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The Medi-Globe® Injectra Needle is used in conjunction with various legally marked, FDA registered flexible endoscopes. The Injectra Needle is used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures.

The Injectra Injection Needle is a device that is used to deliver solutions into tissues of the digestive tract through the accessory channel of a legally marketed endoscope.

Acceptance Criteria and Study Details for Injectra Injection Needle

This submission (K061222) pertains to the Injectra Injection Needle and demonstrates its substantial equivalence to a predicate device. The performance data focuses on verification that the new device meets established requirements and maintains safety, rather than providing complex clinical trial outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state a sample size for a test set in the traditional sense of a clinical or analytical study with a defined dataset. The performance data section refers to "Design verification data" and "Biological testing," which are typically internal engineering and laboratory tests.

• Test Set Sample Size: Not explicitly stated as a defined "sample size" for a dataset. Design verification and biological testing are usually conducted on a set number of manufactured devices or materials.
• Data Provenance: The nature of "Design verification data" and "Biological testing" suggests these are results from internal testing conducted by the manufacturer, Medi-Globe Corporation. The country of origin and whether it is retrospective or prospective are not specified, but such tests are generally prospective (performed on new designs or materials).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This submission does not involve expert-established ground truth for a test set in the context of diagnostic accuracy. The "ground truth" for this type of device (an injection needle) is largely based on engineering specifications, material properties, and established biological safety standards. There is no mention of external experts being used to establish a ground truth for performance.

4. Adjudication Method for the Test Set

Not applicable. The performance data described are based on objective engineering and laboratory tests, not subjective interpretations requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Injectra Injection Needle is an interventional accessory device.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (algorithm only) was not conducted. This device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance relies on:

• Engineering Specifications and Performance Requirements: Measured against pre-defined functional parameters (e.g., fluid delivery capability, structural integrity, compatibility with endoscopes).
• Predetermined Safety Standards: Biological testing confirms the device meets accepted biocompatibility standards.
• Equivalence to Predicate Device: The primary ground truth is established by demonstrating that the new device performs identically or equally well to the legally marketed predicate device (K955558) in terms of its intended function and safety profile.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI system that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.

The SonoTip 11 Ultrasound Needle System is complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single 101 I mo Noode Aspirature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This provides adjusted has been miss to precisely adjust the working length of the instrument to that of the specific ultrasound endoscope scope being used.

The provided text describes the SonoTip II Ultrasound Needle System and its 510(k) clearance. However, it does not contain detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or details about the studies (e.g., standalone, MRMC, or training set specifics) that would allow for a comprehensive breakdown as requested.

The document states:

• "Design verification data has demonstrated that the SonoTip II Ultrasonic Needle System meets design requirements and is as safe and effective as the predicate device."
• "The SonoTip II Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical characteristics and general range of descriptive features as the predicate Medi-Globe Ultrasound Needle System (K990220)."

This indicates that the clearance was based on substantial equivalence to a predicate device (GIP/Medi-Globe GI Ultrasound Needle System (K990220)) rather than a detailed clinical performance study with specific acceptance criteria and metrics. The "Performance Data" section primarily asserts equivalence.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document refers to "Design verification data" but does not detail its source or nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Not specified.

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; an MRMC study was not done. This device is a manual medical instrument (a needle system), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Not applicable. This is a physical medical device (needle system), not an algorithm.

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

• Not specified. Given the nature of the device (FNA needle), a typical "ground truth" for its performance might involve mechanical testing (e.g., needle sharpness, bend resistance, fluid aspiration efficiency) and biocompatibility, as well as a comparison of histological samples obtained with the device vs. the predicate, but these details are not provided.

8. The sample size for the training set

• Not applicable. This device is a physical instrument, not an AI model, so there is no "training set."

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

• Not applicable. As above, no training set.

Summary of available information:

The 510(k) clearance for the SonoTip II Ultrasound Needle System was based on demonstrating substantial equivalence to a legally marketed predicate device (Medi-Globe Ultrasound Needle System, K990220). The documentation does not provide specific performance metrics, detailed study designs, sample sizes, or information about expert involvement typically associated with a human-AI performance study. Instead, it relies on "design verification data" to assert that the device meets design requirements and is as safe and effective as the predicate.

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The Medi-Globe Balloon Dilatation Catheters are intended to be used for Endoscopic Dilation of Biliary Tract, Esophageal or Shincter Stenosis.

The balloon dilatation catheter is a nylon balloon mounted on a double lumen catheter. Proximately the device is fitted with either one or two luer fittings. The balloon dilatation catheters with balloon diameters larger than 12 millimeters have only one luer fitting that allows for balloon inflation. Balloon dilatation catheters with balloon diameters smaller than 12 millimeters have two luer fittings, one for passage of a guide wire and the other for balloon inflation.

The provided document is a 510(k) summary for a medical device (Medi-Globe Balloon Dilatation Catheter) seeking substantial equivalence to existing devices. It focuses on device description, intended use, and comparison to predicate devices, and refers to biological and bench testing.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative manner as one might find for diagnostic accuracy. Instead, it demonstrates equivalence to predicate devices and safety through testing. The reported performance is primarily focused on physical characteristics and safety margins.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study or a "test set" in the context of device performance evaluation against a gold standard for accuracy or diagnostic capability. The "testing" mentioned refers to:

• Biologic testing: on materials for safety.
• Bench testing: on the device (balloon) for mechanical integrity (burst pressure).

Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this context, as there isn't a patient-centric "test set" described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As there is no "test set" evaluated against a ground truth in the context of diagnostic accuracy, this information is not applicable. The safety and mechanical testing would have been conducted by qualified laboratory personnel, but not "experts" establishing a clinical ground truth for a test set.

4. Adjudication Method for the Test Set

This is not applicable as there is no clinical "test set" or adjudication process described.

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

This is not applicable. The device is a balloon dilatation catheter, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance effect size are irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The concept of "ground truth" as typically used for diagnostic or screening devices is not applicable here. The "ground truth" for this device's evaluation is based on:

• Predicate device characteristics: Demonstrating similar physical and functional properties to already approved devices.
• Biocompatibility standards: Evaluating material safety against established biological safety standards.
• Mechanical engineering principles: Testing burst pressure against design specifications and safety margins.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" for an algorithm or a dataset in the context of this physical device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

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The GIP/ Medi-Globe Needle System for Ultrasonic FNA is specifically designed for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).
The Medi-Globe Needle System for Ultrasonic FNA is designed to be used with the Pentax FG32, 34, 36, 38 UA ultrasound endoscopes for ultrasonically guided fine needle aspiration (FNA of submucosal and extra-luminal lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).

Not Found

The provided document is a 510(k) summary for the GIP/Medi-Globe Needle System for Ultrasonic FNA. It is a premarket notification for a medical device and, as such, does not contain the detailed information required to describe acceptance criteria and a study proving a device meets those criteria.

510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device, rather than providing comprehensive efficacy studies that would include acceptance criteria, performance metrics, sample sizes, ground truth establishment, or human reader studies.

Therefore, none of the requested information can be extracted from the provided text, as it focuses on regulatory submission details and claims of substantial equivalence.

Specifically, the document does not contain information related to:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The intended use of the GIP Medi-Globe Hot Biopsy Forceps is identical to the Wilson-Cook device for removal of small polyps in the GI track.

The GIP/Medi-Globe Hot Biopsy Forceps are similar in design, composition (stainless steel and Teflon), and function and performance to the Wilson-Cook GI Hot Biopsy Forceps. The device is designed to be used in conjunction with numerous FDA Approved endoscopes. The entire device can be autoclaved or ETO gas sterilized. The Hot Biopsy Forceps are shipped assembled and sterile in a peel-open package. The working lengths of all of the GIP/Medi-Globe Hot Biopsy Forceps range from 1,200, 1,800, 2,300.

This document does not describe an AI/ML powered medical device. It describes a hot biopsy forceps, a physical medical instrument used for tissue sampling. Therefore, the requested information regarding acceptance criteria, study design, ground truth, and expert involvement for an AI/ML model is not applicable.

The document discusses the safety and effectiveness of the GIP/Medi-Globe Hot Biopsy Forceps by comparing it to a previously cleared device (Wilson-Cook GI Hot Biopsy Forceps, K874314). The assessment is based on design, materials, intended use, method of operation, cleaning/sterilization, and biological reactivity, rather than algorithmic performance.

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