on comparing the new device's design, materials, and intended use to an already legally marketed device, rather than requiring extensive clinical trials or performance studies with explicit acceptance criteria. The "proof" is largely based on the engineering design and functional description, compared to an existing device with a similar purpose.

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The Biopsy Tray is a single patient, single use, disposable device which is intended to conveniently provide components for the administration of biopsy procedures.

The Biopsy Tray is intended to conveniently provide the auxiliary components utilized during biopsy procedures. The components are items that are commonly used during a variety of biopsy procedures. The Biopsy Tray provides the convenience of having these items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.

The provided text describes a "Biopsy Tray" device and its intended use, but it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement. The document, labeled as a "510(k) Summary," primarily focuses on the device's description, classification, and comparison to a predicate device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the given input.

The information provided only includes:

• Submitted By: MedCare Medical Group, Inc.
• Device Name: Biopsy Tray
• Classification Name: Unknown
• Predicate Device: Basic Stereotactic Core Kit Cat. No. MP-002 from Medical Procedures Inc.
• Description: Conveniently provides auxiliary components for biopsy procedures, sterile, disposable, single-patient use.
• Intended Use: "A single patient, single use, disposable device which is intended to conveniently provide components for the administration of biopsy procedures."
• Technological Characteristics: Similar to the predicate device in providing components and flexibility in customization.

To answer your questions, I would need a different type of document, such as a clinical study report, a validation report, or a section within a regulatory submission that specifically addresses performance data and acceptance criteria.

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The Catheter Insertion Trav is a single patient, single use, disposable device which is intended to conveniently provide components to aid in the administration of percutaneous catheterization.

The Catheter Insertion Tray is intended to conveniently provide the components used to aid the insertion of percutaneous catheters such as: TPN/CVP catheters, PICC Line catheters, and Long Line catheters. The Catheter Insertion Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.

This document does not contain the information required to answer your request. The provided text describes a "Catheter Insertion Tray" and its intended use, but it does not include any acceptance criteria, study details, performance metrics, or information about the development and validation of an AI device. The text is a 510(k) summary for a medical device (a catheter insertion tray), not an AI/ML device.

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The MedCare Regional Anesthesia Kit is a single patient, single use, disposable device which is intended to be used for the administration of regional anesthesia.

The MedCare Medical Group Regional Anesthesia Kit is a disposable, single patient, single use device for the administration of regional anesthesia. The componentry within the kit will vary depending on the customers requirements and the type of regional anesthesia procedure being performed; spinal, epidural-caudal, or nerve block.

This document, K961075, describes a Regional Anesthesia Kit. This type of device, a sterile kit for administering anesthesia, is typically subject to performance testing for sterility, biocompatibility, and functional aspects (e.g., needle integrity, fluid path patency, luer lock connections). However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, or study designs to prove that the device meets any such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It describes the device's intended use and technological characteristics, but not its performance against predefined criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance. No such data is present.
2. Sample size used for the test set and the data provenance. No test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts. This is not applicable as no "ground truth" or expert review process is described for this type of device in the provided text.
4. Adjudication method for the test set. Not applicable.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done. Not applicable, as this is not an AI/imaging device.
6. If a standalone performance (algorithm only) was done. Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used. Not applicable.
8. The sample size for the training set. Not applicable, no training set for an AI/algorithm.
9. How the ground truth for the training set was established. Not applicable.

The document is purely descriptive of the device and its intended uses, asserting its similarity to existing predicate devices. It does not present any performance data or studies that would fall under the categories you've requested.

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The General Purpose Dental Tray is a single patient, single use, disposable device which is intended to conveniently provide general use auxiliary components for the administration of dental procedures.

The General Purpose Dental Tray is intended to conveniently provide the auxiliary components utilized during general dental procedures. The components are items that are commonly used during a variety of dental procedures. The general Purpose Dental Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.

This document is a 510(k) summary for a General Purpose Dental Tray. It describes the device, its intended use, and its technological characteristics in comparison to a predicate device.

The provided text does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided. The document focuses on regulatory submission information rather than performance evaluation.

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The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Y ankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source).

The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). The Suction Connecting Tubing is constructed of polyvinyl chloride (PVC) plastic extruded tubing with injection molded tapered connectors solvent bonded to each end. The connectors and made of PVC and have tapered internal diameters with internal ribs

This is a 510(k) summary for a Suction Connecting Tubing device. It describes the device, its intended use, and identifies a predicate device. However, this document does NOT contain information regarding acceptance criteria, performance studies, or any of the detailed data points you've requested about AI/algorithm performance.

The provided text focuses on the regulatory aspects of introducing a physical medical device (suction tubing), not on the validation of an AI or algorithmic medical device. Therefore, I cannot generate the requested table and information based on this input.

To answer your request, I would need a 510(k) summary (or similar regulatory submission document) for a device that involves an algorithm, AI, or software component whose performance is being evaluated and compared to acceptance criteria.

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The MedCare Tracheostomy Care Tray is a single patient, single use, disposable device which is intended to be used for the administration of tracheostomy care.

The Medcare Tracheostomy Care Tray is intended to provide the components necessary for the care and cleaning of tracheostomy tubes and their insertion sites. The procedure of tracheostomy care includes wound care of the stoma, oral/nasal/pharyngeal/tracheal suctioning, and tracheostomy tube or inner cannula cleaning or inner cannula replacement (in the case of a disposable inner cannula (D.I.C.) system). The kits are provided sterile, disposable, and for single patient use.

The provided text describes a medical device, a Tracheostomy Care Tray, and its intended use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies as requested in your prompt.

Therefore, I cannot populate the table or answer the specific questions about device performance and studies based on the provided input. The text is a 510(k) summary focusing on the device's description, intended use, and comparison to predicate devices, but it lacks the detailed performance study information you are looking for.

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