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SAGICO IBF System - ARIA Lumbar implants are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

SAGICO IBF System - ARIA Lumbar are to be filled with autogenous bone graft material. The SAGICO IBF System -ARIA Lumbar implant is intended to be used with supplemental fixation cleared by the FDA to properly utilize this device.

The SAGICO IBF System - ARION Cervical implant is interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) weeks of non-operative treatment.

The SAGICO IBF System - ARION Cervical implant is to be filled with autogenous bone graft material and placed via open anterior approach. The SAGICO IBF System – ARION Cervical implant must be used with additional internal fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

SAGICO IBF System - ARIA Lumbar implants are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. SAGICO IBF System - ARIA Lumbar implants are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral and can expand to the desired height. The SAGICO IBF System - ARIA Lumbar implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO IBF System - ARIA Lumbar implants are to be filled with autogenous bone graft material. Protrusions are located on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

SAGICO IBF System - ARION Cervical implants are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. SAGICO IBF System - ARION Cervical implant is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. SAGICO IBF System - ARION Cervical implants are comprised of PEEK Optima LT1 and include large central hollow window to be filled with autogenous bone graft material. SAGICO IBF System - ARION Cervical implants features protrusions located on the top and bottom surfaces of PEEK spacers to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion. SAGICO IBF System - ARION Cervical includes internal titanium spin blade offering internal fixation and expansion of 1mm in height allowing low profile insertion. SAGICO IBF System - ARION Cervical implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device.

The SAGICO IBF System ARIA Lumbar and ARION Cervical implants are manufactured from medical Grade PEEK (Polyetheretherketone) OPTIMAT LT I (Invibio"") per ISO 10993-1 USP Class VI, and ASTM F2026, Titanium Alloy per ASTM F136 and Tantalum beads /rods to be Grade IINS R05200, IINS R05400 according to ASTM F560.

The SAGICO IBF System ARIA Lumbar and ARION Cervical implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical and lumbar regions.

Here's a breakdown of the acceptance criteria and study information for the SAGICO IBF System - ARIA Lumbar and ARION Cervical devices, based on the provided document:

This document describes a 510(k) premarket notification for intervertebral body fusion devices, which means the approval process focuses on demonstrating substantial equivalence to already legally marketed devices, rather than establishing a completely new safety and effectiveness profile through extensive clinical trials. Therefore, the "study" referred to is a non-clinical performance study comparing the device to predicates, not a clinical trial with human subjects.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For a 510(k), explicit numerical acceptance criteria for each test are often not provided in the summary document but are implicitly understood to be meeting or exceeding the performance of the chosen predicate devices according to recognized standards. The "reported device performance" is essentially that the device performed substantially equivalently to the predicates in these tests.

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

• Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., how many devices were tested for compression, shear, etc.). It refers to "non-clinical performance data testing."
• Data Provenance: This is a non-clinical, in-vitro study. Therefore, there is no country of origin for patient data. The data is generated from laboratory testing of the devices.

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

• This question is not applicable in the context of this 510(k) submission. "Ground truth" usually refers to clinical diagnoses or outcomes established by medical experts for a diagnostic or AI-driven system. Here, the "truth" is established by adherence to engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not applicable. This is a non-clinical engineering study, not a clinical study requiring adjudication of expert opinions.

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

• No. This is a mechanical intervertebral body fusion device, not a diagnostic or AI-driven imaging interpretation system. MRMC studies are not relevant here.

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

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

7. The Type of Ground Truth Used

• The "ground truth" for these types of devices is established by engineering standards and material specifications. The device's performance is compared against the requirements outlined in standards like ASTM F2077, F2267-04, F04.25.02.02, and material standards (ISO 10993-1, ASTM F2026, F136, F560). The "truth" is that the device meets these established performance and material safety benchmarks, demonstrating substantial equivalence to predicate devices that also meet these benchmarks.

8. The Sample Size for the Training Set

• Not applicable. There is no concept of a "training set" for a physical medical implant device in this context. This is not an AI/machine learning application.

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

• Not applicable, as there is no training set for a physical implant device.

Summary of the Study:

The study described is a non-clinical performance evaluation focusing on the mechanical and material characteristics of the SAGICO IBF System - ARIA Lumbar and ARION Cervical devices. The goal was to demonstrate substantial equivalence to legally marketed predicate devices, a requirement for 510(k) clearance by the FDA. The testing included:

• Mechanical Testing: According to ASTM F2077 (Static and Dynamic Compression, Compression Shear, Torsion) and ASTM F2267-04 (Subsidence), and ASTM F04.25.02.02 (Static Push-out Test).
• Material Biocompatibility: Assessed by the use of medical-grade materials (PEEK Optima LT1, Titanium Alloy, Tantalum beads/rods) that comply with established international and ASTM standards (ISO 10993-1 USP Class VI, ASTM F2026, ASTM F136, ASTM F560).

The conclusion of this non-clinical testing was that the SAGICO IBF System devices demonstrated performance substantially equivalent to legally marketed predicate devices, thus supporting their clearance for market.

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1. The ARION Alexandrite Laser is intended for use in dermatology for hair removal for skin types Fitzpatrick I - IV.

The ARION is a 755 nm solid-state long-pulsed Alexandrite laser system. The beam is directed to the treatment area by a transmission system which is connected to the laser device. The EPI Zoom Ax transmission system consists of a hand piece attachment with a firmly attached fiber and a hand piece. The hand piece insert can be moved within the hand piece and determine the application and parameter ranges. The hand piece insert in the transmission system hand piece can snap into various positions. The number located closest to the hand piece indicates the spot diameter on the skin in mm (spot sizes: 6/8/10/12/14 mm). The integrated hand piece detection feature automatically shows the selected spot diameter on the laser display. The parameter range is also automatically adjusted for the corresponding range. The MedArt 928 scanner for ARION consists of a scanner with a connected transmission system and a spacer with a 8, 9, 10 and 12 mm spot size. The spacer determines the spot diameter on the skin and therefore the parameter range of the configurable energy densities as well. The spacers are inserted into the scanner as shown below and must be inserted into the scanner up to the limit stop position. The spacers now automatically sets a spot diameter of 8, 9, 10, and 12 mm on the skin; this is also shown automatically on the laser display. The parameter range is also automatically adjusted for the corresponding range. For epidermal cooling can be a cooling device adapted to the handpiece / scanner.

The provided text is a 510(k) summary for the Wavelight Arion device. A 510(k) summary typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against specific acceptance criteria.

Based on the provided document, here's what can be extracted and what is explicitly stated as not presented:

Acceptance Criteria and Device Performance (Not presented)

The document explicitly states: "6. Performance Data None presented." This means that acceptance criteria and reported device performance against those criteria are not included in this 510(k) summary. The submission relies on substantial equivalence to predicate devices, not on new performance data.

Therefore, the following table cannot be filled from the provided text:

Here's an analysis of the other requested information:

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

• Sample size: Not applicable/Not provided, as no performance data or test set is mentioned.
• Data provenance: Not applicable/Not provided.

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

• Not applicable/Not provided, as no test set or ground truth establishment is mentioned.

4. Adjudication method for the test set:

• Not applicable/Not provided, as no test set or adjudication is mentioned.

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:

• No MRMC comparative effectiveness study was done or reported. This device is a laser system for hair removal, not an AI-assisted diagnostic tool typically evaluated with MRMC studies.

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

• Not applicable. This is a physical medical device (laser system), not a software algorithm or AI model.

7. The type of ground truth used:

• Not applicable/Not provided, as no performance data or ground truth is mentioned. The submission is based on substantial equivalence.

8. The sample size for the training set:

• Not applicable/Not provided, as no machine learning model or training set is mentioned.

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

• Not applicable/Not provided, as no machine learning model or training set is mentioned.

In summary: The 510(k) submission for the Wavelight Arion device explicitly states "Performance Data None presented." This implies that the device achieved marketing clearance through demonstrating substantial equivalence to predicate devices rather than by submitting new clinical or performance data against specific acceptance criteria. Therefore, most of the requested information, which pertains to performance studies and data, is not available in the provided document.

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