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The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, 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 discogenic pain 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). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications

Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.

The Sirion Lateral 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 Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

Here's an analysis of the provided text regarding the SIRION Lateral Lumbar Interbody Fusion device:

The provided document is a 510(k) summary for the SIRION Lateral Lumbar Interbody Fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria through clinical performance.

Based on the provided text, a table of acceptance criteria and reported device performance for a clinical study to prove performance against specific metrics is not available. The document explicitly states: "No clinical studies were performed."

Instead, the submission relies on non-clinical testing and a comparison to predicate devices to establish substantial equivalence.

Here's what can be extracted from the document regarding testing and comparisons:

1. Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing and Equivalence):

Note: The document only states "The results of these evaluations indicate that the Sirion implants are equivalent to predicate devices." It does not provide specific numerical acceptance criteria or detailed results from these non-clinical tests.

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

• Test Set Sample Size: Not applicable. No clinical test set was used, as "No clinical studies were performed."
• Data Provenance: The non-clinical testing (FEA and Mechanical) was conducted internally or by a contracted lab for Astura Medical. The data provenance details (e.g., country of origin, retrospective/prospective) are not specified in the summary but would be part of the full 510(k) submission.

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

• Not applicable. No clinical test set was used, and therefore no ground truth established by experts for performance evaluation.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No MRMC comparative effectiveness study was done. The document explicitly states "No clinical studies were performed."

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

• Not applicable. This device is a physical medical implant, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" would be established by validated engineering standards (ASTM F2077, ASTM F2267, etc.) and direct physical measurements and observations during testing (e.g., expulsion force, deformation under load). This is a technical ground truth based on established engineering principles and standardized test methods.

8. The Sample Size for the Training Set:

• Not applicable. There is no mention of a "training set" in the context of an AI/ML algorithm, as this is a physical medical device. The "training" for this type of device development involves established engineering design principles, material science, and manufacturing processes.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as no training set for an AI/ML algorithm is mentioned.

Summary of the K202495 Submission:

This 510(k) clearance for the SIRION Lateral Lumbar Interbody Fusion device is based on demonstrating substantial equivalence to previously cleared predicate devices (Sirion Lateral Lumbar Interbody Fusion K192006, Half Dome K152512, K163481, K172947, K182877, and ATEC ALIF and LLIF Spacer System K182746). The equivalence is supported by non-clinical testing (FEA for static/dynamic compression and shear, subsidence, and mechanical expulsion testing) which showed the new device to be comparable. No clinical studies were performed or required for this 510(k) clearance. The acceptance criteria are therefore implicit in the demonstrated equivalence to existing legally marketed devices and adherence to relevant ASTM standards for mechanical performance.

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The EL CAPITAN Anterior 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 discogenic pain 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). EL CAPITAN 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 EL CAPITAN Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When used with anchors, the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the Lumbar spine.

The EL CAPITAN Anterior 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). The Spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights, and the plates are offered in multiple fixation types and sizes 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)

This document is a 510(k) summary for the EL CAPITAN Anterior Lumbar Interbody System, a medical device for spinal fusion. This device is not an AI/ML-enabled device, and therefore, the requested information about acceptance criteria and studies demonstrating AI performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) is not applicable.

The document explicitly states: "No clinical studies were performed." This indicates that the device's substantial equivalence to predicate devices was based on non-clinical tests (mechanical and material properties), rather than clinical performance data. Therefore, there are no acceptance criteria related to AI/ML performance metrics, nor any studies proving such performance.

The non-clinical tests conducted establish the device's mechanical safety and performance, demonstrating equivalence to predicate devices. The acceptance criteria for these non-clinical tests would be the established ASTM standards mentioned (e.g., ASTM F2077, ASTM F1717, ASTM F2267).

To summarize why the specific points of your request cannot be answered from this document:

• Acceptance Criteria & Reported Device Performance (Table): Not applicable for AI/ML performance. The device's performance is shown through compliance with mechanical testing standards.
• Sample sizes & Data Provenance (Test/Training Sets): Not applicable as there is no AI/ML component. Mechanical tests have their own sample size requirements per ASTM standards.
• Number of experts & Qualifications: Not applicable as there is no AI/ML component and no clinical studies were performed requiring expert reading.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable.
• Type of ground truth: Not applicable for AI/ML. The "ground truth" for this device's safety and efficacy is derived from its mechanical properties, material biocompatibility, and demonstrated equivalence to previously cleared predicate devices through non-clinical testing.
• Sample size for training set & How ground truth established: Not applicable.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

1. Intended Use
2. Design
3. Materials Used (PEEK-OPTIMA LT120HA, Tantalum, Titanium Alloy, Nitinol)
4. Mechanical Safety and Performance (Non-clinical tests: Static/Dynamic Compression, Static/Dynamic Compression Shear, Subsidence, Expulsion per ASTM standards).

Therefore, this document does not contain the information required to answer your prompt, as it pertains to a traditional medical device, not an AI/ML-enabled one.

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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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