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The Idys™ TLIF 3DTi cages are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a posterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The Idys™ TLIF 3DTi cages, which have various widths and heights, are designed for use as a lumbar intervertebral body fusion device. The device has to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device contains a slot to receive the autologous bone graft to promote the fusion process between the endblates. The Idvs™ TLIF 3DTi cages are made of compliant ASTM F136 Titanium alloy. The device is manufactured using an additive manufacturing process to result in a porous material with tightly defined structure. It is essential to insert implants with instrumentation specifically designed for this purpose.

The provided text describes CLARIANCE's Idys™ TLIF 3DTi, an intervertebral body fusion device. Here's an analysis of the acceptance criteria and study proving the device meets them:

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it refers to industry standards (ASTM F2077 and ASTM F2267) and states that the device's performance was found to be "substantially equivalent" to legally marketed predicate devices.

Here's a summary based on the provided text:

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 mentions "Performance testing was conducted according to ASTM F2077 and ASTM F2267." It does not specify the exact sample size for each test performed (e.g., number of devices tested for axial compression, expulsion, etc.).

• Sample Size: Not explicitly stated as a number (e.g., "n=5" for each test). The ASTM standards themselves would specify minimum sample sizes for such tests.
• Data Provenance: The testing was conducted by CLARIANCE, SAS, located in France. The provenance of the test data is, therefore, from their internal testing. It's a prospective set of tests designed specifically for this regulatory submission.

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 to this type of device and study. The "ground truth" for a mechanical device like an intervertebral fusion cage is established through physical and mechanical testing against predefined standards or comparison to a predicate device's performance, not by expert consensus on clinical findings or images.

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

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving interpretative tasks (e.g., image reading) where multiple experts assess cases to reach a consensus for ground truth. For mechanical performance testing, the results are objectively measured against established criteria or predicate device performance.

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. The device is an orthopedic implant (an intervertebral body fusion device), not an imaging analysis or AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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 physical implant, not an algorithm. Standalone performance for an algorithm would assess its accuracy in tasks like disease detection or measurement without human intervention.

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

The "ground truth" for this device's performance evaluation is based on:

• Compliance with recognized testing standards: ASTM F2077 (for static and dynamic compression, shear, and torsion) and ASTM F2267 (for subsidence). These standards define the methodologies and acceptable performance envelope.
• Mechanical equivalence to predicate devices: The device's performance was compared directly to that of legally marketed predicate devices, meaning the established mechanical characteristics of those predicates served as the benchmark for "ground truth" in terms of what constitutes safe and effective mechanical performance for this type of implant.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI or algorithm development. The "training" for such devices typically refers to the iterative design and development process, which doesn't involve a quantifiable "training set" of data in the same way.

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

This information is not applicable for the same reason as point 8; there is no "training set" in the sense of machine learning for this physical device. The "ground truth" for the design and development process would be established through engineering specifications, material science principles, clinical needs, and regulatory requirements that guide the creation of the device.

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The Renovis S141 Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

The Renovis S141 Lumbar Interbody Cage System is FDA cleared as K143126. This application describes a manufacturing change to the K143126 S141 Ti6Al4Vcages; internal dimensional changes; additional cages geometries; and a packaging change. The new name of the system is the Renovis S141 Lumbar Interbody Fusion System (S141 System).

The S141 System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion.

The Ti6Al4V is compliant with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The system also includes instruments which are manufactured from stainless steel in compliance with ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.

This document describes the Renovis S141 Lumbar Interbody Fusion System, a medical device, and primarily focuses on its substantial equivalence to a predicate device, rather than providing details on a study that proves its performance against acceptance criteria in the context of algorithm-based device performance. The information provided is for a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, not necessarily a performance study against predefined acceptance criteria for an AI/algorithm-driven device.

Therefore, many of the requested sections related to acceptance criteria for algorithmic performance, sample sizes for test sets, expert ground truthing, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as they are not applicable to the type of information presented.

However, I can provide information based on what is available in the document regarding the device's characteristics and the types of testing performed for substantial equivalence.

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

The document does not explicitly state acceptance criteria for the device in the format of a clinical or algorithmic performance study with specific metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on substantial equivalence to a predicate device and bench testing results. The "performance" reported relates to the mechanical and biological safety of the modified device components.

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

This information is not provided in a way that aligns with an algorithmic device test set. The document refers to "testing" that was "successfully conducted" for mechanical and biological properties. No sample size for a "test set" in the context of data for an algorithm is mentioned. Data provenance (country of origin, retrospective/prospective) is also not applicable or mentioned.

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. This device is a physical implant, not an AI/algorithm-driven diagnostic or prognostic tool that would require expert ground truthing of data.

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

Not applicable, as there is no "test set" in the context of an algorithm's performance and associated ground truth 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

Not applicable. This document is for a physical medical implant (lumbar interbody fusion system), not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies are not relevant.

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

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

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

Not applicable. The "ground truth" for this device would relate to its physical properties, material composition, and biological safety as measured by laboratory tests and adherence to standards, which are inherently objective measurements rather than interpretations requiring expert consensus on imaging or clinical data.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/algorithm-driven system.

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

Not applicable, as there is no training set for this device.

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The CASCADIA implants are indicated for use with autgenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use as either one level or two contiguous levels from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intended to be used in patients who have had six months of non-operative treatment.

For all the above indications the CASCADIA implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.

The implants consist of hollow tube structures additively manufactured from titanium alloy. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional implant sizes into the system.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cascadia Interbody System, addressing your specific questions.

Important Note: The provided document is an FDA 510(k) summary for a spinal interbody fusion device. These types of devices are primarily mechanical implants. The document does not describe an AI/software device or a study involving human readers or expert consensus for image interpretation. Therefore, many of your questions related to AI studies, ground truth establishment, reader performance, and training/test set sample sizes for AI models are not applicable to this physical medical device submission.

I will answer the questions based on the information available in the document, clarifying when a question is not applicable to this type of device.

Analysis of Cascadia Interbody System 510(k) Summary (K160547)

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

For mechanical implants, acceptance criteria are typically defined by engineering standards and performance benchmarks against predicate devices. The document states:

Note: Specific numerical acceptance criteria (e.g., "must withstand X N of compression") are not provided in this summary, but are inherent in the referenced ASTM standards and predicate equivalence.

2. Sample sizes used for the test set and the data provenance

• Test Set (for performance evaluation): The document refers to "the worst case implants for the Cascadia Interbody System were previously tested." It does not specify the sample size (N) for these mechanical tests. It implies that only representative "worst-case" configurations were tested, and engineering rationales were used for other sizes.
• Data Provenance: The data provenance for mechanical testing is not explicitly mentioned (e.g., "conducted in a lab in USA"). It's internal company testing or testing done by a contracted lab. The data is inherent to the device's design and manufacturing process.
• Retrospective/Prospective: Not applicable to mechanical testing of physical device performance.

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 mechanical medical device, not an AI or diagnostic imaging device that requires expert ground truth for interpretation. Performance is assessed through engineering testing and comparison to established standards and predicate devices.

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

Not applicable. This is a mechanical medical device study, not a study involving human reader interpretation or clinical 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

Not applicable. This is a mechanical medical device. No human reader studies or AI assistance are involved in this 510(k) submission.

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

Not applicable. This is a mechanical medical device. There is no algorithm for standalone performance.

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

The "ground truth" for this device's performance is established by engineering standards (e.g., ASTM F2077, ASTM F2267) and benchmarking against predicate devices. Its functional safety and effectiveness are supported by demonstrating that it performs "equally to or better than" devices already on the market and that its materials and design are substantially equivalent.

8. The sample size for the training set

Not applicable. This is a mechanical medical device. There is no AI training set.

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

Not applicable. There is no AI training set.

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