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The Tiger Discectomy Device is indicated for use in endoscopic and non-endoscopic spinal procedures to assist in the removal of fibrous disc material between the T12 to S1 spinal segments.

The Tiger Discectomy Device is a single-use manual instrument. The components of the device include a "T" handle, a shaft, two cutting blades and blade holder, retaining pins and a blunt tip. Cutting blades are available in 8mm, 10mm and 12mm widths. A cannula is provided for endoscopic applications. The device is provided sterile.

Here's an analysis of the provided text regarding the "Tiger Discectomy ® Device" and its acceptance criteria, focusing on the requested information.

It's important to note that the provided text is a 510(k) summary for a medical device. This type of filing primarily aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through rigorous clinical studies as might be expected for novel or high-risk devices. Therefore, much of the requested information about clinical study details (like sample size for test sets, expert involvement, MRMC studies, ground truth for training data) is not typically found in a 510(k) summary for this type of device.

The provided document focuses on the design and intended use of the device, rather than detailed performance metrics that would necessitate such studies.

1. Table of Acceptance Criteria and Reported Device Performance

• Disk Whisk Cutting Device (K971342)
• Trans1 Trans-sacral Spinal Access and Preparation Device (K032891) |

Explanation: In a 510(k), acceptance criteria are often implied by demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This means it performs similarly and has similar technological characteristics to previously approved devices. Specific, quantitative performance acceptance criteria (e.g., "removes X grams of tissue with Y% efficiency") are typically not detailed in this type of submission unless a new performance claim is being made or a significant difference from the predicate exists. The "reported device performance" is essentially the description of the device and its intended function, aligning with the predicate.

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

• Sample Size: Not applicable. The 510(k) summary does not describe a clinical study with a "test set" for performance evaluation in the way a diagnostic algorithm or a novel therapeutic device might. Substantial equivalence is often demonstrated through comparisons of design, materials, and intended use, and sometimes non-clinical (e.g., bench) testing, rather than human clinical trials for devices like this.
• Data Provenance: Not applicable, as no dedicated clinical test set is described.

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

• Number of Experts: Not applicable. No clinical test set requiring expert-established ground truth is described.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set is described.

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

• MRMC Study Done? No. This device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve an MRMC study.
• Effect Size of AI Improvement: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done? No. This is a manual surgical instrument, not an algorithm, so a "standalone" or "algorithm-only" performance study is not relevant.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No clinical study with ground truth establishment is described in this 510(k) summary. For a surgical instrument like this, the "ground truth" of its function would likely be demonstrated through mechanical testing (e.g., cutting efficacy on cadaveric tissue) and comparison to the predicate device's design and performance claims, rather than a clinical outcome measure requiring expert-adjudicated ground truth.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device does not use machine learning or AI, so there is no "training set."

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable, as there is no training set for an algorithm.

Summary of Study Type:

The document describes a 510(k) Premarket Notification whose primary purpose is to demonstrate substantial equivalence to existing predicate devices (Disk Whisk Cutting Device K971342 and Trans1 Trans-sacral Spinal Access and Preparation Device K032891). This is not a clinical performance study with defined acceptance criteria in the sense of an efficacy trial. Instead, the "study" is a comparison of the new device's design, materials, indications for use, and technological characteristics to those of the predicate devices. The approval indicates that the FDA found the device to be as safe and effective as the predicate devices, based on this comparison and presumably non-clinical testing data (which is not detailed in this summary).

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The Phenix Cervical Interbody Device (Phenix CID) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Phenix CID implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

The Phenix ® Cervical Interbody Device is a cervical interbody fusion device made from PEEK Optima. It is implanted from the anterior approach. The device is provided in various geometries and is designed to fit within the outer cortex of cervical spine vertebrae. It is to be packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

The provided text is a 510(k) summary for the Phenix® Cervical Interbody Device (Phenix® CID). It describes the device, its indications for use, and identifies predicate devices. However, it does not contain details about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria by comparing it to an AI system or human reader performance.

The "Performance Testing" section states: "The pre-clinical testing performed indicated that the Phenix CID is substantially equivalent to the predicate devices and is adequate for the intended use." This suggests that the device's performance was evaluated against the predicate devices for achieving substantial equivalence, which is a regulatory standard for medical devices. However, it does not provide quantitative acceptance criteria or detailed study results in the context of an AI device and reader performance.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated, with the understanding that detailed performance metrics are not included for AI or reader studies:

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

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

• Not provided. The summary mentions "pre-clinical testing" but does not detail sample sizes, data provenance, or whether the study involved human subjects (which would be the case for a test set in the context of AI/reader 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):

• Not applicable/Not provided. This device is a physical implant, not an AI diagnostic tool that requires ground truth established by experts for performance evaluation in the way a diagnostic AI would. The "pre-clinical testing" would likely refer to mechanical and material tests rather than expert-adjudicated diagnostic performance.

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

• Not applicable/Not provided. Similar to point 3, this is not relevant for the type of device 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:

• No. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

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

• Not applicable. This is a physical medical implant, not an algorithm.

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

• Not applicable/Not provided in the context of AI/reader studies. For this device, "ground truth" for "pre-clinical testing" would refer to established engineering standards for mechanical and material properties (e.g., strength, durability, biocompatibility).

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical medical device, not an AI model.

In summary, the provided document is a 510(k) summary for a cervical interbody fusion device, focusing on its physical properties and intended use, and demonstrating substantial equivalence to predicate devices. It does not contain information related to AI performance, reader studies, or the types of "test sets" and "training sets" that would be relevant for an AI-powered diagnostic device.

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