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510(k) Data Aggregation
(57 days)
The Celling Aspiration Needle is intended for use in aspirating bone marrow.
The Celling Aspiration Needle is a single-use aspiration needle comprised of a stainless steel cannula with a molded plastic handle, and a stainless steel stylet with a molded plastic handle which mates with the cannula handle when the stylet is inserted through the cannula. While holding the mated handles, the user rotates the needle using a clockwise-counter clockwise motion while applying pressure on the bone. The needle bores into the marrow cavity. Once there the stylet is removed and aspiration is accomplished by attaching a luer syringe (not included) to the needle and applying negative pressure.
This document is a 510(k) premarket notification for the Celling Aspiration Needle. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic performance against acceptance criteria for an AI-powered device. Therefore, much of the requested information regarding AI device performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies is not applicable or available within this document.
However, I can extract information related to the device's functional performance testing, which is a form of acceptance criteria for this type of medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Type of Testing) | Reported Device Performance |
|---|---|
| Mechanical Testing | Performed, supports safety and effectiveness. (Details not provided in this summary, but implied to be acceptable based on SE determination). |
| Physical Testing | Performed, supports safety and effectiveness. (Details not provided). |
| Component Biocompatibility Analysis | Performed, supports safety and effectiveness. (Details not provided). |
| Performance Characteristics | Performed, supports safety and effectiveness. (Details not provided, but implies the device functions as intended for bone marrow aspiration). |
| Substantial Equivalence to Predicate Device (Argon Bone Marrow Harvest Needle, K980196) | The Celling Aspiration Needle is "substantially equivalent" in materials, design (stainless steel cannula/stylet, plastic molded handles, side holes, luer lock connections). The only differences are handle color, needle length, and added depth markings. |
| Equivalence to Secondary Predicate (Ranfac Bone Marrow Aspiration Needle, K131157) | Testing was performed to ensure performance equivalent to the Ranfac needle for current customers. |
| Compliance with FDA Special Controls Guidance (Class II Special Controls Guidance Document for Biopsy Devices in Gastroenterology and Urology) | "meets all of the requirements" of the guidance. |
2. Sample size used for the test set and the data provenance:
- Not applicable for an AI device. This document describes testing for a mechanical bone marrow aspiration needle.
- The "testing" mentioned is non-clinical (mechanical, physical, biocompatibility, performance characteristics) rather than clinical studies with human subjects or retrospective data analysis for a diagnostic algorithm. The specific "sample sizes" for these non-clinical tests (e.g., how many needles were subjected to bending tests, etc.) are not provided in this summary.
- Data provenance is not provided for these engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to algorithmic performance and ground truth for diagnostic accuracy, which is not the focus of this 510(k) for a physical medical device. The "ground truth" for this device's performance would be engineering specifications and functional testing outcomes.
4. Adjudication method for the test set:
- Not applicable. This refers to adjudication in diagnostic studies, not engineering verification and validation testing for a physical device.
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, an MRMC study was not done. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used:
- For the non-clinical testing of the Celling Aspiration Needle, the "ground truth" would be established engineering specifications, performance standards, biocompatibility testing results (e.g., meeting ISO standards), and direct comparisons to the physical and functional characteristics of the identified predicate devices.
8. The sample size for the training set:
- Not applicable. This device does not use a training set as it is not an AI device.
9. How the ground truth for the training set was established:
- Not applicable. This device does not use a training set.
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(168 days)
The IN:C2 Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
The IN:C2 System consists of a 'U' shaped PEEK block in multiple footprint configurations and heights. The PEEK implants contain a titanium marker intended to verify position radiologically. The IN:C2 is a stand-alone system, intended for use with its cover plate assembly and two titanium bone screws provided. The IN:C2 implant is intended to be implanted via an open anterior approach.
The anterior cover plate assembly attaches to the anterior most portion of the device, and includes housing features for placement of two bone screws angled cephalad and caudal. The cover plate assembly and integrated screws are supplemental fixation.
The provided document is a 510(k) Premarket Notification from the FDA regarding the SpineSmith IN:C2 Spinal Fixation System. It focuses on demonstrating substantial equivalence to a predicate device rather than on the performance of an AI/ML powered device.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and study details for an AI/ML medical device. Specifically:
- Table of acceptance criteria and reported device performance: Not present, as this is for a physical medical device (spinal fixation system) and not an AI/ML device.
- Sample size and data provenance for test set: Not present.
- Number of experts and their qualifications for ground truth: Not present.
- Adjudication method: Not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable and not present.
- Standalone (algorithm only) performance: Not applicable and not present.
- Type of ground truth used: Not applicable and not present.
- Sample size for training set: Not applicable and not present.
- How ground truth for training set was established: Not applicable and not present.
The document describes mechanical testing performed on the IN:C2 Spinal Fixation System to demonstrate its safety and effectiveness, conforming to ASTM standards for intervertebral body fusion devices. This mechanical testing served as the 'study' to prove the device met the criteria for substantial equivalence to its predicate.
The acceptance criteria for this physical device were its ability to perform comparably to the predicate device under specific mechanical stress tests, as outlined by the mentioned ASTM standards (e.g., F2077-11, F2267-04, F1877-05, and pull-off force testing). The reported device performance was that these tests demonstrated that "any minor differences, modification of the snap interface, do not impact device performance as compared to the predicates and demonstrate that the IN:C2 System is substantially equivalent to the predicate device."
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