(30 days)
The BD K-4000™ Microkeratome System is a battery powered device intended to produce a corneal resection for refractive laser applications and procedures in Ophthalmic surgery, such as Laser In-situ Keratomileuses (LASIK) surgery.
The BD K-4000™ Microkeratome System is a battery operated, fully automated Keratome. The Microkeratome is a precise cutting device uniquely designed for added comfort, speed and accuracy. The Microkeratome's unique shape is designed to offer more comfort and efficiency while delivering precision and accuracy.
The BD K-4000™ Microkeratome major components are:
- Console containing the motor drive and control circuitry, Vacuum system and battery power source
- Front Panel controls for operating the system;
- Surgical Handpiece connected to the console by multi-conductor cable
- Vacuum tubing set:
- Two pedal Footswitch for actuation of the handpiece and vacuum system;
- External Battery Charger.
The provided 510(k) summary for the BD K-4000™ Microkeratome System does not contain detailed acceptance criteria or a specific study proving the device meets those criteria in the way a clinical trial or performance study for a diagnostic AI device would. Instead, this document is a summary for a medical device, specifically a surgical instrument, seeking substantial equivalence to predicate devices already on the market.
Therefore, the information requested, such as specific performance metrics (like sensitivity, specificity, F1 score), sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable in the context of this 510(k) submission for the BD K-4000™ Microkeratome System.
The document states:
- "Performance studies were done to assess the performance and equivalence of the principal devices to the predicate devices currently marketed in the United States."
- "All results from the studies show equivalence between the principal devices and the predicate devices. Therefore, the K-4000 is substantially equivalent to the predicate devices."
This indicates that the "study" was focused on demonstrating substantial equivalence to existing, legally marketed devices (BD K-3000™ Microkeratome, K984537 and K022637), rather than meeting specific quantifiable performance metrics against a defined ground truth for a diagnostic task. The criteria for acceptance were likely related to functional performance (e.g., cutting precision, safety features), material compatibility, and intended use, all benchmarked against the predicate devices.
Here's how to address the questions given the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate microkeratomes (BD K-3000™). | "All results from the studies show equivalence between the principal devices and the predicate devices." |
| Safety features comparable to predicate devices. | Implied by substantial equivalence and Class I classification. |
| Performance of corneal resection for refractive laser applications comparable to predicate devices. | Implied by substantial equivalence. |
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 for Test Set: Not specified. (The studies were likely bench testing, engineering verification, and perhaps limited in-vivo or ex-vivo testing comparing the device's functional outputs to predicate devices, rather than a clinical trial with a "test set" in the diagnostic sense.)
- Data Provenance: Not specified.
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)
- Number of Experts & Qualifications: Not applicable for this type of device and submission. Ground truth in this context would likely be engineering specifications, material standards, and functional output measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No, not applicable. This is a surgical instrument, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a battery-operated, fully automated microkeratome; its "performance" is inherently standalone in its function as a cutting device, but it doesn't involve "algorithms" in the AI sense or human-in-the-loop diagnostic interpretation. The user operates the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated but would likely be based on engineering specifications, physical measurements (e.g., blade precision, suction force), material properties, and comparison of outcomes (e.g., flap thickness, consistency) with the predicate devices through laboratory or ex-vivo testing.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not use machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied.
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.