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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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The CASCADIA implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondvlolisthesis or retrolisthesis 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 intents 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 subject submission describes the Cascadia Interbody System. The implants consist of hollow tube structures made of 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 for a line addition to the lumbar intervertebral body fusion devices previously cleared in the K2M Aleutian Intervertebral Body Fusion System, to include implants additively manufactured from titanium alloy.

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

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the Cascadia Interbody System, which focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than providing detailed performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

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The K7 Lumbar Spacers are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.

The K7 Lumbar Spacers are a collection of radiolucent interbody devices having variously shaped cross-sections. The superior and inferior surfaces are open with parallel serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

The provided text describes the K7 Lumbar Spacers, a medical device for intervertebral body fusion. The study presented focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than a clinical study evaluating the device's performance in a human population.

Therefore, many of the requested categories related to clinical performance metrics, ground truth establishment, expert involvement, and reader studies are not applicable or cannot be extracted from this document, as the FDA 510(k) submission for this device type typically relies on demonstrating engineering and material equivalence for clearance.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression (according to ASTM F2077)
• Dynamic Compression (according to ASTM F2077) | Performance shown to be substantially equivalent to predicate devices. |
  | Subsidence Properties:
• Evaluated according to ASTM F2267 | Performance shown to be substantially equivalent to predicate devices. |
  | Technological Characteristics:
• Intended Use
• Basic Design (hollow column)
• Material (PEEK polymer and tantalum)
• Sizes (widths, lengths, heights within predicate range) | Same as predicate devices. |

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. The mechanical testing was likely performed on a representative sample of K7 Lumbar Spacers of the "worst case" configuration. The specific number of units tested for static, dynamic compression, and subsidence is not provided.
• Data Provenance: The data is from mechanical testing of the device itself (K7 Lumbar Spacers) in a laboratory setting, not from human subjects. Therefore, country of origin or retrospective/prospective clinical data is not applicable.

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

• This is not applicable. The "ground truth" for this device's regulatory clearance is established by engineering standards (ASTM F2077, ASTM F2267) and comparison to predicate device characteristics, not by expert clinical consensus on a "test set" of patient data.

4. Adjudication Method for the Test Set

• This is not applicable, as there was no clinical "test set" involving human interpretation or adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a spinal implant, and its regulatory clearance here is based on mechanical performance and material equivalence, not on the interpretative performance of a diagnostic algorithm or image analysis by human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• No, a standalone study in the context of AI algorithm performance was not done. This device is a physical implant, not an AI algorithm.

7. Type of Ground Truth Used

• For the mechanical performance, the "ground truth" is defined by engineering standards (ASTM F2077 for compression, ASTM F2267 for subsidence) and the established performance/characteristics of legally marketed predicate devices. The goal was to demonstrate that the K7 Lumbar Spacers met or were equivalent to these benchmarks.

8. Sample Size for the Training Set

• This is not applicable. There is no "training set" in the context of machine learning or AI as this is a physical medical device.

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

• This is not applicable. See point 8.

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