(200 days)
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:
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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.
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"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:
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static and Dynamic Compression (ASTM F2077) | Comparable to or exceeding predicate device performance. | "equivalent to predicate devices" with positive results. |
| Static and Dynamic Shear (ASTM F2077) | Comparable to or exceeding predicate device performance. | "equivalent to predicate devices" with positive results. |
| Subsidence (ASTM F2267) | Comparable to or exceeding predicate device performance. | "equivalent to predicate devices" with positive results. |
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.
§ 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.