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The Lumfuse-TP cage is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Lumfuse-TP cage is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Lumfuse-TP cage is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

The Lumfuse-TP cage consists of PEEK cages of various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782). Two versions of the Lumfuse-TP cage are available: cages coated with medical grade CP Ti (ASTM F1580) and non-coated cages, both of which are provided sterile. The device must be used with supplemental fixation.

The purpose of this submission is to gain initial marketing authorization in the United States for the non-coated, sterile and TPS coated Lumfuse-TP devices. Associated instrumentation has already been cleared in K171630.

The provided text from the 510(k) summary (K173189) does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/algorithm-driven device.

The document describes a medical device called "Lumfuse-TP," which is an intervertebral body fusion device (a PEEK cage for spinal fusion). The submission is for marketing authorization, demonstrating substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria for an AI system.

Here's a breakdown of why this information is missing, based on the provided text:

• Device Type: The Lumfuse-TP is a physical implant (a PEEK cage). It's not an AI/algorithm-driven device for diagnosis, image analysis, or any other predictive task that would typically involve acceptance criteria like sensitivity, specificity, or AUC, and a specific study to validate such performance.
• Submission Type: This is a 510(k) premarket notification. For physical devices like this, the primary goal is often to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving novel performance against predefined acceptance criteria for AI.
• "Non-clinical testing" (b)(1): This section details mechanical performance tests (Static and Dynamic Axial Compression, Static and Dynamic Compression Shear, Subsidence) according to ASTM standards (F2077-14, F2267-04(2011)). It also mentions cleaning, sterilization, and biocompatibility. These are standard tests for physical implants to ensure safety and function, not AI performance.
• "Clinical testing" (b)(2): The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This further confirms that a clinical study to assess performance metrics (like those for AI) was not performed or deemed necessary for this submission.

Therefore, I cannot provide the requested table and details because the source document does not pertain to an AI/algorithm-driven medical device and thus does not contain the information requested in your prompt regarding acceptance criteria and performance studies for such a device.

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The Cervage cage is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks on non-operative treatment. The Cervage cage is to be used with supplemental fixation. The Cervage cage is also required to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

The Cervage cage consists of PEEK cages of various lengths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782). The coated cages are coated with medical grade CP Ti (ASTM F1580) and are provided sterile. The non-coated cages are provided sterile or non-sterile. The device must be used with supplemental fixation. The purpose of this submission is to gain initial marketing authorization in the United States.

This document is a 510(k) premarket notification for a medical device called "Cervage," an intervertebral body fusion device. The FDA's letter indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

Based on the provided document, here's a detailed breakdown regarding the acceptance criteria and study that proves the device meets them:

Crucially, this document states that "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." Therefore, the information requested regarding a clinical study with detailed performance metrics, sample sizes, expert involvement, and ground truth establishment will largely be absent.

The acceptance criteria for this device seem to be primarily based on non-clinical testing demonstrating mechanical performance, cleaning/sterilization effectiveness, and biocompatibility, as well as a comparison to predicate devices to establish substantial equivalence.

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

Since clinical testing was not required and no specific performance metrics like accuracy, sensitivity, or specificity are provided for an AI/algorithm-based device, the "acceptance criteria" here relate to the mechanical, chemical, and biological properties of the physical implant.

Regarding an AI/Algorithm-based device, which this is not:

The questions regarding sample size, data provenance, expert establishment of ground truth, MRMC studies, standalone performance, training set details, and ground truth for training are not applicable to this 510(k) submission, as it is for a physical intervertebral body fusion device and explicitly states that clinical testing was not required for substantial equivalence.

To reiterate why the following points cannot be answered from the provided document:

2. Sample sizes used for the test set and the data provenance: Not applicable; no clinical test set involved. The mechanical testing would have specific sample sizes (e.g., number of devices tested for compression), but that data isn't in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical test set requiring expert ground truth for interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable; no clinical test set.
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/software device, and no clinical study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; no clinical data requiring ground truth collection for diagnostic or prognostic purposes.
8. The sample size for the training set: Not applicable; no AI algorithm to train.
9. How the ground truth for the training set was established: Not applicable; no AI algorithm to train.

In summary, the FDA filing for the Cervage device relies on non-clinical bench testing and comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical trial or AI model validation study.

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The Lumfuse-TP cage is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Lumfuse-TP cage is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Lumfuse-TP cage is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

The Lumfuse-TP cage consists of PEEK cages of various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782).

This FDA 510(k) summary is for a medical device (LumFuse-TP, an intervertebral body fusion device) and therefore primarily focuses on substantial equivalence to a predicate device based on mechanical and material properties, rather than AI model performance. As such, the requested information regarding AI model acceptance criteria, study details, and expert involvement is largely not applicable in this context.

However, I can extract the relevant information regarding the device itself and explain why the AI-related questions are not addressed by this document.

Device: LumFuse-TP (Intervertebral Body Fusion Device)

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

Note: The document states that "The worst case devices were evaluated for mechanical performance...". While it lists the standards, it does not provide specific numerical acceptance criteria or performance values. This is typical for a 510(k) summary, which generally affirms compliance to standards rather than detailing raw test results.

The following questions are NOT APPLICABLE as this document describes a physical medical device (intervertebral body fusion cage) and its mechanical/biocompatibility testing, not an AI/software as a medical device (SaMD).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable for this device. (Relates to AI/software validation)

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 for this device. (Relates to AI/software validation)

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable for this device. (Relates to AI/software validation)

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 for this device. (Relates to AI/software validation)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable for this device. (Relates to AI/software validation)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable for this device. For physical devices, "ground truth" generally refers to validated test standards and material specifications.

8. The sample size for the training set
Not Applicable for this device. (Relates to AI/software development)

9. How the ground truth for the training set was established
Not Applicable for this device. (Relates to AI/software development)

Summary from the document:

• Clinical Testing: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This reinforces that the evaluation was based on non-clinical (mechanical, material, sterilization, biocompatibility) testing.
• Purpose: The submission's purpose was to gain initial marketing authorization by demonstrating substantial equivalence to an existing predicate device (Medtronic® CAPSTONE).
• Conclusion: "Based on the information provided in this premarket notification, we believe that the subject Lumfuse-TP demonstrates substantial equivalence to the identified predicate device."

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Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion implants. The size of Kirschner wire should be adapted to the specific indications

The Precifit Medical Kirschner wire is a stainless steel (316LVM) wire available with two point styles: smooth and threaded. The wires are available in various diameters (1.0 - 2.5mm) and lengths (120 -200mm). One end is fixed on standard surgical power tool equipment for insertion. The Precifit Medical Kirschner wire is supplied non-sterilized by the end user. It is intended for single use only.

This document is a 510(k) premarket notification for the Precifit Medical Kirschner Wires and does not contain information about an AI/ML powered device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, and AI/ML specific metrics.

The document pertains to a medical device (Kirschner Wires) that are physical implants used for bone fixation, not a digital health product or algorithm. The sections referring to "Non-clinical testing" and "Clinical testing" confirm that the device conforms to an international standard (ISO 5838-1 (2013)) and that clinical testing was not required to demonstrate substantial equivalence. This indicates a traditional medical device submission, not one involving AI/ML performance evaluation.

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