(164 days)
The Toro-L Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or cortical cancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Toro-L Interbody Fusion System is interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracy disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Toro-L Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis.
Integrity Implants' Toro-L Interbody Fusion System incorporates a bi-directional expandable interbody fusion device and a non-expandable monolithic interbody fusion device intended for use in the thoracolumbar spine from T1-S1. The Toro-L Interbody Fusion System implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and Ti-6Al-4V per ASTM F2924) and polyether ether ketone (PEEK) per ASTM F2026; and are offered in a range of sizes and lordotic options to accommodate variations in patient anatomy.
Once implanted via a lateral surgical approach, the Toro-L interbody fusion devices are designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The Toro-L interbody fusion devices interbody fusion device is intended to be used with autograft and/or allograft, and with supplemental fixation instrumentation that has been cleared for use in the thoracolumbar spine. The Toro-L interbody fusion devices are single use devices. The Toro-L Interbody Fusion System includes manual surgical instruments for delivery of the implant devices and for disc preparation. The Toro-L Interbody Fusion System implant and instrument devices are supplied non-sterile and are intended for steam sterilization by the user prior to use.
The FDA Premarket Notification (510(k)) Summary for the Toro-L Interbody Fusion System (K213355) focuses entirely on non-clinical bench testing and biocompatibility assessment to demonstrate substantial equivalence to predicate devices. It does not present any clinical study data involving human patients or AI/algorithmic performance for medical image analysis.
Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of an AI/human-in-the-loop setting. The document only describes a mechanical device (interbody fusion system) and its physical performance characteristics.
Based on the provided text, the following information is relevant to the device's acceptance, but NOT in the context of AI or diagnostic performance:
Acceptance Criteria and Device Performance (Mechanical/Biocompatibility)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Static Axial Compression (ASTM F2077) | Performance demonstrated in accordance with ASTM F2077. (Specific numerical data not provided in the summary, reliance on demonstrated compliance) |
| Dynamic Axial Compression (ASTM F2077) | Performance demonstrated in accordance with ASTM F2077. |
| Static Compression Shear (ASTM F2077) | Performance demonstrated in accordance with ASTM F2077. |
| Dynamic Compression Shear (ASTM F2077) | Performance demonstrated in accordance with ASTM F2077. |
| Biocompatibility (ISO 10993-1) | Biocompatibility assessment conducted in accordance with ISO 10993-1. (Reliance on standard compliance) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for the standard ASTM and ISO tests. These are bench tests, not patient data.
- Data Provenance: N/A for patient data. These are laboratory bench test results from Integrity Implants Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- N/A. This device does not involve medical image analysis or human interpretation of such. The "ground truth" for mechanical testing is established by the specified ASTM and ISO standards themselves and the physical measurements taken. The "experts" would be the engineers and technicians performing and verifying the tests.
4. Adjudication Method for the Test Set
- N/A. Adjudication is not applicable to standardized mechanical and biocompatibility testing. The tests are designed to yield objective, measurable results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- N/A. No MRMC study was done, as this is a mechanical implant device, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- N/A. As above, this is a mechanical implant. There is no algorithm or standalone performance being evaluated.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance is defined by established engineering standards (ASTM F2077) and biocompatibility standards (ISO 10993-1). Compliance with these standards indicates the device performs as expected mechanically and is biologically safe.
8. The Sample Size for the Training Set
- N/A. This applies to AI models. This device is not an AI/ML product.
9. How the Ground Truth for the Training Set Was Established
- N/A. See point 8.
In summary, the provided document describes a premarket notification for a traditional medical device (an intervertebral body fusion system) that relies on bench testing and biocompatibility assessments to demonstrate substantial equivalence, not on clinical performance data or AI/ML algorithm evaluation.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.