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The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectorny procedures in the cervical, thoracic and lumbar spine.

The modified enSpire™ Discectomy System is a single-use discectomy device that is designed to cut and grind intervertebral disc material. An auger mechanism retrieves the excised debris and ejects it into a collection chamber. The modified enSpire™ Discectorny System is supplied as a sterile, single patient use, disposable device.

The provided text describes a 510(k) submission for the enSpire™ Discectomy System, a medical device for discectomy procedures. It focuses on demonstrating substantial equivalence to a predicate device and outlines non-clinical testing performed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of non-clinical (bench) tests performed and makes a general statement about their success.

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

The document does not specify the sample size for any of the non-clinical tests conducted. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective, as these are in-vitro bench studies.

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)

This information is not applicable and not provided. The testing described is non-clinical (bench testing) and does not involve human subjects or expert assessment for ground truth determination in the typical sense of a clinical study.

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

This information is not applicable and not provided, as the studies are non-clinical bench tests, not clinical studies requiring adjudication of outcomes or diagnoses.

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 such study was performed or mentioned. The device is a surgical discectomy system, not an AI-assisted diagnostic tool requiring MRMC studies.

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

This information is not applicable. The device is a mechanical surgical tool, not an algorithm.

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

For the non-clinical bench studies, the "ground truth" would be established by the design specifications and engineering requirements of the device. For example, for "Tensile Strength," the ground truth would be a defined tensile strength threshold. For "No Breach of Annulus or Endplates," the ground truth is the absence of such breaches, directly observed during the in-vitro tissue volume removal testing.

8. The sample size for the training set

This information is not applicable and not provided. The device described is a mechanical surgical tool, not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided, as there is no training set for this device.

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Surgical accessories are indicated for facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

The SpineVu Endoscopic Spine System (SESS) is a collection of arthroscopic surgical accessories provided sterile (irradiated) and intended for single-use only. As a group, the accessories are provided to facilitate delivery of an endoscope and other instruments to the targeted treatment site. The SpineVu Endoscopic Spine System (SESS) consists of the following devices: enVue Cannula, enVue Sheath, 16G Introducer Cannula with Stylet, Guidewire, Dilator, Beveled Cannula, Ball-Tipped Probe, Infusion Cannula, Suction Cannula.

The provided document is a 510(k) premarket notification for a medical device called the "SpineVu Endoscopic Spine System (SESS)". It outlines the device's description, intended use, technological comparison to predicate devices, and non-clinical performance data.

However, the document does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets those criteria, such as a table of accuracy metrics, sample sizes for test/training sets, expert qualifications, or details on ground truth establishment.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical performance testing.

Here's what can be extracted from the provided text, and what is missing:

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

• Acceptance Criteria (Implicit): The implicit acceptance criteria are that the modified SpineVu Endoscopic Spine System (SESS) performs according to its stated intended use and functions as intended, meeting design specifications and external standard requirements. This is a general statement rather than specific quantitative metrics.

• Reported Device Performance: The document states: "All data fell well within product specifications and external standard requirements. Results of non-clinical testing demonstrated that the SpineVu Endoscopic Spine System (SESS) is substantially equivalent to the predicate devices for its intended use."

  There is no table explicitly detailing acceptance criteria alongside reported performance for each criterion with quantitative results. The non-clinical tests conducted are listed as:

  • Visual and Dimensional Verification
  • Device to Device Compatibility Testing
  • Tensile Testing
  • Flow Rate Testing
  • Luer Attachment Testing
  • Leakage Testing
  • Jaw & Trigger Force Testing
  • Jaw Cycle Integrity Testing
  • Jaw Activation Testing
  • Biocompatibility Testing
  • Design Validation Testing
  • Packaging Testing
  • Sterility Testing

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

• Not specified. The document only mentions "non-clinical testing" without detailing the methodologies or sample sizes for each test. 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:

• Not applicable. This is a 510(k) for a surgical accessory based on substantial equivalence and non-clinical (engineering/lab) testing, not a clinical study involving diagnosis or interpretation by experts to establish ground truth for a test set.

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

• Not applicable, for the same reasons as point 3.

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 device is a manual surgical accessory, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was conducted.

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

• Not applicable. This is a physical surgical accessory, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests listed, the "ground truth" would be established by engineering specifications, validated test methods, and industry standards for mechanical performance, material properties, sterility, and biocompatibility. It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. This device is a manual surgical accessory. There is no concept of a "training set" in this context.

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

• Not applicable, as there is no training set.

Summary of Missing Information:

The provided 510(k) summary focuses on demonstrating substantial equivalence through comparison to predicate devices and non-clinical (benchtop) testing results. It does not contain the detailed clinical study information (like test/training set sample sizes, expert qualifications, ground truth establishment for diagnostic accuracy, or AI performance metrics) that would typically be found for a device requiring performance evaluation in a clinical or diagnostic context. The acceptance criteria are implicitly defined by compliance with product specifications and external standards, rather than specific quantitative performance metrics from a user study.

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