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The HALF DOME POSTERIOR LUMBAR INTERBODY SYSTEM 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 L1-L2 to L5-S1. DDD is defined as discogenc pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). HALF DOME SYSTEM implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

This document is a 510(k) Premarket Notification for a medical device called the "HALF DOME Posterior Lumbar Interbody System". This type of submission is for demonstrating substantial equivalence to a predicate device, rather than for proving safety and effectiveness through clinical trials with specific acceptance criteria related to device performance in generating data. Therefore, the information requested in your prompt regarding acceptance criteria for a study proving the device meets acceptance criteria is not applicable in the context of this 510(k) submission.

Here's why and what information is available:

• 510(k) Submissions are for Substantial Equivalence: A 510(k) seeks to demonstrate that the new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and indications for use, and by performing non-clinical (bench) testing. They generally do not involve clinical studies with acceptance criteria for algorithm performance, expert ground truth, or MRMC studies.

• "Acceptance Criteria" in a 510(k) context: When the term "acceptance criteria" is used in a 510(k) non-clinical test summary, it refers to pre-defined thresholds for mechanical performance during bench testing (e.g., minimum load required to fail, maximum displacement under load). These tests are designed to show the device performs mechanically similar to or better than the predicate device.

Information provided in the document related to your prompt, adapted for a non-clinical device submission:

Here's a breakdown of the relevant sections from your request, with an explanation of why some are not applicable to this type of regulatory submission:

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

Since this is a mechanical interbody fusion device, the "acceptance criteria" and "reported device performance" are related to non-clinical (bench) testing methods to ensure the physical integrity and function of the implant. The document states:

Note: The document explicitly states "The results of these evaluations indicate that the Titanium Half Dome implants are equivalent to predicate devices." This implies that the device met the pre-defined criteria for equivalence to the predicate devices in these mechanical tests. Specific numerical acceptance criteria and performance values are typically detailed in the full test reports, which are not included in this summary.

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

• Sample Size: Not explicitly stated for each test in this summary. For mechanical bench testing, sample sizes are typically small (e.g., n=5 or n=10 per test condition) and determined by statistical considerations for materials testing.
• Data Provenance: The tests are non-clinical, controlled laboratory experiments. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply. The tests were performed by the manufacturer (Astura Medical) or a contracted lab.

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 is a mechanical device, not an AI or diagnostic device that requires expert interpretation to establish ground truth for a test set. The "ground truth" for mechanical testing is derived from physical measurements and material properties.

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

• Not Applicable. As there's no expert interpretation for ground truth, there's no adjudication method.

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 surgical implant, not a diagnostic or AI-powered imaging tool that would involve human readers or AI assistance.

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

• Not Applicable. This device does not involve an algorithm.

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

• Ground Truth: For non-clinical bench testing, the "ground truth" is established through physical measurement standards and engineering specifications. For example, the load at which a device deforms or fractures is a directly measurable physical property, not subject to expert consensus in the same way clinical diagnoses are. The "truth" is defined by the physical laws and material science.

8. The sample size for the training set

• Not Applicable. There is no "training set" for this type of mechanical device submission, as it does not involve machine learning algorithms.

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

• Not Applicable. As there is no training set, this question is irrelevant.

In summary, the provided document relates to a 510(k) submission for a physical medical device (interbody fusion system), not a diagnostic or AI-powered software device. Therefore, many of the questions asked in your prompt are not applicable to this context, as they pertain to the evaluation of algorithms or diagnostic performance with human interpretation. The "proof" for this device meeting acceptance criteria comes from its performance in standardized mechanical bench tests, demonstrating its equivalence to existing predicate devices.

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The Half Dome Posterior Lumbar Intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to LS-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

This document describes the regulatory approval of a medical device, the HALF DOME Posterior Lumbar Interbody System, and focuses on its substantial equivalence to previously approved predicate devices. It does not present a study proving the device meets specific performance acceptance criteria for an AI or diagnostic algorithm.

The document explicitly states: "No clinical studies were performed" for this specific submission (K172947). Instead, the substantial equivalence claim is based on non-clinical tests (mechanical and material properties) demonstrating similarity to predicate devices.

Therefore, I cannot provide the information requested in your prompt as it pertains to a study evaluating an AI or diagnostic algorithm's performance. The prompt's requirements (e.g., sample size, expert consensus, MRMC study, ground truth) are not applicable to this type of medical device submission.

The "acceptance criteria" discussed in this document are primarily related to:

• Mechanical and material performance: Ensuring the device is structurally sound and made of appropriate biocompatible materials.
• Intended Use: The device performs its designed function within the specified patient population and anatomical locations.
• Substantial Equivalence: The new device is as safe and effective as a legally marketed predicate device.

If you had provided a document describing a study for an AI/diagnostic algorithm, I would have extracted the requested information. However, based on the provided text, this is a traditional medical device (implant) approval lacking the type of performance study you are asking about.

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The Half Dome Posterior Lumbar Intervertebral body fusion body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

This document describes the Half Dome Posterior Lumbar Interbody System, a medical device, and does not provide information about an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as AI performance, training/test sets, ground truth establishment by experts, adjudication, or MRMC studies) are not applicable.

The acceptance criteria and study information provided pertain to the non-clinical testing performed to demonstrate substantial equivalence to predicate devices, as is typical for 510(k) submissions of this nature where clinical studies are not performed.

Here's the information based on the provided text, focusing on the device's substantial equivalence:

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

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated in terms of a "sample size" for a clinical or AI test set. Non-clinical testing typically involves a set number of physical samples for each test (e.g., several implants for compression testing). The document does not specify the number of implants tested for each mechanical test.
• Data Provenance: The data is derived from non-clinical bench testing (mechanical tests) performed by the manufacturer, Astura Medical. There is no information on country of origin for this testing, nor is it retrospective or prospective in the clinical sense.

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. The ground truth for this device's acceptance is established through compliance with established ASTM standards for mechanical testing and comparison to legally marketed predicate devices, not through expert consensus on interpretation of data like in an AI/ML context.

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

• Not Applicable. Adjudication methods are relevant for clinical studies or expert consensus, which were not performed for this 510(k) submission.

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-powered device, and no MRMC 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-powered device.

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

• For the non-clinical tests, the "ground truth" is defined by the performance requirements and methodologies outlined in the specified ASTM standards (e.g., ASTM F2077, ASTM F2267) and the performance characteristics of the identified predicate devices. The substantial equivalence argument posits that if the new device performs within acceptable limits established by these standards and similar to the predicate devices, it is safe and effective for its intended use.

8. The sample size for the training set:

• Not Applicable. This is not an AI-powered device.

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

• Not Applicable. This is not an AI-powered device.

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The Half Dome Posterior Lumbar Interbody System are 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 L1-L2 to LS-S1. DDD is defined as discogenic with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Half Dome Posterior Lumbar Interbody TLIF and OTLIF are implants developed for the substitution of the classical autogenous bone graft blocks. They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). X-ray markers allow the position to be determined post-op.

This document is a 510(k) Premarket Notification for the Half Dome Posterior Lumbar Interbody System. It describes the device, its intended use, and its equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for a diagnostic algorithm.

The information provided is for a physical medical device (an intervertebral body fusion device), not a diagnostic algorithm or AI system. Therefore, the questions related to algorithmic performance metrics, sample sizes, ground truth, experts, and MRMC studies are not applicable to the content of this document.

Here's what can be extracted from the document regarding the "study" for this type of device and its equivalence:

The "study" in this context refers to non-clinical testing to demonstrate mechanical safety and performance, and the "acceptance criteria" are implied by showing the device performs similarly to or better than predicate devices according to established engineering standards.

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):

• Sample Size for Test Set: Not specified in the document. For mechanical testing, this would typically refer to the number of physical device samples tested.
• Data Provenance: Not applicable in the traditional sense for non-clinical mechanical testing. The tests are performed in a lab setting by the manufacturer (Astura Medical, located in Carlsbad, CA, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for mechanical testing is based on engineering standards (ASTM F2077, ASTM F2267) and direct measurement of physical properties, not expert consensus on medical images or clinical outcomes.

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

• Not applicable. Mechanical test results are objective measurements against established ASTM standards, not subject to adjudication by medical experts.

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 physical medical device, not a diagnostic algorithm. No MRMC study was performed.

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

• Not applicable. This is a physical medical device.

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

• For non-clinical mechanical testing, the "ground truth" is defined by adherence to specific engineering standards (e.g., ASTM F2077 for static and dynamic compression, ASTM F2267 for subsidence) and objective measurements of device performance under controlled conditions.

8. The sample size for the training set:

• Not applicable. There is no training set as this is not an AI/ML algorithm.

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

• Not applicable. There is no training set.

In summary: The provided document is a 510(k) submission for a physical intervertebral body fusion device. The "study" referenced refers to a series of non-clinical mechanical tests to demonstrate the device's safety and performance characteristics and its substantial equivalence to previously cleared predicate devices. It does not involve patient data, clinical outcomes, or AI algorithm performance metrics.

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