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The Endius Atavi System is indicated for use for posterior access and visualization in the surgical area of cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi system would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The visualization components of the system include: an endoscope, a light source, light guide, a camera control unit, and a camera head.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This 510(k) summary for the Endius Atavi System does not contain any information related to specific acceptance criteria or a study designed to prove the device meets those criteria.

The document is a regulatory submission focused on demonstrating substantial equivalence to previously cleared predicate devices. It describes the device, its intended use, and confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to existing marketed devices.

Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, ground truth establishment, or expert involvement because this information is not present in the provided text.

Here's why:

• No Acceptance Criteria: The document does not define any quantitative or qualitative performance metrics that the device is intended to meet.
• No Study Details: There are no descriptions of any performance studies, clinical trials, or validation tests. The submission hinges on substantial equivalence, meaning it relies on the safety and efficacy of its predicate devices, rather than presenting new performance data for the modified device.
• Focus on Substantial Equivalence: The core of this 510(k) is the assertion that the "proposed Endius Atavi System is substantially equivalent to the current Endius Atavi System" (Section 5.8). This regulatory pathway often means that detailed performance studies might not be required if the device is sufficiently similar to a legally marketed predicate.

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The Endius Atavi System is indicated for use for posterior or anterior access and visualization in the surgical area of the cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi™ System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The overying tobace, as were of the system include, an endoscope, a light source, light guide, a camera control unit, and a camera head.

The provided text is a 510(k) summary for the Endius® Atavi System, which is an endoscopic spinal access system. It describes the device, its indications for use, and states its substantial equivalence to previously cleared devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway that often relies on comparison of design, materials, and intended use, rather than extensive performance studies with acceptance criteria in the same way a de novo or PMA application might require.

Therefore, I cannot provide the requested information based on the input text. The sections of your request (1-9) would typically be found in detailed verification and validation reports, clinical study reports, or specific performance testing summaries, which are not present in this 510(k) filing.

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The Endius® Atavi™ System is indicated for use for posterior or anterior access and visualization in the surgical area of the cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius® Atavi™ System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The visualization components of the system include, an endoscope, a light source, light guide, a camera control unit, and a camera head.

The provided text does NOT contain information about acceptance criteria, device performance metrics, or any study details that would typically be associated with proving a device meets specific acceptance criteria. This document is a 510(k) summary for the Endius Atavi System, which primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

The document discusses:

• Device Name: Endius Atavi System
• Submitter and Contact Information: Endius, Inc.
• Classification: Class II, Endoscope and Accessories
• Predicate Devices: Sofamor Danek Microendoscopic Discectomy System and Medtronic Sofamor Danek METRx System (K002931)
• Device Description: Instruments for tissue dilation, retracting device, visualization components (endoscope, light source, light guide, camera control unit, camera head).
• Indications for Use: Posterior or anterior access and visualization in cervical, thoracic, or lumbar spine for surgical procedures like discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Also, generic surgical use in knee, ankle, shoulder, hand, wrist, and TMJ.
• Substantial Equivalence: Claimed to the listed predicate devices.
• FDA Response Letter: Confirms substantial equivalence and allows marketing.

There is no mention of:

1. Acceptance criteria or reported device performance (e.g., accuracy, sensitivity, specificity, resolution, field of view, etc.).
2. Sample sizes for test sets or training sets.
3. Data provenance (country of origin, retrospective/prospective).
4. Number of experts or their qualifications.
5. Adjudication method.
6. MRMC comparative effectiveness study or effect size with AI assistance.
7. Standalone algorithm performance.
8. Type of ground truth used.
9. How ground truth was established.

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The Endius Atavi System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized.

The Endius Atavi System is also intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateral fusion procedures.

The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The visualization components of the system include, an endoscope, a light source, light guide, a camera control unit, and a camera head.

1. Table of Acceptance Criteria and Reported Device Performance:

   The provided document does not explicitly state acceptance criteria in a quantitative or qualitative manner against which the Endius Atavi System's performance is measured. Instead, it refers to "validation testing (performance testing)" as part of a Special 510(k) submission, confirming compliance with design control requirements.

   Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text. The basis for substantial equivalence is primarily rooted in comparison to predicate devices, indications for use, and technological characteristics, rather than specific performance metrics against pre-defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:
   The document does not provide information regarding a specific "test set" with a sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission is a "Special 510(k): Device Modification," which focuses on demonstrating compliance with design control requirements and relevant validation testing for the modification. This type of submission typically doesn't involve clinical studies with test sets in the same way as a de novo or traditional 510(k) for a new device might.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
   Not applicable. The document does not describe a study involving a "test set" for which ground truth was established by experts.

4. Adjudication Method for the Test Set:
   Not applicable. The document does not describe a study involving a "test set" that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence based on technological characteristics and indications for use compared to predicate devices, and design control compliance for modifications, not on measuring human reader improvement with or without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
   No, a standalone (algorithm only) study was not done. The Endius Atavi System is an endoscopic spinal access system, a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used:
   Not applicable. The document does not describe a study that established "ground truth" using expert consensus, pathology, or outcomes data. The submission is a Special 510(k) for a device modification, focusing on verifying that the modified device continues to meet its intended purpose and safety requirements in line with predicate devices.

8. Sample Size for the Training Set:
   Not applicable. The Endius Atavi System is a physical medical device, not an AI or algorithm that would require a "training set."

9. How Ground Truth for the Training Set Was Established:
   Not applicable. As the device is not an AI or algorithm, there is no "training set" or "ground truth" establishment process for it in this context.

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