Search Results

Ask a specific question about this device

The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

The Integrity Implant is a partially resorbable mesh. The Integrity Implant is designed to provide an augmentation layer over an injured tendon. The patch is comprised of a knitted porous mesh of resorbable Hyaff multifilament fibers and non-resorbable poly(ethylene terephthalate) [PET] multifilament fibers. The patch is provided sterile, for single use only, in a variety of sizes in a thermoformed tray with peelable lid and outer polymer packaging. The device is an easy-to-handle, pliable, nonfriable, porous patch in both the dry and hydrated state.

The Integrity Implant will be made available in 2 sizes:

• 20mm X 25mm
• 25mm X 30mm

The mechanism of action of the Integrity Implant is to function as a protective layer by keeping damaged tendon physically separated from surrounding tissues during healing. It is not intended to replace substantial loss of tendon. Over the course of 4-6 months, the device will be mostly resorbed by the body.

The patch will be used in a surgical environment by a board-certified surgeon. It will be implanted using a standard open or arthroscopic access surgical procedure. It will be fixated at one end to the bone via fixation anchor and at the other end to the repaired tendon via suture or fixation anchor.

The provided document is a 510(k) summary for the Integrity™ Implant, a medical device for managing and protecting tendon injuries. It is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of AI/ML device submissions. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various performance tests. The performance data is presented as evidence that the subject device performs comparably to the predicate.

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

• Animal Study (Test Set):

  • Sample Size: Forty-seven (47) skeletally mature sheep were enrolled.
  • Data Provenance: The study used an adult bilateral infraspinatus model in sheep, making it prospective animal data. The country of origin of the animal study is not specified in this document.

• No human clinical studies were conducted for this 510(k) submission, so there is no human test set data.

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

• For the animal study, the document mentions "gross dissections and harvest," "blood work and distant organ pathology," "radiographic endpoints," and "histology results."
• While these imply expert analysis (e.g., veterinary pathologists, radiologists, histotechnologists/pathologists), the document does not explicitly state the number of experts, their qualifications, or how ground truth was established for the animal study. It only reports the findings (e.g., "Blood work and distant organ pathology were normal," "Histology results from the current study demonstrated...").

4. Adjudication Method for the Test Set:

• The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the animal study. It's typical for animal study results to be interpreted by a single or a small team of experts (e.g., a veterinary pathologist), but this detail is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a surgical implant, not an imaging analysis AI device that would typically involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• No standalone (algorithm only) performance study was done. This device is a physical implant; there is no AI algorithm being evaluated for standalone performance.

7. The Type of Ground Truth Used:

• For the animal study, the "ground truth" was established through a combination of:
  • Direct Observation: Gross macroscopic appearance during dissection.
  • Imaging: Radiographic changes based on AP and lateral radiographs and Micro-Computed Tomography, 3T MRI scanning.
  • Biomechanical Testing: Tensile testing of the repaired rotator cuff.
  • Histopathology: Histological responses.
  • These are all objective biological and physical measurements from the animal model.

8. The Sample Size for the Training Set:

• This submission is for a physical medical device (implant), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning model development. The performance data is generated through bench and animal testing.

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

• As there is no AI/ML algorithm with a training set, this question is not applicable.

Ask a specific question about this device

Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

Integrity Implants Navigated Instruments are specifically designed for use with Medtronic's StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR-based model, finages, or digitized landmarks of the anatomy.

The Integrity Implants Navigated Instruments include non-sterile screw drivers, cannulated and solid taps (4.0 - 10.5 mm), probes, and awls designed to function with the Medtronic StealthStation® System and NavLock® Tracker. The subject devices are for use with the Integrity Implants LineSider® Spinal System (K190360 and K203367). The instruments are manufactured from stainless steel and Radel.

The provided text is a 510(k) summary for the Integrity Implants Navigated Instruments. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for performance as an AI/ML-driven diagnostic or prognostic device.

However, I can extract information related to performance testing and acceptance criteria as much as possible from the provided text, while acknowledging that it's not a typical study report for acceptance criteria in the sense of accuracy, sensitivity, or specificity for AI/ML.

Here's a breakdown of the information based on your request, with limitations due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Limitations: The document does not provide specific quantitative acceptance criteria (e.g., "positional accuracy must be within X mm") or specific quantitative results for each test. It states that tests were "completed to ensure" functionality and compatibility and that the devices are "as safe and effective" as the predicate, implying that acceptance criteria were met, but without detailing them.

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

The document does not specify a "test set sample size" or "data provenance" in the context of typical AI/ML performance studies (e.g., number of images, patient demographics). The performance data cited refers to:

• Accuracy testing: Performed in accordance with ASTM F2554-18. This standard likely dictates the setup and number of measurements, but the specific details (e.g., number of physical instruments tested, number of measurement points per instrument) are not provided.
• Registration testing: Details on the sample size (e.g., number of instruments registered, number of registration attempts) are not provided.
• Dimensional analysis: This likely involved comparing instrument dimensions, but the "sample size" here refers to the number of device types/models evaluated, which can be inferred from Section IV and the comparison table.
• Cleaning and sterilization validation data: Leveraged from a previous 510(k) (K190360). This implies prior validation studies were conducted, but their specific sample sizes are not detailed in this document.

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

This information is not applicable and not provided in the document. This device is a surgical instrument intended for use with a navigation system, not a diagnostic or prognostic AI/ML device that generates clinical findings requiring expert ground truth for a test set. The "ground truth" for its performance would be engineering measurements and physical tests.

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

Not applicable, as this is not an AI/ML diagnostic/prognostic device relying on human expert review for ground truth.

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-assisted diagnostic or prognostic device that involves human readers interpreting output. It's a navigated surgical instrument.

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

This concept is somewhat applicable in the sense that the navigational system's accuracy and the instrument's compatibility with it can be tested independently of a surgeon's clinical use. The "accuracy testing in accordance with ASTM F2554-18" and "registration testing" would fall under this category of standalone performance assessment of the instrument's interaction with the navigation system. The document does not, however, detail specific performance metrics or results from these standalone tests beyond stating they were performed.

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

For the type of device described, the "ground truth" would be established through:

• Physical measurements and engineering standards: For accuracy (e.g., comparing navigated position to physically measured position in a test setup per ASTM F2554-18).
• Functional tests: To confirm proper registration and compatibility with the StealthStation system.
• Dimensional specifications: For dimensional analysis.

It is not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a "training set" process.

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

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

Ask a specific question about this device