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The Spine View Minimally Invasive Surgical (MIS) Decompression System is indicated for use to facilitate access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and is accessorized with surgical tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

The Minimally Invasive Surgical (MIS) Decompression System 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 addition of a new accessory, the enCise Bone Cutter, as an additional surgical tool to facilitate removal of soft and hard (bone) tissue during interventional spinal procedures. The new component will be offered in two configurations: one compatible with flexible endoscopes, and the second compatible with rigid endoscopes. Two additional enVue Cannula models are also being introduced for compatibility with rigid endoscopes: Long and Standard Jaw. Introduction of the new enCise Bone Cutter and additional configurations of the already cleared enVue Cannula do not affect the intended use or alter the fundamental scientific technology of the system.

The additional accessories being proposed in the modified MIS Decompression System are listed below:

• . enCise Bone Cutter: a tubular sheath with a mechanical "chisel" tip feature designed to cut soft and hard (cartilaginous, bone) tissue during spinal procedures. The enCise Bone Cutter is offered in two configurations (one compatible with flexible endoscopes, and the second compatible with rigid endoscopes).
• enVue Cannula, Standard and Long Jaw: configurations for use with rigid . endoscopes. The working end of the accessories is identical to the previously cleared enVue Cannulas. The only difference is in the handle, which is modified to accommodate rigid endoscopes (up to 5.9 mm OD; 205 mm working length).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Spine View, Inc. Minimally Invasive Surgical (MIS) Decompression System:

Based on the provided 510(k) Summary (K121548), the device in question is a minimally invasive surgical system, and the filing primarily focuses on demonstrating substantial equivalence to predicate devices for specific new accessories (enCise Bone Cutter, and new enVue Cannula configurations). This type of submission generally relies on non-clinical performance data to show that the new components perform as intended and do not raise new questions of safety or effectiveness compared to legally marketed devices. It is not a study about the performance of an AI/ML algorithm. Therefore, many of the requested categories regarding AI-specific studies, ground truth establishment, expert consensus, and reader studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in terms of specific thresholds for performance metrics. Instead, it refers to validation against "product specifications and external standard requirements" and aims to demonstrate "substantial equivalence" to predicate devices. The "reported device performance" is summarized as the successful completion of various non-clinical tests.

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

This information is not applicable as the submission describes non-clinical performance testing of mechanical components, not an AI/ML algorithm or a study with a "test set" of patient data. The tests would likely involve prototypes or production units of the device components. There is no mention of country of origin of data or retrospective/prospective in this context.

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

This information is not applicable. The ground truth for this type of medical device submission is typically established through engineering specifications, material science standards, and established biocompatibility principles, performed by qualified engineers and scientists. There are no "patient cases" or an "AI test set" requiring clinical expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. There is no "test set" in the context of clinical data requiring adjudication.

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 information is not applicable. No AI/ML algorithm is involved in this device submission. This is a special 510(k) for mechanical surgical instruments.

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

This information is not applicable. No AI/ML algorithm is involved in this device submission.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" is based on:

• Engineering specifications and design requirements: Each test would have a pre-defined performance envelope or target.
• External standards: Relevant ISO standards, ASTM standards, or other industry benchmarks for material properties, sterility, biocompatibility, and mechanical performance.
• Predicate device characteristics: To demonstrate substantial equivalence, the performance of the new device is compared against the known performance and characteristics of the predicate devices.

8. The sample size for the training set

This information is not applicable. There is no AI/ML algorithm and therefore no "training set" of data in this submission.

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

This information is not applicable. There is no AI/ML algorithm and therefore no "training set." The ground truth for the design and testing of the mechanical device is established through engineering principles, material science, and regulatory standards as described in point 7.

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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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The SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope are indicated for use for endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and are accessorized with surgical and coagulation tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

The SESS kit is a collection of arthroscopic surgical accessories, including a bipolar RF electrosurgical accessory. The Spine Vu MiniScope is an arthroscope.

The provided text is related to a 510(k) Premarket Notification for the "SpineVu Endoscopic Spine System (SESS)" and "SpineVu MiniScope." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a comparative study with a ground truth, as would typically be described for AI/ML device evaluations.

Therefore, many of the requested elements (acceptance criteria table, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of regulatory submission. This document describes a medical device, not a software or AI device that would have performance metrics like sensitivity, specificity, or AUC against a ground truth.

However, I can extract information about the types of testing performed to support the substantial equivalence claim.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Note: This 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device (endoscopic spine system) to previously cleared predicate devices, rather than establishing performance against specific acceptance criteria for an AI/ML algorithm or software as commonly described in device performance studies for AI. Therefore, the response will focus on the types of evidence provided to support the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as typically found in AI/ML device studies, is not present in this document. Instead, the submission relies on demonstrating substantial equivalence based on intended use, design, and certain testing types.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) as it's not an AI/ML performance study with a 'test set' of data.
• Data Provenance:
  • Biocompatibility data and bench testing are laboratory-based.
  • Cadaver testing involves human cadavers. Specific country of origin is not mentioned.
  • The studies described are for regulatory submission to the FDA, implying they were conducted to support this submission. They are not framed as "retrospective" or "prospective" clinical studies.

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

• Not applicable. This submission focuses on the safety and effectiveness of a physical medical device through substantial equivalence, not on the performance of a software or AI algorithm requiring expert-established ground truth. Expert involvement would be in the design, testing, and regulatory review process, but not for "ground truth" calibration for a test set.

4. Adjudication Method

• Not applicable. No adjudication method is described as this is not an AI/ML performance study requiring expert consensus on data labels.

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

• No. An MRMC comparative effectiveness study is not mentioned or implied because this is a physical medical device, not an AI/ML interpretive or diagnostic aid. The "effectiveness" is primarily demonstrated through the intended use and lack of new safety/efficacy concerns compared to predicates.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. The device is a physical endoscopic spine system, not an algorithm.

7. Type of Ground Truth Used

• Not applicable in the AI/ML sense of labeled data. The "truth" for this submission revolves around:
  • Compliance with established standards (ISO 10993 for biocompatibility)
  • Functional performance against engineering specifications and clinical expectations (bench testing)
  • Feasibility of intended use (cadaver testing)
  • Equivalence to predicate devices (demonstrated through comparative analysis of intended use, technology, materials, and safety/performance data).

8. Sample Size for the Training Set

• Not applicable. The device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As there is no AI/ML training set, there is no ground truth establishment process for it.

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